HYDROFIX SURGICAL SHEET

K100905 · Mimedx Group, Inc. · OMR · Jun 2, 2010 · Cardiovascular

Device Facts

• Record ID: K100905
• Device Name: HYDROFIX SURGICAL SHEET
• Applicant: Mimedx Group, Inc.
• Product Code: OMR · Cardiovascular
• Decision Date: Jun 2, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

Device Story

HydroFix™ Vaso Shield is a flexible, sterile, hydrated sheet of polyvinyl alcohol (PVA) used during anterior vertebral surgery. It acts as a protective cover for vessels. The device is provided in various dimensions without holes, perforations, or markings. It is applied by a surgeon during the procedure to shield vessels. Performance is evaluated by the ability to suture, secure to tissue, and cut the sheet, as well as edge sharpness and light reflectivity. The device provides a physical barrier to protect vessels during spinal access.

Clinical Evidence

No human clinical data. Evidence consists of in vitro bench testing (suture pull-out) and an in vivo study in a porcine model evaluating physical handling characteristics including light reflectivity, edge sharpness, suturability, tissue securement, and cutting ability.

Technological Characteristics

Material: Polyvinyl alcohol (PVA). Form factor: Flexible, hydrated sheet of various dimensions. Non-porous, no markings. Sterilization: Provided sterile. No software or electronic components.

Indications for Use

Indicated for use as a vessel cover during anterior vertebral surgery in patients undergoing such procedures.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Predicate Devices

• Paradís Vaso Shield (K090022)
• Paradis Vaso Shield (K093551)

Submission Summary (Full Text)

{0}------------------------------------------------

KIUOTOS

Image /page/0/Picture/1 description: The image shows the logo for MiMedx Group. The logo is black and white and features the company name in a bold, sans-serif font. There are two curved lines above the "edx" portion of the name. The word "GROUP" is below the "edx" portion of the name.

JUN - 2 2010

#### May 27, 2010

## 510(k) Summary as required by section 807.92

| Proprietary Name: | <i>HydroFix</i> ™ Vaso Shield |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Vessel Guard or Cover |
| Classification Name: | Intracardiac patch or pledget made of polypropylene, polyethylene<br>terephthalate, or polytetrafluoroethylene. (per 21 CFR 870.3470) |
| Device Class: | Class II |
| Product Code: | OMR |
| Classification Panel: | Cardiovascular Devices |
| Establishment Registration: | 3006731846 |
| Contact Person: | Sally Thorsen<br>MiMedx Group, Inc.<br>811 Livingston Court SE, Suite B<br>Marietta, GA 30067<br>[phone]<br>Fax [phone]<br>[e-mail] |

#### Performance Standards:

Performance standards do not currently exist for these devices.

#### Device Description:

The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.

#### Indications for Use:

The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for MiMedx Group. The logo is black and white and features the company name in a bold, sans-serif font. The word "MiMedx" is on the top line, and the word "GROUP" is on the bottom line. There is a curved line above the word "MiMedx".

## May 5, 2010

#### Substantially Equivalent Devices:

The following devices as substantially equivalent predicate devices listed below.

K090022 Paradís Vaso ShieldTM K093551 Paradis Vaso ShieldTM

The MiMedx HydroFix™ Vaso Shield was shown to be substantially equivalent to previously cleared device and has the same indications for use, design, function, and/or materials.

#### Brief Comparison Summary:

To demonstrate substantial equivalence of the MiMedx HydroFix™ Vaso Shield to the predicate devices, technological characteristics and performance criterion were evaluated using in vitro and in vivo testing as indicated below:

#### In Vitro Testing

- Suture pull out .
The results from this test demonstrate that the technological characteristics and performance criteria of the MiMedx HydroFix™ Vaso Shield are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

## In Vivo Testing

To assess the performance of the MiMedx HydroFix™ Vaso Shield, an in vivo study was conducted in a porcine model to evaluate the following attributes:

- reflectivity of light from the surgical sheet �
- edge sharpness .
- . ability to suture to tissue
- ability to secure to tissue .
- . ability to cut the sheet

The results of this study show that the MiMedx HydroFix™ Vaso Shield are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

## Conclusion:

The sponsor believes that the data and information presented in this 510(k) application, including in vitro and in vivo testing, and numerous device similarities support a determination of substantial equivalence, and therefore market clearance of the MiMedx HydroFix™ Vaso Shield through this 510(k) Premarket Notification.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, representing care and protection. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle.

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

# JUN = 2 2010

MiMedx Group, Inc. c/o Ms. Sally Thorsen Director, Regulatory Affairs and Quality Assurance 811 Livingston Court SE, Suite B Marietta, GA 30067

Re: K100905

MiMedx HydroFix™ Vaso Shield Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate or polytetrafluoroethylene

Regulatory Class: Class II Product Code: OMR Dated: May 5, 2010 Received: May 6, 2010

Dear Ms. Thorsen:

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.

{3}------------------------------------------------

#### Page 2 - Ms. Sally Thorsen

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.

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known): K100905

Device Name: HydroFix™ Vaso Shield

The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

Prescription Use V (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)

(Division/Sign-Off) Di son of Cardlovascular Devices 510(k) Number K (00965