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K Number
K072859
Device Name
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
Manufacturer
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
Date Cleared
2008-05-23

(231 days)

Product Code
GAM
Regulation Number
878.4493
Type
Traditional
Panel
SU
Reference & Predicate Devices
K022269,K022715
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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-lactideComposed 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.

§ 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.