VASCU-GUARD Peripheral Vascular Patch

K142461 · Synovis Life Technologies, Inc. · DXZ · Nov 25, 2014 · Cardiovascular

Device Facts

• Record ID: K142461
• Device Name: VASCU-GUARD Peripheral Vascular Patch
• Applicant: Synovis Life Technologies, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Nov 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial blood vessels and arteriovenous access revisions.

Device Story

VASCU-GUARD is a bovine pericardium patch cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide; used in peripheral vascular reconstruction (carotid, renal, iliac, femoral, profunda, tibial) and arteriovenous access revisions. Device serves as a surgical patch for vascular repair. It is terminally sterilized via gamma irradiation and supplied in a double sterile barrier pouch. Used by surgeons in clinical settings to reinforce or repair vascular tissue. Benefits include biocompatible material for vascular reconstruction.

Clinical Evidence

No human clinical data. Evidence consists of non-clinical bench testing and animal studies. Bench testing evaluated suture retention, thickness, burst strength, tensile strength, collagenase digestion, chemical residuals, pyrogenicity/LAL, sterilization validation, packaging, shelf-life, and biocompatibility per ISO 10993-1:2009.

Technological Characteristics

Material: Glutaraldehyde-crosslinked bovine pericardium treated with 1M sodium hydroxide. Form factor: Patch. Sterilization: Gamma irradiation. Packaging: Double sterile barrier pouch with foam. Biocompatibility: ISO 10993-1:2009 compliant.

Indications for Use

Indicated for patients requiring peripheral vascular reconstruction of carotid, renal, iliac, femoral, profunda, or tibial blood vessels, and arteriovenous access revisions.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Predicate Devices

• VASCU-GUARD Peripheral Vascular Patch (K983602)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2014

Synovis Life Technologies, Inc. Jodi Jorgenson Manager, Regulatory Affairs 2575 University Ave W. St. Paul, MN 55129

Re: K142461 Trade/Device Name: VASCU-GUARD Peripheral Vascular Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: August 28, 2014 Received: September 02, 2014

Dear Ms. Jorgenson:

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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K142461

Device Name

VASCU-GUARD Peripheral Vascular Patch

Indications for Use (Describe)

VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 5.0 510(K) SUMMARY

## Applicant:

Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Tel: [phone] Fax: [phone]

## Contact Person:

Jodi Jorgenson Manager, Regulatory Affairs At address above

## Date Prepared: August 28, 2014

Device Trade Name: VASCU-GUARD Peripheral Vascular Patch

# Common Name:

Intracardiac patch

## Classification Name:

Intracardiac patch or pledget 21 CFR 870.3470 Product Code: DXZ

## Predicate Devices:

Synovis Life Technologies, VASCU-GUARD Peripheral Vascular Patch: K983602

## Device Description:

VASCU-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. VASCU-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. VASCU-GUARD is terminally sterilized using gamma irradiation.

VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

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## Statement of Intended Use:

VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial blood vessels and arteriovenous access revisions.

## Summary/Comparison of Technological Characteristics:

VASCU-GUARD Peripheral Vascular Patch is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the packaging and method of sterilization, which is the subject of this premarket notification submission.

The safety and performance of VASCU-GUARD Peripheral Vascular Patch was evaluated through non-clinical testing.

The bench and pre-clinical testing assessed the following aspects of the device:

- Suture retention
- Thickness ●
- Burst strength ●
- Tensile strength
- Collagenase digestion ●
- Chemical residuals
- Pyrogenicity/ LAL ●
- Sterilization validation ●
- Packaging and shelf-life
- Biocompatibility
- Animal studies ●

Bench testing results support the performance requirements for VASCU-GUARD Peripheral Vascular Patch. Biocompatibility testing was performed in accordance to ISO 10993-1:2009 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process). Various animal studies were conducted to support the safety and efficacy of VASCU-GUARD Peripheral Vascular Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.

## Conclusions:

The safety and performance of VASCU-GUARD Peripheral Vascular Patch was evaluated through biocompatibility, bench testing and animal studies. VASCU-GUARD Peripheral Vascular Patch is substantially equivalent to the predicate device.