Grams Absorbable Surgical Gut Suture (Plain and Chromic) 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

Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Grams Absorbable Surgical Gut Suture (Plain and Chromic):

This document describes a 510(k) premarket notification for a medical device (surgical suture), not an AI/ML device. Therefore, many of the requested categories related to AI/ML specific studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable. The device's "performance" is based on conformity to established physical and chemical standards for surgical sutures.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Comparison Items (Acceptance Criteria)	Grams American Suture Inc. (Reported Device Performance)	Notes
Absorbable Surgical Gut Suture (Plain & 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.	Same	Grams suture is composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines, aligning with the predicate devices.
Absorbable Surgical Gut Suture (Plain & Chromic) 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.	Same	Grams suture shares the same intended use as the predicate devices.
Absorbable Surgical Gut Suture (Plain & Chromic) supplied for single use only, with or without needles attached, uncoated or coated with a glycerol solution.	Same	This characteristic matches the predicates (with one predicate being "Similar" for coating).
Absorbable Surgical Gut Suture (Plain & Chromic) is packed with a packet fill solution of 90% Isopropyl Alcohol, 0.5% Diethylethanolamine 0.5% Sodium Benzoate and water q.s ad 100%.	Same	This characteristic matches the predicates (with two predicates being "Similar").
Absorbable Surgical Gut Suture (Plain & Chromic) packaged in the same or equivalent manner, and has the same or equivalent labeling claims as the predicate devices including indications, contraindications, warnings, cautions, and precautions.	Same	The packaging and labeling claims are equivalent.
Finished suture material meets or exceeds the performance requirements for "Absorbable Surgical Suture" as defined in the Official Monograph of the United States Pharmacopeia 23 and the current edition USP 24.	Same	The suture material meets or exceeds the general performance requirements of USP 23 and USP 24.
Finished suture material meets the performance requirements defined in the United States Pharmacopeia 23 and the current edition USP 24 for "Diameter" <861>.	Same	The suture meets USP 23 and USP 24 requirements for diameter.
Finished suture material meets or exceeds the performance requirements defined in the United States Pharmacopeia 23 and the current edition USP 24 for "Tensile Strength" <881>.	Same	The suture meets or exceeds USP 23 and USP 24 requirements for tensile strength.
Finish suture material meets or exceeds the performance requirements defined in the United States Pharmacopeia 23 and the current edition USP 24 for "Needle Attachment" <871>.	Same	The suture meets or exceeds USP 23 and USP 24 requirements for needle attachment.
Finished suture material meets the performance requirements defined in the United States Pharmacopeia 23 and the current edition USP 24 for "Finish suture Length Requirement" (95% of stated label length).	Same	The suture meets USP 23 and USP 24 requirements for length.
Finished suture material packaged in a same or equivalent manner with sterile single or double package having labeling conforming to 21 CFR and USP XXIV.	Same	The packaging conforms to 21 CFR and USP XXIV.
Grams Absorbable Gut Suture (Plain & Chromic) is composed of the same material and has the same design as predicate devices, being a sterile, flexible, monofilament-like thread meeting all USP requirements.	Same	Explicitly stated in the conclusion. The device is made from the same raw materials and manufactured in a similar manner to the predicate devices.

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. The document refers to "performance testing data" but does not give specific numbers of sutures tested.
Data Provenance: Not specified, but implied to be from a manufacturing and testing process adhering to USP standards. Given the applicant's address (Grafton, Wisconsin, USA), it's highly likely the testing was conducted in the USA or by a facility adhering to US regulations. The testing methodology would be prospective based on current manufacturing batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. The "ground truth" for suture performance is established by objective, standardized physical and chemical tests defined in the United States Pharmacopeia (USP Monograph). This does not involve expert consensus in the way an AI diagnostic tool would.
Qualifications of Experts: Not applicable for establishing ground truth; however, the testing would be performed by qualified laboratory personnel following USP protocols.

