The Modified NeoTract Anchor System is used for the approximation of soft tissue in open surgical procedures. It consists of a single use delivery device that delivers the permanently implanted Suture Anchor. The delivery system is comprised of a polycarbonate handle and trigger assembly connected to a stainless steel shaft.

AI/ML Overview

The provided text describes a 510(k) summary for the "Modified NeoTract Anchor System." However, it does not contain information about acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document is a premarket notification to the FDA, focusing on substantial equivalence to predicate devices, and mentions in-vitro testing only in a very general sense. It states:

"In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests."

This statement confirms that some testing was done and met specifications, but it does not provide any details about:

Specific Acceptance Criteria: What "required specifications" were, e.g., tensile strength, knot security, degradation rate.
Reported Device Performance: The actual numerical results of the tests.
Study Design: What kind of study was conducted (sample size, data provenance, etc.).
Clinical Performance: There is no mention of studies involving human or animal subjects to assess clinical performance.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them because that information is not present in the provided text. The document is primarily a regulatory submission for substantial equivalence.

Summary

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4. 510(k) SummaryGeneral Information
Date Compile	April 30, 2010	JUL 15 2010
Classificatior	21 CFR 878.5000, Nonabsorbable Polyethylene Terephthalate SurgicaSutureProduct code GAT, GDW
Trade Name	Modified NeoTract Anchor System
CommonName	Surgical Suture
Submitter	NeoTract, Inc.4473 Willow Rd., Suite 100Pleasanton, CA 94588Tel: 415 609 9875Fax: 925 401 0676
	FDA Registration No.: 3005791775
Contact	Kevin MacDonaldVice President, Regulatory, Quality, Clinical Affairs
Intended Use	The Modified NeoTract Anchor System is intended for the approximation of tissue in opensurgical procedures.
Predicate Devices
NeoTract Anchor SystemManufactured by NeoTract, Inc.	K073651
Nonabsorbable Surgical SutureManufactured by Genzyme Corporation	K021019

K073644 StomaphyX Delivery Device , Fasteners and Accessories Manufactured by EndoGastric Solutions, Inc.

Device Description

Materials

All materials used in the manufacture of the Modified NeoTract Anchor System are suitable for this use and are comparable to the predicate products.

Testina

In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

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Summary of Substantial Equivalence

NeoTract, Inc. believes the Modified NeoTract Anchor System is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

NeoTract, Inc. % Mr. Kevin F. MacDonald VP, Regulatory, Quality, Clinical Affairs 4473 Willow Road, Suite 100 Pleasanton, California 94588

JUL 15 2010

Re: K101252

Trade/Device Name: Modified NeoTract Anchor System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GDW Dated: April 30, 2010 Received: May 4, 2010

Dear Mr. MacDonald:

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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Page 2 - Mr. Kevin F. MacDonald

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/ReportalProblem/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 vours.

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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3. Indications for Use Statement

510(k) Number (ifknown):	This applicationK101252
Device Name:	Modified NeoTract Anchor System
Indications for Use:	The Modified NeoTract Anchor System is intended for theapproximation of tissue in open surgical procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (Per 21 CFR 801 Subpart C)

JUL 15 2010

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kisone for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101252

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.