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): 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: 00884908288NT

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

Class of Device: III

Date First CE Certificate Issued: Vascu-PICC® - June 2005 Jet-PICC - August 2002

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 sets, 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 Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheters are intended for use in adult 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.

Indication(s): The 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): Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheters are intended for use in adult 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 not intended for use in pediatric patients.

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.
• History of mastectomy on insertion side.
• 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.

3. Device Description

Device Name: Vascu-PICC®

Description of Device: The Vascu-PICC® Peripherally Inserted Central Catheters are designed for peripheral vein catheterization. The lumen is an open-ended design comprised of a radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a molded hub with integral suture wings for catheter securement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The catheters are available in a range of French sizes in single and dual lumen configurations. The lumen has depth marks every centimeter and numerical marks every 5th centimeter and are available in trimmable 60cm for PICC's. The Vascu-PICC® Peripherally Inserted Central Catheter product line is packaged sterile with the necessary accessories to facilitate catheter insertion.

Device Name: Jet-PICC

Description of Device: The Jet-PICC Peripherally Inserted Central Catheters are designed for peripheral vein catheterization. The lumen is an open-ended design comprised of a radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a molded hub with integral suture wings for catheter securement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The catheters are available in a range of French sizes in single and dual lumen configurations. The lumen has depth marks every centimeter and numerical marks every 5th centimeter and are available in trimmable 60cm for PICC's. Jet-PICC Peripherally Inserted Central Catheter product line is packaged sterile with the necessary accessories to facilitate catheter insertion.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weight of the 3F x 60cm Single Lumen (2.70g) and the 6F x 60cm Double Lumen (7.86g) Vascu-PICC® devices.

The percentage ranges below are based on catheter weights. The 3F x 60 Single Lumen device weighs 2.70 grams. The 6F x 60cm Double Lumen device weighs 7.86 grams.

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 the desired access. The primary difference is one technique utilizes an Introduction Sheath and one does not. The Seldinger techniques for venous access are well-established surgical techniques utilized for insertion of PICC devices. The instructions for use of each catheter are detailed in the respective product 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 given 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 function. Catheter removal is normally accomplished 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 have the following warnings in the IFUs:

• Do not use high-pressure injectors for contrast medium studies. Excessive pressures may damage catheter. 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.

Other Relevant Aspects of Safety: For a period of 01 January 2019 to 30 June 2023 there were 5 complaints for 97,169 units sold, giving an overall complaint rate of 0.005%. 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 Vascu-PICC® Peripherally Inserted Central Catheter, 269 catheters, of a mixed cohort including Vascu-PICC® and two other devices, had a 184 day [Range: 15-1,384 days] duration of use that has been found in clinical use reported to date. Based on this information, the 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 three published literature articles representing 3,147 mixed cohort cases inclusive of the Vascu-PICC® device family. The articles included prospective studies (Cotogni et al., Cotogni et al.) and a retrospective study (Campagna et al.). Bibliography: Campagna, S., Gonella, S., Berchialla, P., Morano, G., Rigo, C., Zerla, P. A., . . . Mussa, B. (2019). Can Peripherally Inserted Central Catheters Be Safely Placed in Patients with Cancer Receiving Chemotherapy? A Retrospective Study of Almost 400,000 Catheter-Days. Oncologist, 24(9), e953-959. doi:10.1634/theoncologist.2018-0281 Cotogni, P., Barbero, C., Garrino, C., Degiorgis, C., Mussa, B., De Francesco, A., & Pittiruti, M. (2015). Peripherally inserted central catheters in non-hospitalized cancer patients: 5-year results of a prospective study. Support Care Cancer, 23(2), 403-409. doi:10.1007/s00520-014-2387-9 Cotogni P, Mussa B, Degiorgis C, De Francesco A, Pittiruti M. Comparative Complication Rates of 854 Central Venous Access Devices for Home Parenteral Nutrition in Cancer Patients: A Prospective Study of Over 169,000 Catheter-Days. Journal of Parenteral and Enteral Nutrition. 2021;45(4):768-76.

• 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. 15 Vascu-PICC® cases inclusive of several variant devices across French size (3F, 4F, and 5F) 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 Vascu-PICC® devices:

The variants included in the dataset are displayed below.:Single Lumen Vascu-PICC

3:3F, 4F:60cm Dual Lumen Vascu-PICC:12:4F, 5F:60cm

• 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. 5 Vascu-PICC® cases inclusive of variant devices across lumen configuration (single and double) were 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:Duration of Use Customer Survey

An email questionnaire was distributed globally to users of Medcomp PICCs and CVCs from 10 October 2019 to 16 October 2019. The questionnaire asked respondents to identify, from their own experience, the number of products used yearly, the average dwell time, and the longest dwell time for each applicable device family. Across the five device families, a total of 69 responses were collected from 14 countries. Means and ranges of responses for each device family were compiled on 16 October 2019. 26 responses were acquired relating to the Vascu-PICC® device family. Across an estimated 9,587 products used yearly, the mean average dwell time was 65 days (Range: 14 – 547.5 days), and the mean longest dwell time was 168 days (Range: 31 – 547.5 days).

• 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 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):

• The following complications were reported for Vascu-PICC® devices:

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 delivery of fluids and medications for treatments including chemotherapy in patients in whom short-term or long-term peripheral access to the central venous system without requiring frequent needlesticks 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