The TVT device is intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI). The TVT device is intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI) for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer, Rigid Catheter Guide and TVT abdominal Guides and Couplers accessories are intended to facilitate placement of the TVT device.

Device Description

The Tension Free Vaginal Tape (TVT) System is comprised of three components; the device (TVT device) and its accessories (TVT Introducer and TVT Rigid Catheter Guide and TVT Abdominal Guides and Couplers). Each is available separately for use at the surgical site. The TVT device is composed of unpigmented or blue pigmented PROLENE polypropylene mesh (tape). The mesh is covered with a polyethylene sheath with a slit in the middle. Both the mesh and sheath are attached to two (2) stainless steel needles. The TVT Introducer (accessory) is made of stainless steel. It is composed of three (3) parts; handle, threaded shaft and rubber O-ring. The introducer functions to facilitate passage of the TVT device from the vagina to the abdominal skin. The TVT Rigid Catheter Guide is made of stainless steel and used to add rigidity to the Foley Catheter during the surgical procedure. The TVT AA (Accessory) Abdominal Guide is made of stainless steel and the couplers are made from polypropylene.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the K012628 device:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device (GYNECARE Tension Free Vaginal Tape (TVT) System with Accessories) is a medical device, not an AI/software device. Therefore, the "acceptance criteria" and "reported device performance" are not presented in terms of AI metrics (like accuracy, sensitivity, specificity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

The acceptance criteria for substantial equivalence are implicitly met by demonstrating that the modified device has the same technological characteristics and functions as clinically intended as the predicate device.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance
Technological Characteristics: The modified device should be technologically the same as the predicate device.	"Technologically both the modified TVT Blue device and the currently marketed predicate device are the same." The TVT-AA Abdominal Guides and Couplers (an accessory) is an addition to facilitate an abdominal approach, but the core device technology is stated to be the same.
Clinical Functionality: The modified device should function as clinically intended.	"Results of bench testing and preclinical evaluations were used to show that the TVT System functioned as clinically intended and have the same product properties."
Product Properties: The modified device should have the same product properties as the predicate device.	"Results of bench testing and preclinical evaluations were used to show that the TVT System functioned as clinically intended and have the same product properties."

2. Sample Size Used for the Test Set and Data Provenance

The submission does not mention a "test set" in the context of an AI/software evaluation. The studies conducted were "bench testing and preclinical evaluations." The sample sizes for these tests are not specified in the provided document.

The data provenance (country of origin, retrospective/prospective) is also not specified, as these are typically not documented for physical device bench and preclinical testing in the same way they would be for a data-driven AI study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is not an AI/software product requiring expert ground truth for image interpretation or diagnosis. The evaluation relies on engineering and biological testing.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" in the context of an AI/software evaluation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to this physical medical device.

6. If a Standalone (Algorithm Only) Performance Study was Done

No, a standalone performance study was not done. This concept is specific to AI algorithms and their direct output without human intervention, which is not relevant for this physical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on:

Bench testing: Involving physical measurements and evaluations of material properties and mechanical performance.
Preclinical evaluations: Likely animal studies or cadaveric studies to assess functionality, tissue interaction, and safety before human use.

The document states these evaluations showed the device "functioned as clinically intended and have the same product properties" as the predicate.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/software product that uses a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this physical medical device.

Summary

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K012628

OCT 2 6 2001

SECTION 7 SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary ofSafety and Effectiveness	Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summaries and510(k) Statements..." (21 CFR 807) and can be used to provide asubstantial equivalence summary to anyone requesting it from theAgency.
ModifiedDevice Name:	GYNECARE Tension Free Vaginal Tape (TVT)System with AccessoriesTVT Reusable IntroducerTVT Reusable Rigid Catheter GuideTVT-AA Abdominal Guides and Couplers
PredicateDevice Name:	GYNECARE Tension Free Vaginal Tape (TVT)System with AccessoriesTVT Reusable IntroducerTVT Reusable Rigid Catheter GuideCook OB/GYN Stamey Needle
510(K) SUMMARY
Device Description	The Tension Free Vaginal Tape (TVT) System is comprised ofthree components; the device (TVT device) and its accessories(TVT Introducer and TVT Rigid Catheter Guide and TVTAbdominal Guides and Couplers). Each is available separately foruse at the surgical site. The TVT device is composed ofunpigmented or blue pigmented PROLENE polypropylene mesh(tape). The mesh is covered with a polyethylene sheath with a slitin the middle. Both the mesh and sheath are attached to two (2)stainless steel needles. The TVT Introducer (accessory) is made ofstainless steel. It is composed of three (3) parts; handle, threadedshaft and rubber O-ring. The introducer functions to facilitatepassage of the TVT device from the vagina to the abdominal skin.The TVT Rigid Catheter Guide is made of stainless steel and usedto add rigidity to the Foley Catheter during the surgical procedure.The TVT AA (Accessory) Abdominal Guide is made of stainlesssteel and the couplers are made from polypropylene.
Intended Use	The TVT device is intended to be used as a pubourethral sling fortreatment of stress urinary incontinence (SUI).
IndicationsStatement	The TVT device is intended to be used as a pubourethral slingindicated for treatment of stress urinary incontinence (SUI) forfemale urinary incontinence resulting from urethral hypermobilityand/or intrinsic sphincter deficiency. The TVT Introducer, RigidCatheter Guide and TVT abdominal Guides and Couplersaccessories are intended to facilitate placement of the TVT device.
TechnologicalCharacteristics	Technologically both the modified TVT Blue device and thecurrently marketed predicate device are the same. The TVT-AAAbdominal Guides and Couplers is an accessory that may be usedwith the modified device or the modified device to facilitate anabdominal approach for the placement of the TVT mesh.
Performance Data	Results of bench testing and preclinical evaluations were used toshow that the TVT System functioned as clinically intended andhave the same product properties.
Conclusions	Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that themodified device is substantially equivalent to the existing legallymarketed device under the Federal Food, Drug and Cosmetic Act.
Contact	Gregory R. JonesDirector of Regulatory Affairs & Quality AssuranceGYNECAREA Division of ETHICON, Inc.Rt. #22 WestSomerville, NJ 08876-0151
Date	August 9, 2001

Continued on next page

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

August 9, 2001

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three flowing lines that form the shape of a person's head and torso. The figure is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter.

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

Mr. Gregory R. Jones Director of Regulatory Affairs and Quality Assurance Gynecare Division of Ethicon P.O. Box 151 SOMERVILLE NJ 08876

SEP 28 2012

Re: K012628

Trade/Device Name: GYNECARE Tension-Free Vaginal Tape (TVT) Blue System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: August 9, 2001 Received: August 13, 2001

Dear Mr. Jones:

This letter corrects our substantially equivalent letter of October 26, 2001.

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 (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 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

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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 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" (21 CFR 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,

Benjamin R. Fuchs

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number (if known):

Device Name:

Indications for Use:

Tension Free Vaginal Tape (TVT) Blue System

The TVT device is intended to be used as a pubourethral sling Indicated for treatment of stress urinary incontinence (SUI) for moreated for a cannontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer, Rigid and of millions and TVT Abdominal Guides and Couplers are accessories intended to facilitate placement of the TVT device.

K0126

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The Counter Use Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-9G) (Division Sign-Off) Division of General, Restorative and Neurological Devices Modified TVT Blue and TVT-AA 510(k) Number_ _ 01262

ና ምጥ፣ የተጣጥለ ነ

חוץ וייחי וי ויי

:::

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.