Summary of Safety and Clinical Performance

Important Information

This Summary of Safety and Clinical Performance (SSCP) is intended to provide public access to an updated summary of the main aspects of the safety and clinical performance of the device. This SSCP is not intended to replace the Instructions for Use as the main document to ensure the safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users or patients.

Applicable Documents

1. Device Identification and General Information

Device Trade Name(s): 1.9F & 2.6F Vascu-PICC® Peripherally Inserted Central Catheter

Manufacturer Name and Address: Medical Components, Inc. 1499 Delp Drive Harleysville, PA 19438 USA

Manufacturer Single Registration Number (SRN): US-MF-000008230

Basic UDI-DI: 00884908289NV

Medical Device Nomenclature: C010201 - Central I.V. Catheters, Peripheral Access

Class of Device: III

Date First CE Certificate Issued: 1.9F & 2.6F Vascu-PICC® - October 2008 1.9 & 2.6 Jet-PICC - October 2008

Authorized Representative Name and SRN: Gerhard Frömel European Regulatory Expert Medical Product Service GmbH (MPS) Borngasse 20 35619 Braunfels, Germany SRN: DE-AR-000005009

Notified Body Name and Single Identification Number: BSI Group The Netherlands B.V. NB2797

Device Grouping and Variants

The devices in scope of this document are all peripherally inserted central catheter (PICC) sets. The catheter part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section “Accessories intended for use in combination with the Device”).

Variant Devices:

Procedure Trays:

Configurations of Procedure Trays:

2. Intended Use of the Device

Intended Purpose: The 1.9F and 2.6F Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheters are intended for use in pediatric and neonate patients requiring frequent needlesticks for whom short-term or long-term peripheral access to the central venous system without requiring frequent needlesticks is deemed necessary based on the direction of a qualified, licensed physician. The device is intended to be used under the regular review and assessment of qualified health professionals. This catheter is for Single Use Only.

Indication(s): The 1.9F and 2.6F Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheter is indicated for short-term or long-term peripheral access to the central venous system for the intravenous administration of fluids or medications.

Target Population(s): 1.9F and 2.6F Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheters are intended for use in pediatric and neonate patients requiring frequent needlesticks for whom short-term or long-term peripheral access to the central venous system without requiring frequent needlesticks is deemed necessary based on the direction of a qualified, licensed physician.

Contraindications and/or Limitations:

• This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels.
• The presence of skin related problems around the insertion site (infection, phlebitis, scars, etc.)
• The presence of device related bacteremia or septicemia.
• Previous history of venous/subclavian thrombosis or vascular surgical procedures at insertion site.
• Fever of unknown origin.
• The patient's body size is insufficient to accommodate the size of the implanted device.
• The patient is known or is suspected to be allergic to materials contained in the device.
• Past irradiation of prospective insertion site.
• Local tissue factors will prevent proper device stabilization and/or access.
• Known tape or Zinc Oxide adhesive allergies.
• This catheter is not suitable for insertion through non- superficial veins.

3. Device Description

Device Name: 1.9F & 2.6F Vascu-PICC® Peripherally Inserted Central Catheter

Description of Device: The 1.9F and 2.6F Vascu-PICC® Peripherally Inserted Central Catheter is used for short- or long-term central venous access, via peripheral insertion, during the administration of fluids, medication and nutritional therapy for neonates, infants and children. The lumen ID and OD are continuous throughout the entire length of the lumen tubing. Each catheter lumen terminates through an extension to a female luer-lock connector. Each extension has an in-line clamp to control fluid flow and is marked with the lumen gauge size. The transition between the lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The lumen is marked with depth markers every centimeter.

Device Name: 1.9F & 2.6F Vascu-PICC® Peripherally Inserted Central Catheter

Description of Device: The 1.9F and 2.6F Vascu-PICC® Peripherally Inserted Central Catheter is used for short- or long-term central venous access, via peripheral insertion, during the administration of fluids, medication and nutritional therapy for neonates, infants and children. The lumen ID and OD are continuous throughout the entire length of the lumen tubing. Each catheter lumen terminates through an extension to a female luer-lock connector. Each extension has an in-line clamp to control fluid flow and is marked with the lumen gauge size. The transition between the lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The lumen is marked with depth markers every centimeter.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weight of the 1.9F x 20cm Single Lumen (2.85g) and 2.6F x 50cm Double Lumen w/ Cuff (4.16g) Vascu-PICC® devices.

