Vygon PICCs

K172899 · Vygon USA · LJS · Feb 26, 2018 · General Hospital

Device Facts

• Record ID: K172899
• Device Name: Vygon PICCs
• Applicant: Vygon USA
• Product Code: LJS · General Hospital
• Decision Date: Feb 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Device Story

Vygon PICCs are sterile, single-use, polyurethane peripherally inserted central catheters (PICCs) designed for short or long-term access to the central venous system. The device is inserted peripherally to provide central venous access for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. The device is operated by healthcare professionals in clinical settings. The catheter allows for the infusion of fluids and medications, and the monitoring of central venous pressure, which assists clinicians in managing patient fluid status and therapy delivery. The device benefits patients by providing reliable, long-term venous access, reducing the need for repeated peripheral venipuncture.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including dimensional inspections, leak tests, flow tests, tensile/burst tests, power injection conditioning, and biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, and implantation).

Technological Characteristics

Polyurethane PICCs; sterile, single-use. Dimensions and form factor vary by French size (4 Fr SL, 5 Fr DL, 6 Fr TL). Complies with ISO 10555-1 and ISO 10555-3. Sterilization via ethylene oxide (EO) per ISO 10993-7. No software or electronic components.

Indications for Use

Indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. For blood sampling, infusion, or therapy, use 4 French or larger catheter. Maximum infusion rate 5mL/sec for contrast media. For central venous pressure monitoring, use 20 gauge or larger lumen.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• 5 Fr DL PowerPICC® Catheter (K051672)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

February 26, 2018

Vygon USA Jillian Mikovich Regulatory Affairs Manager 2750 Morris Rd. Suite A200 Lansdale, Pennsylvania 19460

Re: K172899

Trade/Device Name: Vygon PICCs Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: January 26, 2018 Received: January 29, 2018

Dear Jillian Mikovich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Tina
Kiang-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172899

Device Name

Vygon PICCs

Indications for Use (Describe)

The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/section of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white letters on a green background, with a red triangle above the "V". Below the main logo, the words "Value Life" are written in a smaller, gray font.

## K172899 510(k) Summary (21 CFR 807.92(c))

#### I. Submitter Information

| Submitter Name: | Vygon |
|-----------------|----------------------------------------------------|
| Address: | 2750 Morris Road, Suite A200<br>Lansdale, PA 19446 |
| Telephone: | 215-390-2002 |
| Fax: | 215-672-6740 |

| Contact Person: | Jillian Mikovich |
|-------------------|-----------------------|
| Email of Contact: | [e-mail] |
| Date Prepared: | February 23, 2018 |

#### II. Device

| Device Name: | Vygon PICCs |
|-------------------------|---------------------------------------------------------|
| Common Name: | Vygon PICCs |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Percutaneous, Implanted, Long-Term Intravascular |
| | Catheter |
| Classification Panel: | General Hospital |
| Regulation Device Name: | Catheter, Intravascular, Therapeutic, Long-Term Greater |
| | Than 30 Days |
| Regulation Number: | 21 CFR 880.5970 |
| Regulatory Class: | 2 |
| Product Code: | LIS |
| | |

### III. Predicate Device

| Predicate Name: | 5 Fr DL PowerPICC® Catheter |
|-------------------------|--------------------------------------------------------------------|
| Trade Name: | 5 Fr DL PowerPICC® Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Percutaneous, Implanted, Long-Term Intravascular<br>Catheter |
| Premarket Notification: | K051672 |
| Manufacturer: | Bard Access Systems, Inc. |

Per the FDA Medical Device Recalls Database, this predicate has not been subject to a design related recall.

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Image /page/4/Picture/0 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white letters inside a green rounded rectangle with a red triangle above the "V". Below the rectangle, the words "Value Life" are written in a smaller, gray font.

