POLYGLYCOLIC ACID 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 Description

POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer and 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. POLYGLYCOLIC ACID meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. Offered as monofilament or multifilament in form, and it is offered uncoated or coated with polycarpolactone and calcium stearate, it could also be undyed or dyed with an FDA listed color additive, D&C Violet No. 2 (21CFR74.3602). POLYGLYCOLIC ACID will be offered with or without standard needles attached.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the POLYGLYCOLIC ACID surgical suture:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (USP Standards)	Reported Device Performance
Suture Diameter	Meet U.S.P. Requirements	Meets U.S.P. Requirements
Suture Length	Meet U.S.P. Requirements	Meets U.S.P. Requirements
Knot Pull Tensile Strength	Meet U.S.P. Requirements	Meets U.S.P. Requirements
Needle Attachment Strength	Meet U.S.P. Requirements	Meets U.S.P. Requirements
Original Tensile Strength (at 2 wks)	Retains approximately 65% (implied USP standard for absorbable sutures)	Retains approximately 65%
Original Tensile Strength (at 3 wks)	Retains approximately 40% (implied USP standard for absorbable sutures)	Retains approximately 40%
Suture Absorption	Absorption essentially complete between 60 and 90 days (implied USP standard for absorbable sutures)	Absorption essentially complete between 60 and 90 days
Sterility	Ethylene Oxide Gas sterilization (implied by predicate, conformity to USP)	Ethylene Oxide Gas
Material Composition	Composed of glycolide polymer (implied by product name and predicate comparison)	Composed of glycolide polymer
Biocompatibility	(Implicitly covered by USP standards and substantial equivalence to predicate)	(Not explicitly stated, but implied by USP and substantial equivalence)
Packaging	Dry packaged in Aluminum Foil and Polyester tear open packaging.	Dry packaged in Aluminum Foil and Polyester tear open packaging.
Labeling	In conformance with CDRH instructions and FDA Guidance documents	In conformance with CDRH instructions and FDA Guidance documents

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards." This implies a sample size adequate for the tests required by USP, but the specific number of units tested is not provided.
Data Provenance: Not explicitly stated regarding country of origin. The study is described as "Non-Clinical Testing," which is typically laboratory-based and not tied to specific patient populations or geographical locations. It is a retrospective study in the sense that the tests were performed and then reported, but it's not a retrospective analysis of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. The ground truth for the non-clinical testing is based on the United States Pharmacopeia (U.S.P.) standards. These are established, widely accepted objective performance metrics for medical devices, particularly sutures. No human experts are described as establishing "ground truth" for these physical and chemical tests.

4. Adjudication Method for the Test Set

Not applicable. The evaluation relies on objective measurements against pre-defined U.S.P. standards. There is no human adjudication process described for interpreting the results of these standardized tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and assessing the impact of AI assistance on their performance. The device in question is a surgical suture, which is a physical product, and its evaluation relies on non-clinical performance characteristics.

6. 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 or AI system. The concept of "standalone performance" for an algorithm does not apply here. The evaluation is of the physical product's performance against established standards.

7. The Type of Ground Truth Used

U.S.P. Standards: The ground truth for the device's performance is objective compliance with the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. These standards define the acceptable range for physical properties like diameter, tensile strength, length, and absorption characteristics.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical suture, not an AI or machine learning model. Therefore, there is no "training set" of data in the context of AI development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, the question of establishing its ground truth is not relevant here.

Summary

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FEB 9 2000

T.CAD International 990927/MG-510(k) POLYGLYCOLIC ACID

SECTION III

: 44.4

510(K) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and Title 21 CFR 8807.92

A. Applicant & Submitted by:

Trading Consultants And Distributors International Inc.
(T.CAD International)
157 WindDance Dr.
Chicago, IL 60046-6681
Telephone: (847) 265-7676
Fax: (847) 265-7686
Main M. Ghazal
September 27th 1999.

