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

Device Description

This Silk suture is a nonabsorbable, sterile, surgical sutures composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture.

This nonabsorbable suture is compossed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specification.

This suture may be uncoated or have a silicone coating , a paraffin wax coating , or a natural gum coating ( Virgin Silk) . This sutures come with needles attached.

AI/ML Overview

The provided document is a 510(k) summary for Aurolab's nonabsorbable Silk sutures. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data as typically seen in AI/ML device submissions.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Based on USP Standards)	Reported Device Performance (as stated)
Material Properties	Diameter meets USP specifications	Meets USP standards
Mechanical Properties	Tensile strength meets USP specifications	Meets USP standards
Device Integration	Suture-needle attachment meets USP specifications	Meets USP standards

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

Sample Size: Not explicitly mentioned. The document states that "tests according to methods presented in United States Pharmacopoeia (U.S.P) were conducted for diameter, tensile strength and Suture-needle attachment." USP monographs specify testing methods, which include sample sizes (e.g., 10 suture strands for specific tests), but the exact number of samples tested by Aurolab is not provided in this summary.
Data Provenance: The tests were conducted internally by Aurolab in India. The data is retrospective in the sense that the summary is presenting results of tests already completed.

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

This is not applicable to the provided document. The "ground truth" for this medical device (nonabsorbable silk suture) is established by adherence to recognized industrial standards, specifically the United States Pharmacopoeia (USP). Experts in this context would be laboratory technicians and quality control personnel performing the physical and mechanical tests, not clinical experts establishing a medical "ground truth."

4. Adjudication Method

Not applicable. Performance is determined by objective measurements against predefined USP specifications, not by expert adjudication of clinical outcomes or images.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI/ML devices where human interpretation is involved. For a surgical suture, the effectiveness is demonstrated through mechanical and material property testing and clinical use experience (not detailed in this summary).

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. This is a medical device (surgical suture), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on United States Pharmacopoeia (USP) standards and specifications for nonabsorbable silk sutures. These are objective, measurable physical and chemical properties.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Summary of Acceptance Criteria and Study Design for the Suture:

The study conducted to demonstrate the substantial equivalence of the Aurolab nonabsorbable Silk sutures was a bench testing study focused on characterizing the physical and mechanical properties of the suture.

Acceptance Criteria: The primary acceptance criteria were that the device's diameter, tensile strength, and suture-needle attachment met the specifications outlined in the United States Pharmacopoeia (USP) for nonabsorbable silk sutures.
Study Design:
- Objective: To establish technical equivalency with predicate devices (Ethicon silk nonabsorbable sutures).
- Methodology: Performance tests were conducted in accordance with USP methodologies.
- Results: The tests performed showed that Aurolab devices meet USP standards and are technically equivalent to the predicate devices.
- Conclusion: Based on these tests, the device was deemed substantially equivalent to legally marketed predicate devices.

Summary

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Aravind Eye Hospital 1 Anna Nagar Madurai - 625 020, India

Page 3 of 22 Phone : +91 - 452 - 535573 or 537580 : +91 - 452 - 535274 or 530984 Fax E-mail : aurolab@aurolab.com

024e91 (R 1 of 2)

510(K) Summary

This summary of 510 (k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

The assigned 510 (k) number is:_

FEB 2 8 2003

Applicant:

Aurolab, Aravind Eye Hospital LAICO Building 72 KK Salai, Gandhi Nagar, Madurai - 625020, India.

Tel: 91 — 452 — 535573 Fax: 91 - 452 - 535274 Email: aurolab@aurolab.com bala@aurolab.com

Contact Person:

In India	In United States
Dr.P.Balakrishnan,	U.S.Representative:
Managing Director,
Aurolab,	Michael G. Price
Aravind Eye Hospital	President,
LAICO Building	Visionary Medical Supplies, Inc.
72 KK Salai,	6441 Enterprise Lane, Suite 214
Gandhi Nagar,	Madison, WI 53719
Madurai - 625020,
India.	Phone: 608-270-3880
Tel: 91 - 452 - 535573Fax: 91 - 452 - 535274Email: aurolab@aurolab.com bala@aurolab.com	Phone: 608-270-3880Fax: 608-270-3882Email:visionarymedical@earthlink.net

Date of 510 (k) summary preparation: November 11, 2002

Factory : Aravind Eye Hospital, LAICO Building, 72 KK Salai, Gandhi Nagar, Madurai 625 020. India

Image /page/0/Picture/14 description: The image shows a logo with the letters "UL" inside a circle with the word "REGISTERED" around it. To the right of the logo, the text reads "For Intraocular Lens and Suture Needle Divisions only". Below the logo, the text "aurolab ISO 9002 File No A6187" is present, followed by the partial text "A note".

For Intrancular Needles only

Image /page/0/Picture/16 description: The image shows the CE marking, a symbol indicating conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. Below the CE marking is the number 0543, which is likely a notified body identification number. This number indicates that a third-party organization has been involved in assessing the product's compliance with the relevant CE marking directives.

"A not-for-profit organisation dedicated to supply nroducts and services to eve care provid

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Page 4 of 22
K02 4091 (P. 20f2)

Trade name: ------

Common name: Suture, nonabsorbable, Silk

Predicate devices:

Nonabsorbable Silk sutures manufactured by Aurolab are equivalent to Ethicon silk nonabsorbable sutures.

Device description:

This nonabsorbable suture is compossed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specification.

This suture may be uncoated or have a silicone coating , a paraffin wax coating , or a natural gum coating ( Virgin Silk) . This sutures come with needles attached.

Intended use:

Nonabsorbable Silk suture manufactured by Aurolab is indicated for use in general soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Performance tests to demonstrate substanital equivalency:

To establish the technical equivalency of Non absorbable sutures manufactured by Aurolab with the predicate devices, tests according to methods presented in United States Pharmacopoeia (U.S.P) were conducted for diameter, tensile strength and Suture- needle attachment.

The test results shows that Aurolab devices tested meet USP standards and are technically equivalent to the predicate devices tested.

Bolin

Dr.P.Balakrishnan, M.D., Aurolab

November 11, 2002, Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2003

Aurolab c/o Visionary Medical Supplies Michael G. Price President 6441 Enterprise Lane, Suite 214 Madison, Wisconsin 53719

Re: K024091 Trade/Device Name: Silk Sutures Regulation Number: 878.5030 Regulation Name: Nonabsorbable silk surgical suture Regulatory Class: Class II Product Code: GAP Dated: December 6, 2002 Received: December 11, 2002

Dear Mr.Price:

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.

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Page 2 - Mr. Michael G. Price

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), please contact the Office of Compliance at (301) 594-4659. 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,

Miriam C. Provost

لها 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

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Page 21 of 22

Statement of Indications for Use

Page 1 of 1

510(k) Number (if known): K024691

Device Name: Suture, nonabsorbable, Silk

Trade name: ----------------

Common name: Suture, nonabsorbable, Silk

Instructions for Use:

Aurolab nonabsorbable Silk suture 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 THIS LINE- CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

Division Sign Division of General Restorative and Neurological revices

510(k) Number K024091

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.