(28 days)
Not Found
No
The document describes a physical medical device (a flexible sheet of PVA) and its intended use and performance studies. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
No
The device acts as a physical barrier to minimize tissue contact between vessels and the spine during surgery, rather than treating a disease or condition.
No
The device is described as a "cover for vessels" used during surgery, specifically designed to minimize tissue contact. Its function is protective and physical, not to identify or determine the nature of a disease or condition.
No
The device description clearly states it is a flexible sheet of polyvinyl alcohol (PVA) material, which is a physical material, not software.
Based on the provided information, the MiMedx HydroFix™ Vaso Shield is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as a "cover for vessels during anterior vertebral surgery." This is a surgical device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a physical sheet of material used as a barrier. It does not describe a test, reagent, instrument, or system intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to help diagnose diseases or conditions. The MiMedx HydroFix™ Vaso Shield is a surgical implant/accessory used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.
The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated for use as a cover for vessels during anterior vertebral surgery.
Intended Use: Fusion surgery, Adjacent level surgery, Artificial Disc Implantation, Implant or Hardware Removal, Trauma, Vascular Surgery in the Spine.
Product codes (comma separated list FDA assigned to the subject device)
OMR
Device Description
The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is slippery, clear, pliable, conformable, nanoporous permanent vessel cover 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels during anterior vertebral surgery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In Vitro Testing
- Simulated Use .
- Environmental conditioning testing for 49℃ to 54℃ high temperature exposure limit
The results from these tests 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K090022, K100905, K101826, K101805
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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510(k) Summary as required by section 807.92
MAY 2 0 2011
| Proprietary Name: | HydroFix™ Vaso Shield |
|---|---|
| Common Name: | Vessel Guard or Cover |
| Classification Name: | Intracardiac patch or pledget made of polypropylene, polyethylene |
| 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 |
| MiMedx Group, Inc. | |
| 811 Livingston Court SE, Suite B | |
| Marietta, GA 30067 | |
| (678) 384-6720 | |
| Fax (678) 384-6741 | |
| sthorsen@mimedx.com |
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 slippery, clear, pliable, conformable, nanoporous permanent vessel cover 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.
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Substantially Equivalent Devices:
The following devices as substantially equivalent predicate devices listed below.
K090022 Paradis Vaso ShieldTM K100905 HydroFix™ Vaso Shield K101826 HydroFix™ Vaso Shield K101805 HydroFix™ Vaso Shield
The MiMedx HydroFix™ Vaso Shield was shown to be substantially equivalent to a 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 vitro testing as indicated below:
In Vitro Testing
- Simulated Use .
- Environmental conditioning testing for 49℃ to 54℃ high temperature exposure limit
The results from these tests 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.
Conclusion:
The sponsor believes that the data and information presented in this 510(k) application, including in vitro 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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MiMedx Group, Inc. c/o Sally Thorsen Director, Quality and Regulatory Affairs 811 Livingston Court, Suite B Marietta, GA 30067
MAY 2 0 2011
Re: K111137 Trade Name: HydroFix™ Vaso Shield Regulation Number: 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: OMR Dated: April 21, 2011 Received: April 22, 2011
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). You may, therefore, market the device 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:
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 during 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.
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Page 2 – Ms. Sally Thorsen
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I lease note that the abouting 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 rife i DA minum of basification for your device and permits your device to proceed to the de rice results in a blassillow you to begin marketing your device as described in your Section nuarket: " Pills letter" will ation 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 your device is etablines 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 round in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be artison that i rerruination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I edital Lithe 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 --OI It I art 007); idoomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant by over or visions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your 11 you desire spother most the Office of Compliance at (240) 276-0120. Also, do 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 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 Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 5 – Ms. Sally Thorsen
Indications for Use
510(k) Number (if known): K111137
Device Name: HydroFix™ Vaso Shield
Indications For Use: The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated for use 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Cardiovascular Devices
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510(k) Number K111137