The TVT device is a sterile, single-use device 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 and Rigid Catheter Guide accessories are intended to facilitate placement of the TVT device. The accessories, available separately, are provided nonsterile and are reusable.

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). Each is available separately for use at the surgical site. The TVT device is composed of 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 staft 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.

AI/ML Overview

The provided text describes the regulatory submission for the "Tension Free Vaginal Tape (TVT) System" and its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

The "Performance Data" section merely states: "Results of clinical evaluations were used to show that the TVT System functioned as clinically intended. Sufficient data has been gathered from clinical testing to assess that the TVT System performs as clinically intended." This statement lacks any quantitative or qualitative acceptance criteria and does not provide details about the clinical study itself.

Therefore, many of the requested elements for the response cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated, and what information is missing:

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

Acceptance Criteria: Not specified in the document.
Reported Device Performance: The document only generally states, "TVT System functioned as clinically intended," and "Sufficient data has been gathered from clinical testing to assess that the TVT System performs as clinically intended." No specific performance metrics (e.g., success rates, complication rates, symptom improvement scores) are given.

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

Sample Size: Not specified.
Data Provenance: Not specified (country, retrospective/prospective).

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 specified. The document only mentions "clinical evaluations."

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

Not specified.

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/specified. This device is a surgical implant, not an AI diagnostic tool.

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

Not applicable/specified. This device is a surgical implant, not an AI diagnostic tool.

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

Not explicitly stated, but "clinical evaluations" typically imply patient outcomes or assessments by clinicians. No specific "ground truth" definition is provided beyond "functioned as clinically intended."

8. The sample size for the training set

Not applicable/specified. This device is a surgical implant, not an AI diagnostic tool that requires a 'training set.' Clinical data would be considered a 'test set' or 'validation set' for device performance, but no details are provided.

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

Not applicable/specified (see point 8).

Summary

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K974098

JAN 28 1998

SECTION 7

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summaryof Safety andEffectiveness	Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug and Cosmetic Act, respectingsafety and effectiveness is summarized below. For the convenience ofthe Reviewer, this summary is formatted in accordance with theAgency's final rule "...510(k) Summaries and 510(k) Statements..." (21CFR 807) and can be used to provide a substantial equivalencesummary to anyone requesting it from the Agency.
	New DeviceName:	Tension Free Vaginal Tape (TVT) System
	Predicate DeviceName:	ProteGen Sling Collagen Impregnated Material
	510(K) SUMMARY
Device Description	The Tension Free Vaginal Tape (TVT) System is comprised of threecomponents; the device (TVT device) and its accessories (TVTIntroducer and TVT Rigid Catheter Guide). Each is available separatelyfor use at the surgical site. The TVT device is composed of PROLENEpolypropylene mesh (tape). The mesh is covered with a polyethylenesheath with a slit in the middle. Both the mesh and sheath are attachedto two (2) stainless steel needles. The TVT Introducer (accessory) ismade of stainless steel. It is composed of three (3) parts; handle,threaded staft and rubber O-ring. The introducer functions to facilitatepassage of the TVT device from the vagina to the abdominal skin. TheTVT Rigid Catheter Guide is made of stainless steel and used to addrigidity to the Foley Catheter during the surgical procedure.
Intended Use	The TVT device is intended to be used as a pubourethral sling fortreatment of stress urinary incontinence (SUI), for female urinaryincontinence resulting from urethral hypermobility and/or intrinsicsphincter deficiency.
IndicationsStatement	The TVT device is a sterile, single-use device intended to beused as a pubourethral sling indicated for treatment of stress urinarvincontinence, for female urinary incontinence resulting from urethralhypermobility and/or intrinsic sphincter deficiency. The TVT Introducerand Rigid Catheter Guide accessories are intended to facilitateplacement of the TVT device. The accessories, available separately, areprovided non-sterile and are reusable.
TechnologicalCharacteristics	Technologically both the new device and predicate device are thesame (i.e. both are meshes that provide pubourethral support).Additionally, both devices utilize accessories for use in the surgicalprocedure. Any differences between the two devices do not raise newquestions of safety and effectiveness.
Performance Data	Results of clinical evaluations were used to show that the TVT Systemfunctioned as clinically intended. Sufficient data has been gatheredfrom clinical testing to assess that the TVT System performs asclinically intended.
Conclusions	Based on the 510(k) summaries and 510(k) statements (21 CFR 807)and the information provided herein, we conclude that the modifieddevice is substantially equivalent to the existing legally marketed deviceunder the Federal Food, Drug and Cosmetic Act.
Contact	Gregory R. JonesDirectorRegulatory AffairsETHICON, Inc.Rt. #22 WestSomerville, NJ 08876-0151
Date	October 28, 1997

Continued on next page

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K974098

SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Tension Free Vaginal Tape (TVT) System
ETHICON, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract human figure or symbol, possibly representing health or well-being.

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

Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. P.O. Box 151 SOMERVILLE NJ 08876

SEP 2 8 2012

Re: K974098 Trade/Device Name: Tension Free Vaginal Tape (TVT) System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: October 29, 1997 Received: October 30, 1997

Dear Mr. Jones:

This letter corrects our substantially equivalent letter of January 28, 1998.

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 (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/CDRH0ffices/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 (IVI) System

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR Over-The Counter Use
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(Optional Format 1-2-9G)

(Division Sign-Off)
Device
510(k) Number	K974020

Tension Free Vaginal Tape (TVT) System ETHICON, Inc.

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.