### IV. Indications for Use

The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The Indications for Use statement for the Vygon PICCs is not identical to the predicate device, 5 Fr DL PowerPICC® Catheter, Indications for Use; however, the differences do not alter the intended therapeutic use of the device. Both the subject and predicate devices have the same intended use for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

#### V. Technological Characteristics

All characteristics of the Vygon PICCs are substantially equivalent to the predicate device, the Bard Access Systems 5 Fr DL PowerPICC® catheter. Both the subject and the predicate catheters are sterile, single-use, polyurethane PICCs with the same intended use, indications for use, similar design, similar sizes, similar or the same materials, and similar properties. See comparison table below.

| Attribute | Predicate:<br>Predicate Device<br>DL | Subject Device 1<br>SL | Subject Device 2<br>DL | Subject Device 3<br>TL |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | 5 Fr DL<br>PowerPICC®<br>Catheter | Vygon PICC 4 Fr<br>SL | Vygon PICC 5 Fr<br>DL | Vygon PICC 6 Fr<br>TL |
| 510(k) Number | K051672 | K172899 | K172899 | K172899 |
| 510(k)<br>Submitter | Bard Access<br>Systems (BAS) | Vygon USA | Vygon USA | Vygon USA |
| Trade Name | 5 Fr DL<br>PowerPICC®<br>Catheter | Vygon PICC 4 Fr<br>SL | Vygon PICC 5 Fr<br>DL | Vygon PICC 6 Fr<br>TL |
| Common<br>Name | Peripherally<br>Inserted Central<br>Catheter (PICC) | Same as Predicate | Same as Predicate | Same as Predicate |
| Attribute | Predicate:<br>Predicate Device<br>DL | Subject Device 1<br>SL | Subject Device 2<br>DL | Subject Device 3<br>TL |
| Device Name | 5 Fr DL<br>PowerPICC®<br>Catheter | Vygon PICC 4 Fr<br>SL | Vygon PICC 5 Fr<br>DL | Vygon PICC 6 Fr<br>TL |
| Classification<br>Name | Catheter,<br>Intravascular,<br>Therapeutic, Long-<br>Term Intravascular<br>Catheter | Same as Predicate | Same as Predicate | Same as Predicate |
| Regulatory<br>Class | 2 | Same as Predicate | Same as Predicate | Same as Predicate |
| Classification<br>Regulation | 21 CFR 880.5970 | Same as Predicate | Same as Predicate | Same as Predicate |
| Product Code | LJS | Same as Predicate | Same as Predicate | Same as Predicate |
| Review Panel /<br>Division | General Hospital | Same as Predicate | Same as Predicate | Same as Predicate |
| Indications for<br>Use | The PowerPICC®<br>catheter is<br>indicated for short<br>or long term<br> | The catheter is<br>indicated for short<br>or long term<br>peripheral access to<br>the central venous<br>system for<br>intravenous<br>therapy, power<br>injection of contrast<br>media, and allow(s)<br>for central venous<br>pressure<br>monitoring. For<br>blood sampling,<br>infusion or therapy,<br>use 4 French or<br>larger catheter. The<br>maximum<br>recommended<br>infusion rate is<br>5mL/sec for power<br>injection of contrast<br>media. For central<br>venous pressure<br>monitoring, it is | The catheter is<br>indicated for short<br>or long term<br>peripheral access to<br>the central venous<br>system for<br>intravenous<br>therapy, power<br>injection of contrast<br>media, and allow(s)<br>for central venous<br>pressure<br>monitoring. For<br>blood sampling,<br>infusion or therapy,<br>use 4 French or<br>larger catheter. The<br>maximum<br>recommended<br>infusion rate is<br>5mL/sec for power<br>injection of contrast<br>media. For central<br>venous pressure<br>monitoring, it is | The catheter is<br>indicated for short<br>or long term<br>peripheral access to<br>the central venous<br>system for<br>intravenous<br>therapy, power<br>injection of contrast<br>media, and allow(s)<br>for central venous<br>pressure<br>monitoring. For<br>blood sampling,<br>infusion or therapy,<br>use 4 French or<br>larger catheter. The<br>maximum<br>recommended<br>infusion rate is<br>5mL/sec for power<br>injection of contrast<br>media. For central<br>venous pressure<br>monitoring, it is |
| Attribute | Predicate:<br>Predicate Device<br>DL | Subject Device 1<br>SL | Subject Device 2<br>DL | Subject Device 3<br>TL |
| Device Name | 5 Fr DL<br>PowerPICC®<br>Catheter | Vygon PICC 4 Fr<br>SL | Vygon PICC 5 Fr<br>DL | Vygon PICC 6 Fr<br>TL |
| | catheter may not<br>exceed 300 psi. | catheter lumen of<br>20 gauge or larger<br>be used. | catheter lumen of<br>20 gauge or larger<br>be used. | catheter lumen of<br>20 gauge or larger<br>be used. |
| Intended Use | The catheters are<br>intended for short<br>or long term<br>peripheral access<br>to the central<br>venous system for<br>intravenous<br>therapy and blood<br>sampling. | Same as Predicate | Same as Predicate | Same as Predicate |

