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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called VASCU-GUARD Peripheral Vascular Patch. It demonstrates substantial equivalence to a predicate device, rather than providing a study proving acceptance criteria for a new AI/software device. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/software device is not applicable to this document.

However, I can extract information related to the device's performance evaluation and testing, even if it's not in the context of AI/software acceptance criteria.

Here's an analysis based on the provided text, addressing the applicable points:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a quantitative table with specific target values and reported performance. Instead, it lists the aspects of the device that were evaluated through non-clinical testing. The conclusion states that "Bench testing results support the performance requirements for VASCU-GUARD Peripheral Vascular Patch," and that the device is "substantially equivalent to the referenced predicate device."

Evaluated Aspects of Device Performance (from "Summary/Comparison of Technological Characteristics"):

Evaluated Aspect	Reported Performance (Qualitative)
Suture retention	Bench testing results support performance requirements.
Thickness	Bench testing results support performance requirements.
Burst strength	Bench testing results support performance requirements.
Tensile strength	Bench testing results support performance requirements.
Collagenase digestion	Bench testing results support performance requirements.
Chemical residuals	Bench testing results support performance requirements.
Pyrogenicity/ LAL	Bench testing results support performance requirements.
Sterilization validation	Bench testing results support performance requirements. Packaging and method of sterilization are the subject of this submission.
Packaging and shelf-life	Bench testing results support performance requirements. Packaging and method of sterilization are the subject of this submission.
Biocompatibility	Performed according to ISO 10993-1:2009. Biocompatibility indicates the device is biocompatible.
Animal studies	Various animal studies conducted to support safety and efficacy. Studies indicate the device is safe and efficacious.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify exact sample sizes for each bench test or animal study. It mentions "various animal studies" without quantification.
Data Provenance: Not specified. The studies are non-clinical (bench testing and animal studies), not human data, so "country of origin of the data" or "retrospective/prospective" in the human data sense are not directly applicable. These are likely internal laboratory/pre-clinical study results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the non-clinical testing described. This type of information would be relevant for clinical studies involving expert interpretation of medical images or patient outcomes, which are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies with human assessors to establish a consensus ground truth, which is not what is being described for these non-clinical tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical medical device (vascular patch) and its non-clinical performance, not an AI or software device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" would be established by the specifications and measurement standards for each test (e.g., specific force required for suture retention, material integrity under enzymatic digestion, absence of pyrogens in LAL test, histological findings from animal studies). These are objective measurements against predefined standards, and the "ground truth" is inherent in the test methodology and expected outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: 651-796-7300 Fax: 651-642-9018

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 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.

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
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.(b)
Classification. Class II (performance standards).