BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

K992088 · Genzyme Surgical Product (Genzyme Biosurgery) · GAM · Sep 3, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992088
• Device Name: BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
• Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bondek Plus Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Device Story

Bondek Plus is a sterile, absorbable, braided multifilament surgical suture; composed of a homopolymer of glycolic acid; coated with a copolymer of polycaprolactone and polyglycolic acid. Used by surgeons in clinical settings for soft tissue approximation and ligation. Device provides temporary wound support during healing before being absorbed by the body. Performance relies on material properties and mechanical strength.

Clinical Evidence

Bench testing only. Evidence includes performance testing and conformance with voluntary standards: ISO 10993-1 for biological evaluation and USP Section 1475 for absorbable surgical sutures.

Technological Characteristics

Braided multifilament suture; homopolymer of glycolic acid; coated with polycaprolactone/polyglycolic acid copolymer. Conforms to USP Section 1475 and ISO 10993-1 standards.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures. Contraindicated for cardiovascular and neurological procedures.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Bondek Synthetic Absorbable Surgical Suture (K905482, K930378, K991191)
• Sherwood-Davis & Geck Dexon PGA Suture (K972566, K951352, K900198)
• Lukens Medical Corp. Lukens PGA suture (K965162)

Submission Summary (Full Text)

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## EXHIBIT A

## 510(k) Summary of Substantial Equivalence

### BONDEK ® PLUS Synthetic Absorbable Surgical Suture

In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule "....510(k) Summaries and 510(k) Statements ... " and can be used to provide equivalence summary to anyone requesting it from the Agency.

| Manufacturer | Genzyme Surgical Products Corp.<br>600 Airport Road<br>Fall River, MA 02720-4740 |
|----------------------|-------------------------------------------------------------------------------------------|
| Contact Person | Mary E. Gray<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Device Information | |
| Trade Name: | Bondek® Plus Polyglycolic Acid Synthetic<br>Absorbable Surgical Suture |
| Common Name: | Polyglycolic Acid Synthetic Absorbable<br>Surgical Suture |
| Classification Name: | Absorbable poly(glycolide/L-lactide)<br>surgical suture (per 21 CFR § 878.4493) |

#### Indications for Use

Bondek Plus Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

#### Device Description

Bondek Plus Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid. The suture material is coated with a copolymer of polycaprolactone and polyglycolic acid.

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## EXHIBIT A

# 510(k) Summary of Substantial Equivalence Cont. BONDEK ® PLUS Synthetic Absorbable Surgical Suture

#### Substantial Equivalence

The Bondek Plus Synthetic Absorbable Surgical Suture is similar in intended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp. Lukens® PGA suture (#K965162).

The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ISO 10993-1 Biological Evaluation of Medical Deices, U.S.P. Section 1475 - Absorbable Surgical Sutures, and the FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA"

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999 SEP .

Ms. Mary E. Gray, RAC Genzyme Surgical Products Corp. 600 Airport Road Fall River, Massachusetts 02720

Re: K992088

> Trade Name: Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture Regulatory Class: II Product Code(s): GAM Suture, Absorbable, Synthetic, PolyGlycolic Acid (PGA) Dated: June 18, 1999 Received: June 21, 1999

Dear Ms. Gray:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Monday, December 11, 1989 (Vol. 54, No. 236, Pages 50737 and 50738). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at [phone] or [phone]. You may, therefore, market the devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- The Polyglycolic acid (PGA) Surgical Sutures are indicated for use in general soft 1. tissue approximation and/or ligation. including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
- 2. The Polyglycolic acid (PGA) Surgical Sutures may not be manufactured from any material other than homopolymers and copolymers made from glycolide and/or Llactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be sumitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed changes. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacturing of the PGA surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and FDA clearance prior to commercial distribution of the modified device.

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Page 2 - Ms. Mary E. Gray, RAC

The sale, distribution and use of these devices are restricted to prescription use in accordance with 21 CFR 801.109.

The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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,

Colin M. Witt, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known) Device Name

K992088 Bondek® Plus Synthetic Absorbable Surgical Suture

Indications for Use

Bondek® Plus Synthetic Absorbable Surgical Suture is indicated for use in general soft Bonder Title Byntholio riosofbacts burghthalmic procedures, but not for use in cardiovascular and neurological procedures.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K992088
510(k) Number

Prescription Use X (Per 21 CFR § 801.109)

OR

111

Over-the-Counter Use _

(Optional Format 1-2-96)