CV Peri-Guard™ is intended for use as a patch for intracardiac, great vessel, valve repair and suture line buttressing (i.e. atrial septal defect (ASD) patch, atrial patch, valve annuloplasty, coronary graft buttress). May be used for repair of ventricular septal defect (VSD) using either a single patch or reinforced patch technique. May also be used in other applications exposed to peak systolic pressure using a reinforced patch technique (i.e. ventricular aneurysm patch, aortic graft suture line buttress).

CV Peri-Guard™ is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.

Device Description

CV Peri-Guard™ - Cardiovascular Patch. CV Peri-Guard is composed of bovine pericardium, crosslinked with glutaraldehyde. Available in configurations ranging from 1 cm x 1 cm to 14 cm x 16 cm.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (CV Peri-Guard™ Cardiovascular Patch) and its associated FDA clearance letter. It does not contain the detailed information necessary to fully address all aspects of your request, particularly regarding specific acceptance criteria and the comprehensive study design typically associated with AI/ML device evaluations.

Here's an analysis based on the available information, highlighting what can be extracted and what is missing:

The device, CV Peri-Guard™, is a cardiovascular patch made of bovine pericardium. The premarket notification is for an extension of indications for use in intracardiac and great vessel repair. The core argument for substantial equivalence is based on the device's similarity to existing predicate devices (Gore-Tex Cardiovascular Patch, Peri-Guard, and Vascu-Guard) and a history of safe and effective use of the base material.

Missing Information (Crucial for an AI/ML context):

No AI/ML device: This document describes a traditional medical device (a surgical patch), not an AI/ML diagnostic or predictive device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.
Quantitative Acceptance Criteria: The document focuses on demonstrating substantial equivalence to existing devices rather than meeting specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy thresholds) that would define "acceptance criteria" for an AI/ML system. The "acceptance criteria" here are qualitative and relate to the overall safety and effectiveness compared to predicates.
Detailed Study Design for Performance Metrics: While studies are mentioned (calcification, canine, clinical report), the methodology, statistical analysis, and specific performance outcomes in a quantifiable manner (e.g., "device performed at X% sensitivity") are not provided.

Based on the available information, here is an attempt to populate the table and answer the questions, with explicit notes about missing or non-applicable data:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criterion (Implicitly from 510(k))	Reported Device Performance (Implicitly from 510(k))
Material Properties	Physical/mechanical properties substantially equivalent to predicate devices for intracardiac and great vessel repair.	"[T]he physical and mechanical properties critical for performance... are substantially equivalent between CV Peri-Guard and the predicate device."
Biocompatibility	Demonstrate biocompatibility, especially non-hemolytic nature for intracardiac use.	"[A] long history of biocompatibility. Peri-Guard has been marketed since 1982 with no indication of biocompatibility problems." "Biocompatibility testing... consistent with this clinical experience and the nonhemolytic nature of CV Peri-Guard is especially relevant."
Calcification	Clinically insignificant calcification, comparable to or better than predicates.	"Peri-Guard and Supple Peri-Guard have demonstrated clinical insignificant calcification and significantly less calcification than either a glutaraldehyde-treated control or a competitor's bovine pericardial patch product." "No calcification related to the Peri-Guard patch up to a mean of 17 months post-op in clinical use."
In Vivo Performance	Perform in a similar manner in vivo compared to existing materials.	"A Canine implant study show that Supple Peri-Guard and ePTFE perform in a similar manner, in vivo."
Clinical Safety & Effectiveness	Safe and effective performance in clinical use, substantially equivalent to alternative materials for intracardiac and great vessel repair.	"The clinical data, gathered under the Peri-Guard Retrospective study protocol, demonstrated that our bovine material performed safe and effectively, and in a substantially equivalent fashion to alternative intracardiac and great vessel patch materials."
History of Use	Long history of safe and effective use in similar applications.	"Processed bovine pericardium has been used widely as an implant material for well over two decades and has been shown to be safe and effective in a variety of medical applications."

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not explicitly stated in a quantifiable number.
- For the Calcification Studies: "Peri-Guard and Supple Peri-Guard have been evaluated in a proven model for calcification: the juvenile rat subcutaneous mode." No specific number of rats/samples is provided. Clinical evaluation involved "mittal valve annulus position, and other intracardiac patch positions" with outcome "up to a mean of 17 months post-op." The number of patients is not specified.
- For Canine Studies: "A Canine implant study." Single study mentioned, but sample size (number of canines or implants) not specified.
- For Clinical Report: "The clinical data, gathered under the Peri-Guard Retrospective study protocol." No specific number of patients or cases is mentioned.
Data Provenance:
- Country of Origin: Not specified. Implicitly, as the submitting company is US-based and FDA is the regulatory body, some studies might be US-based, but this is not confirmed.
- Retrospective or Prospective:
  - Clinical Report: Explicitly states "Retrospective study protocol."
  - Other studies (Calcification, Canine): Not specified, but likely experimental laboratory/animal studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable in the context of an AI/ML device. The "ground truth" here relates to biological and clinical outcomes assessed through animal models, pathology (in calcification studies), and clinical evaluation. The evaluations would have been conducted by relevant scientific and medical professionals (e.g., pathologists, surgeons, veterinarians), but no specific "expert panel" for establishing a diagnostic ground truth for a test set is described, as would be common for AI/ML performance assessment.

