(117 days)
No
The summary describes a biological mesh for soft tissue repair and reinforcement, with no mention of AI or ML technology in its function, design, or performance evaluation.
Yes
The device is described as an implantable surgical mesh intended to reinforce soft tissue and provide a scaffold for tissue incorporation, which directly serves a therapeutic purpose in repairing or reinforcing bodily tissues.
No
The device description indicates it is an implantable surgical mesh for reinforcing and repairing soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an implantable, animal-sourced, acellular surgical mesh, which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to be implanted to reinforce soft tissue". This describes a surgical implant used directly on a patient's body.
- Device Description: The description details an "implantable, animal-sourced, acellular surgical mesh". This further confirms its use as a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural support.
N/A
Intended Use / Indications for Use
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Product codes
OXH, FTM
Device Description
The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
In support of this Special 510(k), a risk analysis was performed. The potential risks introduced by quilting of two or more meshes together were identified per ISO 14971:2007 Medical devices - Application of risk management to medical devices. The risk analysis method used was Failure Modes Effect Analysis (FMEA). Using this risk analysis method, Miromatrix identified the risks and verification and validation activities were performed to demonstrate that the quilted device meets the pre-determined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2016
Miromatrix Medical Inc. % Miriam Provost, Ph.D. Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington St Suite 100 Alexandria, Virginia 22314
Re: K160400
Trade/Device Name: Miromatrix Biological Mesh Regulation Number: 21 CFR 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXH, FTM Dated: May 12, 2016 Received: May 13, 2016
Dear Dr. Provost:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160400
Device Name Miromatrix Biological Mesh
Indications for Use (Describe)
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the Miromatrix Biological Mesh is provided below.
SUBMITTER 1.
Miromatrix Medical Inc. 10399 West 70th Street Eden Prairie, MN 55334
Contact Person: Jeff Ross, Ph.D. Phone: 763-458-8801 Email: jross@miromatrix.com Date Prepared: February 10, 2016
2. DEVICE
Name of Device: Miromatrix Biological Mesh Common Name: Surgical Mesh Classification Regulation: 21 CFR 878.3300 Regulatory Class: II Product Code: OXH and FTM Panel: General and Plastic Surgery
3. PREDICATE DEVICE
Predicate Device: Miromatrix Biological Mesh (cleared as Miromatrix Biological Mesh RS), K150341
Reference Device: K134033, Miromatrix Biological Mesh
DEVICE DESCRIPTION 4.
The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
5. INDICATIONS FOR USE
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
The similarities and differences in technological characteristics between the subject Miromatrix Biological Mesh and the predicate mesh are summarized below.
6.1. Similarities
The subject and the predicate device are identical with regard to indication for use, design, manufacturing, sterilization, packaging, and shelf life. The proposed and predicate device have the same range of sizes of the individual mesh, the same mesh thickness range, and the same origin and processing of the source material
Differences 6.2.
The difference between the subject and predicate device is a change to the labeling (Instructions for Use). Specifically, the labeling has been modified to provide instructions for physicians to quilt two or more meshes together when deemed clinically necessary. The quilting is being performed solely by the physician and not Miromatrix (i.e., no changes have been made to the device as a result of this labeling change).
These differences in the labeling do not raise a new question of safety and effectiveness because there is no change in the mesh product that is manufactured by Miromatrix, and the risk analysis showed that quilted mesh met the pre-determined acceptance criteria for the individual cleared mesh.
7. PERFORMANCE DATA
In support of this Special 510(k), a risk analysis was performed. The potential risks introduced by quilting of two or more meshes together were identified per ISO 14971:2007 Medical devices - Application of risk management to medical devices. The risk analysis method used was Failure Modes Effect Analysis (FMEA). Using this risk analysis method, Miromatrix identified the risks and verification and validation activities were performed to demonstrate that the quilted device meets the pre-determined acceptance criteria.
8. CONCLUSIONS
The only difference between the subject and predicate device is a change to the labeling (Instructions for Use). Specifically, the labeling has been modified to provide instructions for physicians to quilt two or more meshes together when deemed clinically necessary. The quilting is being performed solely by the physician and not Miromatrix (i.e., no changes have been made to the device as a result of this labeling change).
Quilting does not alter the fundamental scientific technology of the device. The verification and validation activities met the pre-determined acceptance criteria were met.
In conclusion, the subject Miromatrix Biological Mesh with modified labeling is substantially equivalent to the predicate device cleared under K150341.