Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic orthopedic and neurological procedures.

Device Description

Polyester Nonabsorbable Surgical Suture, USP size 9-0 through 9 available as undyed, dyed D & C Green No. 6 and as a co-braid of the undyed and dyed. The suture is sterile, braided and is provided in a variety of lengths, with or without pledgets, with or without needles and may be supplied in a variety of cut lengths or on ligating reels.

AI/ML Overview

This submission is for a surgical suture and therefore the concept of AI/ML performance acceptance criteria and study design does not apply. The provided text describes the device, its intended use, and its substantial equivalence to a predicate device, relying on established performance standards for surgical sutures rather than AI/ML-specific evaluations.

Here's why the AI/ML-focused questions are not applicable:

Device Type: The device is a "Polyester Nonabsorbable Surgical Suture." This is a tangible medical device used for physically joining tissues, not a software algorithm, diagnostic imaging tool, or any other device that would typically involve AI/ML.
Evaluation Basis: The determination of substantial equivalence is based on:
- Detailed device description.
- Performance testing (implied by conformance to standards).
- Conformance with voluntary performance standards (e.g., ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXV - Nonabsorbable Surgical Sutures, and the Guidance Document "Guidance for Surgical Suture 510(k)s"). These are standards for the physical and biological properties of sutures, not for algorithmic performance.
Lack of AI/ML Metrics: The document does not mention any metrics like sensitivity, specificity, AUC, F1-score, precision, recall, or any other terms typically associated with AI/ML model performance.
No "Readers" or "Ground Truth" as defined for AI: The concepts of human "readers" interacting with an AI, "ground truth" derived from expert consensus for image interpretation, or "training sets" and "test sets" for machine learning are absent from the provided text.

Therefore, since this device does not involve AI/ML, I cannot provide details on:

A table of acceptance criteria and reported device performance related to AI/ML.
Sample sizes for test sets or data provenance for AI/ML.
Number and qualifications of experts for AI/ML ground truth.
Adjudication method for AI/ML test sets.
MRMC comparative effectiveness study or human reader improvement with AI.
Standalone AI algorithm performance.
Type of ground truth used for AI/ML.
Sample size for AI/ML training set.
How ground truth for AI/ML training set was established.

Summary

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EXHIBIT A

510(k) Summary of Substantial Equivalence KO21019

Substantial Equivalence

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 BiosurgeryA Division of Genzyme Corporation600 Airport RoadFall River, MA 02720-4740
Contact Person	Mary E. GrayPhone: (508) 677-6512Fax: (508) 677-6663e-mail: mgray@genzyme.com
Date Prepared	March 14, 2002
Device Information
Trade Name:	'COTTONY' II, "silky" II POLYDEK® &TEVDEK® II Polyester NonabsorbableSurgical Suture.
Common Name:	Polyester Nonabsorbable Surgical Sutures
Classification	Name: Non-Absorbable Poly(ethyleneterephthalate) Surgical Sutures

Indications for Use

Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic orthopedic and neurological procedures.

Device Description

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EXHIBIT A

510(k) Summary of Substantial Equivalence Cont.

Substantial Equivalence

The device is similar in intended use, materials, design, and performance characteristics to the currently cleared Polyester Nonabsorbable Surgical Sutures (#K930738).

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. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXV -Nonabsorbable Surgical Sutures, and the Guidance Document "Guidance for Surgical Suture 510(k)s" issued on August 10, 2000.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2002

Ms. Mary E. Gray, RAC Regulatory Affairs Specialist Genzyme Corporation 600 Airport Road Fall River, MA 02720-4740

Re: K021019

Trade/Device Name: 'COTTONY' II, "silky" II POLYDEK® & TEVDEK® Polyester Nonabsorable Surgical Suture Regulation Number: 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: March 25, 2002 Received: March 29, 2002

Dear Ms. Gray:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Mary E. Gray, RAC

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

fo Mark N. Williamson

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

Enclosure

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K021019

510(k) Number (if known) Device Name

'cottony' II DACRON, "silky" II POLYDEK® & TEVDEK® II Polyester Nonabsorbable Surgical Suture

Indications for Use

Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.

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

Mark N Milkman

ivicion Sion ivision of ( .. eral, Restorative and Neurolo; Jual Devices

510(k) Number: K021019

Prescription Use (Per 21 CFR § 801.109)

Over-the-Counter Use _

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.