PDS* Plus Antibacterial monofilament synthetic absorbable sutures are indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS Plus is not indicated in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

Device Description

PDS* Plus (Polydioxanone) Antibacterial monofilament synthetic absorbable suture is prepared from a polyester, poly (p-dioxanone). The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 ug/m.

AI/ML Overview

This document describes the marketing authorization for the PDS* Plus (Polydioxanone) Antibacterial Suture (K061037) by Ethicon, Inc. However, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device submission.

Instead, this document is a 510(k) summary for a medical suture, which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data.

Therefore, the requested information elements related to acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment cannot be extracted from the provided text.

Here's what can be extracted based on the nature of the submission:

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

Not applicable / Not provided. The document states "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures" and "in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed." However, specific acceptance criteria values and corresponding performance results are not detailed.

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

Not applicable / Not provided. This information is for clinical studies or performance studies involving a "test set" for an AI/ML device. For a suture, "non-clinical laboratory testing" and "in-vivo/in-vitro testing" are mentioned, but sample sizes, provenance, or retrospective/prospective nature of these tests are not disclosed.

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 / Not provided. This pertains to expert-annotated ground truth for AI/ML performance evaluation, which is not relevant to a suture submission.

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

Not applicable / Not provided. This pertains to ground truth establishment for AI/ML performance evaluation, which is not relevant here.

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 / Not provided. An MRMC study is for evaluating the impact of an AI device on human readers' performance. This is not relevant for a surgical suture.

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

Not applicable / Not provided. This is for evaluating AI algorithm performance, not relevant for a surgical suture.

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

Not applicable / Not provided. The "performance data" mentioned refers to conformity with USP Monograph and "in-vivo/in-vitro testing" which likely involves physical and biological property measurements, not a "ground truth" as understood in AI/ML evaluation.

8. The sample size for the training set

Not applicable / Not provided. This is relevant for AI/ML model training, not for a medical suture.

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

Not applicable / Not provided. This is relevant for AI/ML model training, not for a medical suture.

Summary of what is available:

Device: PDS* Plus (Polydioxanone) Antibacterial Suture
Purpose of Submission: Demonstrate substantial equivalence to predicate devices (PDS II* (Polydioxanone) Suture, VICRYL* Plus Antibacterial Suture, MONOCRYL* Plus Antibacterial Suture).
Performance Data Mentioned:
- Non-clinical laboratory testing demonstrating conformity to the USP Monograph for absorbable surgical sutures (except for diameter - this deviation is likely assessed as acceptable given the claim of substantial equivalence).
- In-vivo/in-vitro testing showing the device performed as intended and claimed.
Conclusion: Based on the provided information, the FDA found the device substantially equivalent to its predicate devices.

Summary

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K061037 page 1 of 2

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:

Brvan A. Lisa Sr. RA Associate, 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)

Trade Name:

PDS* Plus (Polydioxanone) Antibacterial Suture

Predicate Devices:

PDS II* (Polydioxanone) Suture (N18331) VICRYL* Plus Antibacterial Suture (K032420) MONOCRYL* Plus Antibacterial Suture (K050845)

Statement of Intended Use:

Device Description:

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Summary of Technological Characteristics of New Device to Predicate Devic

The modified device has similar technological characteristics as the predicate devices. Like currently marketed PDS* II Suture, it is a sterile, monofilament synthetic absorbable suture that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. Like the currently marketed Coated VICRYL Plus Antibacterial suture and MONOCRYL Plus Antibacterial suture, the modified device contains Irgacare** 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

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon, Inc., a Johnson & Johnson Co. % Mr. Bryan A. Lisa Senior Regulatory Affairs Associate Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

JUL 1 4 2006

Re: K061037

Trade/Device Name: PDS* Plus (Polydioxanone) Antibacterial Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: July 5, 2006 Received: July 6, 2006

Dear Mr. Lisa:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a showe 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 may of Saily 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. Bryan A. Lisa

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chubary Buckup

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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Page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: PDS* Plus (Polydioxanone) Antibacterial Suture

Indications for Use:

Prescription Use X__ _ _ _ _ _ _ _ _ _ _ AND/OR _ Over-The-Counter 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)

Electric Bulletin

Division of Gen eral. Restorative. and Neurological Devices

510(k) Number K(661053)

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.