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

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.

AI/ML Overview

The provided text is a 510(k) summary for a "Modified Polysorb Suture." This document focuses on demonstrating substantial equivalence to a predicate device (Polysorb Suture, K970863) to gain market clearance. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way one would typically describe a clinical or algorithmic performance study.

Medical devices like sutures are often evaluated based on material properties, biocompatibility, and mechanical strength to ensure they function as intended and are safe for use. However, the provided text does not detail the specific tests conducted or their results.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I discuss sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case studies, as these types of studies are not described in the given documents for this product.

Instead, the document primarily focuses on:

Device Description: Modified Polysorb Suture is composed of a glycolide/lactide copolymer and coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate.
Intended Use: Soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Materials: All component materials are in accordance with ISO Standard # 10993-1, which addresses biocompatibility.
Predicate Device: Polysorb* Suture (K970863). The substantial equivalence is based on the similarities in composition, intended use, and general characteristics to this already legally marketed device.
FDA Clearance: The FDA found the device substantially equivalent to transitional devices reclassified into Class II, subject to general controls and specific limitations regarding manufacturing materials.

For a medical device like a suture, performance would typically be evaluated through:

Mechanical Testing: Tensile strength, knot security, degradation profile.
Biocompatibility Testing: According to ISO 10993 standards (which is mentioned for the materials).
Sterilization Validation: Ensuring the device can be effectively sterilized.
In vivo animal studies: To assess tissue reaction, absorption, and wound healing in a biological environment.

However, the provided K981935 summary does not contain the detailed results of such studies. It only states that the materials conform to ISO 10993-1 and that manufacturing processes and material changes would require new premarket notification.

Summary

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K981935

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

SUBMITTER:	United States Surgical Corporation150 Glover AvenueNorwalk, 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 (800) 638-2041 or (301) 443-6597. 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.
1. 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
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.(b)
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.