(115 days)
No
The 510(k) summary describes a physical surgical mesh and its material properties and performance through standard testing, with no mention of AI or ML technology.
No
The device is a surgical mesh intended for repair and/or reinforcement of soft tissues; it is not described as a therapeutic device that actively treats disease or injury.
No
The device is a surgical mesh intended for repair and reinforcement of soft tissues, not for diagnosing medical conditions. Its purpose is therapeutic/reconstructive rather than diagnostic.
No
The device description clearly states it is a "non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers," indicating it is a physical mesh, not software.
Based on the provided information, the Biomerix Composite Surgical Mesh is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery." This describes a surgical implant used directly on a patient's body.
- Device Description: The description details a "non-absorbable porous polymer scaffold... incorporating knitted polypropylene monofilament fibers." This is a physical material designed to be implanted.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Biomerix Composite Surgical Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery.
Product codes
FTL
Device Description
Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.
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
Material testing was performed to demonstrate that the material properties are suitable for the intended use.
Bench testing was performed to demonstrate that the devices as manufactured meet the performance specifications. Test results demonstrate that the device meets the specifications and is acceptable for clinical use.
Biocompatibility testing in accordance to ISO 10993-1 recommended standards was conducted, and results demonstrated that the device is biocompatible according to these standards.
Animal testing demonstrates that the mesh exhibits a well-tolerated long-term histomorphologic response with good integration with surrounding tissue, minimal foreign body response, and no evidence of device degradation or adjacent tissue necrosis.
Key Metrics
Not Found
Predicate Device(s)
Biomerix Composite Surgical Mesh (K082941), Atrium Advanta PTFE Facial Implant (K992991), Tissue Sciences Laboratories Permacol (K013625), Lifecell LTM-BPS Surgical Mesh (K082176)
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
510(K) SUMMARY 3.0
| Applicant Name: | Biomerix Corporation
47757 Fremont Boulevard
Fremont, CA 94538
Phone: (510) 933-3450
Fax: (510) 933-3451 | DEC 23 2011 |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Maybelle Jordan
VP of Regulatory Affairs & Business Development | |
| Date Prepared: | December 22, 2011 | |
| Device Trade Name:
Device Common Name:
Classification Name: | Biomerix Composite Surgical Mesh
Polymeric surgical mesh
Mesh, surgical, polymeric | |
| Predicate Devices: | Biomerix Composite Surgical Mesh (K082941)
Atrium Advanta PTFE Facial Implant (K992991)
Tissue Sciences Laboratories Permacol (K013625)
Lifecell LTM-BPS Surgical Mesh (K082176) | |
| Device Description | Biomerix Composite Surgical Mesh is a non-absorbable
porous polymer scaffold (polycarbonate polyurethane
urea) incorporating knitted polypropylene monofilament
fibers. | |
| Intended Use | The Biomerix Composite Surgical Mesh is intended for
repair and/or reinforcement of soft tissues where
weakness exists in plastic and reconstructive surgery. | |
| Device Technological
Characteristics and
Comparison to
Predicate Device(s): | The Biomerix Composite Surgical Mesh is similar in
materials, design, performance and intended use to
other surgical mesh devices. Any differences in the
above characteristics have been adequately tested to
support substantial equivalence. | |
| Performance Data: | Material testing was performed to demonstrate that the
material properties are suitable for the intended use.
Bench testing was performed to demonstrate that the
devices as manufactured meet the performance
specifications. Test results demonstrate that the device
meets the specifications and is acceptable for clinical
use.
Biocompatibility testing in accordance to ISO 10993-1
recommended standards was conducted, and results
demonstrated that the device is biocompatible according
to these standards.
Animal testing demonstrates that the mesh exhibits a | |
p 1/2
1
02
well-tolerated long-term histomorphologic response with good integration with surrounding tissue, minimal foreign body response, and no evidence of device degradation or adjacent tissue necrosis.
Based on the material, biocompatibility, bench, and Conclusion: animal testing, and the proposed device labeling, the Biomerix Composite Surgical Mesh is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomerix % Ms. Maybelle Jordan Vice President of Regulatory Affairs & Business Development 47757 Fremont Boulevard Fremont, California 94538
DEC 2 3 2011
Re: K112499
Trade/Device Name: Biomerix Composite Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 19, 2011 Received: December 22, 2011
Dear Ms. Jordan:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Maybelle Jordan
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/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 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
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE 4.0
112499
ps 1071
Indications for Use
510(k) Number (if known): K112499
Device Name: Biomerix Composite Surgical Mesh
Indications for Use:
The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive 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)
Daniel Kine for NKM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112499