The black silk braided nonabsorbable sutures, USP, are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

The black silk braided nonabsorbable sutures, USP, manufactured by Johnson & Johnson Medical (China) Ltd. can be braided, coated with wax, dyed black (Logwood), available in a range of gauge sizes and lengths, and attached to stainless steel needles of varying types and sizes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Mersilk® Black Silk Braided Non-absorbable suture:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from USP XXIIII and other regulations)	Reported Device Performance
Suture diameter requirements (USP XXIIII)	Meets or exceeds USP specifications.
Suture length requirements (USP XXIIII)	Meets or exceeds USP specifications.
Knot pull tensile strength requirements (USP XXIIII)	Meets or exceeds USP specifications.
Needle attachment strength requirements (USP XXIIII)	Meets or exceeds USP specifications.
Additive (Logwood) content (Handbook of U.S. Colorants: Foods, Drugs, Cosmetics and Medical Device, version 3)	In conformance with the requirement addressed in Handbook of U.S. Colorants: Foods, Drugs, Cosmetics and Medical Device, version 3. Additionally, Logwood and coating wax are proved to be nontoxic.
Labeling compliance (USP XXIIII)	Complies with the specific requirement of USP XXIIII.
Symbol on packaging compliance (ISO/TR 15223)	Complies with the requirements of ISO/TR 15223 Medical Devices-Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied.
Sterilization validation and monitoring (corporate and international regulations)	Process of gamma sterilization, implemented by contract sterilizer, is validated and approved in conformance to corporate and international regulations. The gamma sterilization is approved and monitored according to established procedures.
Incoming material, in-process material, and finished goods acceptance/rejection criteria	Established procedures define the criteria of acceptance and rejection for incoming material, in process material and finished goods. The requirements are stricter than or in conformance to that of USP.
Biocompatibility (proven non-toxic)	Additives including Logwood and coating wax, are proved to be nontoxic. (Mentioned under "Performance Data" and "Performance and section 7.0 Biocompatibility").

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

The document mentions "various testing and clinical study contained in this submission," but does not explicitly state the sample size for the test set used to demonstrate adherence to USP XXIIII standards (suture diameter, length, knot pull tensile strength, needle attachment strength) or for the biocompatibility testing.

The data provenance is retrospective, as the testing was conducted on manufactured products to demonstrate compliance with established standards. The manufacturer is Johnson & Johnson Medical (China) Ltd., indicating the data would originate from China.

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

The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of a clinical diagnostic study. The ground truth for the physical and chemical properties of the suture (e.g., diameter, strength, content) is established by conformance to established industry standards like USP XXIIII and ISO/TR 15223. For biocompatibility, it's stated that the additives are "proved to be nontoxic," implying testing against accepted toxicological standards, but details on the experts involved in interpreting such tests are absent.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation is based on objective, quantifiable measurements against pre-defined specifications from USP and other regulatory standards, not on subjective expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and an AI's impact on their performance is measured. This submission is for a surgical suture, a physical medical device, where performance is measured by objective physical and chemical properties, not by human interpretation of data aided by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in essence, standalone performance was assessed. The device's characteristics (diameter, length, strength, additive content) were tested directly against the USP and other regulatory specifications. There is no "human-in-the-loop" component for the performance evaluation of the suture itself; its performance is independently verifiable.

7. The Type of Ground Truth Used:

The primary type of ground truth used is established industry and regulatory standards.

USP XXIIII (United States Pharmacopeia): For physical properties like suture diameter, length, knot pull tensile strength, and needle attachment strength.
Handbook of U.S. Colorants: Foods, Drugs, Cosmetics and Medical Device, version 3: For additive (Logwood) content.
ISO/TR 15223: For symbols on packaging.
Corporate and international regulations: For sterilization validation.
Biocompatibility testing: Proving non-toxicity, which implies testing against accepted toxicological protocols.

8. The Sample Size for the Training Set:

Not applicable. The device is a surgical suture, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing processes are validated, and quality control procedures are established, but these are not equivalent to training an AI model.

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

Not applicable, as there is no training set for an AI algorithm. For the manufacturing and quality control aspects, the "ground truth" for ensuring product quality is established through validated processes, established procedures for acceptance/rejection criteria, and adherence to regulatory standards (like USP) for incoming materials, in-process materials, and finished goods.

