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

Device Description

Restorelle Y is a mesh is constructed of knitted nonabsorbable 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 text describes the Restorelle® Y surgical mesh and its 510(k) submission for an expanded indication for use.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of numerical targets for clinical performance that the device had to meet to be cleared. Instead, it presents the results of a clinical study and concludes "The performance data and clinical data on similar mesh devices provided in this submission demonstrate that the Restorelle Y mesh is substantially equivalent to its predicate devices."

However, we can infer performance metrics from the reported clinical outcomes.

Metric (Implied Acceptance Criteria)	Reported Device Performance (Restorelle Y)
Objective anatomical cure rate (POP-Q Stage 0 or 1)	89.1%
Clinical cure rate (POP-Q points and subjective measures)	93.5%
Resolution of preoperative dyspareunia	78%
Patients sexually active (postoperative)	63%
New onset of dyspareunia	8%
Mesh erosions	0%

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

Sample Size for Test Set: Not explicitly stated as a number of patients. The study is described as an "independent prospective cohort study." However, one of the referenced abstracts, "Prospective Cohort Study of Robotic Sacrocolpopexy using Lightweight Polypropylene Y Mesh," by Salamon et al., is the source of the clinical data. Without access to the full abstract, the exact number of patients in that specific study cannot be extracted directly from this 510(k) summary. The summary refers to the study's results after "twelve-month postoperative assessments," implying a follow-up period for the cohort.
Data Provenance: The study was conducted by clinicians whose affiliations are not explicitly stated in the 510(k) summary, but the names (Christa Lewis DO, Charbel Salamon MD, etc.) are common in US medical practice. The abstracts were presented at the "AAGL 40th Global Congress of Minimally Invasive Gynecology (November 6-10, 2011 in Hollywood, FL)," suggesting a US or international context, but predominantly American names. It was a prospective cohort study.

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

The document does not provide details on how "ground truth" was established within the prospective cohort study, nor does it specify the number or qualifications of experts involved in data collection or assessment for objective or clinical cure rates. The measurements of POP-Q stages and subjective measures would typically be performed by trained medical professionals (e.g., gynecologists or urogynecologists) involved in the study.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes reported in the prospective cohort study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No, a standalone (algorithm only) performance study was not done. This is a physical medical device (surgical mesh), not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established through a combination of:

Objective anatomical assessment: Specifically, POP-Q (Pelvic Organ Prolapse Quantification) Stage 0 or 1 for anatomical cure. This is a standardized clinical measurement.
Subjective measures: These would have been patient-reported outcomes or clinician assessments of symptoms, as indicated by "simultaneously considering POP-Q points and subjective measures" for clinical cure rate. This also included patient-reported dyspareunia (painful intercourse) and sexual activity.

8. The Sample Size for the Training Set

This question is not applicable in the context of this device. A "training set" typically refers to data used to train an artificial intelligence or machine learning model. The Restorelle Y is a physical surgical mesh, not an AI algorithm. Its development would involve engineering and material science, not a data-driven training set in the AI sense.

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

This question is not applicable for the reasons stated above (see point 8).

Summary

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112322

510(k) Summary of Safety and Effectiveness Information

MAY 1 7 2012

Submitter:	Coloplast A/SHoltedam 1Humlebaek Denmark
Company Contact:	Tim CrabtreeRegulatory Affairs MPhone: 612.302.4922

fairs Manager 2.4922 Fax: 612.287.4138 E-mail: usticr@coloplast.com

Date Prepared: May 16, 2012

Restorelle® Y Device Name:

510(k) Number: K12322

Common Name: Surgical Mesh

Regulation: 21 CFR §878.3300

Regulatory Class: Class II

Product Code: OTO-Mesh, Surgical, Gynecological, For Apical Vaginal Prolapse, Transabdominally Placed.

Predicate Devices: AL YTE™ Y-Mesh Graft (Bard Medical K101722) Restorelle Y Mesh (Mpathy Medical K092207)

Purpose of Submission: The purpose of this submission is to obtain a specific indication for use statement for sacrocolpopexy for the previously cleared Restorelle Y Mesh (K092207).

Description of Device: Restorelle Y is a mesh is constructed of knitted nonabsorbable 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.

