OCU-GUARD AND OCU-GUARD SUPPLE

K983581 · Bio-Vascular, Inc. · HQX · Nov 6, 1998 · Ophthalmic

Device Facts

• Record ID: K983581
• Device Name: OCU-GUARD AND OCU-GUARD SUPPLE
• Applicant: Bio-Vascular, Inc.
• Product Code: HQX · Ophthalmic
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.3340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.

Device Story

Ocu-Guard Supple is a bovine pericardium-derived orbital implant wrap; cross-linked with glutaraldehyde; treated with 1M sodium hydroxide. Used in enucleation surgery; applied by surgeons to cover orbital implants. Functions as a physical barrier to protect surrounding orbital tissue from implant surface; reduces risk of implant exposure; facilitates tissue ingrowth via vascularization; allows muscle reattachment to improve implant motility. Device is trimmed and shaped by the clinician to conform to the specific implant used.

Clinical Evidence

Bench testing only. Comparative analysis of NaOH-treated vs. non-treated pericardium included shrink, suture, and thickness testing, as well as bioburden, sterility, pH, pyrogen, and chemical testing. Animal testing evaluated biocompatibility and inflammation. Results showed no significant differences between treated and control samples.

Technological Characteristics

Bovine pericardium cross-linked with glutaraldehyde; treated with 1M sodium hydroxide (NaOH) for 60-75 minutes at 20-25 C. Form factor: flat or preformed wrap. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing enucleation surgery requiring an orbital implant wrap to cover any type or shape of orbital implant.

Regulatory Classification

Identification

An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

Predicate Devices

• Ocu-Guard Supple (K973552)

Submission Summary (Full Text)

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K983581/

## 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: | Ocu-Guard Supple™ Orbital Implant Wrap (Flat & Preformed) |
| Device Classification Name: | Eye sphere implant |
| Substantial Equivalence: | Ocu-Guard Supple K973552 |
| Device Description: | Ocu-Guard Supple is prepared from bovine pericardium<br>which is cross-linked with glutaraldehyde. |
| Statement of Intended Use: | Ocu-Guard Supple is indicated for use as an orbital implant<br>wrap to cover any type or shape of orbital implant used in<br>enucleation surgery. The product is easy to handle and trim<br>and conforms to the shape of the implant. Ocu-Guard<br>Supple allows for tissue ingrowth through the vascularization<br>process and protects the surrounding orbital tissue from the<br>surface of the orbital implant, decreasing the risk of implant<br>exposure. Ocu-Guard Supple also allows for muscle<br>reattachment to facilitate motility of the implant. |

## 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

Bio-Vascular, Inc. c/o Dianna L. Geck Regulatory Affairs Associates 2575 University Avenue St. Paul, MN 55114-1024

Re: K983581 Trade Name: Ocu-Guard ™ Supple Orbital Implant Wrap (Flat&Performed) Regulatory Class: II Product Code: 86 HQX Dated: October 9, 1998 Received: October 13, 1998

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 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 assumptions. Failure to comply with the GMP regulation may result in regulatory 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. Dianna L. Geck

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,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K98 3581 510(k) Number (if known):

Ocu-Guard™ Supple Orbital Implant Wrap (Flat & Preformed) Device Name:

## Indications for Use:

Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.

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

Susan Gougé Acting Branch Chief

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K983581

Prescription Use -Per 21 CFR 801.109

OR

Over-The-Counter Use