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.

AI/ML Overview

Acceptance Criteria and Study for HydroFix™ Vaso Shield (K101805)

The provided document describes the 510(k) premarket notification for the HydroFix™ Vaso Shield. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a new study with predefined acceptance criteria. Instead, the "acceptance criteria" are implied by the demonstration of comparable performance to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Technological Characteristics and Functionality comparable to predicate devices.	The device is a flexible sheet of polyvinyl alcohol (PVA). It is described as slippery, clear, pliable, conformable, and nanoporous, designed to minimize tissue contact between vessels and the spine. It has no holes or perforations, no markings, and is provided sterile and hydrated. This aligns with the basic function of a "vessel guard."
Similar Indications for Use as predicate devices.	Indicated as a cover for vessels during anterior vertebral surgery. This is directly comparable to the stated intended use of the Paradis Vaso Shield™ (K090022 and K093551) and Gore PRECLUDE® Vessel Guard (K061727).
Demonstrated reduction in risk of potential vessel damage in vivo.	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 (HydroFix™ Vaso Shield) allowed a separation of the soft tissue adjacent to the study site from the study site. This provides evidence for the device's protective function.
Safety profile comparable to predicate devices.	While not explicitly detailed, the 510(k) process inherently requires a demonstration that the new device does not introduce new or different questions of safety or effectiveness compared to predicate devices. The absence of adverse findings in the animal study and the comparison to established predicate devices serve as the basis for this.
Materials comparable to predicate devices or acceptable for medical use.	The device is made of polyvinyl alcohol (PVA). The overall assessment of substantial equivalence suggests this material is acceptable for the intended purpose, aligning with the materials of predicate devices (polypropylene, polyethylene terephthalate, or polytetrafluoroethylene for the general class, though specific predicate materials are not detailed for comparison).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions a "Large Animal Implantation A sheep model (animal study)." It does not specify the exact number of sheep used in the study.
Data Provenance: The study was an in vivo animal study conducted on sheep. The country of origin for the data is not specified. It is a prospective study as an experiment was conducted to generate the data for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number or qualifications of experts used to establish ground truth for the animal study. Veterinary surgeons or researchers would likely have been involved in the implantation and assessment of the devices in the sheep model.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the animal study data. The results would likely have been analyzed and interpreted by the research team involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of images or other data, which is not applicable to this physical implantable device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not
applicable. The HydroFix™ Vaso Shield is a physical implantable device, not an algorithm or software. Its performance is assessed through its physical interaction with tissues in vivo.

7. Type of Ground Truth Used

The ground truth for the in vivo testing was established through direct observation and assessment of the implanted devices in the animal model. This would likely involve:

Direct observation/histology: Assessing the physical separation of soft tissue, the presence or absence of vessel damage, and tissue responses at the implant site.
Pathology: Likely the most definitive ground truth, involving histological examination of tissues around the implant to confirm device presence, tissue separation, and absence of adverse reactions or damage.

8. Sample Size for the Training Set

No training set is mentioned or applicable. This device's performance was evaluated through an in vivo study, not through a machine learning or algorithm-based approach that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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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, polyethyleneterephthalate, or polytetrafluoroethylene. (per 21 CFR 870.3470)
Device Class:	Class II
Product Code:	OMR
Classification Panel:	Cardiovascular Devices
Establishment Registration:	3006731846
Contact:	Sally ThorsenMiMedx Group, Inc.811 Livingston Court SE, Suite BMarietta, GA 30067(678) 384-6720Fax 678-384-6741sthorsen@mimedx.com

Performance Standards:

Performance standards do not currently exist for these devices.

Device Description:

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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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion, indicating the department's name and national affiliation.

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 (240) 276-0120. 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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Page 3 - Mr. William Jackson

toll-free number (800) 638-2041 or (240) 276-3150 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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Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
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.(b)
Classification. Class II (performance standards).