STRATAFIX Symmetric PDS Plus Devices are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . STRATAFIX Symmetric PDS Plus Devices will contain IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg /m. STRATAFIX Symmetric PDS Plus Devices are dyed with D&C Violet No. 2 (21CFR§ 74.3602) at a maximum of 0.15% w/w. STRATAFIX Symmetric PDS Plus Devices consists of an absorbable monofilament 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

This document describes a 510(k) premarket notification for the STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device. The information provided is sufficient to answer some, but not all, of your specific questions.

Here's a breakdown of the requested information based on the provided text:

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

The document states: "STRATAFIX Symmetric PDS PLUS Devices met all testing criteria to demonstrate substantial equivalence to the predicate device." However, specific numerical acceptance criteria and reported device performance values are not provided in this summary. The performance data section describes what was tested, but not the quantitative results or the specific criteria for "adequacy" or "integrity."

Test Category	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Summary, not quantitative)
Tissue Holding Strength	Not specified (implied to be comparable to predicate)	"verify the integrity and adequacy... in a simulated wound closure and support substantial equivalence"
Initiation Strength	Not specified (implied to be comparable to predicate)	"verify the integrity and adequacy... during application at the proximal end of a simulated wound closure compared to the predicate device."
Cyclic Compression	Not specified (implied to be comparable to predicate)	"verify the integrity and adequacy... when subjected to a cyclic compressive load on a simulated wound closure compared to the predicate device."
Usability Study	Not specified (usability confirmed, IFU refined)	"confirmed the usability of the device and to refine the Instructions for Use."
Preclinical Survival Study	Not specified (implied to be comparable to predicate)	"demonstrated substantial equivalence in wound approximation and healing to the predicate device."

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

Sample sizes for the test set: Not provided. The document states "performance testing-bench models" and "performance testing-animal models" but does not specify the number of samples, animals, or human users involved in these tests.
Data provenance:
- Country of origin of the data: Not specified.
- Retrospective or prospective: Not specified. The nature of the "Preclinical Survival Study" suggests it was prospective, but this is not explicitly stated for all tests.

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

Not applicable. This device is a surgical suture, not an AI/CAD diagnostic device that typically relies on expert interpretation for ground truth. The "ground truth" for its performance would be derived from physical measurements (strength, cyclic loading) and biological observations (wound healing in animal models), not expert consensus on images or diagnoses. No experts are mentioned for establishing ground truth in this context.

4. Adjudication method for the test set

Not applicable. As above, this is not an AI/CAD diagnostic device. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting data, which is not relevant to the described performance testing of a physical medical device.

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 physical surgical device, not an AI diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant.

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

Not applicable. This is a physical surgical device. "Standalone performance" in the context of an algorithm is not relevant here.

7. The type of ground truth used

For the performance tests mentioned, the "ground truth" implicitly would be:

Physical measurements: For Tissue Holding Strength, Initiation Strength, and Cyclic Compression. This would involve calibrated instruments measuring force, displacement, etc.
Biological observations: For the Preclinical Survival Study, ground truth would be based on direct observation and potentially histological analysis of wound approximation and healing in the animal models.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.

Summary

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

October 15, 2014

Ethicon Incorporated Mr. Peter Cecchini Fellow, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K141776

Trade/Device Name: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: July 22, 2014 Received: July 23, 2014

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 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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Binita S. Ashar -S 2014.10.15 21:27:47 -04'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141776

Device Name

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below:

Device Common Name:	Suture, Surgical, Absorbable, Polydioxanone
Device Proprietary Name:	STRATAFIX™ Symmetric PDS™ Plus Knotless TissueControl Device
Submitter:	Ethicon Inc.
	P.O. Box 151
	Route 22 West
	Somerville, NJ 08876
	USA
Contact:	Peter Cecchini
	Fellow, Regulatory Affairs
	Phone: 908-218-2457
	Fax: 908-218-2595
	pcecchin@its.jnj.com
Date Prepared:	September 15, 2014
Classification Regulation:	Absorbable Polydioxanone Surgical Suture, Class II, 21
	CFR 878.4840
Panel:	General and Plastic Surgery Devices
Product Code:	NEW
Predicate Device:	STRATAFIX™ Symmetric PDS™ Plus Knotless TissueControl Device

Indication for Use:

STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

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Device Description:

Performance Data:

Performance testing to demonstrate equivalence was conducted using performance testingbench models and performance testing-animal models. Testing results are summarized as follows.

. Performance Testing-Bench Models:
- 1. Tissue Holding Strength The results of the tissue holding testing verify the integrity and adequacy of the STRATAFIX Symmetric PDS PLUS device performance in a simulated wound closure and support substantial equivalence to the predicate device.
- 1. Initiation Strength- The results of the initiation strength testing verify the integrity and adequacy of the device during application at the proximal end of a simulated wound closure compared to the predicate device.
- 1. Cyclic Compression- The results of the cyclic compression testing verify the integrity and adequacy of the device when subjected to a cyclic compressive load on a simulated wound closure compared to the predicate device.
- 1. Usability Study- The results of this study were used to confirm the usability of the device and to refine the Instructions for Use.
Performance Testing-Animal Models:
- 1. Preclinical Survival Study The results of the survival study demonstrated substantial equivalence in wound approximation and healing to the predicate device.

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Substantial Equivalence:

STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices has the same intended use, design, materials and technological characteristics as the predicate device. Modification to the labeling is the only difference from the predicate device.

Conclusions:

The STRATAFIX Symmetric PDS Plus Device has the same intended use and identical indications for use as the predicate device. In comparison, the technological characteristics are the same. The differences in labeling (IFU) between the proposed device and the predicate device raise no new questions of safety or effectiveness. STRATAFIX Symmetric PDS PLUS Devices met all testing criteria to demonstrate substantial equivalence to the predicate device.

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

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.