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

Adjudication Method: Not applicable. The performance is based on objective measurements against USP standards, not subjective assessment 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 traditional medical device (suture), not an AI/ML device.

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

Standalone Study: Not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the physical and chemical characteristics of the suture itself.

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

Type of Ground Truth: The ground truth is defined by objective, standardized measurements against the specifications and test methods outlined in the United States Pharmacopeia (USP 23 and USP 24) for "Absorbable Surgical Suture", "Diameter" <861>, "Tensile Strength" <881>, "Needle Attachment" <871>, and "Finish suture Length Requirement".

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/ML device. The "training" for a physical device is its manufacturing process and quality control, which is implicitly ongoing.

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

How Ground Truth for Training Set was Established: Not applicable. For a manufactured product like a suture, ongoing quality control and adherence to manufacturing specifications ensure consistency. The "ground truth" for the manufacturing process is its ability to consistently produce sutures that meet the USP standards, which are verified through the performance testing mentioned in the document.

Summary

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JUN 2 1 2002

Image /page/0/Picture/1 description: The image shows the logo for GRAMS American Suture, Inc. The word "GRAMS" is written in large, bold, black letters with a curved line underneath it. Below the word "GRAMS" is the text "American Suture, Inc." in a smaller font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

Summary of Safety & Effectiveness Absorbable Surgical Gut Suture (Plain and Chromic)

KO21043

This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of Grams American Sutures to those of the legally marked devices listed.

A. Applicant:
Grams American Suture, Inc. 2225 Dakota Drive Grafton, Wisconsin 53024 USA
B. Contact Person: A. J. Dimercurio
C. Date Prepared: March 25, 2002
D. Device Name:
- Grams Absorbable Surgical Gut Suture o Trade Name: Plain & Chromic Common Name: Plain & Chromic Cat Gut Absorbable Suture O Classification Name: Absorbable Surgical Gut Suture O
E. Predicate Devices: Grams Absorbable Surgical Gut Suture is substantially equivalent to these predicate devices:
- AESCULAP Absorbable Surgical Gut Suture, Plain & Chromic & Softcat Gut Suture, O 510K Number K991223, AESCULAP, San Diego California.
- o T. Cad International, Plain/Chromic Catgut Suture, Trading Consultants& Distributors International Inc. 510K Number K994002, Chicago IL.
- CP Medical, Plain and Chromic Absorbable Surgical Gut Suture, o 510K Number K001299, CP Medical Portland Oregon.
F. Device Description:

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Image /page/1/Picture/0 description: The image shows the logo for GRAMS American Suture, Inc. The word "GRAMS" is written in large, bold, black letters with a curved line above it. Below the word "GRAMS" is the text "American Suture, Inc." in a smaller font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

G. Intended Use:

"Grams Absorbable Surgical Gut Suture (Plain and Chromic) 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".

