POLYSORB SUTURE

K981935 · United States Surgical, A Division of Tyco Healthc · GAM · Jun 25, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981935
• Device Name: POLYSORB SUTURE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jun 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Device Story

Modified Polysorb Suture is a synthetic absorbable surgical suture composed of a glycolide/lactide copolymer. The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate. It is intended for use by surgeons in clinical settings for soft tissue approximation or ligation and ophthalmic surgery. The device functions as a mechanical support for tissue healing and is absorbed by the body over time. It is not for use in cardiovascular or neural tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic absorbable suture; glycolide/lactide copolymer core; caprolactone/glycolide copolymer and calcium stearoyl lactylate coating. Materials comply with ISO Standard # 10993-1. Restricted to homopolymers and copolymers made from glycolide and/or L-lactide.

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

• Polysorb* Suture (K970863)

Submission Summary (Full Text)

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K981935

#### JUN 25 ાજુકા 510(k)_Summary of Safety and Effectiveness

| SUBMITTER: | United States Surgical Corporation<br>150 Glover Avenue<br>Norwalk, CT 06856 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Jamie Yieh |
| DATE PREPARED: | June 1, 1998 |
| CLASSIFICATION NAME: | Absorbable Surgical Suture |
| COMMON NAME: | Synthetic Absorbable Surgical Suture |
| PROPRIETARY NAME: | Not yet determined |
| PREDICATE DEVICES: | Polysorb* Suture (K970863) |
| DEVICE DESCRIPTION: | Modified Polysorb* Suture is composed of a glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate. |
| INTENDED USE: | Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. |
| MATERIALS: | All component materials of the Modified Polysorb* Suture are comprised of materials which are in accordance with ISO Standard # 10993-1. |

510(k) Premarket Notification June 1, 1998

:

RA05

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with its wings forming a human profile, symbolizing the department's focus on health and human well-being. The text is in all caps and the eagle is in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 1998

Mr. Jamie Yieh Associate. Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk. Connecticut 06856

Re: K981935 Trade Name: Modified Polysorb Suture Regulatory Class: II Product Code: GAM Dated: June 1, 1998 Received: June 2, 1998

Dear Mr. Yieh:

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 Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). 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 Modified Polysorb Surgical Suture is indicated for use in general soft tissue 1. approximation 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 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 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 manufacture of the Modifies Polysorbsurgical 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 Two - Mr. Jamie Yieh

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 annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) 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 vour 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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# Modified Polysorb* Suture

## 1V. Indications For Use:

510(k) Number (if known): K981935

Name: Modified Polysorb* Suture

### Indications For Use:

Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use: OR Over-The-Counter Use: (Per 21 CFR §801.109)

Jo C. DeLeon

· Trademark name not yet determined

KVOR