L-25 ABSORBABLE SURIGCAL SUTURE by UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

L-25 synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) summary for the L-25 Absorbable Surgical Suture, which is a traditional medical device (suture) and not an AI/ML powered medical device. Therefore, the questions related to AI/ML powered medical device performance, such as acceptance criteria based on AI performance metrics (e.g., sensitivity, specificity, AUC), sample size for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, and MRMC studies, are not applicable.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a surgical suture.

Here's a breakdown of the available information based on the request, noting where information is not applicable:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics typical for AI/ML devices. For a surgical suture, acceptance criteria would generally relate to biocompatibility, tensile strength, absorption profile, knot security, and sterility, often benchmarked against predicate devices and relevant standards. The "Performance (Clinical & Non Clinical) and Biocompatibility" section, though not provided in full, would likely contain this information.
- Reported Device Performance: Not provided in the excerpt in a quantitative table format. The document states that "Comparison of the L-25 absorbable surgical suture with the predicate devices provides confirmation of substantial equivalence." This implies that the performance of the L-25 suture was found to be comparable to the predicate devices across relevant characteristics.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This device is a surgical suture, not an AI/ML powered device that would typically have a "test set" for algorithm evaluation in the sense implied by the question. Performance data would stem from material testing, animal studies, and potentially clinical studies, but not an "AI test set."
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: There is no "ground truth" establishment in the context of an AI test set for this device. Ground truth for a surgical suture would refer to established scientific and clinical standards for its physical properties and biological interactions.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This concept is irrelevant to a surgical suture.
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 device is not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This concept is irrelevant to a surgical suture.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI context): For a surgical suture, "ground truth" would be the established scientific and clinical parameters for evaluating its performance (e.g., ASTM standards for tensile strength, ISO standards for biocompatibility, histological assessment in animal models for absorption). The document implies that the L-25 suture's performance was compared to these established benchmarks and predicate devices.
The sample size for the training set
- Not Applicable: This device is a surgical suture; there is no "training set" in the context of AI/ML.
How the ground truth for the training set was established
- Not Applicable: This concept is irrelevant to a surgical suture.

Summary of what can be extracted from the document regarding substantial equivalence for this type of device:

The document focuses on demonstrating Substantial Equivalence (SE) of the L-25 Absorbable Surgical Suture to existing predicate devices (K885018: Gut Suture (Surgigut™), K000037: Biosyn™ Suture, K944110: Vicryl™ Rapide Suture).

Indications for Use: The L-25 suture is indicated for "general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery," which are the same indications as at least one of the predicate devices.
Materials: Composed of Glycolide, Caprolactone, Tri-Methylene Carbonate, and Lactide polymers, which are common components in absorbable synthetic sutures and likely similar to those found in the predicate devices.
Performance (Clinical & Non-Clinical) and Biocompatibility: The document states that "Comparison of the L-25 absorbable surgical suture with the predicate devices provides confirmation of substantial equivalence." This implies that the L-25 suture's performance characteristics (e.g., tensile strength, absorption profile, knot security, degradation products, tissue reaction) were tested and found to be comparable to the predicate devices. Detailed results are not included in the provided excerpt but would be part of the full 510(k) submission. These tests would adhere to recognized standards for surgical implants and sutures.
Acceptance Criteria (Implied): For a traditional device like a suture seeking 510(k) clearance, the primary "acceptance criterion" is sufficient evidence to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This is typically shown through comparative performance data against the predicate, adherence to relevant industry standards, and biocompatibility testing. The FDA letter confirms that the device was found substantially equivalent.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS X.

JAN 0 8 2002

SUBMITTER:	United States Surgical,a division of Tyco Healthcare Group, LP150 Glover AvenueNorwalk, CT 06856
CONTACT PERSON:	Robert Zott
DATE PREPARED:	November 1, 2001
CLASSIFICATION NAME:	Absorbable poly(glycolide/L-lactide)surgical suture
COMMON NAME:	Surgical Suture
PROPRIETARY NAME:	To be determined
PREDICATE DEVICES:	K885018: Gut Suture (SurgigutTM)K000037: BiosynTM SutureK944110: VicrylTM Rapide Suture
INDICATIONS:	The device is indicated for use in general softtissue approximation and/or ligation, but not foruse in cardiovascular or neurological surgery,microsurgery, or ophthalmic surgery.
MATERIALS:	Glycolide, Caprolactone, Tri-MethyleneCarbonate, and Lactide polymers.

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Image /page/1/Picture/2 description: The image is a black and white 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 - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three horizontal lines representing the snakes and a wavy line at the bottom representing the staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2002

Robert Zott Senior Associate, Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

Re: K013671

Trade Name: L-25 Absorbable Surgical Suture Regulation Number: 878.4493 Regulation Name: Absorbable polyglycolide surgical suture Regulatory Class: II Product Code: GAM Dated: November 5, 2001 Received: November 6, 2001

Dear Mr. Zott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 he 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. Robert Zott

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.

Neil R.P. Ogden

Celia M. Witten. Ph.D., M.D. H. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE V.

510(k) Number (if known): K013671

Device Name: L-25 Absorbable Surgical Suture (Trade name to be determined)

Indications For Use:

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)

Nho forcmw

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

510(k) Number K01367/

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.