DEMETECH POLYESTER NONABSORBABLE SUTURE by DEMETECH CORP.

The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.

Device Description

The DemeTECH Polyester Nonabsorbable Suture is a braided green, individually packaged nonabsorbable Polyester surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes.

AI/ML Overview

The DemeTECH Polyester Nonabsorbable Suture is a medical device and thus does not involve AI/ML performance.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Set by USP)	Reported Device Performance
Meets United States Pharmacopeia (USP) 23 requirements	Device demonstrated to meet USP 23 requirements
Meets United States Pharmacopeia (USP) 24 requirements	Device demonstrated to meet USP 24 requirements
Equivalent to legally marketed predicate device	Device demonstrated to be equivalent to predicate device

Sample size used for the test set and the data provenance: Not applicable. The study involved testing the physical properties of sutures against USP standards and comparing them to a predicate device, not analyzing patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established by adherence to published United States Pharmacopeia (USP) standards, which are defined by scientific testing methodologies rather than expert consensus on individual cases.
Adjudication method: Not applicable. The assessment was based on physical property testing against USP standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device for surgical procedures, not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical suture, not an algorithm.
The type of ground truth used: The ground truth used was based on established United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures. This involves standardized physical and chemical testing methods to ensure quality and performance. Additionally, equivalence to a legally marketed predicate device (Grams Polyester Nonabsorbable Suture) served as a benchmark.
The sample size for the training set: Not applicable. This is a medical device, not an AI/ML model that requires a training set. The study involves quality control testing for manufacturing standards.
How the ground truth for the training set was established: Not applicable.

Summary

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JUN 1 8 2003 DEMETECH CORP 510(k) Summary of Safety and Effectiveness

for 510 (k) No. KO2 30 30

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

DemeTECH Corp (A)(1) Submitter's name: Submitter's address: 12119 SW 131 Ave. Miami, FL 33186
Submitter's telephone number: (305) 251-2700

Mr. Luis Arguello, President Contact Person:

Date Summary Prepared: September 9, 2002

(2) Trade or proprietary device name: DemeTECH Polyester Nonabsorbable Suture

Common or usual name: Polyester Nonabsorbable Surgical Suture

Classification Name:

Nonabsorbable Poly (ethylene terephthalate) Surgical Suture

Panel: General and Plastic Surgery Class: II

(3) Legally marketed predicate device: Grams Polyester Nonabsorbable Suture [Grams American Suture, Inc., Grafton, WI] (510(k) No.: K003590)
(4) Subject device description:

(5) Subject device intended use:
The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
(6) Performance data:
The DemeTECH Polyester Nonabsorbable Suture has been demonstrated as both equivalent to the predicate device and meets United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a central emblem. The emblem consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection.

Public Health Service

JUN 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Luis Arguello President DemeTECH Corporation 12119 SW 131 Avenue Miami, Florida 33186

Re: K023030

Trade/Device Name: DemeTECH Polyester Nonabsorbable Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: April 25, 2003 Received: May 8, 2003

Dear Mr. Arguello:

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, listing 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 - Mr. Luis Arguello

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), 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) you may obtain. 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 yours,

Miriam C. Provost

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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DEMETECH CORP

510 (k) Premarket Notification DemeTECH Polyester Nonabsorbable Suture

C. Indications for use of the Device

Page 1 of 1

510(k) Number): Not known

DemeTECH Polyester Nonabsorbable Suture Device Name:

Indications for Use:

The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.

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

- - - - 本 * *

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division of General, Restorative and Neurological Devices

510(k) Number K023030

Prescription Use_X or Over-the-Counter Use ________ (Per 21 CFR 801.109)

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.