Indications for Use: Restorelle Y is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle Y has same intended use as the ALYTE™ Y-Mesh Graft.

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Technological Characteristics Summary: The Restorelle Y has different technological characteristics compared to the AL YTE™ Y-Mesh Graft (e.g. dimensions, pore size and density) which may affect safety and efficacy. However, these differences in technological characteristics do not raise new safety and effectiveness questions because the Restorelle Y is the same Restorelle Y Mesh cleared in K092207. Accepted scientific methods exist to assess these new characteristics as described in the following sections.

Non Clinical Testing: Non-clinical performance of the subject device was characterized in accordance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999) to demonstrate substantial equivalence to the predicate device intended for use of sacrocolposuspension. The following performance characteristics were evaluated:

Mesh Thickness
Pore Size
Mesh Density
Stiffness
Tensile Strength
Suture Pullout Strength
Burst Strength

The results of non-clinical performance testing on Restorelle Y were acceptable.

Performance testing was performed on samples that were all subjected to shelf life validations and testing.

Biocompatibility Testing: Restorelle Y has been subjected to and successfully passed the following biocompatibility testing in accordance with ISO 10993:

Cytotoxicity .
Irritation .
Sensitization
Systemic toxicity
Pyrogenicity
Genotoxicity (Ames Bacterial Study).
Implantation
Hemolysis

Clinical Testing: An independent prospective cohort study was conducted to assess the subjective and objective outcomes using Restorelle Y and robotic . sacrocolpoplexy for patients with prolapse stages 2-4 (see references below). The following results were reported after twelve month postoperative assessments:

· Objective anatomical cure rate was 89.1% (was defined as POP-Q Stage 0 or 1 at all postoperative intervals);
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Clinical cure rate was 93.5% (was defined as by simultaneously considering � POP-Q points and subjective measures);
78% of patients with preoperative dyspareunia reported resolution; .
63% of patients were sexually active;
8% of patients developed new onset of dyspareunia:
No mesh erosions occurred.

References:

Abstracts presented at AAGL 40th Global Congress of Minimally Invasive Gynecology (November 6-10, 2011 in Hollywood, FL)

Bowel Function after Robotic Sacrocolpopexy: Christa Lewis DO, Charbel Salamon MD, Amir Shariati MD, Jennifer L. Priestley PhD, Emil Gurshumov MD, Patrick Culligan MD
. Prospective Cohort Study of Robotic Sacrocolpopexy using Lightweight Polypropylene Y Mesh; Charbel Salamon MD. Christa Lewis DO, Amir Shariati MD, Jennifer L. Priestley PhD, Emil Gurshumov MD, Patrick Culligan MD

Literature Reviews:

Restorelle Case Reports: Coloplast has conducted literature reviews that included case reports in which Restorelle mesh has been used in sacrocolpopexy. The case reports were as follows:

North, C.E. et al. (2005) A preliminary study to compare the vaginal palpability of two different mesh materials used for laparoscopic sacrocolpopexy. International Urogynecology Journal.
. Hawthorn R. et al. (2007). Uses of an ultra light weight mesh in vaginal vault repairs to minimize complications A two-centre observation study. British International Congress of Obstetrics and Gynaecology
North C. et al. (2007). The anatomical and function outcome laparoscopic . sacrocolpopexy using an ultra light weight, polypropylene mesh. International Urogynecology Journal

Other Commercially Available Mesh Devices: Additional literature and clinical reviews were conducted for other mesh products. The criteria included the treatment of pelvic organ prolapse via open, robotic or laparoscopic sacrocolpopexy. The data from this review are supportive of the safety and effectiveness of synthetic mesh for sacrocolpopexy.

Conclusions: The performance data and clinical data on similar mesh devices provided in this submission demonstrate that the Restorelle Y mesh is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

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

Coloplast A/S % Mr. Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road N MINNEAPOLIS MN 55411

Re: K112322

Trade/Device Name: Restorelle® Y Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: May 4, 2012 Received: May 7, 2012

Dear Mr. 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 or any I 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

MAY 1 7 2012

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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" (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/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. Fisher, Ph.D.

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): K112322

Device Name: Restorelle® Y

Indications for Use: Restorelle Y is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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sion Sian-Off n of Reproductive, Gastro-Renal, and (0(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.