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Image /page/5/Picture/0 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white letters inside a green rounded rectangle with a red triangle above the "V". Below the rectangle, the words "Value Life" are written in gray.

2750 Morris Road, Suite A200 • Lansdale, PA 19446 • Telephone: [phone] • Fax: [phone] Email: [e-mail] • Website: www.vygonusa.com

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Table 1: Substantial Equivalence Comparison Table

## VI. Performance Testing

Vygon PICCs were tested per Table 2 and Table 3 below.

Special controls for the Product Code LJS include the guidance document "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters" and the consensus standards:

- ISO 10555-1 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-● use intravascular catheters -- Part 1: General requirements
- ISO 10555-3 Second edition 2013-06-15 Intravascular catheters -- Sterile and singleuse catheters -- Part 3: Central venous catheters
- . ISO 10555-1 and ISO 10555-3 requirements have been addressed and met.

Other requirements listed in the guidance document "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters" have been met in the development of the device and are described below.

### Bench Testing

Bench tests are listed below.

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Image /page/7/Picture/0 description: The image is a logo for Vygon. The logo consists of the word "VYGON" in white letters on a green rounded rectangle. There is a red triangle above the "V" in Vygon. Below the green rectangle, the words "Value Life" are written in gray.

| Standard | Sterile Device Test | Result |
|-------------------------------|--------------------------------|--------|
| ISO 9626:2016 | Dimensional Inspections | Passed |
| ISO 10555-1:2014 | Catheter Conditioning (Saline) | Passed |
| ISO 10555-1:2014 | Leak Test | Passed |
| Internal Requirement | Priming Volume Test | Passed |
| ISO 10555-1:2014 | Gravity Flow Test | Passed |
| ISO 10555-1:2014 | Pump Flow Test | Passed |
| ISO 10555-1:2014 | Tensile Test | Passed |
| ISO 10555-1:2014 | Burst Test | Passed |
| ISO 10555-1:2014 | Power Injection Conditioning | Passed |
| Internal Requirement | Printing Font Size | Passed |
| ASTM F1842-15 | Ink Permanence | Passed |
| ISO 594-1: 1986 Via | Luer Taper Test | Passed |
| ISO 80369-7:2016 | | |
| Functional Testing | | |
| ASTM F1842-15 | Ink Integrity Test | Passed |
| Vygon Internal<br>Requirement | Aspiration Flow Test | Passed |
| Vygon Internal<br>Requirement | Luer Color/Orientation Test | Passed |
| Vygon Internal<br>Requirement | Clamp Closure Maintenance Test | Passed |
| Vygon Internal<br>Requirement | Clamp and ID Tag Fit Test | Passed |
| Vygon Internal<br>Requirement | Clamp Actuation Test | Passed |

Table 2: Vygon PICCs Performance Testing

| Standard | Sterile, Aged (Accelerated 12 Months)<br>Device Test | Result |
|------------------|------------------------------------------------------|--------|
| ISO 10555-1:2014 | Power Injection Conditioning | Passed |
| ISO 10555-1:2014 | Burst Test | Passed |

