MONOCRYL* Plus Antibacterial (poliglecaprone 25) sutures (dyed or undyed) are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Description

MONOCRYL* Plus Antibacterial (poliglecaprone 25) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broadspectrum antibacterial agent, at no more than 2360 ug/m.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, MONOCRYL* Plus Antibacterial Suture. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies as might be described in a PMA (Premarket Approval) application.

Therefore, many of the requested details, such as specific acceptance criteria for numerical performance metrics, sample sizes for test sets to establish ground truth, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or not explicitly provided in this type of submission document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The primary acceptance criterion for this 510(k) is substantial equivalence to predicate devices. This means the new device must be as safe and effective as a legally marketed device and share similar technological characteristics and indications for use.
- Specifically, for performance, the device had to conform to the USP Monograph for absorbable surgical sutures (except for diameter) and perform as intended and claimed in in-vivo/in-vitro testing.
Reported Device Performance:
- "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures."
- "Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed."

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance
Substantial equivalence to predicate devices (K960653, K964072, K032420) in terms of safety, effectiveness, technological characteristics, and intended use.	Concluded by FDA to be substantially equivalent based on the provided information.
Conformity to USP Monograph for absorbable surgical sutures (except for diameter).	Non-clinical laboratory testing performed, demonstrating conformity.
Performance as intended and claimed in in-vivo/in-vitro testing.	In-vivo/in-vitro testing provided, showing performance as intended and claimed.

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

Not explicitly stated. The document mentions "non-clinical laboratory testing" and "in-vivo/in-vitro testing" but does not provide specific sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required or included in a 510(k) summary.

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

Not applicable. This submission doesn't involve subjective interpretations or diagnoses that would require expert-established ground truth in the way clinical diagnostic devices do. The testing described (USP monograph compliance, in-vivo/in-vitro performance) relies on objective measurement standards.

4. Adjudication method for the test set

Not applicable. As there's no expert-established ground truth in this context, no adjudication method would be used.

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 device is a surgical suture, not a diagnostic imaging device or an AI-powered system that would involve human readers or AI assistance in interpretation.

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

Not applicable. This is a physical medical device (suture) and does not involve algorithms or AI.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective, standardized measurements against the USP Monograph for absorbable surgical sutures and general biological/mechanical performance evaluations (in-vivo/in-vitro testing) to ensure it performs as intended and claimed. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the manner of diagnostic devices.

8. The sample size for the training set

Not applicable. The device is a physical suture, not a software algorithm requiring a training set.

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

Not applicable. (See point 8).

Summary

{0}------------------------------------------------

K050845$_{1/2}$

JUN 2 9 2005

JMP-2005-008

Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.

Submitted by:

Jennifer M. Paine Sr. Project Manager, Regulatory Affairs Ethicon, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville. NJ 08876

Name/Classification of Device:

Class II in 21 CFR § 878.4493, Absorbable poly(glycolide/l-lactide) surgical suture (GAM) and § 878.4830, Absorbable surgical gut suture (GAN)

Trade Name:

MONOCRYL * Plus (Poliglecaprone 25) Antibacterial Suture

Predicate Devices:

MONOCRYL* (poliglecaprone 25) Suture (K960653 and K964072) VICRYL* Plus Antibacterial Suture (K032420)

Statement of Intended Use:

MONOCRYL* Plus Antibacterial sutures are indicated for use in general soft tissue approximation and/or !igation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Description:

Summary of Technological Characteristics of New Device to Predicate Devices:

The modified device has similar technological characteristics as the predicate devices. Like currently marketed MONOCRYL* Suture, it is a sterile, monofilament synthetic absorbable suture that conforms to the USP

{1}------------------------------------------------

K05afYS$_{2/2}$

ﻳﺔ ﺍﻟ

Monograph for absorbable surgical sutures, except for diameter. Like the Monograph is aboutsation VICRYL Plus Antibacterial suture, the modified ourrently manologiaane** MP, an antibacterial agent.

Performance Data:

Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed.

Conclusions:

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act.

Trademark of Ethicon, Inc.

**Trademark of Ciba Specialty Chemicals Corporation.

{2}------------------------------------------------

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 - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2005

Ms. Jennifer M. Paine Senior Project Manager, Regulatory Affairs Ethicon Incorporated Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K050845

Trade/Device Name: MONOCRYL* Plus Antibacterial (Poliglecaprone 25) Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L- lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: April 1, 2005 Received: April 4, 2005

Dear Ms. Paine:

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.

{3}------------------------------------------------

Page 2- Ms. Jennifer M. Paine

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 Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Kosofys

Indications for Use

510(k) Number (if known): _____________

Device Name: MONOCRYL* Plus Antibacterial (Poliglecaprone 25) Suture

Indications for Use:

(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

ivision Sign-Can Division of Gerenal, Restorative and Neurological Devices

Number K050845

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.