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

Device Description

NYLON is a nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6. NYLON meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered coated or uncoated, undyed and dyed with an appropriate FDA listed color additive, D&C Blue No. 2. (21CFR74.3102) or Logwood extract, C.I. Natural Black 1. (21CFR74.1410). NYLON will be offered with or without standard needles attached.

AI/ML Overview

Acceptance Criteria and Device Performance Study for NYLON Surgical Suture

This analysis focuses on the acceptance criteria and the study performed for the T.CAD International NYLON surgical suture, as presented in the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by USP Standards)	Reported Device Performance (NYLON)
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 composition: Long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6	Composed of long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6.
Sterilization Method	Gamma Irradiation (Acceptable and comparable to predicate)
Biocompatibility and safety	Implied by meeting USP and substantial equivalence to predicate, which are already deemed safe.
Predicate Device Comparability (Functional Equivalence)	Functions identically to predicate devices (DERMALON®, Ethilon®) in intended use and characteristics.

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

The document does not explicitly state the sample size used for the non-clinical testing. The provenance of the data is not specified beyond being "non-clinical testing" conducted to prove conformance to U.S.P. standards. It is implied the testing was performed by or for T.CAD International. The nature of the testing (physical properties and functionality) suggests it was retrospective in the sense that the suture material was already manufactured and then tested.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the number or qualifications of experts used to establish ground truth for the test set. The ground truth for the non-clinical tests appears to be the United States Pharmacopeia (U.S.P.) standards themselves.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The testing was against pre-defined U.S.P. standards, implying a pass/fail outcome based on direct measurement compared to the standard, rather than subjective expert opinion requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study performed. Surgical sutures are not typically evaluated using MRMC studies, as their effectiveness is primarily gauged by their physical and biological performance rather than interpretative tasks. Clinical testing was explicitly stated as "Not available at the present time."

6. Standalone Performance Study (Algorithm Only)

This question is not applicable as the device is a physical surgical suture, not an algorithm or software. Therefore, there was no "algorithm only" performance study.

7. Type of Ground Truth Used

The primary ground truth used for the device's acceptance was United States Pharmacopeia (U.S.P.) Standards. This represents established regulatory and performance benchmarks for surgical sutures. The comparison to predicate devices also implies a ground truth established by the long-standing safe and effective use of those predicate devices.

8. Sample Size for the Training Set

This question is not applicable. Surgical sutures, being physical devices, do not typically involve "training sets" in the context of machine learning or algorithms. The manufacturing process is controlled to produce sutures that consistently meet specifications.

9. How Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8. The production of surgical sutures relies on established manufacturing processes and quality control to ensure consistency, rather than a "training set" with established ground truth in the AI sense.

Summary

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FEB. 4 2000 K 493948

T.CAD International 991001/MG-510(k) NYLON

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 October 1ª 1999. Date Prepared:

B. Device Name:

Trade Name: NYLON ત્વ.
Common or Usual Name: Polyamide Surgical Suture b.
Classification Name: Nonabsorbable Polyamide Surgical Suture C. (Per 21CFR878.5020)

C. Predicate Device:

DERMALON® Non-Absorbable Polyamide Surgical Sutures of Davis & Geck Ethilon® Nonabsorbable Polyamide Surgical Suture (Ethicon, Inc.)

D. Device Description:

NYLON is a nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6.

NYLON meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered coated or uncoated, undyed and dyed with an appropriate FDA listed color additive, D&C Blue No. 2. (21CFR74.3102) or Logwood extract, C.I. Natural Black 1. (21CFR74.1410). NYLON will be offered with or without standard needles attached.

E. Intended Use:

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

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T.CAD International
991001/MG-510(k)
NYLON

	NYLON	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	L-chain aliphatic polymers Nylon6 and/or Nylon 6,6.	L-chain aliphatic polymers Nylon6 and/or Nylon 6,6.
SutureCharacteristics	Not absorbed, progressivedegradation of the nylon in vivomay result in gradual loss of all ofthe suture's tensile strength overtime.	Not absorbed, progressivedegradation of the nylon in vivomay result in gradual loss of all ofthe suture's tensile strength overtime.
Sterilization Method	Gamma Irradiation	Same or equivalent method.
How Supplied	Monofilament thread, coated oruncoated, undyed or dyed with anFDA listed color additive.Sterile and offered for Single UseOnly. Available with or withoutsurgical needle.	Same of equivalent manner.Monofilament, uncoated, undyedor dyed with the same FDA listedcolorants (Blue or Black).Available with or without needles.
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 "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

F. Comparison to Predicate Device:

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T.CAD International 991001/MG-510(K) NYLON

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

a. United States Pharmacopeia Standards.
b. ISO 9002, EN 46002 & EN 552 Standards
FDA Guidance documents " Alternate Suture Labeling" Resulting from c. 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 2000

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

K993998 Re: Trade Name: Nylon Regulatory Class: II Product Code: GAR 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:

1. The Nylon Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
1. This device may not be manufactured from any long chain aliphatic polymers other than nylon 6 and/or nylon 6,6. 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 Nylon 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 yours,

Nat. R.P. Ogden.

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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K993998

T.CAD International 991001/MG-510(k) NYLON

SECTION II

Statement of indication for use

Device Name: NYLON

510(k) Number:

Indication for use:

NYLON 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

NRO fr Tzd

(Division Sign-Off) (Division of General Restorative Devir" ( 99 3998

Regulation Number and Section

§ 878.5020 Nonabsorbable polyamide surgical suture.

(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; 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.