NovaSilk 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

NovaSilk Mesh is an implantable, permanent, non-resorbable, synthetic support mesh manufactured from knitted, monofilament polypropylene. It is square in shape, measuring 150mm x 150mm, and 0.25mm thick.

AI/ML Overview

Here's an analysis of the provided text regarding the NovaSilk Mesh device, specifically addressing the acceptance criteria and study information:

Based on the provided K122968 510(k) summary, the device is NovaSilk Mesh, and this submission is for a "Traditional 510(k) with Narrowed Indications." This type of submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device, rather than new extensive clinical trials for performance. Therefore, many of the typical "acceptance criteria" and "study" details you'd find for a new, novel AI or diagnostic device will not be present.

Acceptance Criteria and Reported Device Performance

The provided documentation does not define specific quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or numerical efficacy targets that the NovaSilk Mesh needs to meet. This is characteristic of a 510(k) submission for a surgical mesh, where the primary focus is on demonstrating substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) process):

Acceptance Criteria (Inferred from 510(k) process for substantial equivalence)	Reported Device Performance
Technological Characteristics:
- Identical materials (knitted monofilament polypropylene)	"identical to NovaSilk Mesh (K053414, predicate device)"
- Identical design (square, 150mm x 150mm, 0.25mm thick)	"identical to NovaSilk Mesh (K053414, predicate device)"
- Identical fundamental scientific technology	"The fundamental scientific technology has not changed from the predicate device to the subject device."
- Similar materials to another predicate (Vertessa K120327)	"NovaSilk Mesh (subject device) also has similar materials... as Vertessa (K120327, predicate device)."
Indications for Use:
- Indications for use either identical or narrower than predicate	"NovaSilk Mesh (subject device) has narrower indications for use than NovaSilk Mesh (K053414, predicate device)."
- Similar indications for use to another predicate (Vertessa K120327)	"NovaSilk Mesh (subject device) also has similar...indications for use as Vertessa (K120327, predicate device)."
Performance Testing:
- Design verification, biocompatibility, sterilization, and shelf life	"Design verification, biocompatibility, sterilization, and shelf life testing completed on the predicate Novasilk Mesh confirm the subject device meets the established design specifications and is substantially equivalent to the predicate."

Study Details:

Given that this is a 510(k) for substantial equivalence of a surgical mesh, the "study" is primarily a non-clinical comparison and verification of physical and material properties against predicate devices. There is no mention of a clinical study or performance study in the context of diagnostic accuracy, AI performance, or human reader improvement, as these types of studies are generally not required for this class and type of device in a 510(k).

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical performance study as might be expected for an AI device. The testing refers to non-clinical bench testing.
- Data Provenance: Not specified, but the testing was likely conducted in a lab setting by the manufacturer or contracted labs. Retrospective/prospective terms do not apply here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of device submission. The "ground truth" for the non-clinical testing is compliance with established engineering and safety standards.
Adjudication method for the test set:
- Not applicable. There is no expert adjudication process for this type of non-clinical testing.
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 MRMC study was done. This is not an AI device or a diagnostic device where human reader performance would be a relevant metric.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used:
- For the non-clinical performance data mentioned ("Design verification, biocompatibility, sterilization, and shelf life testing"), the "ground truth" is adherence to established industry standards, regulatory guidelines (e.g., ISO standards for biocompatibility), and internal design specifications for surgical meshes.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of Approach:

The provided document describes a 510(k) submission for a surgical mesh device. The regulatory strategy is based on demonstrating substantial equivalence to previously cleared predicate devices (NovaSilk Mesh K053414 and Vertessa K120327). This involves showing that the subject device has identical or similar technological characteristics (materials, design, fundamental scientific technology) and identical or narrower indications for use compared to the predicates.

The "performance data summary" refers to non-clinical testing (design verification, biocompatibility, sterilization, and shelf life testing) that was previously completed on the predicate NovaSilk Mesh, which then supports the substantial equivalence claim for the new NovaSilk Mesh (subject device) because the subject device is technologically identical. No new clinical performance data or studies defining specific acceptance criteria in terms of clinical outcomes or reader performance are presented in this 510(k) summary.

Summary

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K122968 Page 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is made up of horizontal lines that are thicker at the bottom and thinner at the top. The word "Coloplast" is in a bold, sans-serif font.

Ostomy Care Urology & Continence Care Wound & Skin Care

510(k) Summary

DEC 1 8 2012

Submitter:	ColoplastA/SHoltdam 13050 Humelbaek, DenmarkEstablishing Registration: 9610694Owner/Operator: 8010144
Contact:	Janell Colley1601 West River RoadMinneapolis, MN 55411Office: 612-344-2334Fax: 612-287-4138
Date Prepared:	December 17, 2012
Trade Name:	NovaSilk Mesh
Common Name:	Surgical Mesh
Classification:	II
Product Code:	OTO-Mesh, Surgical, Gynecological, forApical Vaginal Prolapse, Transabdominally Placed
Regulation:	21 CFR 878.3300
Panel:	Obstetrics/Gynecology
Predicate Devices:	NovaSilk Mesh, Coloplast (K053414)cleared 12/27/2005Vertessa, Caldera Medical (K120327)cleared 5/10/2012

Device Description:

Intended Use:

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K122968 Page 2 of 2

Image /page/1/Picture/1 description: The image shows the Coloplast logo. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is divided into two parts, with the top part having horizontal lines and the bottom part being a solid color. The word "Coloplast" is written in a bold, sans-serif font.

Ostomy Care Urology & Continence Care Wound & Skin Care

Predicate Device Comparison:

The technological characteristics of NovaSilk Mesh (subject device) are identical to NovaSilk Mesh (K053414, predicate device). NovaSilk Mesh (subject device) has narrower indications for use than NovaSilk Mesh (K053414, predicate device). The fundamental scientific technology has not changed from the predicate device to the subject device. NovaSilk Mesh (subject device) also has similar materials and indications for use as Vertessa (K120327, predicate device).

Performance Data Summary:

Design verification, biocompatibility, sterilization, and shelf life testing completed on the predicate Novasilk Mesh confirm the subject device meets the established design specifications and is substantially equivalent to the predicate:

Conclusions:

NovaSilk Mesh is substantially equivalent to the proposed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

December 18, 2012

Coloplast Corp. % Ms. Janell Colley Regulatory Affairs Manager 1601 West River Road North MINNEAPOLIS MN 55411

Re: K122968

Trade/Device Name: NovaSilk Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: September 24, 2012 Received: September 25, 2012

Dear Ms. Colley:

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.

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Page 2 – Ms. Janell Colley

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert R. Lerner

for 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 5

K122968 510(k) Number (if known): _

Device Name: NovaSilk Mesh

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

Herbert R. Lerner

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122968 510(k) Number

NovaSilk Narrowed Indications Traditional 510(k) 11 of 518

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.