RESTORELLE Y CONTOUR MESH by COLOPLAST A/S

Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Description

Restorelle Y Contour Polypropylene Mesh is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It is designed for the treatment of vaginal vault prolapse. The Y shape design allows the two Y-leg segments to be attached to the anterior and posterior vaginal walls. The base of the Y segment is designed to attach to the sacral ligament.

AI/ML Overview

The provided document is a 510(k) summary for the Restorelle Y Contour Polypropylene Mesh. It is a submission for a Special 510(k), which indicates that the device has the same technological characteristics as a previously cleared predicate device (Restorelle Y Contour, K123914), with only minor changes.

Due to the nature of a Special 510(k) for a surgical mesh, the focus of the submission is on demonstrating that the changes made do not affect the safety or effectiveness of the device compared to the predicate. The "performance data" section explicitly states:

"The changes proposed in this Special 510(K) were evaluated through sterilization validation and packaging integrity testing."

This means there was no clinical study comparing the device's performance in patients, nor was there an AI component. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, expert opinions, and comparative effectiveness studies for an AI/device performance assessment is not applicable to this document.

Here's a breakdown based on the information provided and the nature of this 510(k):

Table of acceptance criteria and the reported device performance
- Acceptance Criteria (for a Special 510(k) on this device type): The primary acceptance criteria for this Special 510(k) revolved around demonstrating that the modified device maintained equivalent sterility and packaging integrity to its predicate device. This is typically assessed against established standards for sterilization validation (e.g., ISO 11137 for radiation sterilization, or other relevant standards for the chosen sterilization method) and packaging integrity (e.g., ASTM F88, F1929, F2096).
- Reported Device Performance: The document states that the changes "were evaluated through sterilization validation and packaging integrity testing." It then concludes that the device "is substantially equivalent to its proposed predicate device." While specific numerical performance values against the acceptance criteria are not provided in this summary, the FDA's clearance (K140116) indicates that these tests met the required acceptance criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This 510(k) is for a physical surgical mesh and does not involve a "test set" of data in the context of an AI or diagnostic device. The "testing" involved physical validation of manufacturing processes (sterilization and packaging).
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)
- N/A. Ground truth establishment by clinical experts is not applicable to this type of device submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable.
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 is a physical surgical mesh, not a diagnostic device involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not applicable to this device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A. Not applicable. The "ground truth" for this submission would be adherence to validated manufacturing and quality control standards (e.g., successful sterilization, intact packaging) to ensure the device performs as intended and is safe for use.
The sample size for the training set
- N/A. Not applicable. This device does not use a training set as it's not an AI or machine learning product.
How the ground truth for the training set was established
- N/A. Not applicable.

Summary

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K140116 pg 1 of 2

510(k) Summary

FEB 12 2014

510(k) Owner's Name:	Coloplast A/S
Address:	Holtedam 13050 Humlebaek, DenmarkEstablishment Registration: 9610694Owner/Operator: 8010144
Phone/Fax/Email:	Office: (612) 302-4922Fax: (612) 287-4138
Name of Contact Person:	Tim CrabtreeRegulatory Affairs Manager
Date Prepared:	February 10, 2014
Trade or Proprietary Name:	Restorelle Y Contour Polypropylene Mesh
Common or Usual Name:	Surgical mesh
CFR Number/Product Code:	21 CFR §878.3300/OTO (mesh, surgical,synthetic, urogynecologic, for apical vaginaland uterine prolapse, transabdominallyplaced)
Predicate Devices:	Restorelle Y Contour (K123914)

Description of Device: Restorelle Y Contour Polypropylene Mesh is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It is designed for the treatment of vaginal vault prolapse. The Y shape design allows the two Y-leg segments to be attached to the anterior and posterior vaginal walls. The base of the Y segment is designed to attach to the sacral ligament.

Indication for Use: Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension and/or sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

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The Indications for Use statement for the Restorelle Y Contour Polypropylene Mesh is identical to that of its proposed predicate device.

Technological Characteristics Summary: Restorelle Y Contour Polypropylene Mesh has the same technological characteristics as the proposed predicate device include material, dimensions, and design.

Performance Data: The changes proposed in this Special 510(K) were evaluated through sterilization validation and packaging integrity testing.

Conclusions: Restorelle Y Contour Polypropylene Mesh is substantially equivalent to its proposed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

February 12, 2014

Coloplast A/S Timothy Crabtree Regulatory Affairs Manager 1601 West River Road Minneapolis, MN 55411

Re: K140116

Trade/Device Name: Restorelle® Y Contour Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OTO Dated: January 14, 2014 Received: January 16, 2014

Dear Timothy Crabtree,

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 comply with all the Act's requirements, including, but not limited to: registration and listing

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Page 2 - Timothy Crabtree

(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 contact 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 vours.

Image /page/3/Picture/6 description: The image shows the name "Benjamin Fisher-S" with the letters "FDA" in between the first and last name. The letters "FDA" are stylized with a triple outline. The text is in black and the background is white.

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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Statement of Indications for Use

Indications for Use

K140116 510(k) Number (if known):

Restorelle Y Contour Polypropylene Mesh Device Name:

(Prescription Use	X)
-------------------	----

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use

AND/OR (21 CFR 801 Subpart C)

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

Benjamin Disk -S .
2014.02 -05'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.