Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Device Description

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Suture are synthetic absorbable sterile coated surgical sutures composed from a copolymer of glycolide L-lactide. This product is offered as dyed with an FDA listed color additive, D&C Violet No. 2.

AI/ML Overview

This device is a surgical suture, not an AI or diagnostic device, therefore, the typical acceptance criteria and study designs provided in the prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies) are not applicable.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and physical properties, and conformance to recognized performance standards.

Here's a breakdown of the relevant information from the provided text:

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

Acceptance Criteria (Standards and Characteristics)	Reported Device Performance
Material Composition: Copolymer of glycolide L-lactide	Composed of a copolymer of glycolide L-lactide.
Sterile:	Sterile.
Coated:	Coated.
Synthetic Absorbable:	Synthetic absorbable.
Conformance to USP (United States Pharmacopoeia):	Conforms to USP, except for diameter.
Conformance to FEUM (Mexicans United States Farmacopoeia, Medical Devices Supplement):	Conforms to FEUM for absorbable surgical sutures.
Biocompatibility:	Poly(glycolide-co-L-lactide) material used in both new and predicate devices is commonly used in surgical applications and has been proven to be biocompatible.
Intended Use: General soft tissue approximation and/or ligation (excluding cardiovascular, neurological, or ophthalmic in the initial summary, but including ophthalmic in the final indications for use).	Performed as intended and as claimed in in-vivo/in-vitro testing.
Conformance to ISO 9001:	Conforms to ISO 9001.
Conformance to ISO 13485:	Conforms to ISO 13485.
Conformance to FDA Guidance for Surgical Suture 510(k):	Conforms to FDA Guidance for Surgical Suture 510(k).

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

Not applicable. No clinical trials were conducted for this submission. The evaluation was based on in-vivo/in-vitro testing and comparison to standards and a predicate device. The text states: "In-vivo/in vitro testing was provied showing that the device performed as intended and as claimed." No specific sample sizes or data provenance for these tests are mentioned.

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):

Not applicable. Ground truth in the context of expert review for diagnostic/AI performance is not relevant here. The "ground truth" for a surgical suture is its physical and chemical properties and performance according to established standards.

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

Not applicable. No adjudication method for a test set is mentioned or relevant to this type of device submission.

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 a surgical suture, not a diagnostic device or AI system that would involve human readers.

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

Not applicable. This is a surgical suture, not an algorithm.

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

The "ground truth" for this device is based on established industry standards and regulatory requirements for surgical sutures, including:
- United States Pharmacopoeia (USP)
- Mexicans United States Farmacopoeia (FEUM)
- Applicable ISO standards (ISO 9001, ISO 13485)
- FDA Guidance for Surgical Suture 510(k)
- The known biocompatibility and performance characteristics of the predicate device (Vicryl®).
- Results from in-vivo/in-vitro testing (details of which are not provided in this summary but were submitted).

8. The sample size for the training set:

Not applicable. This is a surgical suture without a "training set" in the context of machine learning.

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

Not applicable. No training set is involved.

Summary of the Study (Device Evaluation):

The study to "prove the device meets the acceptance criteria" for the Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Suture was not a clinical trial or AI performance study. Instead, it was a demonstration of substantial equivalence to a legally marketed predicate device (Vicryl® Suture, K022269 and K022715) based on:

Technological Characteristics: The device has similar material composition (copolymer of glycolide L-lactide), is sterile, coated, and synthetic absorbable, just like the predicate.
Physical Properties: The submission indicates that the device's physical properties are comparable to the predicate.
Conformance to Standards: The device conforms to the requirements of the United States Pharmacopoeia (USP) (except for diameter), Mexicans United States Farmacopoeia (FEUM) for absorbable surgical sutures, ISO 9001, ISO 13485, and FDA Guidance for Surgical Suture 510(k).
Biocompatibility: The material used is commonly employed in surgical applications and is known to be biocompatible.
In-vivo/in-vitro testing: This testing was performed to show that the device "performed as intended and as claimed." No specific details on the methodology, sample sizes, or results of these tests are provided in the 510(k) summary, as is common for this type of submission where full test reports would be included in the larger application.

The overall conclusion was that, based on these factors, the subject device is substantially equivalent to the predicate device and is safe and effective for its intended use.

Summary

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K072859
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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® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures

Common or Usual Name: Poly(glycolide-co- L-lactide) Surgical Sutures

Classification of Device:

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

Classification Panel:

General & Plastic Surgery Devices Panel

Product Code:

GAM

Predicate Devices:

Vicryl* (Polyglactin 910) Suture (K022269 and K022715)

Device Description

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K072859
pg 2-2

Intented Use:

Atramat® PGLA90 Poly(glycolide-co-L-lactide) 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.

Summary of Thechnological Characteristics, comparison to predicate device

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures have similar technological characteristics as the predicate Like the predicate device, Atramat® PGLA90 device. Poly(glycolide-co-l.-lactide) Surgical Sutures are sterile, coated 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(glycolide-co-L-lactide) material used for both "new" and "predicate" medical devices is commonly used in surgical applications and has been proven to be biocompatible. In-vivo/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 PGLA90 Poly(glycolide-co-L-lactide) 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized feathers and wings.

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: K072859

Trade/Device Name: Atramat® PGLA90 Poly(glycolide-co-L-lactide) 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 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. Alan P. Schwartz

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 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 vours.

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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K072f59

ATTACHMENT # 3

Page 1 of ﻠﺴ

510(k) Number (if known):

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Device Name: 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) 5 Mar (Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K072859

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.