(112 days)
Not Found
No
The summary describes a physical medical device (surgical mesh) and its material properties and performance, with no mention of software, algorithms, or AI/ML technologies.
No.
A therapeutic device is one that treats a disease or condition. This device is used for "repair and/or reinforcement of soft tissues where weakness exists," which is a reconstructive and supportive function, not directly treating a disease in a therapeutic sense.
No.
The device is a surgical mesh intended for repair and/or reinforcement of soft tissues, not for diagnosis.
No
The device description clearly states it is a sterile, composite mesh comprised of physical materials (Biomerix Biomaterial, knitted polypropylene monofilament fibers, and a resorbable lactide-caprolactone film). It is a physical implant, 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 "repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a sterile, composite mesh comprised of materials like polypropylene and a resorbable film. This is a physical device intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Biomerix ASSURE™ is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device.
Product codes
FTL
Device Description
Biomerix ASSURE is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film.
The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of tissue attachment to the device during the wound healing period.
ASSURE is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.
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)
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 Biomerix ASSURE performs equivalently to a predicate device in terms of minimization of tissue attachment to the device and histological response.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K093123, K992991, K013625, 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.
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3.0 510(K) SUMMARY
| Applicant Name: | Biomerix Corporation
47757 Fremont Boulevard
Fremont, CA 94538
Phone: (510) 933-3450
Fax: (510) 933-3451 |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maybelle Jordan
VP, Regulatory Affairs & Business Development |
| Date Prepared: | December 22, 2011 |
| Device Trade Name: | Biomerix ASSURE™ |
| Device Common Name: | Polymeric surgical mesh |
| Classification Name: | Mesh, surgical, polymeric |
| Predicate Devices: | Biomerix Ventral Hernia Repair Mesh (K093123)
Atrium Advanta PTFE Facial Implant (K992991)
Tissue Sciences Laboratories Permacol (K013625)
Lifecell LTM-BPS Surgical Mesh (K082176) |
| Device Description: | Biomerix ASSURE is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film.
The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of tissue attachment to the device during the wound healing period.
ASSURE is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes. |
| Intended Use: | Biomerix ASSURE™ is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device. |
| Device Technological
Characteristics and
Comparison to
Predicate Device(s): | The Biomerix ASSURE 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. |
1
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 Biomerix ASSURE performs equivalently to a predicate device in terms of minimization of tissue attachment to the device and histological response.
Conclusion: Based on the material, biocompatibility, bench, and animal testing, and the proposed device labeling, the Biomerix ASSURE is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or other bird-like figure, with three curved lines forming the body and wings.
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: K112567
Trade/Device Name: Biomerix ASSURE™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 20, 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). and Oosmetie ! for ( 10 ) the 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 additeration. " Trease now u, 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 or any I edital statuated and registements, 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 forth in the quality of events (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 IT you desire specific advice to: your lections offices/CDRH/CDRHOffices/ucm115809.htm for go to intp://www.lua.gov.ribadiological Health's (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of CORH Book mote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Tou may obtain other general my 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,
Mark A. Milkens
N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE 4.0
K112567 p th
Indications for Use
510(k) Number (if known): K112567
Device Name: Biomerix ASSURE™
Indications for Use:
Biomerix ASSURE™ is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device.
× 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 Kane for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112567