C-QUR Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

Device Description

C-QURTM Mesh is a sterile, knitted polypropylene monofilament mesh material for tissue reinforcement with a bio-absorbable, animal derived oil coating (O3FA) composed of fatty acids, lipids and glycerides. The C-QUR Mesh family is available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA regarding surgical mesh devices (C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document specifically states: "This submission does not contain technological changes for subject devices. C-QUR Mesh has the same technological characteristics as previously cleared C-QUR Mesh devices (K050311, K082748, K090909, K100076, K110110 and K121070). The subject devices differ only from the predicate devices in the indications for use, contraindications, and MR compatibility in the labeling." It also states, "The mesh materials used to construct the Atrium C-QurTM Mesh have not been modified and remain the same as those described in predicate C-QUR Mesh devices."

The document focuses on demonstrating substantial equivalence based on existing, previously cleared devices and labeling changes, rather than presenting a new performance study to prove the device meets acceptance criteria. Therefore, the information required to answer the prompt directly is not available within this document. The document is essentially a regulatory filing affirming that these updated versions of the C-QUR mesh family do not represent a new device that requires a de novo performance study, but rather are equivalent to those already on the market.

Based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria, because such information is not present. This document is a regulatory approval based on substantial equivalence, not a report of a new performance study.

Therefore, I cannot populate the table or provide details about sample size, expert involvement, or ground truth establishment for a new performance study of this device. The document explicitly states that there are no technological changes and that the device characteristics are the same as previously cleared predicates.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and movement.

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

October 22, 2015

Atrium Medical Corporation Mr. Timothy J. Talcott Senior Director of Regulatory Affairs 5 Wentworth Drive Hudson, New Hampshire 03051

Re: K151386

Trade/Device Name: C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: September 21, 2015 Received: September 22, 2015

Dear Mr. Talcott:

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 (21

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Page 2 - Mr. Timothy J. Talcott

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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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510(k) Number (if known) K15386

Device Name

C-QUR Mesh

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K151386

Device Name

C-QUR FX Mesh

Indications for Use (Describe)

C-QUR FX Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K151386

Device Name

C-QUR V-Patch Mesh

Indications for Use (Describe)

C-QUR V-Patch Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K151386

Device Name

C-QUR TacShield Mesh

Indications for Use (Describe)

C-QUR TacShield Mesh is intended for use in soft tissue deficiencies including hemia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and comblete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

510(k) Number (if known) K151386

Device Name

C-QUR CentriFX Mesh

Indications for Use (Describe)

C-QUR CentriFX Mesh is intended for use in soft tissue deficiencies including hemia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K151386

Device Name

C-QUR Mosaic Mesh

Indications for Use (Describe)

C-QUR Mosaic Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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1 510(K) Summary

Submission Date:

1.1 Submitter Information:

Submitted by:	Atrium Medical Corporation
	5 Wentworth Drive
	Hudson, NH 03051
Contact Person:	Timothy J. Talcott
	Senior Director of Regulatory Affairs
	Phone: (443) 283-2768
	Email: timothy.talcott@maquet.com
	Phone: (603) 880-1433 x 5342
	Fax: (603) 821-1420

1.1 Device Information

Trade/ProprietaryName	C-QUR Mesh, C-QUR FX Mesh, C-Qur V-Patch Mesh, C-QUR TacShield Mesh, C-QUR CentriFX Mesh, and C-QURMosaic Mesh
Common/Usual Name:	Mesh, Surgical, Polymeric
Regulation Name:	Surgical Mesh
Device Class:	21 CFR 878.3300, Class II
Product Code:	FTL
Reviewing Panel:	General & Plastic Surgery

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Predicate Devices:	K050311	Atrium C-QURTM Mesh
	K082748	Atrium C-QURTM FX Mesh
	K090909	Atrium C-QUR V-PatchTM Mesh
	K100076	Atrium C-QUR TacShieldTM Mesh
	K110110	Atrium C-QUR CentriFXTM Mesh
	K121070	Atrium C-QUR MosaicTM Mesh
Device Description:	C-QURTM Mesh is a sterile, knitted polypropylenemonofilament mesh material for tissue reinforcement with abio-absorbable, animal derived oil coating (O3FA) composedof fatty acids, lipids and glycerides. The C-QUR Meshfamily is available in various configurations with sizes up to12" X 18". The devices are terminally sterilized usingEthylene Oxide and intended as a single use device.
Indications for Use:	C-QUR Mesh is intended for use in soft tissue deficienciesincluding hernia repair, traumatic or surgical wounds andchest wall reconstruction procedures requiring reinforcementwith a non-absorbable supportive material.
TechnologicalCharacteristics	This submission does not contain technological changes forsubject devices. C-QUR Mesh has the same technologicalcharacteristics as previously cleared C-QUR Mesh devices(K050311, K082748, K090909, K100076, K110110 andK121070).The subject devices differ only from the predicate devices inthe indications for use, contraindications, and MRcompatibility in the labeling.
	There are no new types of questions of safety andeffectiveness raised by these differences, thereby supportingsubstantial equivalence to predicates.
PerformanceCharacteristics	The mesh materials used to construct the Atrium C-QurTMMesh have not been modified and remain the same as thosedescribed in predicate C-QUR Mesh devices.
Conclusion:	This notification contains all information required by 21 CFR807.87. Atrium believes the labeling changes allow thedevices to be remain substantially equivalent to each otherand do not raise any new types of safety or effectivenessquestions.

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.