VICRYL PERIDONTAL MESH

K955646 · ETHICON, Inc. · NPK · May 20, 1996 · Dental

Device Facts

• Record ID: K955646
• Device Name: VICRYL PERIDONTAL MESH
• Applicant: ETHICON, Inc.
• Product Code: NPK · Dental
• Decision Date: May 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VICRYL periodontal mesh is intended for use as a barrier to provide temporary support during the early stages of the healing process following periodontal surgery.

Device Story

VICRYL periodontal mesh is a synthetic, bioabsorbable woven mesh made from a copolymer of glycolide and lactide; identical material to VICRYL (polyglactin 910) sutures. Device acts as a physical barrier to prevent apical migration of gingival epithelium into periodontal defects during ligament regeneration. Provided sterile in various sizes/shapes with affixed bioabsorbable ligatures. Used by dental surgeons during periodontal procedures. Unlike the predicate GORE-TEX material, the device is bioabsorbable and does not require surgical removal post-implantation. Benefits include temporary support during healing and elimination of a second procedure for barrier removal.

Clinical Evidence

Clinical and preclinical evaluations were conducted to assess safety and effectiveness. Analytical characterization included thermal properties and molecular weight assessment. Clinical data supported the device's function as a barrier for periodontal defect healing.

Technological Characteristics

Synthetic, bioabsorbable copolymer of glycolide and lactide (polyglactin 910). Woven mesh construction. Provided sterile. Includes affixed bioabsorbable ligatures. Bioabsorbable nature eliminates need for post-implantation removal.

Indications for Use

Indicated for patients undergoing periodontal surgery requiring a barrier to aid in the healing of periodontal defects and to provide temporary support during the early stages of the healing process.

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

• GORE-TEX Periodontal Material

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville, Maryland 20850

John D. Paulson, Ph.D.
Vice President, Regulatory Affairs
Ethicon, Incorporated
Route 22 West
Somerville, New Jersey 08876

Re: K955646
Trade Name: Vicryl Peridontal Mesh
Regulation Number: 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: 2
Product Code: NPK
Dated: March 27, 1996
Received: March 28, 1996

Dear Dr. Paulson:

This letter corrects our substantially equivalent letter of May 20, 1996.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,


Chiu Lin, Ph.D.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health


Protecting and Promoting Public Health

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K955646
MAY 20 1996

# SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 510(k) Summary of Safety and Effectiveness | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

NEW DEVICE NAME: VICRYL (polyglactin 910) Periodontal Mesh

PREDICATE DEVICE NAME: GORE-TEX^{R} Periodontal Material |
| --- | --- |
| | 510(k) SUMMARY |
| Device Description | VICRYL periodontal mesh is prepared from a synthetic, bioabsorbable copolymer of glycolide and lactide. The woven mesh is prepared from undyed strands identical to the strands used in VICRYL (polyglactin 910) synthetic, bioabsorbable suture.

VICRYL periodontal mesh is provided sterile, available in various sizes and shapes each with synthetic, bioabsorbable VICRYL ligatures affixed to the barrier. |
| Intended Use | VICRYL periodontal mesh is intended for use as a barrier to provide temporary support during the early stages of the healing process following periodontal surgery. |

Continued on next page

VICRYL (polyglactin 910) Periodontal Mesh ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Indications Statement
510(k) SUMMARY, Continued

Technology Statement
VICRYL periodontal mesh is a bioabsorbable implantable material intended to aid in the healing of periodontal defects.

Technological Characteristics
The new device provides a membrane barrier to apical migration of gingival epithelium during a period of periodontal ligament regeneration. Unlike the predicate device, the new device does not need to be removed post-implantation.

Performance Data
Analytical characterization to assess thermal properties and molecular weight was conducted. Preclinical laboratory and clinical evaluations were conducted to ensure that the device functioned as intended. Sufficient data has been gathered from preclinical and clinical testing to assess the safety and effectiveness of the new device.

Conclusions
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.

Contact
John D. Paulson, Ph.D.
Director, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151

Date
December 8, 1995

VICRYL (polyglactin 910) Periodontal Mesh
ETHICON, Inc.