Restorelle L Polypropylene Mesh 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 L Polypropylene Mesh is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a flat mesh measuring 24cm x 8cm and is designed for the treatment of apical vaginal prolapse.

AI/ML Overview

This 510(k) summary for the Coloplast Restorelle® L surgical mesh does not describe a study that involves analyzing device performance based on acceptance criteria in the manner typically seen for AI/ML or diagnostic devices. Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis based on the information provided, specifically addressing your points where possible:

Analysis of Acceptance Criteria and Device Performance Study for Restorelle® L (K122440)

The provided document describes a 510(k) submission for substantial equivalence of the Restorelle® L surgical mesh. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, and often doesn't involve the same kind of performance study with defined quantifiable acceptance criteria as might be expected for an AI/ML or diagnostic device.

The core argument for equivalence is that the Restorelle® L is identical in materials and design to a predicate device (Restorelle® Y), with the only difference being its size, which falls within the range of existing predicate devices. For this reason, the submission states that "Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle L since the proposed mesh is identical in materials and design as that used in the predicate Restorelle Y device. The results and data from these studies are applicable to the Restorelle L device."

Therefore, many of the typical acceptance criteria and study details you'd expect are not explicitly present for the subject device itself in this document, as its performance is inferred from predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this submission primarily focuses on comparative characteristics for substantial equivalence, rather than a standalone performance study against specific acceptance criteria for the Restorelle® L itself. The "performance" for Restorelle® L is essentially that it matches the properties of its predicate devices, implying equivalent safety and effectiveness.

Property	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Restorelle® L)
Indications for Use	Must be for sacrocolposuspension / sacrocolpopexy for vaginal vault prolapse.	Identical to Restorelle Y: indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Materials of Construction	Non-absorbable, monofilament polypropylene mesh.	Non-absorbable, monofilament polypropylene mesh.
Dimensions	(Implied to be acceptable if within range of existing meshes)	24x8cm (Falls between Restorelle Y's 24x4cm & 27x4cm and Vertessa's 12x20cm/Flat).
Shape	Flat (as per Vertessa) or Y-shaped (as per Restorelle Y).	Flat
Pore Size (mm)	1.80 x 1.83 (as per Restorelle Y)	1.80 x 1.83
Sterilization Method	Ethylene Oxide.	Ethylene Oxide.
Product Code	OTO (Mesh, Surgical, Gynecological, For Apical Vaginal Prolapse, Transabdominally Placed).	OTO
Biocompatibility	Demonstrated by predicate device Restorelle Y.	Results and data from Restorelle Y are applicable.
Shelf Life	Validated for predicate device Restorelle Y.	Results and data from Restorelle Y are applicable.
Sterilization Validations	Validated for predicate device Restorelle Y.	Results and data from Restorelle Y are applicable.

The study that "proves" the device meets the acceptance criteria is the substantial equivalence comparison to predicate devices. The primary proof is the identical nature of its materials and manufacturing processes to the Restorelle Y, and its size falling within the acceptable range of established meshes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this type of submission. There is no "test set" in the sense of patient data or clinical imagery evaluated against ground truth. The submission relies on comparative physical and material characteristics and the established safety and performance of predicate devices.

3. 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)

Not applicable. No expert review for ground truth was performed for the Restorelle® L in this context. The "ground truth" for its equivalence is based on engineering and material specifications matching predicate devices.

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

Not applicable. See point 3.

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/ML or diagnostic device.

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

Not applicable. This is a medical device (surgical mesh), not an algorithm.

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

The "ground truth" for this substantial equivalence determination is the physical and material specifications and established safety/efficacy profiles of its predicate devices (Restorelle® Y and Vertessa™ Polypropylene Mesh), as previously cleared by the FDA. Specifically, the material composition, pore size, sterilization method, and indications for use being identical to Restorelle® Y, and the dimensions being within an acceptable range.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. See point 8.

Summary

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Page 1 of 2

510(k) Summary

K122440

Submitter:	Coloplast A/SHoltedam 1Humlebaek Denmark		NOV 1 9 2012
Company Contact:	Tim CrabtreeRegulatory Affairs ManagerPhone: 612.302.4922 Fax: 612.287.4138usticr@coloplast.com
Date Prepared:	November 6, 2012
Device Name:	Restorelle® L
Common Name:	Surgical Mesh
Regulation:	21 CFR §878.3300
Regulatory Class:	Class II
Product Code:	OTO-Mesh, Surgical, Gynecological, For Apical VaginalProlapse, Transabdominally Placed.
Predicate Devices:	Restorelle® Y (K112322), Vertessa™ Polypropylene Mesh(K120327)

Description of Device: Restorelle L Polypropylene Mesh is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a flat mesh measuring 24cm x 8cm and is designed for the treatment of apical vaginal prolapse.

Indication for Use: Restorelle L Polypropylene Mesh 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.

Technological Characteristics Summary: The Coloplast Restorelle L shares the same materials, features, intended use, and technological characteristics as Restorelle Y. Restorelle L also shares the same materials, intended use and shape of the Vertessa Polypropylene Mesh. The follow table lists the properties associated with the subject and predicate devices.

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K122440
Page 2 of 2

Property	Subject DeviceRestorelle L	Predicate DeviceRestorelle Y	Predicate DeviceVertessaPolypropylene Mesh
Indications	Restorelle LPolypropylene Mesh isindicated for use as abridging material forsacrocolposuspension /sacrocolpopexy(laparotomy laparoscopicor robotic approach) wheresurgical treatment forvaginal vault prolapse iswarranted.	Restorelle YPolypropylene Mesh isindicated for use as abridging material forsacrocolposuspension /sacrocolpopexy(laparotomy laparoscopicor robotic approach)where surgical treatmentfor vaginal vault prolapseis warranted.	Vertessa may be usedfor the repair of uterineor vaginal vaultprolapse that requiressupport material. Itmay be used in open orlaparoscopic abdominalprocedures.
Materials ofConstruction	Non-absorbable,monofilamentpolypropylene mesh	Non-absorbable,monofilamentpolypropylene mesh	Non-absorbable,monofilamentpolypropylene mesh
Dimensions	24x8cm	24 x 4cm & 27 x 4cm	12x20cm / Flat
Shape	Flat	Y	Flat
Pore Size (mm)	1.80 x 1.83	1.80 x 1.83	1.47 x 0.64
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Product Code	OTO	OTO	OTO

The only difference in properties between the subject and predicate devices is size. Since the subject device falls in the range between the predicated devices, no new issues, regarding safety and efficacy, have been identified. Therefore the subject device is substantially equivalent to the cited predicate devices for indications, materials and technological features.

Performance Summary: Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle L since the proposed mesh is identical in materials and design as that used in the predicate Restorelle Y device. The results and data from these studies are applicable to the Restorelle L device.

Conclusions: The performance and non-clinical cited supporting this submission demonstrates that the Restorelle L is substantially equivalent to Restorelle Y and Vertessa Polypropylene Mesh.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 19, 2012

Coloplast A/S % Mr. Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 5541 I

Re: K122440

Trade/Device Name: Restorelle® L Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: October 10, 2012 Received: October 11, 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 vour 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.

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Page 2 - Mr. Tim Crabtree

You must 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.

ff 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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): K122440

Device Name: Restorelle® L

Indications for Use: Restorelle L is indicated for use as a bridging material for Indications for Use: Resiorene L Is millementomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

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

Benjamin R. Fisher -S 2012.11.19 15:12:57,05500'

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number	K122440

Colopiast Restorelle L

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.