The Mentor ObTape Trans-obturator Surgical Kit consists of an implantable, suburethral support tape and introducers. It is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or sphincter deficiency.

Device Description

The Mentor ObTape Trans-obturator Surgical Kit consists of two components: the Mentor ObTape Trans-obturator Tape and a set of Introducer Needles.

The Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The tape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, allows tissue colonization and facilitates positioning during surgery.

A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Kit.

AI/ML Overview

The provided text describes a 510(k) submission for the Mentor ObTape™ Trans-obturator Surgical Kit. This is a medical device clearance process, not a study evaluating an AI algorithm, and therefore many of the requested elements (like sample size for test sets, number of experts, MRMC studies, standalone performance of an algorithm, and training set details) are not applicable to this type of regulatory submission.

The "study" in this context refers to the pre-clinical and mechanical testing performed to demonstrate that the device is substantially equivalent to a previously cleared predicate device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Mentor ObTape Trans-obturator Tape:
Substantial equivalence in material, function, performance, and design to the predicate Mentor ObTape Trans-obturator Tape cleared under 510(k) K031767.	"The tape included in the Mentor ObTape Trans-obturator Surgical Kit is identical to the Mentor ObTape which was cleared under 510(k) K031767."
Introducer Needles:
Meet established criteria for mechanical performance.	"Mechanical testing of the sterile introducers showed that the introducers met all established criteria for mechanical performance." (Specific criteria are not detailed in this summary, but would have been part of the full submission).
Be non-toxic and non-irritant (biocompatibility).	"Biocompatibility testing on the sterile, disposable introducers demonstrated that the introducers are non-toxic and a non-irritant." (Specific tests like cytotoxicity, sensitization, irritation would have been performed, but are not detailed in this summary).
Overall Kit:
Substantial equivalence to the predicate Mentor ObTape Trans-obturator Tape and Introducers cleared under 510(k) K031767.	"The Mentor ObTape Trans-obturator Surgical Kit is substantially equivalent in material, function, performance and design to the Mentor ObTape Trans-obturator Tape and Introducers which were cleared under 510(k) K031767." This is the overarching claim for the entire kit, based on the individual components meeting their respective criteria and remaining identical/equivalent to the predicate.

Additional Information (Not applicable for AI algorithms)

2. Sample size used for the test set and the data provenance:

Not applicable. This submission focuses on the substantial equivalence of a physical medical device (surgical tape and introducers), not an AI algorithm. The testing involved mechanical and biocompatibility assessments of the physical components, not a "test set" of data in the AI sense. The text does not provide sample sizes for these tests. Data provenance in this context would refer to the origin of the materials and manufacturing standards, which are not detailed in the summary.

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

Not applicable. There is no "ground truth" establishment in the AI sense for this device. The tape component's equivalence is based on it being identical to a previously cleared device. The introducers' performance is based on mechanical and biocompatibility testing against predefined standards, likely conducted by qualified engineers and toxicologists/biologists, but not "experts" establishing a "ground truth" for a test set.

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

Not applicable. No adjudication method is relevant as there is no "test set" or human interpretation of data in the AI context.

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 not an AI-assisted device.

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

Not applicable. This is not an AI device.

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

Not applicable. For the tape, the "ground truth" is that it is identical to a predicate device already deemed safe and effective. For the introducers, the "ground truth" is adherence to established mechanical performance specifications and demonstrated biocompatibility as per relevant standards. These are not "ground truths" in the diagnostic AI sense.

8. The sample size for the training set:

Not applicable. This is not an AI device with a training set.

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

Not applicable. This is not an AI device.

Summary

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NOV - 9 2004

KOY2851/1/2

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is:

Contact Person:	Donna A. CrawfordDirector, Corporate Regulatory AffairsMentor Corporation201 Mentor DriveSanta Barbara, CA 93111
Telephone:	805-879-6304
FAX:	805-879-6015
Date Prepared:	June 6, 2003

Device Name and Classification

Proprietary Name:	Mentor ObTape™ Trans-obturator Surgical Kit
Common Name:	Pubourethral Support Sling
Classification Name:	Surgical Mesh, polymeric
Class:	Class II
Product Code:	OTN
CFR #:	§878.3300

Device Description

The Mentor ObTape Trans-obturator Surgical Kit consists of two components: the Mentor ObTape Trans-obturator Tape and a set of Introducer Needles.

A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Kit.

Substantial Equivalence Claim

The Mentor ObTape Trans-obturator Surgical Kit is substantially equivalent in material, function, performance and design to the Mentor ObTape Trans-obturator Tape and Introducers which were cleared under 510(k) K031767.

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KOY2851
2/2

Indications for Use

Mentor ObTape Trans-obturator Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Summary of Testing

The tape included in the Mentor ObTape Trans-obturator Surgical Kit is identical to the Mentor ObTape which was cleared under 510(k) K031767.

Mechanical testing of the sterile introducers showed that the introducers met all established criteria for mechanical performance. Biocompatibility testing on the sterile, disposable introducers demonstrated that the introducers are non-toxic and a non-irritant.

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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 eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

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

Ms. Donna A. Crawford Director, Corporate Regulatory Affairs Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111

SEP 2 8 2012

K042851 Re: Trade/Device Name: Mentor ObTape™ Trans-obturator Surgical Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: October 14, 2004 Received: October 20, 2004

Dear Ms. Crawford:

This letter corrects our substantially equivalent letter of November 9, 2004.

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/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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K042851

Indications for Use

510(k) Number (if known): K042851

Device Name: Mentor ObTape™ Trans-obturator Surgical Kit

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General. Restorative. and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.