CV PERI-GUARD AND VASCU-GUARD

K983602 · Bio-Vascular, Inc. · DXZ · Nov 12, 1998 · Cardiovascular

Device Facts

• Record ID: K983602
• Device Name: CV PERI-GUARD AND VASCU-GUARD
• Applicant: Bio-Vascular, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions. Supple Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

Device Story

Devices consist of bovine pericardium cross-linked with glutaraldehyde and treated with 1M sodium hydroxide (NaOH). Treatment process involves 60-75 minute exposure to 1M NaOH at 20-25°C, followed by deionized water rinse and citrate neutralization. Patches are used by surgeons in clinical settings for cardiovascular, peripheral vascular, and soft tissue repairs. NaOH treatment serves to reduce infectivity without altering physical or biocompatibility properties. Output is a surgical patch material providing structural support or defect closure. Clinical benefit includes effective tissue repair and reconstruction.

Clinical Evidence

Bench testing only. Comparative studies between 1M NaOH-treated and non-treated pericardium evaluated physical properties (shrink, suture, thickness) and safety (bioburden, sterility, pH, pyrogen, chemical residuals). Biocompatibility and animal testing confirmed no significant differences in inflammation or biocompatibility between treated and control samples.

Technological Characteristics

Bovine pericardium cross-linked with glutaraldehyde. Subjected to 1M NaOH treatment (60-75 min, 20-25°C) for infectivity reduction. Neutralized with citrate solution. Physical properties (shrink, suture, thickness) verified against non-treated controls.

Indications for Use

Indicated for patients requiring surgical repair of intracardiac defects, great vessel/septal/annulus repair, suture-line buttressing, peripheral vascular reconstruction (carotid, renal, iliac, femoral, profunda, tibial, AV access), pericardial structure repair, or soft tissue deficiency repair (abdominal/thoracic wall, gastric banding, muscle flap, prolapse, pelvic floor, hernias).

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

• CV Peri-Guard (K971726)
• Vascu-Guard (K942010)
• Supple Peri-Guard (K961810)
• Supple Peri-Guard (K921895)

Submission Summary (Full Text)

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K9 8 3602

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant Name & Address:<br>NOV 12 1998 | Bio-Vascular, Inc.<br>2575 University Avenue<br>St. Paul, MN 55114-1024<br>Fax: [phone] |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dianna L. Geck<br>Regulatory Affairs Associate<br>Phone: [phone] |
| Date Prepared: | September 9, 1998 |
| Common or Usual Name: | CV Peri-Guard™ Cardiovascular Patch |
| Device Classification Name: | Intracardiac patch or pledget |
| Substantial Equivalence: | CV Peri-Guard K971726 |
| Device Description: | CV Peri-Guard is prepared from bovine pericardium which is<br>cross-linked with glutaraldehyde. |
| Statement of Intended Use: | CV Peri-Guard is intended for use as a patch material for<br>intracardiac defects, great vessel, septal defect and annulus<br>repair, and suture-line buttressing. |

#### Summary/Comparison of Technological Characteristics:

Cross-linked pericardium was treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodium hydroxide treated and control (non-NaOH-treated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical resting. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium.

Bio-Vascular believes that product subjected to 1M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.

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## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant Name & Address: | Bio-Vascular, Inc.<br>2575 University Avenue<br>St. Paul, MN 55114-1024<br>Fax: [phone] |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dianna L. Geck<br>Regulatory Affairs Associate<br>Phone: [phone] |
| Date Prepared: | September 9, 1998 |
| Common or Usual Name: | Vascu-Guard® Peripheral Vascular Patch |
| Device Classification Name: | Intracardiac patch or pledget |
| Substantial Equivalence: | Vascu-Guard K942010 |
| Device Description: | Vascu-Guard is prepared from bovine pericardium which is<br>cross-linked with glutaraldehyde. |
| Statement of Intended Use: | Vascu-Guard is intended for peripheral vascular<br>reconstruction including the carotid, renal, iliac, femoral,<br>profunda, and tibial blood vessels and arteriovenous access<br>revisions |

#### Summary/Comparison of Technological Characteristics:

Cross-linked pericardium was treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodium hydroxide treated and control (non-NaOH-treated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical resting. Results showed no significant difference between the test and control samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium.

Bio-Vascular believes that product subjected to 1M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.

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# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant Name & Address: | Bio-Vascular, Inc.<br>2575 University Avenue<br>St. Paul, MN 55114-1024<br>Fax: [phone] |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dianna L. Geck<br>Regulatory Affairs Associate<br>Phone: [phone] |
| Date Prepared: | September 9, 1998 |
| Common or Usual Name: | Supple Peri-Guard® Pericardium |
| Device Classification Name: | Mesh, surgical, polymeric |
| Substantial Equivalence: | Supple Peri-Guard K961810, K921895 |
| Device Description: | Supple Peri-Guard is prepared from bovine pericardium<br>which is cross-linked with glutaraldehyde. |
| Statement of Intended Use: | Supple Peri-Guard is intended for the repair of pericardial<br>structures and for use as a prosthesis for the surgical repair<br>of soft tissue deficiencies which include: defects of the<br>abdominal and thoracic wall, gastric banding, muscle flap<br>reinforcement, rectal and vaginal prolapse, reconstruction of<br>the pelvic floor, and hernias (including diaphragmatic,<br>femoral, incisional, inguinal, lumbar, paracolostomy, scrotal,<br>and umbilical hernias) |

#### Summary/Comparison of Technological Characteristics:

Cross-linked pericardium was treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution. followed by a final DI water rinse. Sodium hydroxide treated and control (non-NaOH-treated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical residuals testing. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium.

Bio-Vascular believes that product subjected to 1M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 12 1998

Ms. Dianna L. Geck Regulatory Affairs Associate Bio-Vascular, Inc 2575 University Avenue Saint Paul, MN 55114-1024

Re: K983602 Various Tissue Patches Requlatory Class: II Product Code: DXZ Dated: October 9, 1998 October 13, 1998 Received:

Dear Ms. Geck:

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 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). 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. Any promotional or advertisement materials referring to the sodium hydroxide treatment must contain the lanquaqe agreed upon regarding reducing infectivity.

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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have

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Page 2 - Ms. Dianna L. Geck

under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (21CFR 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahar Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K98 3602 510(k) Number (if known):

CV Peri-Guard™ Cardiovascular Patch Device Name:

#### 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)

Thomas J. Callahon

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices ka83602 510(k) Number _

Prescription Use Per 21 CFR 801.109

OR

Over-The-Counter Use

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510(k) Number (if known): KAB

Vascu-Guard® Peripheral Vascular Patch Device Name:

#### Indications for Use:

Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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Supple Peri-Guard® Pericardium Device Name:

#### Indications for Use:

Supple Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hemias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

OR

Over-The-Counter Use