CV PERI-GUARD - CARDIOVASCULAR PATCH

K971726 · Bio-Vascular, Inc. · DXZ · Apr 10, 1998 · Cardiovascular

Device Facts

• Record ID: K971726
• Device Name: CV PERI-GUARD - CARDIOVASCULAR PATCH
• Applicant: Bio-Vascular, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Apr 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K971726 · Apr 10, 1998	CV PERI-GUARD - CARDIOVASCULAR PATCH	Bio-Vascular, Inc.	Retrospective clinical study; Clinical experience/medical records (mitral valve annulus and other intracardiac positions)	Retrospective clinical data was used to demonstrate the safety and effectiveness of the bovine pericardium patch in intracardiac and great vessel repair applications, supporting substantial equivalence to predicate devices.	Retrospective study; Clinical experience; Intracardiac repair; Bovine pericardium

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Peri-Guard Retrospective study; Retrospective study; Follow-up/Duration: Mean of 17 months post-op (for calcification evaluation)	Patients undergoing intracardiac and great vessel repair	Alternative intracardiac and great vessel patch materials	Safety, effectiveness, and calcification

Indications for Use

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).

Device Story

CV Peri-Guard is a cardiovascular patch composed of glutaraldehyde-crosslinked bovine pericardium. Used by surgeons in clinical settings for intracardiac and great vessel repair, valve repair, and suture line buttressing. The patch provides structural reinforcement for defects such as atrial or ventricular septal defects and aortic graft suture lines. It functions as a biocompatible, non-hemolytic implant material to repair soft tissue deficiencies and withstand peak systolic pressures. The device is provided in various configurations to accommodate different surgical requirements.

Clinical Evidence

Evidence includes a retrospective clinical study, a juvenile rat subcutaneous calcification model, and a canine implant study. The rat model demonstrated clinically insignificant calcification, outperforming glutaraldehyde-treated controls and competitor bovine patches. Clinical evaluation in mitral valve annulus and other intracardiac positions showed no calcification up to 17 months post-op. Canine studies confirmed performance similarity to ePTFE. Retrospective clinical data indicated the material performed safely and effectively, equivalent to alternative patch materials.

Technological Characteristics

Material: Glutaraldehyde-crosslinked bovine pericardium. Form factor: Sheets ranging from 1 cm x 1 cm to 14 cm x 16 cm. Biocompatibility: Non-hemolytic, established history since 1982. Mechanical properties: Designed for high-pressure applications including intracardiac and great vessel repair.

Indications for Use

Indicated for patients requiring intracardiac, great vessel, septal defect, and annulus repair, or suture-line buttressing. Prescription use only.

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

• Gore-Tex Cardiovascular Patch
• Peri-Guard
• Vascu-Guard

Submission Summary (Full Text)

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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:

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).

### 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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)