SURGISORB

K990432 · Sutures , Ltd. · GAM · May 27, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990432
• Device Name: SURGISORB
• Applicant: Sutures , Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 27, 1999
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgisorb 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

Surgisorb Surgical Suture is a synthetic absorbable suture used for soft tissue approximation and ligation. It is manufactured from homopolymers and copolymers of glycolide and/or L-lactide. The device is intended for use by clinicians in surgical settings. It functions as a mechanical fastener to hold tissue edges together during healing. The device is provided sterile and is restricted to prescription use.

Clinical Evidence

No clinical data provided; bench testing and compliance with GMP regulations are the basis for the substantial equivalence determination.

Technological Characteristics

Synthetic absorbable suture composed of homopolymers and copolymers of glycolide and/or L-lactide. Sterilization is required. Device must adhere to specific material composition constraints; any deviation requires a new premarket notification.

Indications for Use

Indicated for general soft tissue approximation and ligation, including ophthalmic procedures. Contraindicated for cardiovascular and neurological procedures. Prescription use only.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1999

Ms. Eleanor Jones, BSc Quality Assurance Manager Sutures, Ltd. Vauxhall Industrial Estate Ruabon, Wrexham LL14 6HA, Wales United Kingdom

Re: K990432 Trade Name: Surgisorb Surgical Suture Regulatory Class: II Product Code: GAM Dated: April 12, 1999 Received: April 12, 1999

Dear Ms. Jones:

This letter supercedes our May 27, 1999 letter. We have reviewed your Section 510(k) notification of intent to market the dcvice 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 Foodsal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- The Surgisorb Surgical Suture is indicated for use in general soft tissue approximation 1. and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
- 2. This device may not be manufactured from any material other than homopolymers and copolymers madc from glycolide and/or L-lactidc. 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 sourcc material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacturing of the Surgisorb 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. Eleanor Jones, BSc

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 Fedcral 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,

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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TO KENICA r coux 1

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an State, Russian State, Shares (23664 - Fax: [phone] \$10669 dustrial Estate, Ruabon, Tordanalia Galleria (0) 1978 810669
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510(k) Number (if known): K990432
Device Name: SURGISORB

Indications For Use:

Surgisorb is indicated for use in general tissue approximation and or ligation, including
es. Surgisorb is indicated for use in general use in cardiac or neurological procedures.
use in ophthalmic procedures but not for use in cardiac or neurological procedures.

(PLEASE DO NOT WRIT I BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | K990432 |
| 510(k) Number | |

| Prescription Use | <span style="text-decoration: underline;">✓</span> | OR | Over-The-Counter Use |
|----------------------|----------------------------------------------------|----|----------------------|
| (Pcr 21 CFR 801.109) | | | |

(Optional Format 1-2-96)

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Rog. Wa. 1415215 England