The percentage ranges in the table below are based on the weight of the 1.9F x 20cm Single Lumen (2.85g) and 2.6F x 50cm Double Lumen w/ Cuff (4.16g) Vascu-PICC® devices.

Note: Accessories containing stainless steel may contain up to 0.4% weight of the CMR substance cobalt.:

Note: Per the instructions for use, the device is contraindicated for patients with known or suspected allergies to the above materials.:

Information on Medicinal Substances in the Device:

How the Device Achieves its Intended Mode of Action: The subject devices utilize a Seldinger or Modified Seldinger technique to obtain access. The main difference is one technique utilizes an Introduction Sheath and one does not. The Seldinger techniques for venous access are well-known surgical techniques used for inserting PICC devices. The instructions for use of each catheter are detailed in the IFUs. Catheters are to be inserted, manipulated and removed by a qualified, licensed physician or other qualified health care professional utilizing strict aseptic technique. Once in place, fluids are delivered or blood is withdrawn via the PICC catheter most commonly with a disposable tubing set or syringe. Catheter care includes use of a locking solution to maintain catheter patency. Catheter removal is normally done by gently pulling on the catheter, but removal may require that a surgical procedure be performed by a physician familiar with the appropriate techniques in some circumstances.

Sterilization Information: Contents sterile and non-pyrogenic in unopened, undamaged package. Sterilized by Ethylene Oxide.

Previous Generations / Variants:

Accessories Intended for Use in Combination with the Device:

Other Devices or Products Intended for Use in Combination with the Device:

4. Risks and Warnings

Residual Risks and Undesirable Effects: As per product IFUs, All surgical procedures carry risk. Medcomp has implemented risk management processes to proactively find and mitigate these risks as far as possible without adversely affecting the benefit-risk profile of the device. After mitigation, residual risks and the possibility of adverse events from use of this product remain. Medcomp has determined that all residual risks are acceptable.

Warnings and Precautions:

All warnings have been reviewed against the risk analysis, PMS, and usability testing to validate consistency between the sources of information. The devices in scope of this clinical evaluation have the following warnings in the IFUs:

• Do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmHg (14.5 psi).
• Do not use high-pressure injectors for contrast medium studies. Excessive pressures may damage catheter.
• Do not use the securement device where loss of adherence could occur, such as with a confused patient or nonadherent skin.
• Do not insert catheter in thrombosed vessels.
• Do not advance the guidewire or catheter if unusual resistance is encountered.
• Do not insert or withdraw the guidewire forcibly from any component. If the guidewire becomes damaged, guidewire and any associated componentry must be removed together.
• Do not resterilize the catheter or accessories by any method.
• Contents sterile and non-pyrogenic in unopened, undamaged package. STERILIZED BY ETHYLENE OXIDE
• Do not re-use catheter or accessories as there may be a failure to adequately clean and decontaminate the device which may lead to contamination, catheter degradation, device fatigue, or endotoxin reaction.
• Do not use catheter or accessories if package is opened or damaged.
• Do not use catheter or accessories if any sign of product damage is visible or the use-by date has passed.
• Do not use sharp instruments near the extension lines or catheter lumen.
• Do not use scissors to remove dressing. Precautions listed in the IFUs are as follows:
• Syringes smaller than ten (10) ml will generate excessive pressure and may damage the catheter. Ten (10) ml or larger syringes are recommended.
• Bolus injections should be slow and must not exceed the maximum bolus pressure of 1.2bar/900mmHg (17.4 psi).
• Hydrate guidewire prior to use.
• Always flush catheter prior to removing stylet.
• Catheter will be damaged if clamps other than what is provided with this kit are used.
• Clamping of the tubing repeatedly in the same location may weaken tubing. Avoid clamping near the luer(s) and hub of the catheter.
• Examine catheter lumen and extension(s) before and after each infusion for damage.
• To prevent accidents, assure the security of all caps and connectors prior to and between uses.
• Use only Luer Lock (threaded) Connectors with this catheter.
• In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism.
• Repeated overtightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure.
• This is not a right atrium catheter. Avoid positioning the catheter tip in the right atrium. Placement or migration of the catheter tip into the right atrium may cause cardiac arrhythmia, myocardia erosion, or cardiac tamponade.
• Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the securement device.
• Avoid securement device contact with alcohol or acetone. Both can weaken bonding of components and the securement device pad adherence.
• Minimize catheter/tube manipulation during application and removal of the securement device.
• Remove oil and moisturizer from targeted skin area prior to placing the securement device.
• The securement device should be monitored daily and replaced when clinically indicated, at least every 7 days.
• Confirm catheter tip position by x-ray prior to use. Monitor tip placement routinely per institution policy.
• Discard biohazard according to facility protocol.
• Refer to standards of practice and institutional policies for compatible infusion agents for central venous access.
• Follow all contraindications, warnings, precautions, and instructions for all infusates as specified by their manufacturer.
• The CMR substance Cobalt is a naturally occurring component of stainless steel. Based on biocompatibility evaluation it was determined that the main hazards of stainless steels are related to the processing of the material, especially welding, thus not applicable to the intended use of the device. Stainless steels used in these devices are unlikely to reach exposure levels that will elicit carcinogenicity, mutagenicity, or reproductive toxicity.

