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

Device Description

SILK is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.

SILK is offered braided, uncoated or silicon coated, undyed or dyed with an FDA listed color additive, D&C Blue No. 9 (21CFR74.1109), or Logwood extract, C.I. Natural Black 1 (21CFR74.1410). SILK meets the United States Pharmacopeia (U.S.P.) monograph requirements for nonabsorbable silk surgical sutures.

AI/ML Overview

This is a 510(k) summary for a medical device called SILK, which is a nonabsorbable surgical suture. The provided text describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. It is important to note that this document is for a surgical suture, not an AI-powered diagnostic device. Therefore, the typical acceptance criteria and study designs associated with AI performance (like accuracy, sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this submission.

The "acceptance criteria" for a surgical suture like SILK are related to its physical properties and biocompatibility, typically established by adherence to recognized standards like the United States Pharmacopeia (USP). The "study" proving it meets these criteria is non-clinical testing.

Here's the information extracted and interpreted in the context of a surgical suture, addressing your points where applicable:

Acceptance Criteria and Device Performance (for a Surgical Suture)

1. A table of acceptance criteria and the reported device performance

For a surgical suture, the "acceptance criteria" are compliance with established industry standards and functional requirements compared to a predicate device. The "device performance" is simply meeting these standards and demonstrating substantial equivalence.

Acceptance Criteria (for Surgical Suture)	Reported Device Performance (SILK)
Intended Use Equivalence: General soft tissue approximation and/or ligation (including cardiovascular, ophthalmic, neurological procedures).	Meets: Indicated for use identical to the predicate device: general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Suture Material Equivalence: Natural Organic Protein (Fibroin), Braided or Twisted, White/Dyed.	Meets: Natural Organic Protein (Fibroin) from Bombyx mori. Braided, uncoated or silicon coated, undyed or dyed (D&C Blue No. 9 or Logwood extract).
Suture Characteristics Equivalence: Not absorbed, gradual loss of tensile strength in vivo.	Meets: Not absorbed, progressive degradation of proteinaceous silk fiber in vivo may result in gradual loss of all of the suture's tensile strength over time.
Sterilization Method Equivalence: Same or equivalent process as predicate.	Meets: Gamma Irradiation. Predicate device uses "Same or equivalent process."
How Supplied Equivalence: Sterile, single use, braided, coated/uncoated, undyed/dyed, with/without needle. Meets USP requirements.	Meets: Sterile, single use, braided, uncoated or coated, undyed or dyed with FDA listed color additive. Available with or without surgical needle. Meets U.S.P. Requirements. Predicate is "Same or equivalent manner" and also meets U.S.P. Requirements.
Suture Diameter, Suture Length, Knot Pull Tensile Strength, Needle Attachment Strength Equivalence.	Implied Meets: The table includes these categories but the cells are blank. However, the text 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. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses." This implies these specific parameters meet the USP standards and are substantially equivalent.
Packaging Equivalence: Similar dry packaging.	Meets: Dry packaged in Aluminum Foil and Polyester tear open packaging. Predicate is "Dry packaged in Tyvek/Mylar." (Considered equivalent as both are dry, tear-open packaging).
Labeling Equivalence: Conformance with CDRH instructions and FDA Guidance documents.	Meets: In conformance with CDRH instructions and FDA Guidance documents ("Alternate Suture Labeling"). Predicate is "Same."
Conformance to U.S.P. Standards.	Meets: "Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Absorbable surgical suture." (Note: The device is nonabsorbable, so this might be a typo in the original text, likely meaning nonabsorbable surgical suture standards). The device description explicitly states SILK "meets the United States Pharmacopeia (U.S.P.) monograph requirements for nonabsorbable silk surgical sutures."
Conformance to ISO 9002, EN 46002 & EN 552 Standards.	Meets.

Study Details (Relevant to a Surgical Suture)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated as a distinct "test set" in the context of AI. For a surgical suture, non-clinical testing involves mechanical and material tests. The number of samples for these tests would follow USP and ISO testing protocols, but the specific quantity is not provided.
Data Provenance: Not applicable in the AI sense. This is non-clinical performance and physical property testing of manufactured suture samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable. Ground truth for a suture is established by objective physical and chemical testing against recognized standards (e.g., USP monographs for tensile strength, diameter, sterility, material composition). It doesn't rely on expert consensus in the same way an AI diagnostic image interpretation would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. Performance is measured objectively against standards, not through human interpretation requiring adjudication.

