(90 days)
No
The device description focuses on the material composition and physical properties of a biological mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies section also relies on equivalence to a predicate device based on material and design, not algorithmic performance.
No
The device is intended for soft tissue repair and reinforcement by providing a scaffold for tissue incorporation, not for treating a disease or condition therapeutically.
No
Explanation: The device is an implantable surgical mesh used for reinforcing soft tissue, not for diagnosing medical conditions. It provides a scaffold for tissue incorporation and repair, rather than detecting diseases or conditions.
No
The device description clearly states it is an implantable, animal-sourced, acellular surgical mesh, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details an "implantable, animal-sourced, acellular surgical mesh" derived from porcine liver tissue, intended to function as a "surgical mesh for soft tissue repair." This further confirms its use as a physical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The description of the Miromatrix Biological Mesh RS does not involve any such testing of specimens.
Therefore, the Miromatrix Biological Mesh RS is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Product codes (comma separated list FDA assigned to the subject device)
OXH
Device Description
The Miromatrix Biological Mesh RS 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
Not Found
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)
Because the materials and design of the subject Miromatrix Biological Mesh RS are identical to that of the predicate Miromatrix Biological Mesh (K134033), no new biocompatibility, bench or animal testing is required to support the substantial equivalence to the predicate device.
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.
Miromatrix Biological Mesh (K134033)
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.
SIS Plastic Surgery Mesh, K034039
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
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing to the right, resembling a bird in flight. The profiles are depicted in a simple, flowing line style.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2015
Miromatrix Medical Incorporated % Miriam Provost, Ph.D. Biologics Consulting Group Incorporated 400 North Washington Street, Suite 100 Alexandria, Virginia 22314
Re: K150341
Trade/Device Name: Miromatrix Biological Mesh RS Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXH Dated: February 9, 2015 Received: February 11, 2015
Dear Dr. Provost:
This letter corrects our substantially equivalent letter of May 12, 2015.
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
1
Page 2 – Dr. Miriam Provost
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as sea forth io 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 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) K150341
Device Name Miromatrix Biological Mesh RS
Indications for Use (Describe)
The Miromatrix Biological Mesh RS is 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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| Device Common Name: | Surgical Mesh |
|---|---|
| Device Trade Name: | Miromatrix Biological Mesh RS |
| Applicant: | Miromatrix Medical, Inc. |
| 18683 Bearpath Trail | |
| Eden Prairie, MN 55347 | |
| Contact: | Jeff Ross |
| VP Product Development | |
| Miromatrix Medical, Inc. | |
| Phone: 763-458-8801 | |
| Email: jross@miromatrix.com | |
| Date Prepared: | February 9, 2015 |
| Classification Regulation: | 21 CFR 878.3300, Class II |
| Panel: | General and Plastic Surgery |
| Product Code: | OXH |
| Predicate Device: | Miromatrix Biological Mesh (K134033) |
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Miromatrix Biological Mesh RS is provided below.
Indication for Use:
The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Device Description:
The Miromatrix Biological Mesh RS 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.
The Miromatrix Biological Mesh RS is identical in materials and design to the predicate Miromatrix Biological Mesh (K134033). The design is consistent with other FDA-cleared meshes indicated for use for plastic and reconstructive surgery. There is no change to the fundamental scientific technology and, thus, no new questions of safety or effectiveness compared to the predicate device.
4
Performance Data:
Because the materials and design of the subject Miromatrix Biological Mesh RS are identical to that of the predicate Miromatrix Biological Mesh (K134033), no new biocompatibility, bench or animal testing is required to support the substantial equivalence to the predicate device.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) | ||
| Number | K150341 | K134033 |
| Applicant | Miromatrix Medical Inc. | Miromatrix Medical Inc. |
| Device Name | Miromatrix Biological Mesh RS | Miromatrix Biological Mesh |
| Classification | ||
| Regulation | 21 CFR 888.3300 | same |
| Product Code | OXH | FTM |
| Indication | The Miromatrix Biological Mesh RS is for | |
| implantation to reinforce soft tissue where | ||
| weakness exists in patients requiring soft tissue | ||
| repair or reinforcement in plastic and | ||
| reconstructive surgery. | The Miromatrix Biological | |
| Mesh is intended to be | ||
| implanted to reinforce soft | ||
| tissue. | ||
| Design | Single-layer biologic mesh that is derived from | |
| porcine liver tissue. The mesh is acellular and not | ||
| cross-linked. The mesh provides a scaffold during | ||
| tissue repair. The mesh is terminally sterilized in | ||
| its packaging and is hydrated, moist and flexible | ||
| when its packaging is opened. | same | |
| Sizes | Available in sizes ranging from 1x2cm to | |
| 20x30cm. Can be cut to shape. | same | |
| Thickness | 0.5-3 mm | same |
| Tissue Origin | porcine | same |
| Single Use | Yes | Yes |
| Sterile | Yes | Yes |
Device Comparison Table:
5
Substantial Equivalence Conclusion:
The Miromatrix Biological Mesh RS is identical in materials and design to the predicate Miromatrix Biological Mesh (K134033). The design is consistent with other FDA-cleared meshes indicated for use for plastic and reconstructive surgery. There is no change to the fundamental scientific technology and, thus, no new questions of safety or effectiveness compared to the predicate device.
The proposed indication for the subject device is different than that of the predicate device. However, the use of the mesh for plastic and reconstructive surgery does not raise any new safety or effectiveness questions compared to its previous indication for reinforcement of soft tissue. Furthermore, similar to other surgical meshes that have been cleared for plastic and reconstructive surgery (e.g., SIS Plastic Surgery Mesh, K034039), the Miromatrix Biological Mesh RS does not provide full mechanical support when used for this indication. Therefore, this proposed indication does not represent a new intended use.
In conclusion, based on identical materials and design, similar indications, and the same intended use, the subject Miromatrix Biological Mesh RS is substantially equivalent to the predicate device, the Miromatrix Biological Mesh (K134033).