BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

K991191 · Genzyme Surgical Product (Genzyme Biosurgery) · GAM · Jun 22, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991191
• Device Name: BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
• Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bondek 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 is a sterile, absorbable, braided multifilament surgical suture composed of polyglycolic acid homopolymer. The suture is coated with a polycaprolactone-glycerol monostearate solution. It is used by surgeons in clinical settings for soft tissue approximation and ligation. The device functions as a mechanical support for tissue healing, eventually being absorbed by the body. It is provided as a finished surgical product for professional use.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and conformance to established performance standards (ISO 10993-1, U.S.P. Section 1475).

Technological Characteristics

Material: Polyglycolic acid homopolymer; Coating: Polycaprolactone-glycerol monostearate. Form: Braided multifilament. Standards: ISO 10993-1 (Biological Evaluation), U.S.P. Section 1475 (Absorbable Surgical Sutures).

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)
• Bondek Synthetic Absorbable Surgical Suture (K930378)
• Vicryl suture (K946271)
• Vicryl suture (K915835)
• Lukens PGA suture (K965162)

Submission Summary (Full Text)

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## EXHIBIT I

## 510(k) Summary of Substantial Equivalence - -

## BONDEK ® 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.

| <b>Manufacturer</b> | Genzyme Surgical Products<br>600 Airport Road<br>Fall River, MA 02720-4740 |
|---------------------------|---------------------------------------------------------------------------------|
| <b>Contact Person</b> | Mary E. Gray |
| | Phone: [phone] |
| | Fax: [phone] |
| | e-mail: [e-mail] |
| <b>Device Information</b> | |
| Trade Name: | Bondek ^® 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 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 Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The suture material is coated with a polycaprolactone-glycerol monostearate solution.

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# K99

### EXHIBIT I

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

### Substantial Equivalence

The Bondek Synthetic Absorbable Surgical Suture is similar in intended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482 and #K930378), Ethicon, Inc. Vicryl® suture (#K946271, #K915835), 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 1999

Ms. Mary Gray Regulatory Affairs Specialist Genzyme Surgical Products Corp. 600 Airport Road Fall River, Massachusetts 02720

Re: K991191

Trade Name: Bondek® Synthetic Absorbable Surgical Suture Regulatory Class: II Product Code: GAM Dated: April 7, 1999 Received: April 8, 1999

Dear Ms. Gray:

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 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 Wednesday, September 18, 1991 (Vol. 56, No. 18, Pages 47150 and 47151). 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 device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- The Bondek® Synthetic Absorbable Surgical Suture is indicated for use in general 1. soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
- This device may not be manufactured from any material other than homopolymers 2. and copolymers made from glycolide and/or L-lactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be submitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed change(s). 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 Bondek® Synthetic Absorbable 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 Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.

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Page 2 - Ms. Mary Gray

The sale, distribution and use of this device 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 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) regulation (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. 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.

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,

L. Celie M. Witten, 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

Enclosure

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KSgn91

510(k) Number (if known) Device Name

Bondek® Synthetic Absorbable Surgical Suture

. .

Indications for Use

Bondek® 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.

:

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

(Division Sigh-Off) Division of General Restorative Devices 12991191 510(k) Number __

Prescription Use (Per 21 CFR § 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)