Other Relevant Aspects of Safety: For a period of 01 January 2019 to 31 August 2024 there were 132 complaints for 222,776 units sold, giving an overall complaint rate of 0.059%. There were no death-related events. No events resulted in recalls during the review period.

5. Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

Clinical performance was measured using parameters including but not limited to dwell time, catheter insertion outcomes, and adverse event rates. Critical clinical parameters extracted from these studies met standards set forth in the guidelines for the State of the Art. There were no unforeseen adverse events or other high occurrences of adverse events detected in any of the clinical activities. Survivability of a given implant is a multi-factorial event that depends on numerous factors, including: the limits of the implant, surgical technique, difficulty level of the surgical procedure, patient health, patient activity level, patient medical history, and other factors. In the case of the 1.9F and 2.6F Vascu-PICC® Peripherally Inserted Central Catheter, 57 catheters had a 14 day [Range: 1-70 days] median duration of use that has been found in clinical use reported to date. Based on this information, the 1.9F and 2.6F Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheter has a 12 month lifetime; however, the decision to remove and/or replace the catheter should be based on clinical performance and need, and not any predetermined point in time.

Summary of Clinical Data Related to the Equivalent Device

Clinical evidence from published literature and PMCF activities has been generated specific to known and unknown variants of the subject device. The equivalency rationale in the updated clinical evaluation report will demonstrate that the clinical evidence available for these variants is representative of the range of device variants in the device family. There are no clinical or biological differences between variants within the subject device family, and the potential impact of the technical differences will be rationalized in the updated clinical evaluation report.

Summary of Clinical Data from Pre-Market Investigations (if applicable)

No pre-market clinical investigations were used for the device's clinical evaluation.

Summary of Clinical Data from Other Sources

Source:Summary of Published Literature

Clinical evidence literature searches have found nine published literature articles representing 844 cases specific to the 1.9F & 2.6F Vascu-PICC® device family. The articles included two prospective studies (Yang et al., Zhou et al.), five retrospective studies (Luo et al., Richter et al., Uygun et al., Wang et al., Yanping et al.), and two case reports (Chen et al., Chen et al.). Bibliography: Chen Q, Hu Y, Su S, Huang X, Li Y. “AFGP” bundles for an extremely preterm infant who underwent difficult removal of a peripherally inserted central catheter: A case report. WJCC. 2021;9(17):4253-61. Chen Q, Hu Y, Li Y, Huang X. Peripherally inserted central catheter placement in neonates with persistent left superior vena cava: Report of eight cases. WJCC. 2021;9(26):7944-53. Luo, F., Cheng, X., Lou, X., Wang, Q., Fan, X., & Chen, S. (2020). Insertion of a 1.9F central venous catheter via the internal jugular vein in neonates. J Int Med Res, 48(6). doi:10.1177/0300060520925380 Uygun, I. (2016). Peripherally inserted central catheter in neonates: A safe and easy insertion technique. Journal of pediatric surgery, 51(1), 188-191. Xu YP, Shang ZR, Dorazio RM, Shi LP. Risk factors for peripherally inserted central catheterization-associated bloodstream infection in neonates. Zhongguo Dang Dai Er Ke Za Zhi. 2022 Feb 15; 24(2):141-146. English, Chinese. doi: 10.7499/j.issn.1008- 8830.2109147. PMID: 35209978; PMCID: PMC8884050. Yang, L., Bing, X., Song, L., Na, C., Minghong, D., & Annuo, L. (2019). Intracavitary electrocardiogram guidance for placement of peripherally inserted central catheters in premature infants. Medicine (Baltimore), 98(50). doi:10.1097/md.0000000000018368 Richter, R. P., Law, M. A., Borasino, S., Surd, J. A., & Alten, J. A. (2016). Distal superficial femoral vein cannulation for peripherally inserted central catheter placement in infants with cardiac disease. Congenital heart disease, 11(6), 733-740. Wang Y, Chen S, Yan W, et al. Congenital Short-Bowel Syndrome: Clinical and Genetic Presentation in China. Journal of Parenteral and Enteral Nutrition. 2021;45(5):1009- 15. Zhou, L., Xua, H., Xu, M., Hu, Y., & Lou, X. F. (2017). An Accuracy Study of the Intracavitary Electrocardiogram (IC-ECG) Guided Peripherally Inserted Central Catheter Tip Placement among Neonates. Open Med (Wars), 12, 125-130. doi:10.1515/med-2017- 0019

