PDS Barbed Sutures (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . PDS Barbed Sutures will be available marketed with and without IRGACARE®+ MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 ug /m. PDS Barbed Sutures are dved with D&C Violet No. 2 (21CFR& 74.3602). PDS Barbed Sutures consists of an absorbable monofilament strand thread with unidirectional barbs, with a surgical needle attached at one end and a fixation tab at the other. The barbs and fixation tab design allow for tissue approximation without the need to tie surgical knots.

AI/ML Overview

The provided text does not contain information about an AI-powered device. Instead, it describes a PDS™ Barbed Suture, which is a physical surgical device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria. The questions you've asked are specifically tailored to the evaluation of AI/ML-based medical devices, and this document pertains to a traditional medical device (a surgical suture).

Here's why each of your requested points cannot be addressed with the provided text:

Table of acceptance criteria and reported device performance: The document states "non-clinical laboratory testing was performed demonstrating that the device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter." It also mentions "bench, human cadaver and animal testing was provided showing that the device performed as intended and as claimed." However, it does not provide specific acceptance criteria values (e.g., minimum tensile strength, degradation rates) nor detailed performance data.
Sample size for the test set and data provenance: Not applicable. This refers to AI model testing.
Number of experts used to establish ground truth and qualifications: Not applicable. This refers to AI model testing.
Adjudication method for the test set: Not applicable. This refers to AI model testing.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This refers to AI model testing.
Standalone (algorithm only) performance: Not applicable. This refers to AI model testing.
Type of ground truth used: Not applicable. This refers to AI model testing.
Sample size for the training set: Not applicable. This refers to AI model training.
How ground truth for the training set was established: Not applicable. This refers to AI model training.

In summary, the provided document is a 510(k) summary for a surgical suture, not an AI device. Therefore, the requested information cannot be extracted.

Summary

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K113004
page 1 of 2

510(k) Summary

DEC 2 0 2011

Applicant:	Ethicon Inc.P.O. Box 151Route 22 WestSomerville, NJ 08876USAPhone: +1-918-218-2457Fax: +1-918-218-2595
Date:	October 6, 2011
Contact Person:	Peter Cecchini
Proprietary Device Name:	PDSTM Barbed Sutures
Common Device Name:	Suture, Surgical, Absorbable, Polydioxanone
Classification:	Absorbable Polydioxanone Surgical Suture, Class II, 21CFR 878.4840, Product Code: NEW
Predicate Devices:	PDS IITM (polydioxanone) Suture (N18331)PDSTM Plus Antibacterial (polydioxanone) Suture (K061037)Quill™ Self-Retaining System (SRS) (K080985)
Manufacturer:	Ethicon Inc.P.O. Box 151Route 22 West Somerville, NJ 08876USA

Substantially Equivalent To:

ジ

PDS Barbed sutures are substantially equivalent to the following devices:

PDS II (polydioxanone) Suture (N18331) PDS Plus Antibacterial (polydioxanone) Suture (K061037) Quill™ Self-Retaining System (SRS) (K080985)

The V-Loc™ 180 device (K091087) is being referenced as a device with unidirectional barbs. Therefore, the technology of unidirectional barbs is not new.

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113004
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Description of the Device Subject to Premarket Notification:

Indications for Use:

PDS Barbed Sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

Performance Data:

Non-clinical laboratory testing was performed demonstrating that the device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. In addition, bench, human cadaver and animal testing was provided showing that the device performed as intended and as claimed.

Summary of Technological Characteristics of the New Device to Predicate Devices:

The new device has similar technological characteristics as the predicate devices. Like the currently marketed devices, PDS Barbed Suture is a sterile, monofilament synthetic absorbable suture intended for the approximation of soft tissue that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. Similar to the currently marketed PDS Plus suture. PDS Barbed Suture will also be available as a suture product with IRGACARE @+ MP. an antibacterial agent.

Conclusions:

PDS Barbed Sutures have the same intended use and similar indications for use as the predicate devices. The technological differences between PDS Barbed Sutures and the predicate devices raise no new questions of safety or effectiveness. PDS Barbed Sutures met all testing criteria to demonstrate substantial equivalence to the predicates devices.

* Trademark

IRGACARE®+ MP (triclosan) "Registered Trademark of BASF Group"

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

DEC 2 0 2011

Ethicon. Inc. % Mr. Peter Cecchini P.O. Box 151 Route 22 West Somerville, New Jersey 08876

Re: K113004

Trade/Device Name: PDS™ Barbed Sutures Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture -Regulatory Class: Class II Product Code: NEW Dated: October 06, 2011 Received: October 07, 2011

Dear Mr. Cecchini:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Peter Cecchini

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

INDICATIONS FOR USE STATEMENT

510(k) No (if known): K113004

Device Name: PDSTM Barbed Sutures

Indications for Use:

PDS Barbed Sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113004

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.