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

MRMC Study: No. This is a surgical suture, not an AI diagnostic device. MRMC studies are specific to evaluating AI's impact on human diagnostic performance.

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

Standalone Performance: Not applicable. This is a physical device, a suture, not an algorithm. The "standalone performance" is its physical and chemical properties as tested.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Established by recognized physical and chemical standards and specifications from regulatory bodies (e.g., United States Pharmacopeia (USP)) and international standards organizations (e.g., ISO, EN). This includes specifications for material composition, dimensions, tensile strength, sterility, and biocompatibility.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for a surgical suture's regulatory submission outside of potentially manufacturing process validation data, which is not described here in detail.

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

Ground Truth for Training Set Establishment: Not applicable as there is no training set for this type of device.

Summary for this specific device (SILK Surgical Suture):

The "acceptance criteria" are adherence to the U.S.P. standards for nonabsorbable silk surgical sutures, ISO 9002, EN 46002, and EN 552 Standards, and substantial equivalence to the predicate device (Davis & Geck Silk Non-Absorbable Surgical Sutures, K930590) in terms of material, characteristics, intended use, manufacturing, and labeling.

The "study that proves the device meets the acceptance criteria" is Non-Clinical Testing. This testing focused on:

Conformance to U.S.P. standards.
Physical properties and functionality testing to assure safety and effectiveness.
Demonstrating substantial equivalence to the predicate device.

No clinical testing was available or required for this 510(k) submission, indicating that the non-clinical data was deemed sufficient for establishing substantial equivalence for this Class II surgical suture.

Summary

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

T.CAD International 991002/MG-510(K) SILK

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:	October 2nd 1999.

B. Device Name:

Trade Name: SILK a.
Common or Usual Name: Silk Surgical Suture, Nonabsorbable ﻓ
c. Classification Name: Natural nonabsorbable silk surgical suture (Per 21CFR878.5030)

C. Predicate Device:

Silk Non-Absorbable Surgical Sutures of Davis & Geck (K930590)

D. Device Description:

E. Intended Use:

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

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

493999

T.CAD International
991002/MG-510(k)
SILK

	SILK	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	Natural Organic Protein (Fibroin).Braided or Twisted, available inWhite (Virgin) or Dyed (Black orBlue).	Natural Organic Protein (Fibroin).Braided or Twisted, available inWhite (Virgin) or Dyed (Black orBlue).
SutureCharacteristics	Not absorbed, progressivedegradation of the proteinaceoussilk fiber in vivo may result ingradual loss of all of the suture'stensile strength over time.	Not absorbed, progressivedegradation of the proteinaceoussilk fiber in vivo may result ingradual loss of all of the suture'stensile strength over time.
Sterilization Method	Gamma Irradiation	Same of equivalent process
How Supplied	Sterile and offered for Single UseOnly. Braided, uncoated or coated,undyed or dyed with an FDAlisted color additive. Availablewith or without surgical needle.Meet U.S.P. Requirements	Same or equivalent manner.Predicate device is offeredbraided, coated with silicon,undyed or dyed with the sameFDA listed colorants.Meet U.S.P. Requirements
Suture Diameter,Suture Length,Knot Pull TensileStrength and NeedleAttachmentStrength
Packaging	Dry packaged in Aluminum Foiland Polyester tear open packaging.	Dry packaged in Tyvek/Mylar
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:

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

K943999

T.CAD International 991002/MG-510(k) SILK

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
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.

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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: K993999 Trade Name: Silk Regulatory Class: II Product Code: GAP 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 Tuesday, October 26, 1993 (Vol. 58, No. 205, Pages 57557 and 57558). 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 Silk 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 material other than multifilamentous fibers composed of fibroin, an organic protein that is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. 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 Silk. 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.

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

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,

Neil 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

{5}------------------------------------------------

K993999

T.CAD International 991002/MG-510(k) SILK

SECTION II

Statement of indication for use

Device Name: SILK

510(k) Number:

Indication for use: SILK 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 for J20

(Division Sign-Off) Division of General Restorative De--- ----------------------------------------------------------------------------------------------------------------------------------------

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.