Table 3: Vygon PICCs Aged Performance Testing

### Sterilization Testing

Sterilization tests are listed in Table 4 and Table 5 below.

| Standard | Sterile, Aged (Accelerated 13 Months)<br>Packaging Test | Result |
|--------------------|---------------------------------------------------------|--------|
| ASTM F88 / F88M-15 | Seal Strength | Passed |

2750 Morris Road, Suite A200 • Lansdale, PA 19446 • Telephone: [phone] • Fax: [phone] Email: [e-mail] • Website: www.vygonusa.com

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Image /page/8/Picture/0 description: The image shows the Vygon logo. The word "VYGON" is in white letters on a green background. Above the "V" is a red triangle pointing downwards. Below the logo is the text "Value Life" in a smaller, gray font.

| ASTM F2096-11 | Bubble Leak | Passed |
|---------------------------------------------|-------------|--------|
| Table 4: Vygon PICCs Aged Packaging Testing | | |

| Standard | Sterile Device Test | Result |
|---------------------|---------------------|--------|
| ANSI/AAMI ST72:2011 | LAL Testing | Passed |
| ISO 10993-7:2008 | EO Residual Testing | Passed |

Table5: Vygon PICCs Sterile Testing

In addition, performance testing for catheter stiffness and catheter flexural fatigue tolerance was completed on the final finished sterile devices with acceptable results.

### Clinical Testing

No clinical testing was performed.

### Biocompatibility Testing

Biocompatibility tests are listed below in Table 6.

| Standard | Test Name | Result |
|----------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------|
| ISO 10993-5:2009/(R)2014 | Cytotoxicity | Non-cytotoxic |
| AAMI/ANSI/ISO 10993-<br>10:2010/(R)2014 | Sensitization | Non-sensitizer |
| AAMI/ANSI/ISO 10993-<br>10:2010/(R)2014 | Irritation | Non-irritant |
| ISO 10993-11:2006 | Acute Systemic Injection | Non-toxic |
| USP37 | Material Mediated Pyrogen | Non-pyrogenic |
| ISO 10993-4: 2002/(R) 2013<br>& A1: 2006/ (R) 2013 | Hemolysis (extract) | Non-hemolytic |
| ISO 10993-4: 2002/(R) 2013<br>& A1: 2006/ (R) 2013 | Hemolysis (direct) | Non-hemolytic |
| ISO 10993-4: 2002/(R) 2013<br>& A1: 2006/ (R) 2013 | Complement Activation<br>Predicate: PowerPICC®<br>Catheter | Similar when compared to<br>predicate |
| ISO 10993-4: 2002/(R) 2013<br>& A1: 2006/ (R) 2013 | Partial Thromboplastin Time<br>(PTT)<br>Predicate: PowerPICC®<br>Catheter | Minimal activator (same as<br>predicate) |
| ISO 10993-4: 2002/(R) 2013<br>& A1: 2006/ (R) 2013 | Dog Thrombogenicity | Equivocal similar |
| AAMI/ANSI/ISO 10993-<br>6:2007/(R)2014 | Implantation | Non-irritant |

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Image /page/9/Picture/0 description: The image shows the Vygon logo. The logo features the word "VYGON" in white letters on a green, rounded rectangle. Above the "V" is a small, red triangle. Below the logo is the text "Value Life" in a smaller, gray font.

| Standard | Test Name | Result |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------|
| ISO 10993-18 (Nelson Labs<br>Report does not specify<br>year.) | Extractable/Leachable Analysis | Summarized in project<br>#MJ16357-BIO01 |
| ISO 10993-17:2008 | Subacute/Subchronic Toxicity,<br>Genotoxicity, Chronic Toxicity<br>and Carcinogencity | Evaluated in Toxicological<br>Risk Assessment |

Table 6: Vygon PICCs Biocompatibility Testing

### VII. Conclusion

Through performance bench testing the subject devices have demonstrated that they are substantially equivalent to the predicate device, 5 Fr DL PowerPICC® Catheter, K051672.