HYDROFIX VASO SHIELD

K101805 · Mimedx Group, Inc. · OMR · Apr 8, 2011 · Cardiovascular

Device Facts

• Record ID: K101805
• Device Name: HYDROFIX VASO SHIELD
• Applicant: Mimedx Group, Inc.
• Product Code: OMR · Cardiovascular
• Decision Date: Apr 8, 2011
• Decision: SESU
• Submission Type: Traditional
• 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, clear, pliable, nanoporous sheet composed of polyvinyl alcohol (PVA). Device acts as a physical barrier to minimize tissue contact between vessels and the spine during anterior vertebral surgery. Provided sterile and hydrated in various dimensions; contains no holes, perforations, or markings. Used by surgeons in the operating room to separate soft tissue from the surgical site. Benefit includes potential reduction in risk of vessel damage during anterior vertebral revision surgery. Output is the physical presence of the shield itself, which remains in the patient to provide separation.

Clinical Evidence

No human clinical data. Evidence consists of in vivo large animal (sheep) implantation study demonstrating the device's ability to separate soft tissue from the surgical site to reduce potential vessel damage risk during anterior vertebral revision surgery.

Technological Characteristics

Flexible, nanoporous sheet made of polyvinyl alcohol (PVA). Dimensions vary. Provided sterile and hydrated. Non-absorbable physical barrier. No electronic components, software, or energy source.

Indications for Use

Indicated for use as a cover for vessels following 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

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

Reference Devices

• Gore PRECLUDE® Vessel Guard (K061727)

Submission Summary (Full Text)

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# K101805 APR - 8 2011

## 510(k) Summary

| Proprietary Name: | HydroFix™ 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: | 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. It is a slippery, clear pliable, conformable, nanoporous provided in valled over that minimizes tissue contact between the vessels and the spine. 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.

#### Substantially Equivalent Devices:

The following devices as substantially equivalent predicate devices listed below.

K090022 Paradis Vaso Shield™ K093551 Paradis Vaso Shield™

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#### K100905 HydroFix™ Vaso Shield K061727 Gore PRECLUDE® Vessel Guard

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.

Intended Use: Fusion Surgery, Adjacent Level Surgery, Artificial Disc Implantation, Implant or Hardware Removal, Trauma, Vascular Surgery in the Spine

#### 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 vivo testing as indicated below:

#### In Vivo Testing

- Large Animal Implantation A sheep model (animal study) was conducted to . demonstrate the reduction in the risk of potential vessel damage during anterior vertebral revision surgery. The implanted devices allowed a separation of the soft tissue adjacent to the study site from the study site.
#### Conclusion:

The sponsor believes that the data and information presented in this 510(k) application, including 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.

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

## APR - 8 2011

MiMedx Group, Inc. c/o Mr. William Jackson 811 Livingston Court SE Suite B Marietta, GA 30067

Re: K101805

Trade Name: HydroFix Vaso ShieldTM Regulation Number: 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: OMR Dated: March 15, 2011 Received: March 16, 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). You may, therefore, market the device with a 6 month shelf life, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling and any promotional materials:

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Page 2 - Mr. William Jackson

The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established.

Furthermore, the indication for use as a cover for vessels following anterior vertebral surgery must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International, and Consumer Assistance at its

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toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Christy foreman

Christy Foreman Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K101805

Device Name: MiMedx HyroFix Vaso Shield™

Indications For Use: The HydroFix Vaso Shield™ is indicated for use as a cover for vessels following anterior vertebral surgery.

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diana R. James

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_K וַט 180 5

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