Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Description

Atramat® Poly(glycolide-co-epsilon-caprolactone) PGC25 Surgical Suture are synthetic absorbable sterile monofilament surgical sutures composed from a copolymer of glycolide and epsilon-caprolactone. This product is offered as undyed or dyed with an FDA listed color additive, D&C Violet No. 2.

AI/ML Overview

The provided document is a 510(k) summary for a surgical suture device (Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Suture). It does not describe an AI medical device or a study involving acceptance criteria and device performance in the context of AI.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is not available in the provided text.

Here's what can be extracted based on the nature of the device (a traditional medical device, not AI):

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

The document states: "Invivo/in vitro testing was provied showing that the device performed as intended and as claimed." It also mentions conformance with:

USP 30 (United States Pharmacopoeia)
ISO 9001 and ISO 13485 (Quality Management Systems)
FDA Guidance for Surgical Suture 510(k)

However, specific numerical acceptance criteria (e.g., tensile strength, degradation rates) and their corresponding reported device performance values are not detailed in the provided summary. The summary broadly states that the device "conforms" to these standards and performed "as intended and as claimed," which implies meeting the (unspecified in this document) acceptance criteria within those standards.

2. Sample sized used for the test set and the data provenance

Sample size: Not specified. The document only mentions "Invivo/in vitro testing."
Data provenance: Not specified.

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

Not applicable. This information is relevant for studies involving human interpretation or subjective assessment, typically for diagnostic or screening AI devices. For a surgical suture, performance is evaluated against physical and chemical properties.

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

Not applicable. This is relevant for subjective assessments in diagnostic studies.

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

No. This is not an AI device. The document explicitly states: "No clinical trials were conducted."

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

Not applicable. This is not an AI algorithm.

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

For this type of device, the "ground truth" would be established by objective measurements against established physical, chemical, and biological standards (e.g., tensile strength, degradation profile, biocompatibility as per USP, ISO, and FDA guidance). The document refers to "Invivo/in vitro testing."

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

Summary relevant to the provided text:

The submission highlights that the device (Atramat® PGC25 Surgical Sutures) is marketed as "substantially equivalent" to predicate devices (Monocryl* (poliglecaprone 25) Suture). This equivalence is based on:

Technological Characteristics: Similar composition (copolymer of glycolide and epsilon-caprolactone), sterile, monofilament, synthetic, absorbable.
Performance Standards: Conformance to USP 30, ISO 9001, ISO 13485, and FDA Guidance for Surgical Suture 510(k).
Testing: "Invivo/in vitro testing was provied showing that the device performed as intended and as claimed." No clinical trials were conducted.

Summary

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K07 2863
pg 1022

510(k) SUMMARY

MAY 2 3 2008

This Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requeriments of SMDA 1990 and 21 CFR§807.92

The assigned 510(k) number is:

Submitter's identification:

Internacional Farmacéutica, S.A. de C.V. Carreteraco 44 Col. Párque San Andrés Coyoacán C.P. 04040 México, D.F. Contact: Mr. Alejandro von Mohr, General Director Phone: (52 55) 55 44 87 60 to 62 ext. 227, 219 Fax: (52 55) 55 49 42 34

US Contact: Mr. Alan P. Schwartz 55 Northern Boulevard Great Neck, New York 11021 Phone: 516-482-9001 Fax: 516-482-0186

Date Summary prepared: May 31, 2007

Trade Name of the Device:

Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures

Common or Usual Name:

Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures

Classification of Device:

Class II in 21 CFR § 878.4493, Absorbable poly(glycolide/Ilactide) Surgical Suture

Classification Panel:

General & Plastic Surgery Devices Panel

Product Code:

GAM

Predicate Devices:

Monocryl* (poliglecaprone 25) Suture (K960653 and K964072)

Device Description

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K072863
pg 292

Intented Use:

Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surqical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Summary of Thechnological Characteristics, comparison to predicate device

PGC25 Atramat® Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures have similar technological characteristics as the predicate device. Like the predicate device, Atramat® Poly(glycolide-co-epsilon-caprolactone) Surgical PGC25 Sutures are sterile, monofilament synthetic absorbable surgical sutures that conform to the requeriments of United States Pharmacopoeia (USP), except for diameter, and Mexicans United States Farmacopoeia, Medical Devices Supplement (FEUM) for absorbable surgical sutures. The poly(glycolideco-epsilon-caprolactone) material used for both "new" and "predicate" medical devices is commonly used in surgical applications and has been proven to be biocompatible. Invivo/in vitro testing was provied showing that the device performed as intended and as claimed.

Discussion of Clinical Test Performed:

No clinical trials were conducted.

Conclusions

Based on the technological characteristics and physical properties of the Poly(glycolide-co-epsilon-caprolactone) sutures, the description, the intented use of the device and conformance with the following performance standars like:

USP 30 ISO 9001 and ISO 13485

FDA Guidance for Surgical Suture 510(k)

Internacional Farmaceutica believes that the subject devices demonstrate a substantial equivalence to the predicate devices and are safe and effective for their intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Internacional Farmaceutica S.A. de C.V. % mdi Consultants, Inc. Mr. Alan P. Schwartz 55 Northern Boulevard Great Neck, New York 11021

Re: K072863

Trade/Device Name: Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) surgical sutures Regulation Number: 21 CFR 878.4493

Regulation Name: Absorbable poly(glycolide/L- lactide)surgical suture Regulatory Class: II Product Code: GAM Dated: May 01, 2008 Received: May 22, 2008

Dear Mr. Schwartz:

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

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Page 2 - Mr. Alan P. Schwartz

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.

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 Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (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 M 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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KO72863

ATTACHMENT # 3

Page 1 of 1

510(k) Number (if known):

Device Name: Atramat® PGC25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures

Indications for Use:

Prescription use X (Per 21 CFR 801.109)

Over-The Counter Use OR (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for mka
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(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.