Contact Person: Date Prepared:

B. Device Name:

Trade Name: POLYGLYCOLIC ACID a.
Common or Usual Name: Polyglycolic Acid Surgical Suture b.
Classification Name: Absorbable Poly (glycolide/L-lactide) Surgical C. Suture (Per 21CFR878.4493)

C. Predicate Device:

DEXON II® Polyglycolic Acid Surgical Suture, Davis & Geck (K972566) Ethicon Absorbable Poly (L-lactide/glycolide) Surgical Suture, Undyed. (K964345)

D. Device Description:

E. Intended Use: POLYGLYCOLIC ACID 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.

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Ky44001

T.CAD International
990927/MG-510(k)
POLYGLYCOLIC ACID

F. Comparison to Predicate Device:	POLYESTER	Predicate Device
Intended Use	General soft tissue approximationand/or ligation, including use inophthalmic procedures, but not foruse in cardiovascular andneurological procedures.	Same
Suture Material	Composed of glycolide polymer.	Ethicon: Composed of copolymersmade of glycolide and L-lactideDavis & Geck: composed ofglycolide polymer.
SutureCharacteristics	Retains approximately 65% of itsoriginal tensile strength at twoweeks post implantation, withapproximately 40% remaining atthree weeks. Absorption of thesuture is essentially completebetween 60 and 90 days.	Same.
Sterilization Method	Ethylene Oxide Gas	Same or equivalent process.
How Supplied	Monofilament or Braided, coatedwith polycaprolactone & calciumstearate or uncoated, undyed ordyed with D&C Violet No. 2.Sterile and offered for Single UseOnly with or without needle.	Same or equivalent manner. BothPredicate devices are offeredBraided. Both are coated withPolycaprolactone; a copolymer ofcaprolactone and glycolide. Davis& Geck is dyed with D&C violetNo. 2. Ethicon is undyed.
Suture Diameter,Suture Length,Knot Pull TensileStrength and NeedleAttachment Strength	Meet U.S.P. Requirements	Meet U.S.P. Requirements
Packaging	Dry packaged in Aluminum Foiland Polyester tear open packaging.	Same or equivalent manner.
Labeling	In conformance with CDRHinstructions of the "Medical DeviceQuality Manual" dated December1996. Package Inserts in accordancewith the FDA Guidance documents "Alternate Suture Labeling" Resultingfrom the January 11th 1993 meetingwith HIMA, reformatted onDecember 17th 1997.	Same

F. Comparison to Predicate Device:

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Kaquool

T.CAD International 990927/MG-510(k) POLYGLYCOLIC ACID

G. Clinical & Non-Clinical Testing:

Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Absorbable surgical suture.

Clinical Testing: Not available at the present time.

H. Conclusion:

Based on the technological characteristics and physical properties of the device, the device description, the intended use of the device, and conformance with voluntary performance standards like:

a. United States Pharmacopeia Standards
b. ISO 9002 & EN 46002.
FDA Guidance documents " Alternate Suture Labeling" Resulting from ﻦ ﺍ the January 11th 1993 meeting with HIMA.

T.CAD International believes that the subject device demonstrates a substantial equivalence to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, arranged in a row.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

- 9 2000

Mr. Main M. Ghazal Trading Consultants and Distributors International, Inc. 157 WindDance Drive Chicago, Illinois 60046-6681

Re: K994001 Trade Name: Polyglycolic Acid Regulatory Class: II Product Code: GAM Dated: November 22, 1999 Received: November 24, 1999

Dear Mr. Ghazal:

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 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 (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 Polyglycolic Acid 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 change(s). 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 manufacturing of the Polyglycolic Acid 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 - Mr. Main M. Ghazal

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 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 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 (301) 594-4595. 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" (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 vours.

Sincerely yours,

Neil R.P. Ogden

SED James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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K994001

T.CAD International 990927/MG-510(k) POLYGLYCOLIC ACID

SECTION II

Statement of indication for use

Device Name: POLYGLYCOLIC ACID

510(k) Number:

Indication for use:

POLYGLYCOLIC ACID 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.

ま

(PLEASE DO NOT WRITE BELOW THE LINE - CONTINUE ON ANOTHER PACE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) √

Over-the-Counter Use OR

Nho fr J2D

IT mision Sign-Off) Division of General Restorative Devices 1994001 510(k) Number __

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.