The GYNECARE TVT ABBREVO™ Continence System is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

GYNECARE TVT ABBREVO™ device is a sterile, single-patient use device which consists of one piece of blue (phtalocyanine blue, color index number 74160) PROLENE™ polypropylene mesh (mesh implant) approximately 1.1 cm x 12 cm covered by a polyethylene sheath.

The Helical Passer Sheaths (white polyethylene tube receptacles) are attached along with the mesh implant sheath by PROLENE polypropylene Positioning Lines to each end of the mesh implant to accommodate the Helical Passers. The Helical Passers come assembled to the GYNECARE TVT ABBREVO™ device and are used to deliver the mesh implant via the trans-obturator 'inside-out" approach.. Further, there is a GYNECARE TVT ABBREVO™ Placement Loop consisting of a loop of PROLENE Polypropylene Monofilament with an attached polypropylene button, pre-assembled as part of the GYNECARE TVT ABBREVO™ Implant Assembly at the center of the mesh to aid in symmetric placement of the mesh.

AI/ML Overview

This document describes the GYNECARE TVT ABBREVO™ Continence System, a surgical mesh device for treating stress urinary incontinence (SUI) in women. Based on the provided text, here's a breakdown of the acceptance criteria and the study information:

Key Observation:

The provided document is a 510(k) submission summary for the GYNECARE TVT ABBREVO™ Continence System. The purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to perform a full clinical trial to establish new safety and effectiveness claims from scratch (unless specific performance data is required to establish substantial equivalence for a novel aspect). Therefore, the study described is focused on demonstrating equivalence and device performance, rather than clinical efficacy studies often associated with AI/software devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format often seen for AI/software-based medical devices (e.g., sensitivity, specificity thresholds). Instead, safety and performance were evaluated through a series of tests to demonstrate the device fulfills predefined user specifications and functions as intended, supporting its substantial equivalence to predicate devices.

Acceptance Criteria Category	Reported Device Performance / Evaluation Method
Biocompatibility	Tested in accordance with ISO 10993-1 standard recommendations. (Implies compliance with biological safety standards).
Physical/Performance Measurements	Benchtop tests including "Length of Positioning Line + Mesh" and "Attachment Strength" were conducted. (Implies meeting predefined physical strength and dimensional specifications, though specific numeric values are not provided).
Initial Fixation & Anatomic Pathway	Studied in a cadaver model. (Implies successful deployment and initial stability in a simulated anatomical environment).
Tissue In-growth	Studied in an animal model. (Implies suitability for tissue integration, a key aspect of mesh function).
Overall Equivalence	Demonstrated to have the same indications for use, principle of operation, and fundamental scientific technology as its predicate device (GYNECARE TVT™ Obturator System).

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

The document does not specify sample sizes for the benchtop, cadaver, or animal model tests. It only lists the types of tests performed.

Data Provenance:
- Benchtop tests: Likely conducted in a laboratory setting.
- Cadaver model: Human cadavers (origin not specified, but typically conducted in specialized labs or medical institutions).
- Animal model: Animals (species not specified, but this would be a prospective study on the animal subjects).
- Given the nature of the device (surgical mesh), this is not a data-driven AI study with retrospective or prospective patient data in the typical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For benchtop, cadaver, and animal studies, "ground truth" would generally be established by adherence to protocols, engineering specifications, and established biological/anatomical measures, evaluated by qualified lab personnel, engineers, and potentially veterinarians/surgeons, rather than "experts" in the context of clinical image interpretation or AI model validation.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the types of studies described (biocompatibility, benchtop, cadaver, animal model testing). Adjudication is more relevant in clinical trials or expert-driven evaluations where there might be disagreement in interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not performed. This type of study is specifically relevant for AI/software devices intended to assist human readers (e.g., radiologists interpreting images). The GYNECARE TVT ABBREVO™ is a physical surgical mesh device, not an AI software.

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

No, a standalone performance study in the context of AI algorithms was not done. The device is a physical implant requiring direct surgical placement by a human surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission would derive from:

Engineering Specifications: For benchmark physical tests like "Length of Positioning Line + Mesh" and "Attachment Strength."
Established Biological Standards: For biocompatibility (ISO 10993-1) and tissue in-growth studies.
Anatomical Accuracy/Feasibility: For cadaver model studies assessing initial fixation and anatomic pathway.
Predicate Device Performance: The ultimate ground truth for this 510(k) submission is that the new device performs "as safe and effective as the predicate device" based on direct comparison of technological characteristics and the performance data listed above.

8. The Sample Size for the Training Set

This information is not applicable (N/A). The GYNECARE TVT ABBREVO™ is a physical medical device (surgical mesh), not an AI/machine learning algorithm, and therefore does not have a "training set" in the computational sense.

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

This information is not applicable (N/A) for the same reasons mentioned in point 8.

Summary

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Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.

Submitted by:

Susan Lin Manager, Regulatory Affairs Ethicon, Inc., A Johnson & Johnson Company

Route 22 West. PO Box 151 Somerville, NJ 08876

JUL - 1 2010

Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh / OTN

Trade Name:

GYNECARE TVT ABBREVO™ Continence System

Predicate Devices:

GYNECARE TVT™ Obturator System (K033568), ETHICON, Inc.

Statement of Intended Use:

Device Description:

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Summary of Technological Characteristics of New Device to Predicate Devices:

The principle of operation and fundamental scientific technology of the proposed device are equivalent to the predicate devices. Both the GYNECARE TVT™ Obturator and the GYNECARE TVT ABBREVO™ function in the same manner - Introducing a sub-urethral synthetic mesh sling in the patient from a vaginal incision that provides mid-urethral support.

Performance Data:

GYNECARE TVT ABBREVO™ underwent an extensive safety and performance testing program to support that GYNECARE TVT ABBREVO™ fulfills the device requirements defined in user specifications, functions as intended, and is substantially equivalent to the predicate device. The tests conducted include:

Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 . standard
Bench top physical/performance measurements including Length of Positioning Line + Mesh . and Attachment Strength
Initial fixation force and anatomic pathway studies in cadaver model .
� Tissue in-growth studies in animal model

Conclusions:

GYNECARE TVT ABBREVO™ has the same indications for use, principle of operation, and fundamental scientific technology as its predicate device. Performance data demonstrates that the device is as safe and effective as the predicate device for the intended use. Thus we conclude that the proposed device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

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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 is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure with outstretched arms, resembling an eagle or bird in flight.

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

Ethicon, Inc. % Ms. Susan Lin Manager, Regulatory Affairs Route 22 West, P.O. Box 151 SOMERVILLE NJ 08876

SEP 2 8 2012

Re: K100936 Trade/Device Name: GYNECARE TVT ABBREVO™ Continence System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: April 2, 2010 Received: April 5, 2010

Dear Ms. Lin:

This letter corrects our substantially equivalent letter of July 7, 2010.

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/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. Perkins

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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K100936

SL-2010-002

Indications for Use

510(k) Number (if known):

Device Name: GYNECARE TVT ABBREVO™ Continence System

Indications for Use:

The GYNECARE TVT ABBREVO™ Continence System is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urelhral hypermobility and/or intrinsic sphincter deficiency.

Over-The-Counter Use Prescription Use X . AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kianefor MXM
(Division Sign-Off)

Division of Surgical, Orthopedic and Restorative Devices

510(k) Number: K100936

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.