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

Device Description

POLYPROPYLENE is a nonabsorbable sterile surgical monofilament suture composed of flexible thread prepared from Long-chain polyolefin polymer known as polypropylene and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYPROPYLENE meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered undyed or dyed with an FDA listed color additive, either D&C Blue No. 6, (21CFR74.3106) or D&C Blue No. 6 (21CFR74.3106) or [Phthalocyaninato(2-)] copper (21CFR74.3045). It will be offered with or without standard needles attached.

AI/ML Overview

This document describes the safety and effectiveness of the POLYPROPYLENE surgical suture. Due to the nature of the device (a surgical suture), the study criteria and results are focused on physical and material properties rather than AI/software performance. Therefore, many of the requested numbered points, typically applicable to AI/ML-based medical devices, are not relevant or cannot be found in this document.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by U.S.P. Standards)	Reported Device Performance
Suture Diameter meets U.S.P. Requirements	Meets U.S.P. Requirements
Suture Length meets U.S.P. Requirements	Meets U.S.P. Requirements
Knot Pull Tensile Strength meets U.S.P. Requirements	Meets U.S.P. Requirements
Needle Attachment Strength meets U.S.P. Requirements	Meets U.S.P. Requirements
Material: Long-chain polyolefin polymer known as polypropylene	Long-chain polyolefin polymer known as polypropylene
Not absorbed and no significant change in tensile strength retention in vivo	Not absorbed and no significant change in tensile strength retention known to occur in vivo
Sterilization Method (Same or equivalent to predicate device)	Gamma Irradiation
Packaging (Same or equivalent to predicate device)	Dry packaged in Aluminum Foil and Polyester tear open packaging.
Labeling Conformance (CDRH instructions, FDA Guidance documents)	In conformance with CDRH instructions and FDA Guidance documents

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" sample size in the context of typical AI/ML studies. Instead, it refers to non-clinical testing performed to prove conformance to U.S.P. standards. The data provenance would be from laboratory testing of the POLYPROPYLENE suture. The country of origin of the data is not explicitly stated but implies testing was conducted by or for T.CAD International, which is based in Chicago, IL, USA. The testing is prospective in the sense that it was conducted on the manufactured device to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This point is not applicable. For a physical device like a surgical suture, "ground truth" is established by manufacturing specifications and adherence to recognized performance standards (U.S.P. in this case), not by expert human interpretation of data.

4. Adjudication method for the test set

This point is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of medical images or data. For physical product performance, results are based on objective measurements against engineering and material science standards.

5. 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

This point is not applicable. The device is a surgical suture, not an AI-assisted diagnostic or decision-support system involving human readers.

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

This point is not applicable. The device is a surgical suture, not an algorithm.

7. The type of ground truth used

The ground truth for the device's performance is based on United States Pharmacopeia (U.S.P.) standards for Nonabsorbable Surgical Suture. These are widely recognized and established performance benchmarks and specifications for medical devices.

8. The sample size for the training set

This point is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This point is not applicable. There is no training set for this type of device. The specifications and performance requirements are defined by the U.S.P. monograph.

Summary

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4 2000 FEB

K 993997

T.CAD International 990929/MG-510(k) POLYPROPYLENE

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 §807.92

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
Date Prepared:	September 29th 1999.

B. Device Name:

Trade Name: POLYPROPYLENE a.
b. Common or Usual Name: Polypropylene Surgical Suture
Classification Name: Nonabsorbable Polypropylene Surgical Suture C. (Per 21CFR878.5010)

C. Predicate Device:

Surgilene® Non-Absorbable Polypropylene Surgical Sutures (Davis & Geck) (K945701)

Prolene® Nonabsorbable Polypropylene Surgical Suture (Ethicon, Inc.)

D. Device Description:

e. POLYPROPYLENE is a nonabsorbable sterile surgical monofilament suture composed of flexible thread prepared from Long-chain polyolefin polymer known as polypropylene and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYPROPYLENE meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered undyed or dyed with an FDA listed color additive, either D&C Blue No. 6, (21CFR74.3106) or D&C Blue No. 6 (21CFR74.3106) or [Phthalocyaninato(2-)] copper (21CFR74.3045). It will be offered with or without standard needles attached.

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T.CAD International 990929/MG-510(k) POLYPROPYLENE

E. Intended Use:

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

F. Comparison to Predicate Device:

	POLYPROPYLENE	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	Long-chain polyolefin polymerknown as polypropylene	Long-chain polyolefin polymerknown as polypropylene
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	Monofilament thread, undyed ordyed with an FDA listed coloradditive. Sterile and offered forSingle Use Only. Available withor without surgical needle.	Same
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

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大 793497

T.CAD International 990929/MG-510(k) POLYPROPYLENE

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 features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

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

Re: K993997 Trade Name: Polypropylene Regulatory Class: II Product Code: GAW 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, Drug, and Cosmetic Act (Act) and the following limitations:

The Polypropylene Suture is indicated for use in general soft tissue approximation and/or 1. ligation, including use in cardiovascular, ophthalmic and neurological procedures.
1. This device may not be manufactured from any material other than a long chain polyolefin polymer known as polypropylene. 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 Polypropylene 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.

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) 594-4595. 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 vours.

Nel R.P. Ogden
James E. Dillard III

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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K99 3997

T.CAD International 990929/MG-510(K) POLYPROPYLENE

SECTION II

Statement of indication for use

Device Name: POLYPROPYLENE

510(k) Number:

Indication for use:

POLYPROPYLENE 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 21 CFR 801.109)

Over-the-Counter Use _ OR

NRO IJD

(Division Sign-Off) Division of General Restorative Devices K993997 510(k) Number _

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.