4. Adjudication method for the test set

Not Applicable. As this is not an AI/ML device assessing a "test set" for diagnostic accuracy, no adjudication method (like 2+1 or 3+1 consensus) for expert decisions is described. The "judgement" of the device's performance is based on direct measurement, observation, and clinical outcomes.

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 is not an AI-assisted device. An MRMC study is not relevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Expert Consensus: Not explicitly described for a specific "ground truth" decision-making process.
Pathology: Likely used in the calcification studies ("juvenile rat subcutaneous mode," "glutaraldehyde-treated control").
Outcomes Data: Yes, this is a primary ground truth.
- Clinical outcomes (e.g., clinical insignificance of calcification, safe and effective performance over time, "no calcification related to the Peri-Guard patch up to a mean of 17 months post-op" from the clinical report).
- In vivo animal model outcomes (canine study showing similar performance to ePTFE).
- Biocompatibility testing results.

8. The sample size for the training set

Not Applicable in an AI/ML context. This device does not have a "training set." The "experience" or "data" is derived from historical use of the base material and predicate devices, as well as the studies mentioned.

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

Not Applicable. No training set exists for this type of device. The "ground truth" for the overall understanding of the material's performance (analogous to how a training set might inform an AI model) comes from decades of historical clinical use of processed bovine pericardium and predicate devices, as well as the preclinical and clinical studies conducted.

Summary

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K91726

SUMMARY OF SAFETY AND EFFECTIVENESS

	Applicant Name & Address: Bio-Vascular, Inc., 2575 University Ave.,St. Paul, MN 55114-1024
Contact:	Barbara Atzenhoefer, Regulatory Affairs Manager
Date Prepared:	May 7, 1997
Common or Usual Name:	Cardiovascular patch
Device Classification Name:	Intracardiac and Great Vessel Repair
Substantial Equivilance:	Gore-Tex Cardiovascular Patch, Peri-Guard and Vascu-Guard

Device Description:

CV Peri-Guard™ - Cardiovascular Patch. CV Peri-Guard is composed of bovine pericardium, crosslinked with glutaraldehyde. Available in configurations ranging from 1 cm x 1 cm to 14 cm x 16 cm.

Statement of Intended Use:

Summary/Comparison of Technological Characteristics:

We maintain that CV Peri-Guard™ is substantially equivalent to the predicate devices and that the extended indication for use in intracardiac and great vessel repair does not pose new questions of safety and effectiveness. This claim of substantial equivalence is based upon the following elements.

1.Configuration

The additional sizes of CV Peri-Guard are configured for intracardiac and great vessel repair and are substantially equivalent to those sold by the predicate device.

2.Extension of Indications (Labeling)

Processed bovine pericardium and the material used in the predicate device have a history of being used in similar prosthetic applications. The material used in CV Peri-Guard is already indicated for pericardial closure and repair of soft tissue deficiencies. As summarized below and discussed earlier, we have shown that extension of these indications to include intracardiac and great vessel repair does not pose new questions of safety and effectiveness.

3.Physical/Mechanical Properties

The physical and mechanical properties critical for performance as an intracardiac and great vessel patch are substantially equivalent between CV Peri-Guard and the predicate device.

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4. Biocompatibility

Processed bovine pericardium has a long history of biocompatibility. Peri-Guard has been marketed since 1982 with no indication of biocompatibility problems. The biocompatibility testing summarized herein is consistent with this clinical experience and the nonhemolytic nature of CV Peri-Guard is especially relevant to the intracardiac and great vessel repair indication under consideration in this premarket notification.

5.Calcification Studies

Peri-Guard has been evaluated in a proven model for calcification: the juvenile rat subcutaneous mode. Peri-Guard and Supple Peri-Guard have demonstrated clinical insignificant calcification and significantly less calcification that either a glutaraldehyde-treated control or a competitor's bovine pericardial patch product. Additionally, Peri-Guard has been evaluated clinically in the mittal valve annulus position, and other intracardiac patch positions, and has demonstrated no calcification related to the Peri-Guard patch up to a mean of 17 months post-op.

6.Canine Studies

A Canine implant study show that Supple Peri-Guard and ePTFE perform in a similar manner, in vivo.

7.Clinical Report

The clinical data, gathered under the Peri-Guard Retrospective study protocol, demonstrated that our bovine material performed safe and effectively, and in a substantially equivalent fashion to alternative intracardiac and great vessel patch materials.

8.History of Safety and Effectiveness

Peri-Guard (and thus CV Peri-Guard) processed bovine pericardium has been used widely as an implant material for well over two decades and has been shown to be safe and effective in a variety of medical applications.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara Atzenhoefer Regulatory Affairs Manager Bio-Vascular, Inc. 2575 University Avenue Saint Paul, MN 55114-1024

APR 1 0 1998

Re: K971726 CV Peri-Guard - Cardiovascular Patch Regulatory Class: II (Two) Product Code: DXZ Dated: February 11, 1998 March 23, 1998 Received:

Dear Ms. Atzenhoefer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: . General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Barbara Atzenhoefer

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page 1 _of_1

510(k) Number (if known):_K971726

Device Name:_CV Peri-Guard™

Indications For Use: CV Peri-Guard™ is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bale L. Simperle

(Division Sign-Off) ------Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use_X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).