CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Device Description

CATGUT, Plain and Chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. CATGUT meets the United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures. It will be offered uncoated or coated with glycerol and with or without standard needles attached.

AI/ML Overview

The acceptance criteria for the T.CAD International PLAIN/CHROMIC CATGUT surgical sutures are primarily based on conformance to established standards and similarity to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Characteristic)	Reported Device Performance (T.CAD International CATGUT)
Intended Use	Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Suture Material	Absorbable, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine.
Suture Characteristics (Tensile strength loss & absorption rates)	Factors which can affect tensile strength loss and absorption rates: a. Type of suture (Plain vs. Chromic), b. Infection, c. Tissue Sites (e.g., presence of proteolytic enzymes).
Sterilization Method	Gamma Irradiation
How Supplied	Sterile and undyed. Offered for Single Use Only with or without surgical needles. Also offered uncoated or coated with glycerol.
Suture Diameter	Meets U.S.P. Requirements
Suture Length	Meets U.S.P. Requirements
Knot Pull Tensile Strength	Meets U.S.P. Requirements
Needle Attachment Strength	Meets U.S.P. Requirements
Packaging	Packaged with an alcohol solution in Aluminum Foil and Polyester tear open packaging.
Labeling	In conformance with CDRH instructions of the "Medical Device Quality Manual" dated December 1996 and FDA Guidance documents "Alternate Suture Labeling," reformatted on December 17th, 1997.
Compliance with Standards	Conformance to U.S.P. standards, ISO 9002, EN 46002 & EN 552 Standards, and FDA Guidance documents "Alternate Suture Labeling."

Study Proving Acceptance Criteria:

The device's acceptance was proven through non-clinical testing designed to demonstrate conformance to U.S.P. standards and substantial equivalence to the predicate device.

2. Sample Size and Data Provenance (Test Set):

Sample Size: Not specified in the provided text for the non-clinical testing.
Data Provenance: The testing was "Non-Clinical Testing ... conducted on the subject device." This suggests the data was generated as part of a regulatory submission process. The origin (e.g., country) of the specific data points is not mentioned, but the overall regulatory framework is the U.S. FDA. The testing is implicitly prospective as it's for a new device submission.

3. Number of Experts and Qualifications (Ground Truth for Test Set):

This information is not applicable/not provided as there's no mention of a clinical study, expert review of images, or diagnostic interpretation. The acceptance criteria are based on physical properties and manufacturing standards, not expert interpretations of medical data.

4. Adjudication Method (Test Set):

None specified. As the evaluation is against physical and material standards (U.S.P. requirements, etc.), expert adjudication of subjective findings is not relevant.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Not available at the present time." The device is cleared based on non-clinical testing and substantial equivalence to a predicate.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical surgical suture, not an AI algorithm. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. Type of Ground Truth Used:

The "ground truth" used was based on established industry standards and specifications:
- United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures.
- Relevant ISO and EN standards (ISO 9002, EN 46002 & EN 552).
- FDA Guidance documents related to suture labeling.
- The characteristics and performance of the chosen predicate device (Plain and Chromic Absorbable Surgical Sutures of Davis & Geck - K930589).

8. Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of this device. This is a physical medical device, not a machine learning model.

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

Not applicable. As there is no training set for an AI model, this question is irrelevant to the provided information.

Summary

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FEB 4 2000

T.CAD International 990930/MG-510(k) CATGUT

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 2nd 1999. Date Prepared:

B. Device Name:

Trade Name: PLAIN/CHROMIC CATGUT a.
Common or Usual Name: Absorbable Surgical Gut Sutures, Plain & Chromic ﻓ
Classification Name: Absorbable surgical gut Suture. (Per 21CFR878.4830) C.

C. Predicate Device:

Plain and Chromic Absorbable Surgical Sutures of Davis & Geck (K930589) SOFTGUT® Plain and Chromic Absorbable Surgical Suture (Davis & Geck)

D. Device Description:

E. Intended Use:

CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

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1944002

T.CAD International 990930/MG-510(k) CATGUT

F. Comparison to Predicate Device:

	CATGUT	Predicate Device
Intended Use	CATGUT is indicated for use ingeneral soft tissue approximationand/or ligation, including use inophthalmic procedures, but not foruse in cardiovascular andneurological procedures.	Is indicated for use in general softtissue approximation and/orligation, including use inophthalmic procedures, but not foruse in cardiovascular andneurological procedures.
Suture Material	Absorbable, flexible threadprepared from either the serosalconnective tissue layer of beef(bovine) or the submucosal fibroustissue of sheep (ovine) intestine	Absorbable, flexible threadprepared from either the serosalconnective tissue layer of beef(bovine) or the submucosal fibroustissue of sheep (ovine) intestine
SutureCharacteristics	Factors which can affect tensilestrength loss and absorption ratesare:a. Type of suture-Plain gutgenerally is expected toabsorb more rapidly thanchromic gut.b. Infection-Surgical gut isabsorbed more rapidly ininfected tissue than in non-infected tissue.Tissue Sites-Surgical gut willabsorb more rapidly in tissuewhere increased levels ofproteolytic enzymes arepresent, as in the secretionsexhibited in the stomach, cervixand vagina.	Same
Sterilization Method	Gamma Irradiation	Same or equivalent method
How Supplied	Sterile and undyed. Offered forSingle Use Only with or withoutsurgical needles. Also offereduncoated or coated with glycerol.	Same or equivalent manner.SOFTGUT® is offered coatedwith glycerol.
Suture Diameter,Suture Length,Knot Pull TensileStrength and NeedleAttachment Strength	Meet U.S.P. Requirements	Meet U.S.P. Requirements
Packaging	Packaged with an alcohol solutionin Aluminum Foil and Polyestertear 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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T.CAD International 990930/MG-510(k) CATGUT

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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

Re: K994002 Trade Name: Plain/Chromic Catgut Regulatory Class: II Product Code: GAL 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 Monday, December 11, 1989 (Vol. 54, No. 236. Pages 50737 and 50738). 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 Plain/Chromic Catgut Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
1. This device may not be manufactured from any material other than serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine. 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 manufacturing of the Plain/Chromic Catgut surgical suture. Any deviation of the polymer composition or processing as described in this 510(k) notification must be submitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed change(s).

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Page 2 -- Mr. Main M. Ghazal

The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.

The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (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 the Radiation Control for Health and Safety Act of 1968, 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.

Nail 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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K 944002

T.CAD International 990930/MG-510(k) CATGUT

SECTION II

Statement of indication for use

Device Name: PLAIN/CHROMIC CATGUT

510(k) Number:

Indication for use:

CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

NRo for JzD

Division Sign-Off) Division of General Restorative Devices 994002 510(k) Number _

(PLEASE DO NOT WRITE BELOW THE LINE - CONTINUE ON ANOTHER PACE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use OR

Regulation Number and Section

§ 878.4830 Absorbable surgical gut suture.

(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.