The proposed LITE Pelvic Floor Repair Kits are indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Description

The proposed devices were submitted to introduce lightweight versions of previously cleared pelvic floor repair kits: Pinnacle Anterior/Apical, Pinnacle Posterior, Pinnacle Duet and Uphold Vaginal Support System. The proposed mesh configurations were designed for performing transvaginal vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs. These devices are sterile, single use devices, consisting of one or two light-weight synthetic mesh assemblies and a needle holder.

The mesh assemblies consist of a macroporous polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the Capio The Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.

AI/ML Overview

The provided text from K103426 describes the LITE Pelvic Floor Repair Kits and their substantial equivalence to predicate devices, rather than a study with acceptance criteria for device performance in detecting or diagnosing conditions, or comparing AI assistance with human performance. The "performance testing" mentioned refers to bench testing of the physical characteristics of the mesh, not clinical performance or diagnostic accuracy.

Therefore, many of the requested fields cannot be populated based on the provided document.

Here's a breakdown of what can be extracted and what cannot:

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

The document describes several mechanical performance tests and biocompatibility tests. It does not provide specific acceptance criteria or quantitative reported values in the format of a table. It states that "The results of the performance testing demonstrate equivalence of the LITE Pelvic Floor Repair kits to the predicate devices." This implies that the LITE kits met the performance characteristics consistent with the predicate devices but doesn't quantify those.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Mesh thickness consistent with predicate devices	Demonstrated equivalence to predicate devices.
Pore size consistent with predicate devices	Demonstrated equivalence to predicate devices.
Density consistent with predicate devices	Demonstrated equivalence to predicate devices.
Tensile strength consistent with predicate devices	Demonstrated equivalence to predicate devices.
Stiffness consistent with predicate devices	Demonstrated equivalence to predicate devices.
Burst strength consistent with predicate devices	Demonstrated equivalence to predicate devices.
Suture pullout strength consistent with predicate devices	Demonstrated equivalence to predicate devices.
Mesh flexibility consistent with predicate devices	Demonstrated equivalence to predicate devices.
Tensile strengths of mesh assembly components consistent with predicate devices	Demonstrated equivalence to predicate devices.
Force to remove leg assemblies from mesh consistent with predicate devices	Demonstrated equivalence to predicate devices.
Biocompatibility:
Cytotoxicity within acceptable limits	Demonstrated equivalence to predicate devices.
Sensitization within acceptable limits	Demonstrated equivalence to predicate devices.
Irritation within acceptable limits	Demonstrated equivalence to predicate devices.
Acute systemic toxicity within acceptable limits	Demonstrated equivalence to predicate devices.
Sub acute toxicity within acceptable limits	Demonstrated equivalence to predicate devices.
Genotoxicity within acceptable limits	Demonstrated equivalence to predicate devices.
Implantation response within acceptable limits	Demonstrated equivalence to predicate devices.

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

Not applicable. The document describes bench testing of materials and device components, not a clinical study on a patient test set.

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

Not applicable. This was bench testing, not an expert-based evaluation of clinical images or data.

4. Adjudication method for the test set

Not applicable.

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

No. This document does not mention any MRMC studies or AI assistance.

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

No. This document does not describe an algorithm or AI.

7. The type of ground truth used

For the mechanical and biocompatibility testing, the "ground truth" was established by standardized test methods and validated measurements for the physical and biological properties of the mesh and its components, with predicate device characteristics serving as the benchmark for equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

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K103426
Page 1 of 2.

510(k) Summary for the LITE Pelvic Floor Repair Kits

Date Prepared: September 13, 2011

SEP 1 4 2011

A. Sponsor

Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01756

B. Contact

Michelle Berry Senior, Regulatory Affairs Specialist 508-683-4941 or Donna Gardner

Director, Regulatory Affairs 508-683-4398

C. Device Name

LITE Pelvic Floor Repair Kits Tradename: Common/usual name: Surgical Mesh Classification Name: OTP .- Mesh, Surgical, Polymeric and OTP - Mesh, Surgical, gynecologic, for pelvic organ prolapse, transvaginally placed 21 CFR 878.3300, Class II

D. Predicate Device(s)

Tradename: Common/usual name: Classification Name:

Premarket Notification:

Tradename: Common/usual name: Classification Name:

Premarket Notification:

Tradename: Common/usual name: Classification Name:

Premarket Notification:

Pinnacle and Uphold Pelvic Floor Repair Kits Surgical Mesh Oil - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II Boston Scientific, K071957, K081048, K091131

Novasilk Mesh Surgical Mesh OTP - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II K053414

Restorelle Polypropylene Mesh Surgical Mesh OTY oldMesh, Surgical, Polymeric 21 CFR 878.3300, Class II K092207

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K103426 Page 2 of 2

E. Device Description

F. Intended Use

The proposed LITE mesh kits are intended for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

G. Technological Characteristics

The proposed device has the same mesh fiber materials and fiber diameter as the predicates but is knit with a larger pore size to create a lighter, lower density mesh.

H. Substantial Equivalence/ Performance Testing (Bench)

Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" and "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", a direct comparison of key characteristics demonstrates that the proposed mesh is substantially equivalent to the predicate mesh in terms of intended use, technological characteristics, and performance characteristics tested.

Boston Scientific conducted mechanical performance and biocompatibility testing to demonstrate the equivalence of the LITE mesh to the predicate devices. The mesh mechanical performance testing included mesh thickness, pore size, density, tensile strength, stiffness, burst strength, suture pullout strength, and mesh flexibility. In addition, Boston Scientific evaluated the tensile strengths of the mesh assembly including the components of the leg assemblies (needle, lead, dilator, protective sleeve and leader loop). Boston Scientific also evaluated the force to remove the leg assemblies from the mesh.

Biocompatibility testing on the LITE kits' materials of construction included cytotoxicity, sensitization, irritation, acute systemic toxicity, sub acute toxicity, genotoxicity and implantation.

The results of the performance testing demonstrate equivalence of the LITE Pelvic Floor Repair kits to the predicate devices.

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract shape.

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

Ms. Michelle Berry Sr. Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752

SEP 2 8 2012

Re: K103426

Trade/Device Name: LITE Pelvic Floor Repair Kits Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: September 2, 2011 Received: September 6, 2011

Dear Ms. Berry:

This letter corrects our substantially equivalent letter of September 14, 2011.

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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Page 2 -

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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Indications for Use Statement

510(k) Number (if Known): _ K 1034 2 6

Device Name: LITE Pelvic Floor Repair Kits

Indications For Use:

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hl. Leun

ro-Renal, and

Regulation Number and Section

§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.

(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.