• Source:PMCF_Infusion_201

The CVAD Registry was acquired from CVAD Resources, LLC on 23 August 2020. All data received was de-identified, but otherwise represented exactly what was entered by clinicians on a consecutive basis. Medcomp received only data pertaining to devices with the manufacturer listed as “Medcomp" and all case information was sourced from two US hospitals. Hospital ID 121 is described as a "Vascular Access team in a Not-for-Profit Community Based Hospital”, and Hospital ID 123 is described as a “PICC (peripherally inserted central catheter) team in an Academic Medical Center”. Insertion of device dates range from 06 August 2012 through 21 April 2015. Removal of device dates from 09 August 2012 through 07 May 2015. 1 1.9F & 2.6F Vascu-PICC® case, described as 1.9F and Single Lumen, was collected. The following outcome measure was confirmed to be within State of the Art safety and performance outcome measures from published literature for Medcomp Vascu-PICC® devices:

• Source:PMCF_Infusion_211

The Infusion Product Line Data Collection Survey aimed to assess safety and performance outcome information for all variants of Medcomp Infusion Ports, PICCs, Midlines, and CVCs. 70 survey responses were collected from 17 countries representing 471 device cases. 10 1.9F & 2.6F Vascu-PICC® cases inclusive of several variant devices across French size (1.9F and 2.6F) and lumen configuration (single and dual) were collected. The following outcome measures were confirmed to be within State of the Art safety and performance outcome measures from published literature for Medcomp 1.9F & 2.6F Vascu-PICC® devices:

• Source:PMCF_Medcomp_211

The Medcomp User Survey acquired responses from healthcare personnel familiar with any number of Medcomp's product offerings. 13 respondents responded that they or their facility have used Medcomp PICCs, with 2 of those respondents using the 1.9F & 2.6F Vascu-PICC device. There were no differences in mean user sentiments within PICCs across State of the Art Performance and Safety Outcome Measures or between device types relating to safety or performance. The following data points were collected from users of Medcomp PICCs (n=13):

Overall Summary of Clinical Safety and Performance

Upon review of the data across all sources, it is possible to conclude that the benefits of the subject device, which is facilitating delivery of fluids and medications in patients with small blood vessels, including neonates, in whom short-term or long-term peripheral access to the central venous system without requiring frequent needlesticks is deemed necessary based on the direction of a qualified, licensed physician, outweigh the overall and individual risks when the device is used as intended by the manufacturer. It is the manufacturer's and clinical expert evaluator's opinion that activities both complete and ongoing are sufficient to support the safety, efficacy, and acceptable benefit/risk profile of the subject devices.

On-going or Planned Post-Market Clinical Follow-Up (PMCF)

No emerging risks, complications or unexpected device failures have been detected from PMCF activities.

6. Possible Therapeutic Alternatives

The Infusion Nurses Society (INS) Standards 2021 clinical practice guidelines have been used to support the below recommendations for treatments.

7. Suggested Profile and Training for Users

The catheter should be inserted, manipulated, and removed by a qualified, licensed physician or other qualified health care professional under the direction of a physician.

8. Reference to Any Harmonized Standards and Common Specifications (CS) Applied

Revision History