BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE

K992216 · Integra Lifesciences Corp. · LYC · Jul 26, 1999 · Dental

Device Facts

• Record ID: K992216
• Device Name: BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
• Applicant: Integra Lifesciences Corp.
• Product Code: LYC · Dental
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioMend Extend™ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Device Story

BioMend Extend™ is a white, compressed, non-friable, absorbable collagen membrane derived from bovine Achilles tendon. Used in dental surgery for guided tissue regeneration; acts as a physical barrier to retard epithelial downgrowth into periodontal defects while allowing nutrient passage. Implanted by clinicians; semi-occlusive design (0.004-micron pore size) integrates into surrounding tissue; completely absorbed within 18 weeks. Eliminates need for second surgical procedure for membrane removal. Provides hemostatic properties; can be cut to size in wet or dry state.

Clinical Evidence

Bench testing only. Biocompatibility studies conducted: cytotoxicity, dermal sensitization/irritation, ISO acute intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation/absorption, sub-chronic toxicity, muscular implantation, and hemolysis. Manufacturing process complies with FDA and European standards for animal tissue sourcing and viral inactivation.

Technological Characteristics

Type I collagen derived from bovine deep flexor (Achilles) tendon. Morphology: condensed laminated sheets with textured surface. Pore size: 0.004 microns. Form factor: flexible membrane, cuttable. Sterilization: Ethylene oxide (ETO). Biocompatible, non-pyrogenic, non-cytotoxic.

Indications for Use

Indicated for guided tissue regeneration in periodontal defects to enhance regeneration of the periodontal apparatus.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• BioMend® Absorbable Collagen Membrane (K924408)

Submission Summary (Full Text)

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Integra LifeSciences Corporation Special 510(k): Device Modification BioMend Extend™ Absorbable Collagen Membrane

Kaqazale

## BioMend Extend™ Absorbable Collagen Membrane SUMMARY OF SAFETY AND EFFECTIVENESS

#### Submitter's name and address:

Integra LifeSciences Corporation 105 Morgan Lane Plainsboro, NJ 08536

#### Contact person and telephone number:

Judith E. O'Grady Senior Vice President, Regulatory Affairs, Quality Assurance and Clinical Research [phone]

#### Date Summary was prepared:

June 30, 1999

#### Name of the device:

| Proprietary Name: | BioMend Extend™ Absorbable Collagen Membrane |
|----------------------|------------------------------------------------------|
| Common Name: | Resorbable Periodontal Barrier |
| Classification Name: | Bone Filling Augmentation Material, Product Code LYC |

### Substantial Equivalence:

BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent in function and intended use to the product, BioMend™ Absorbable Collagen Membrane which has been cleared to market under Premarket Notification 510(k) K924408.

#### Device Description:

BioMend Extend™ Absorbable Collagen Membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon. Bovine tendon is known to be one of the purest sources of Type I Collagen that can be readily obtained and processed in commercial amounts. BioMend Extend is completely absorbable, eliminating the need for the second surgical procedure often required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.

Under scanning electron microscopy, BioMend Extend™ has a morphology of condensed laminated sheets in cross-section and a textured surface. BioMend Extend" appears paperwhite in the dry state and translucent and non-slippery when wet. BioMend Extend" can be cut to any size or shape in the wet or dry state, without tearing or fragmenting.

BioMend Extend™ has an effective pore size of 0.004 microns, which will effectively retard epithelial downgrowth during early phases of healing. Being semi-occlusive, it allows essential nutrients to pass through the membrane. BioMend Extend™ incorporates into the surrounding tissue and is completely absorbed within 18 weeks.

BioMend Extend™ is sterilized by ethylene oxide gas.

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### Statement of the intended use:

BioMend Extend™ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

### Comparison of technological characteristics to predicate devices:

A table comparing characteristics of BioMend Extend™ Absorbable Collagen Membrane and the predicate device is provided in Table 1.

| | BioMend Extend™ Absorbable<br>Collagen Membrane | BioMend® Absorbable<br>Collagen Membrane |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for guided tissue<br>regeneration procedures in<br>periodontal defects to enhance<br>regeneration of the periodontal<br>apparatus. | Used for guided tissue<br>regeneration procedures in<br>periodontal defects to enhance<br>regeneration of the periodontal<br>apparatus. |
| Incorporates Same Basic<br>Design | Yes | Yes |
| Utilizes the same operating<br>principle | Cell occlusive (effective<br>pore size 0.004 microns)<br>Implantable<br>Resorbable<br>Hemostatic | Cell occlusive (effective<br>pore size 0.004 microns)<br>Implantable<br>Resorbable<br>Hemostatic |
| Incorporates same materials? | Yes, Type I Collagen | Yes, Type I Collagen |
| Sterilization Process | ETO | ETO |
| Biocompatible | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | 24 months | 24 months |
| Product Size | 15 mm x 20 mm<br>20 mm x 30 mm<br>30 mm x 40 mm | 15 mm x 20 mm<br>20 mm x 30 mm<br>30 mm x 40 mm |

## Table I: BioMend Extend™ Absorbable Collagen Membrane and Predicate, BioMend® Absorbable Collagen Membrane Comparison Chart

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### Safety

Biocompatibility studies have demonstrated BioMend Extend™ Absorbable Collage Membrane to be: noncytotoxic, nonpyrogenic, nonirritating, and nonsensitizing. The following studies were conducted:

- Cytotoxicity a)
- b) Dermal Sensitization /Irritation
- ISO Acute Intracutaneous Reactivity c)
- d) Acute Systemic Toxicity
- e) Genotoxicity
- Implantation/ Absorption f)
- Sub-Chronic Toxicity g)
- h) Muscular Implantation
- Hemolysis i)

The BioMend Extend™ Absorbable Collagen Membrane manufacturing process complies with the United States Food and Drug Administration and European Standards for animal tissue sourcing and viral inactivation.

#### Conclusion

BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent to the unmodified device, BioMend® Absorbable Collagen Membrane. The modifications do not affect the intended use or fundamental scientific technology of the device.

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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health & Human Services. The logo is a stylized image of three human figures, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 1999

Judith E. O'Grady, RN, MSN Senior Vice President Requlatory Affairs, Quality Assurance and Clinical Research Integra LifeSciences Corporation 105 Morgan Lane Plainsboro, New Jersey 08536

Re : K992216 BioMed® Extend™ Absorbable Collagen Trade Name: Membrane Unclassified Requlatory Class: Product Code: LYC Dated: June 30, 1999 Received: July 1, 1999

Dear Ms. O'Grady:

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 The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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.

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Page 2 - Ms. O'Grady

this response to your premarket notification Please note: 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asbeing 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 ens robet 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,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

## 510(k) Number:

Device Name: BioMend Extend™ Absorbable Collagen Membrane

# Indications for Use:

BioMend Extend™ Absorbable Collagen Membrane is an absorbable, implantable material that is Dioinend Exema - 110001 views - Somiga procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use | Or | Over-the-Counter Use ______ |
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| (Per 21 CFR 801.109 | | |

Optional Format 1-2-96)

| | Susan Runne <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> <div>"(k) Number 1990216</div> |
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