(495 days)
No
The device description and performance studies focus on the material properties and physical performance of a surgical sheet, with no mention of AI or ML technologies.
No.
Explanation: The device is described as a "surgical sheet" indicated for the "management and protection of tendon injuries" and minimizes tissue attachment to the device. This aligns with providing physical support and protection rather than actively treating or healing the injury through a therapeutic action.
No
The device is indicated for the management and protection of tendon injuries and acts as a physical barrier. It is not used to diagnose a condition or disease.
No
The device description clearly states it is a flexible sheet made of PVA material with specific dimensions and physical properties, indicating it is a physical medical device, not software.
Based on the provided information, the MiMedx HydroFix™ Surgical Sheet is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management and protection of tendon injuries." This is a therapeutic and protective function applied directly to the patient's body during surgery.
- Device Description: The device is a physical sheet made of PVA material, designed to be surgically implanted or applied to a tendon.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical properties of the sheet (tensile strength, tear resistance) and its in-vivo performance in animal models related to tissue interaction and protection. These are not diagnostic performance metrics.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. The HydroFix™ Surgical Sheet is used in vivo (inside the body) for a therapeutic and protective purpose.
N/A
Intended Use / 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.
Product codes
FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tendons
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 criterion 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.
0
$\K_1 10 0313$
1082
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
MiMedx Group, Inc.
811 Livingston Court SE, Suite B
Marietta, GA 30067
sthorsen@mimedx.com |
| ----------------- | ---------------------------------------------------------------------------------------------------------------------- |
|---|
| 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.
1
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
2082
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).
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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