ANOVA CONTAINMENT DEVICE

K063461 · Anova Corporation · EZX · Aug 13, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K063461
• Device Name: ANOVA CONTAINMENT DEVICE
• Applicant: Anova Corporation
• Product Code: EZX · General, Plastic Surgery
• Decision Date: Aug 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Device Story

Flexible, synthetic composite implantable mesh; polyester mesh component connected by mono-filament suture to porous expanded polytetrafluoroethylene (ePTFE) component. Used in spinal fusion procedures; attached to spine via four suture anchors (two per adjacent vertebra). ePTFE component placed between mesh and overlying soft tissues; not anchored to disc. Sutures overlay mesh to hold it against vertebral body and reinforce against graft material pressure. Intended to maintain position of weak bony tissue (allografts/autografts) as adjunct to traditional rigid fixation. Not load-bearing. Operated by surgeons in clinical/OR setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible synthetic composite mesh; polyester mesh and ePTFE components. Attached via four suture anchors. Non-load bearing. Sterilization method not specified.

Indications for Use

Indicated for use in spinal fusion procedures to maintain the position of weak bony tissue (allografts or autografts) in conjunction with rigid fixation. Not for load-bearing indications.

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

• MYSTIQUE™ Resorbable Graft Containment Plating System (K041105)
• OptiMesh™ 1500 (K014200)
• Graft Containment Device (K070148)

Submission Summary (Full Text)

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K063461...

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Anova Corporation Page 6

#### 2.0 510(K) SUMMARY FOR THE ANOVA CONTAINMENT DEVICE

Submission Date: November 15, 2006

## Submitter Information:

| Company: | Anova Corporation<br>25 DeForest Avenue<br>Summit, NJ 07901 | AUG 13 200. |
|-----------------|----------------------------------------------------------------------------------|-------------|
| Contact Person: | Bret Ferree, M.D.<br>President and CEO<br>Tel: [phone]<br>Fax: [phone] | |

## Correspondent Information:

Campbell Tuskey, M.S.P.H. 2001 Pennsylvania Avenue, NW Suite 575 Washington, DC 20006 Tel: [phone] Fax: [phone]

### Device Information:

| Trade Name: | Anova Containment Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical mesh<br>Spinal intervertebral body fixation orthosis |
| Classification: | 21 CFR §878.3300 EZX<br>21 CFR §888.3060 KWQ |
| Device Class: | Class II |
| Trade Name: | MYSTIQUE™ Resorbable Graft Containment Plating<br>System |
| Manufacturer: | MacroPore Biosurgery, Inc. |
| K Number: | K041105 |
| Product Code: | K WQ |
| Trade Name: | OptiMesh™ 1500 |
| Manufacturer: | Spineology, Inc. |
| K Number: | K014200 |
| Product Code: | EZX |
| Trade Name: | Graft Containment Device |
| Manufacturer: | NuVasive, Incorporated |
| K Number: | K070148 |
| Product Code: | KWQ |
| Intended Use: | The Anova Containment Device, in conjunction with<br>traditional rigid fixation, is intended for use in spinal fusion<br>procedures as a means to maintain the relative position of<br>weak bony tissue such as allografts or autografts. The<br>device is not intended for load bearing indications. |
| Device Description: | The Anova Containment Device is a flexible, synthetic<br>composite implantable mesh. It includes a polyester mesh<br>component connected by a mono-filament suture to a<br>porous expanded polytetrafluoroethylene or "ePTFE"<br>component. This ePTFE component is placed between the<br>polyester mesh and the overlying soft tissues. The ePTFE<br>component is not anchored to the disc. |
| | The Anova Containment Device is attached to the spine<br>with four suture anchors (two fastened to the vertebra<br>above and two fastened to the vertebra below the disc).<br>The sutures from the anchors overlay the mesh and hold it<br>against the vertebral body and to reinforce the mesh against<br>pressure from the graft material. |

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# Predicate Devices:

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510(k) Premarket Notification Anova Containment Device

Anova Corporation Page 8 100

Comparison to Predicate Devices: The Anova Containment Device has the same intended use and similar technological characteristics as the predicate devices. Differences in the design and performance from the cited predicates do not affect either the safety and/or effectiveness of the Anova Containment Device for its intended use. The safety and effectiveness evaluations based on data provided in this 510(k) demonstrate that the Anova Containment Device is substantially equivalent to the cited predicate devices. Conclusion: The results of our evaluation of the Anova Containment Device support the conclusion that it is as safe and effective as legally marketed devices for its intended use and that because it has the same intended use and similar technology, it is substantially equivalent to the cited predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Anova Corporation % Becker & Associates Consulting, Inc. Ms. Campbell T. Hutton, MSPH 2001 Pennsylvania Avenue, SW Washington, District of Columbia 20006

Re: K063461

Trade/Device Name: Anova Containment Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: EZX, KWO Dated: July 8, 2009 Received: July 8, 2009

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

AUG 18 2009

Dear Ms. Hutton:

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.

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 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.

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## Page 2 - Ms. Campbell T. Hutton, MSPH

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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Barbara Buchr

Mark N. Melkerson Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 1.0 STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K

Device Name:

Anova Containment Device

Indications for Use:

The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.

Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

signature

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K063461

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