C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic

K151386 · Atrium Medical Corporation · FTL · Oct 22, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151386
• Device Name: C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
• Applicant: Atrium Medical Corporation
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Oct 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

C-QUR Mesh family consists of sterile, knitted polypropylene monofilament mesh coated with bio-absorbable, animal-derived oil (O3FA) composed of fatty acids, lipids, and glycerides. Intended for surgical use in soft tissue reinforcement; provides non-absorbable support for hernia repair, traumatic/surgical wounds, and chest wall reconstruction. Devices are single-use and terminally sterilized via Ethylene Oxide. No technological changes were made to the mesh material; submission focuses on labeling updates regarding indications, contraindications, and MR compatibility.

Clinical Evidence

No clinical data provided; bench testing only. The submission relies on the established safety and effectiveness of the predicate devices, noting no modifications to the mesh materials.

Technological Characteristics

Knitted polypropylene monofilament mesh; coated with bio-absorbable animal-derived oil (O3FA) containing fatty acids, lipids, and glycerides. Available in various configurations up to 12" x 18". Sterilized via Ethylene Oxide.

Indications for Use

Indicated for soft tissue deficiencies, including hernia repair, traumatic or surgical wounds, and chest wall reconstruction requiring non-absorbable reinforcement.

Regulatory Classification

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.

Predicate Devices

• Atrium C-QUR Mesh (K050311)
• Atrium C-QUR FX Mesh (K082748)
• Atrium C-QUR V-Patch Mesh (K090909)
• Atrium C-QUR TacShield Mesh (K100076)
• Atrium C-QUR CentriFX Mesh (K110110)
• Atrium C-QUR Mosaic Mesh (K121070)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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.*

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

{4}------------------------------------------------

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.*

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

{5}------------------------------------------------

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.*

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

{7}------------------------------------------------

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.*

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

{8}------------------------------------------------

# 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: [phone] |
| | Email: [e-mail] |
| | Phone: [phone] x 5342 |
| | Fax: [phone] |

# 1.1 Device Information

| Trade/Proprietary<br>Name | C-QUR Mesh, C-QUR FX Mesh, C-Qur V-Patch Mesh, C-<br>QUR TacShield Mesh, C-QUR CentriFX Mesh, and C-QUR<br>Mosaic 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 polypropylene<br>monofilament mesh material for tissue reinforcement with a<br>bio-absorbable, animal derived oil coating (O3FA) composed<br>of fatty acids, lipids and glycerides. The C-QUR Mesh<br>family is available in various configurations with sizes up to<br>12" X 18". The devices are terminally sterilized using<br>Ethylene Oxide and intended as a single use device. | |
| Indications for Use: | C-QUR Mesh is intended for use in soft tissue deficiencies<br>including hernia repair, traumatic or surgical wounds and<br>chest wall reconstruction procedures requiring reinforcement<br>with a non-absorbable supportive material. | |
| Technological<br>Characteristics | This submission does not contain technological changes for<br>subject devices. C-QUR Mesh has the same technological<br>characteristics as previously cleared C-QUR Mesh devices<br>(K050311, K082748, K090909, K100076, K110110 and<br>K121070).<br>The subject devices differ only from the predicate devices in<br>the indications for use, contraindications, and MR<br>compatibility in the labeling. | |
| | There are no new types of questions of safety and<br>effectiveness raised by these differences, thereby supporting<br>substantial equivalence to predicates. | |
| Performance<br>Characteristics | The mesh materials used to construct the Atrium C-QurTM<br>Mesh have not been modified and remain the same as those<br>described in predicate C-QUR Mesh devices. | |
| Conclusion: | This notification contains all information required by 21 CFR<br>807.87. Atrium believes the labeling changes allow the<br>devices to be remain substantially equivalent to each other<br>and do not raise any new types of safety or effectiveness<br>questions. | |