Demetech 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

Demetech 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

The provided document is a 510(k) summary for the Demetech Absorbable Surgical Gut Suture (Plain and Chromic), demonstrating substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, study types (MRMC, standalone), expert involvement, and ground truth establishment is not applicable in this context.

However, I can extract the relevant information from the document to address the aspects that are present:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here refers to meeting the performance requirements defined by the United States Pharmacopeia (USP) for absorbable surgical sutures, specifically USP 23 and the current edition USP 24. The reported device performance is that Demetech's suture "meets or exceeds" these requirements.

Comparison Item (Acceptance Criteria)	Reported Device Performance (Demetech)
Finished suture material meets or exceeds performance requirements for "Absorbable Surgical Suture" as defined in USP 23 and USP 24.	Same (Meets or exceeds)
Finished suture material meets performance requirements for "Diameter" <861> in USP 23 and USP 24.	Same (Meets)
Finished suture material meets or exceeds performance requirements for "Tensile Strength" <881> in USP 23 and USP 24.	Same (Meets or exceeds)
Finished suture material meets or exceeds performance requirements for "Needle Attachment" <871> in USP 23 and USP 24.	Same (Meets or exceeds)
Finished suture material meets performance requirements for "Finish suture Length Requirement" (95% of stated label length) in USP 23 and USP 24.	Same (Meets)

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of data in the context of AI/ML. The performance testing is likely conducted on batches of manufactured sutures. The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for suture performance is established by standardized physical tests, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used:
The ground truth used for evaluating the Demetech suture is standardized physical tests against the requirements of the United States Pharmacopeia (USP 23 and USP 24). This includes:

General performance requirements for "Absorbable Surgical Suture"
Specific requirements for "Diameter" (<861>)
Specific requirements for "Tensile Strength" (<881>)
Specific requirements for "Needle Attachment" (<871>)
Specific requirements for "Finish suture Length Requirement" (95% of stated label length)

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for DemeTECH. The logo consists of a circular graphic on the left and the word "DemeTECH" on the right. The circular graphic appears to be a stylized representation of a mountain range. The word "DemeTECH" is written in a bold, sans-serif font.

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

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 Demetech Sutures to those of the legally marked devices listed.

A. Applicant:
B. Contact Person: Anthony J. Dimercurio

Demetech 3530 NW 115 Ave Miami FL. 33178

Phone 262-387-1610

C. Date Prepared:
October 8, 2007
D. Device Name:
0
Trade Name: O Demetech Absorbable Surgical Gut Suture Plain & Chromic
- Common Name: Plain & Chromic Cat Gut Absorbable Suture
Classification Name: o Absorbable Surgical Gut Suture
E. Predicate Devices: Demetech 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.
T. Cad International, Plain/Chromic Catgut Suture, Trading Consultants& Distributors o 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/1 description: The image shows the logo for DemeTECH. The logo consists of a circular graphic on the left and the word "DemeTECH" in bold, sans-serif font on the right. The circular graphic appears to be a stylized representation of a mountain or a similar shape. A period is present after the word "DemeTECH".

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

G. Intended Use:

"Demetech 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 DEMETECH TO PREDICATE DEVICES
Comparison Items	Demetech	T. CadInternational	CPMedical	AESCULAP
Absorbable Surgical Gut Suture (Plain & Chromic) isan absorbable, sterile, flexible thread prepared fromeither the serosal connective tissue laver 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% Diethanolamine 0.5% Sodium Benzoateand water q.s ad 100%	Same	Similar	Similar	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

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Image /page/2/Picture/1 description: The image shows the logo for DemeTECH. The logo consists of a stylized mountain range on the left and the word "DemeTECH" on the right. The mountain range is black and white and has a textured appearance. The word "DemeTECH" is in a bold, sans-serif font and is also black.

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

Technological Comparison to Predicate Devices Continued:

Comparison Items	Demetech	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

I. Conclusion:

Demetech 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. Demetech 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 Demetech 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 Demetech Absorbable Gut Suture (Plain & Chromic) to that of the predicated devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DemeTECH % Mr. Anthony J. Dimercurio Vice President of MFG 3530 NW 115 Avenue Miami, Florida 33178

APR 3 0 2008

Re: K072930

Trade/Device Name: Absorbable Surgical Gut Suture Regulation Number: 21 CFR 878.4830 Regulation Name: Absorbable surgical gut suture Regulatory Class: II Product Code: GAL Dated: February 22, 2008 Received: April 11, 2008

Dear Mr. Dimercurio:

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. Dimercurio

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse venturion (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for use

510K Number: K072930

Device Name: Absorbable Surgical Gut Suture. As per 21CFR 878.4830

Indication for Use:

"Y" AND/OR Over the-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K072930 510(k) Number 3530 NW 115 Ave, Miami, Florida, 33178 - USA Tel (305) 597-5277 · Toll Free (888) 324-2447 · Fax: (305) 437-7607 Web: www.demetech.us · Email luis@demetech.us

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.