Summary

{0}------------------------------------------------

SEP 1 9 2001

Image /page/0/Picture/2 description: The image shows a logo with a globe and an arrow. The globe is a wireframe style, showing the continents. An arrow is pointing upwards and to the right, with three lines that make up the arrow. The text is illegible.

ron Medical (China) Ltd. 国)医疗器材有限公司

#660 Xin Hua Road, Man Po International Center, 3rd Floor, Shanghai 200052, China Tel: 8621-62826988 Fax: 8621-62825037

510(K) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

"The assigned 510(K) number is :

Applicant:	Johnson & Johnson Medical (China) Ltd.#660 Xin Hua Road, Man Po International Center, 3rd FloorShanghai 200052, China



	Tel: 8621-62826988 Fax: 8621-62825037

Contact: Ben Tang #75 Nan Gu Zhi Road, Minhang, Shanghai 200245, China Tel: 6821-64635010 Fax:8621-64622528

Date: March 30, 2001

Name of Device:

Common or Usual Name: Silk Nonabsorbable Surgical Sutures. Classification Name: Suture, Nonabsorbable, Silk. Proprietary/Trade Name: Mersilk® Black Silk Braided Non-absorbable suture, USP

Predicate Device Information:

ARC Medical Supplies (beijing) Co., Ltd., Silk Nonabsorbable Surgical Suture, USP. 510(K) number is K000541.

Device Description:

Intended Use:

The black silk braided nonabsorbable sutures, USP, are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. (See sec 3.0 Labeling)

{1}------------------------------------------------

Technological Characteristics:

All the equipment and processes concerned with product quality have been validated before put into place. Process of gamma sterilization, implemented by contract sterilizer, is validated and approved in conformance to corporate and international regulations. The gamma sterilization is approved and monitored according to established procedures. (See sec 8.0 Sterilization)

The established procedures define the criteria of acceptance and rejection for incoming material, in process material and finished goods. The requirements are stricter than or in conformance to that of USP. (See sec 9.0 Manufacturing and Quality Assurance)

Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength according to methods outlined in USP XXIIII demonstrates that Johnson & Johnson Medical (China) Ltd. silk surgical sutures meet or exceed USP specifications. The additive (Logwood) content is in conformance with the requirement addressed in Handbook of U.S. Colorants: Foods, Drugs, Cosmetics and Medical Device, version 3. (See sec 6.0 Performance)

Labeling comply with the specific requirement of USP XXIIII, and the symbol on the packaging comply with the requirements of ISO/TR 15223 Medical Devices-Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied (See section 3.0 Labeling).

Performance Data:

Mersilk® Black Silk Braided Non-absorbable suture, USP, meet or exceed the requirements of USP XXIIII. And the additives including Loogwood and coating wax, are proved to be nontoxic. (See section 6.0 Performance and section 7.0 Biocompatibility)

Substantial Equivalence:

The black silk braided nonabsorbable sutures, USP, have the same intended use, and similar principles of operation and technological characteristics as the predicate device. Moreover, various testing and clinical study contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, Mersilk® Black Silk Braided Non-absorbable sutures, USP, are substantially equivalent to the predicate devices. (See sec 10.0 Comparison)

Comparison to Predicate Devices:

The black silk braided nonabsorbable sutures, USP, are substantially equivalent to the silk nonabsorbable surgical sutures, USP, manufactured by ARC Medical Supplies (Beijing) Co., Ltd..

Simon Li, Managing Director

April 25 2001
Date

{2}------------------------------------------------

Image /page/2/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 heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

SEP 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Johnson & Johnson Medical (China) Ltd. c/o Mr. Ben Tang Ouality Assurance Manager #75 Nan Gu Zhi Road, Minhang Shanghai 200245 China

Re: K012124

Trade/Device Name: Mersilk Black Silk Braided Non-absorbable Suture Regulation Number: 878.5030 Regulation Name: Non-absorbable silk suture Regulatory Class: II Product Code: GAP Dated: March 30, 2001 Received: July 6, 2001

Dear Mr. Tang:

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.

{3}------------------------------------------------

Page 2 - Mr. Ben Tang

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Susan Wolken, MD

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

{4}------------------------------------------------

Page_ I_of_

012124 510(k) Number (if known); Jon-abso Silk Black ersilk Device Name: Indications For User

general C:16 indicated suture । C ligation ાડણ and for approximation નંડવાદ 9100 proced frees and neurolo ophth almic cardiovascular ,

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER I AGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Form t 3-10-98)

SU
K012124

(Division Sign-Off) (Division Sign-Off)
Division of General, Restorative
Division of General, Devices Division of General, and Neurological Devices

KOIZIZ 510(k) Number -

Regulation Number and Section

§ 878.5030 Natural nonabsorbable silk surgical suture.

(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.