HYDROFIX SURGICAL SHEET

K100313 · Mimedx Group, Inc. · FTL · Jun 14, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K100313
• Device Name: HYDROFIX SURGICAL SHEET
• Applicant: Mimedx Group, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jun 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MiMedx HydroFix™ Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.

Device Story

HydroFix™ Surgical Sheet is a flexible, sterile, hydrated 30 Wt.% polyvinyl alcohol (PVA) sheet. Used in surgical procedures to manage and protect tendon injuries where no substantial loss of tendon tissue has occurred. Minimizes tissue attachment to the device upon direct contact. Provided in various shapes and sizes; features rounded corners; no holes, perforations, or markings. Applied by surgeons during procedures to provide a protective barrier. Benefits patients by reducing post-surgical tissue adhesion at the injury site.

Clinical Evidence

No human clinical data. Evidence consists of in vitro bench testing (suture pull-out, tensile strength, burst strength, tear resistance) and in vivo animal studies (sheep and rabbit models) assessing tissue attachment, suturability, and handling. Results indicate performance comparable to predicate devices.

Technological Characteristics

Material: 30 Wt.% polyvinyl alcohol (PVA). Form: Flexible sheet, 1.0 ±0.2 mm thickness. Sterilization: Provided sterile in saline solution. Non-porous, no perforations or markings.

Indications for Use

Indicated for management and protection of tendon injuries without substantial loss of tendon tissue.

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

• Mast Biosurgery, Ortho-Wrap Bioresorbable Sheet (K072190)
• Xylos Corporation, MTA Protective Sheet (K090778)

Submission Summary (Full Text)

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# 510(k) Summary

DRAFT 9-27-2010

JUN 1 4 2011

HydroFix™ Surgical Sheet Proprietary Name:

Surgical Sheet Common Name:

21 CFR § 878.3300, Surgical Mesh Classification Name:

Device Class: II

FTL Product Code:

Classification Panel: General & Plastic Surgery

Establishment Registration: 3006731846

| Contact Person: | Sally Thorsen<br>MiMedx Group, Inc.<br>811 Livingston Court SE, Suite B<br>Marietta, GA 30067<br>[e-mail] |
|-----------------|----------------------------------------------------------------------------------------------------------------------|
|-----------------|----------------------------------------------------------------------------------------------------------------------|

| Manufacturer: | MiMedx Group, Inc. |
|-----------------------------------|--------------------|
| 811 Livingstone Court SE, Suite B | |
| Marietta, GA 30067 | |

## Performance Standards:

Testing performed indicates the HydroFix™ Surgical Sheet is substantially equivalent to predicate devices.

## Device Description:

The HydroFix™ Surgical Sheet is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions 60 ±6 mm X 50 ±5 mm and 60 ±6 mm X 100 ±10 mm with a thickness of 1.0 ±0.2 mm. The comers of the sheet are rounded. 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 in saline solution.

The HydroFix™ Surgical Sheet will be provided in other shapes and sizes as needed for particular surgical procedures.

## Indications For Use:

-

The MiMedx HydroFix™ Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.

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### Substantially Equivalent Device(s):

The following are substantially equivalent predicate devices.

K072190 Mast Biosurgery, Ortho-Wrap Bioresorbable Sheet K090778 Xylos Corporation, MTA Protective Sheet

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

100313

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#### Brief Comparison Summary:

To demonstrate substantial equivalence of the MiMedx HydroFix™ Surgical Sheet 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 .
- Tensile Strength .
- Burst Strength .
- Tear resistance ●

The results of these tests demonstrate that the technological characteristics and performance r iteria of the MiMedx HydroFix™ Surgical Sheet 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

In 7 vo Testing
To assess the performance of the MiMedx HydroFix™ Surgical Sheet, in vivo studies have been conducted in both sheep and rabbit models to evaluate the following attributes:

- Tissue attachment .
- Ability to suture to tissue .
- Ability to cut the sheet �
- Ability to secure to tissue .
- Ability to manage and protect tendon injuries .

The results of these studies show the MiMedx HydroFix™ Surgical Sheet are comparable to 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™ Surgical Sheet through this 510(k).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

MiMedx Group % Mr. William Jackson VP, Regulatory Affairs and Quality Assurance 811 Livingston Court SE, Suite B Marietta, GA 30067

JUN 1 4 201

Re: K100313 Trade/Device Name: MiMedx HydroFix™ Surgical Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh

Regulatory Class: II Product Code: FTL Dated: June 2, 2011 Received: June 2, 2011

Dear Mr. Jackson:

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. William Jackson

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Pete Vm mo mt
Mark N. Melkerson Ne/kln Dr

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

Enclosure

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## Indications for Use

510(k) Number (if known): __K100313_

Device Name: MiMedx HydroFix™ Surgical Sheet

The MiMedx HydroFix™ Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.

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)

Daniel Keane for MXCM

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

510(k) Number K100313