POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

POLYESTER is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, longchain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYESTER meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form. POLYESTER could be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). POLYESTER will be offered with or without standard needles attached.

AI/ML Overview

This document describes the Polyester Surgical Suture, a nonabsorbable, sterile suture composed of Poly (ethylene terephthalate), intended for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Tri-Cron® Non-Absorbable Polyester Surgical Suture and Ethibond® Nonabsorbable Polyester Surgical Suture) through non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the POLYESTER surgical suture are primarily based on conformance to United States Pharmacopeia (U.S.P.) standards and demonstrating substantial equivalence to the predicate devices. The document explicitly states that the device meets these requirements.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures (matching predicate).	POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Suture Material	Flexible fibers of high-molecular weight, long-chain, linear poly-(ethylene terephthalate) having recurrent aromatic rings as an integral component (matching predicate).	Flexible fibers of high-molecular weight, long-chain, linear poly-(ethylene terephthalate) having recurrent aromatic rings as an integral component.
Suture Characteristics	Not absorbed and no significant change in tensile strength retention known to occur in vivo (matching predicate).	Not absorbed and no significant change in tensile strength retention known to occur in vivo.
Sterilization Method	Gamma Irradiation (same as or equivalent to predicate).	Gamma Irradiation.
How Supplied	Multifilament thread; offered coated or uncoated, undyed or dyed with FDA listed color additive D&C Green No. 6 (21CFR74.3206); sterile and for single use only; available with or without surgical needles (same as or equivalent to predicate).	Multifilament thread, it will be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). Sterile and offered for Single Use Only. Available with or without surgical needles.
Physical Properties	Suture Diameter, Suture Length, Knot Pull Tensile Strength, and Needle Attachment Strength must meet U.S.P. Requirements.	Meet U.S.P. Requirements.
Packaging	Dry packaged in Aluminum Foil and Polyester tear open packaging (same as or equivalent to predicate).	Dry packaged in Aluminum Foil and Polyester tear open packaging.
Labeling	In conformance with CDRH instructions of the "Medical Device Quality Manual" dated December 1996 and FDA Guidance documents "Alternate Suture Labeling," reformatted on December 17th, 1997.	In conformance with CDRH instructions of the "Medical Device Quality Manual" dated December 1996. Package Inserts in accordance with the FDA Guidance documents "Alternate Suture Labeling" Resulting from the January 11th 1993 meeting with HIMA, reformatted on December 17th 1997.
Overall Equivalence	Demonstrate substantial equivalence to the predicate device.	T.CAD International believes that the subject device demonstrates a substantial equivalence to the predicate device.

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

The document states: "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."

Sample Size: The specific sample sizes for the non-clinical tests are not provided in this summary.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's non-clinical testing for a device intended for U.S. market (submitted to FDA), it's highly likely the testing was conducted in a controlled laboratory environment, potentially in the U.S. or by a compliant international facility.

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

This section is not applicable as the ground truth for this device is established through non-clinical, objective measurements against U.S.P. standards, not through expert consensus on qualitative assessments.

4. Adjudication Method for the Test Set

This section is not applicable as the ground truth for this device is established through non-clinical, objective measurements against U.S.P. standards, not through human adjudication of qualitative data.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Not available at the present time." The device relies on demonstrating substantial equivalence to already approved predicate devices through non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical surgical suture, not a software algorithm or AI model.

7. The Type of Ground Truth Used

The ground truth used for evaluating the POLYESTER surgical suture is based on United States Pharmacopeia (U.S.P.) standards for Nonabsorbable Surgical Suture. This involves objective physical and functional property measurements (e.g., suture diameter, length, knot pull tensile strength, needle attachment strength).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical surgical suture and does not involve AI or machine learning models that require training sets.

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

This question is not applicable as the device is a physical surgical suture and does not involve AI or machine learning models that require training sets.

In summary, the Polyester Surgical Suture demonstrated conformance to U.S.P. standards and substantial equivalence to predicate devices through non-clinical laboratory testing of its physical and functional properties. No clinical studies, expert-based ground truth, or AI-related evaluations were performed or required for this 510(k) submission.

Summary

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SECTION III

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 Contact Person: Main M. Ghazal, President September 28th 1999. Date Prepared:

B. Device Name:

Trade Name: POLYESTER a.
b. Common or Usual Name: Polyester Surgical Suture
Classification Name: Nonabsorbable Poly (ethyleme terephthalate) C.
- Surgical Suture (Per 21CFR878.5000)

C. Predicate Device:

Tri-Cron® Non-Absorbable Polyester Surgical Suture (Davis & Geck (K930591)) Ethibond@ Nonabsorbable Polyester Surgical Suture (Ethicon, Inc.)

D. Device Description:

E. Intended Use:
POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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	POLYESTER	Predicate Device
Intended Use	General soft tissue approximationand/or ligation, including use incardiovascular, ophthalmic andneurological procedures.	General soft tissue approximationand /or ligation, including use incardiovascular, ophthalmic andneurological procedures.
Suture Material	Flexible fibers of high-molecularweight, long-chain, linear poly-(ethylene terephthalate) havingrecurrent aromatic rings as anintegral component	Flexible fibers of high-molecularweight, long-chain, linear poly-(ethylene terephthalate) havingrecurrent aromatic rings as anintegral component
SutureCharacteristics	Not absorbed and no significantchange in tensile strength retentionknown to occur in vivo.	Not absorbed and no significantchange in tensile strength retentionknown to occur in vivo.
Sterilization Method	Gamma Irradiation	Same or equivalent process.
How Supplied	Multifilament thread, it will beoffered coated or uncoated,undyed or dyed with an FDAlisted color additive, D&C GreenNo. 6. (21CFR74.3206). Sterileand offered for Single Use Only.Available with or without surgicalneedles.	Same or equivalent manner.Offered in a multifilament form,coated or uncoated, undyed anddyed with the same FDA listedcolorant. Sterile and for single useonly. Available with or withoutsurgical needles.
Suture Diameter,Suture Length,Knot Pull TensileStrength and NeedleAttachmentStrength	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 "MedicalDevice Quality Manual" datedDecember 1996. Package Insertsin accordance with the FDAGuidance documents "AlternateSuture Labeling" Resulting fromthe January 11th 1993 meeting withHIMA, reformatted on December17th 1997.	Same

Comparison to Predicate Device: F.

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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 & EN 552 Standards
c. FDA Guidance documents " Alternate Suture Labeling" Resulting from 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

FEB 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Rc: K994000 Trade Name: Polyester Regulatory Class: II Product Code: GAT 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 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, Ilrug, and Cosmetic Act (Act) and the following limitations:

1 . The Polyester Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procecurrys.
1. This device may not be manufactured from any material other than high molecular weight fibers composed of long chain linear polyester having recurrent aromatic rings as an integral component. 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 Polyester surgical suture. Any devization 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 pror to commercial distribution of the modified device.

The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.

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Page 2 - Mr. Main M. Ghazal

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 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 yours,

Neil K.P. Eglen

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

Enclosure

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SECTION II

Statement of indication for use

Device Name: POLYESTER

510(k) Number:

Indication for use: POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21CFR 801.109) OR

Over-the-Counter Use

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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.