H. Technological Comparison to Predicate Devices:

COMPARISON TABLE GRAMS TO PREDICATE DEVICES
Comparison Items	GramsAmericanSutureInc.	T. CadInternational	CPMedical	AESCULAP
Absorbable Surgical Gut Suture (Plain & Chromic) isan absorbable, sterile, flexible thread prepared fromeither the serosal connective tissue layer of beef(bovine) or the submucosal fibrous tissue of sheep(ovine) intestine.	Same	Same	Same	Same
Absorbable Surgical Gut Suture (Plain & Chromic) is"Intended for Use" in soft tissue approximation and/or ligation, including use in ophthalmic procedures,but not for use in cardiovascular and neurologicalprocedures.	Same	Same	Same	Same
Absorbable Surgical Gut Suture (Plain & Chromic)supplied for single use only, with or without needlesattached, uncoated or coated with a glycerol solution.	Same	Same	Similar	Same
Absorbable Surgical Gut Suture (Plain & Chromic) ispacked with a packet fill solution of 90% IsopropylAlcohol, 0.5% Diethylethanolamine 0.5% SodiumBenzoate and water q.s ad 100%	Same	Similar	Same	Similar
Absorbable Surgical Gut Suture (Plain & Chromic)packaged in the same or equivalent manner, and hasthe same or equivalent labeling claims as the predicatedevices including indications, contraindications,warnings, cautions, and precautions.	Same	Same	Same	Same
Finished suture material meets or exceeds theperformance requirements for "Absorbable SurgicalSuture" as defined in the Official Monograph of theUnited States Pharmacopeia 23 and the current editionUSP 24.	Same	Same	Same	Same
Comparison Items	GramsAmericanSuture Inc.	T. CadInternational	CPMedical	AESCULAP
Finished suture material meets the performancerequirements defined in the United StatesPharmacopeia 23 and the current edition USP24 for "Diameter" $< 861 >$	Same	Same	Same	Same
Finished suture material meets or exceeds theperformance requirements defined in the UnitedStates Pharmacopeia 23 and the current editionUSP 24 for "Tensile Strength" $< 881 >$	Same	Same	Same	Same
Finish suture material meets or exceeds theperformance requirements defined in the UnitedStates Pharmacopeia 23 and the current editionUSP 24 for "Needle Attachment" $< 871 >$	Same	Same	Same	Same
Finished suture material meets the performancerequirements defined in the United StatesPharmacopeia 23 and the current edition USP24 for "Finish suture Length Requirement"(95% of stated label length)	Same	Same	Same	Same
Finished suture material packaged in a same orequivalent manner with sterile single or doublepackage having labeling conforming to 21 CFRand USP XXIV.	Same	Same	Same	Same

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Image /page/2/Picture/0 description: The image shows the logo for GRAMS American Suture, Inc. The word "GRAMS" is written in a bold, sans-serif font, with a curved line above and below the word. Below the word "GRAMS" is the text "American Suture, Inc." in a smaller, serif font. The logo is simple and professional, and it effectively communicates the company's name and industry.

Technological Comparison to Predicate Devices Continued:

I. Conclusion:

Grams Absorbable Gut Suture (Plain & Chromic) is composed of the same material, as are the predicated devices and the same design, being a sterile, flexible, monofilament like threads meeting all the requirements of the United States Pharmacopeia. Grams American Absorbable Gut Suture (Plain & Chromic) is manufactured in the same manner as the predicate devices, being produced from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and produced in operations considered standard in the industry to form the finished suture strand. The raw suture material manufacturer supplies to Grams American Suture the same suture materials as it does to other suture manufacturers, which may include some of them listed above.

The results of the performance testing data presented demonstrate the substantial equivalence of Grams American Absorbable Gut Suture (Plain & Chromic) to that of the predicated devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is an emblem that resembles a stylized eagle or bird-like figure, with three curved lines representing its wings or feathers. The emblem is positioned in the center of the circle, and the overall design is simple and monochromatic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anthony J. Demercurio Grams American Suture, Inc. 2225 Dakota Drive Grafton, WI 53024

JUN 2 1 2002

Re: K021043

Trade/Device Name: Grams Absorbable Surgical Gut Suture Plain and Chromic Regulation Number: 878.4830 Regulation Name: Absorbable surgical gut suture Regulatory Class: II Product Code: GAL Dated: March 29, 2002 Received: April 1, 2002

Dear Mr. Demercurio:

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. Anthony J. Demercurio

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.

O. Mark A. Millerson

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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Image /page/5/Picture/0 description: The image shows the logo for GRAMS American Suture, Inc. The word "GRAMS" is in large, bold, black letters with a curved line underneath. Below the word "GRAMS" is the text "American Suture, Inc." in a smaller font. The logo is simple and professional.

Intended Use Statement

FDA Document Number K021043

Addendum Information

Device Name per 21CFR 878.4830 "Absorbable Surgical Gut Suture"

Indication for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE

for Mark M
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K021043

Prescription Use
(Per 21CFR 801.109)
Or
Over-The Counter Use __

(Optional Format 1-2-96)

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.