(223 days)
Not Found
No
The summary describes a physical surgical mesh device and its materials, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: A therapeutic device is used to treat or manage a disease or condition. This device, while used in surgery for repair, is a mesh for reconstruction and physical support, not a therapeutic agent itself that directly heals a condition.
No
The provided text describes a surgical mesh intended for hernia repair and tissue reconstruction, not a device for diagnosing medical conditions.
No
The device description clearly states it is a physical mesh comprised of multiple layers of materials, intended for surgical implantation. It is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "sterile, composite mesh comprised of three layers" designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not implanted within the body for structural support or repair.
N/A
Intended Use / Indications for Use
The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.
Product codes
FTL
Device Description
The Biomerix Ventral Hernia Repair Mesh 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 a tissue attachment to the device during the wound healing period. The Biomerix Ventral Hernia Repair Mesh 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
Bench testing, conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (issued March 2, 1999), was performed to demonstrate that the device as manufactured meets the performance specifications. Test results demonstrate that the device meets the specifications, performs comparably to predicate devices and is acceptable for clinical use. Biocompatibility testing in accordance ISO 10993-1 standards was conducted, and results demonstrate that the device is biocompatible according to these standards. Animal testing demonstrates that the Biomerix Ventral Hernia Repair Mesh performs equivalently to a predicate device in terms of minimization of tissue attachment to the device and histological response.
Key Metrics
Not Found
Predicate Device(s)
K082941, K060713, K072974, K062558, K050332, K042811
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 1.0
| Applicant Name: | Biomerix Corporation
47757 Fremont Boulevard
Fremont, CA 94538
Phone: (510) 933-1222
Fax: (510) 933-3451 | MAY 13 2010 |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Christina L Kichula
Sr. Director, RA/QA/CA | |
| Date Prepared: | May 11, 2010 | |
| Device Trade Name:
Device Common Name:
Classification Name: | Biomerix Ventral Hernia Repair Mesh
Polymeric surgical mesh
Mesh, surgical, polymeric | |
| Predicate Devices: | • Biomerix Composite Surgical Mesh (K082941) | |
| | • Ethicon PROCEED Surgical Mesh (K060713) | |
| | • Apside Surgimesh XB (K072974) | |
| | • Biomet Mesofol® Surgical Sheet (K062558) | |
| | • MAST Biosurgery Surgi-Wrap MAST Bioresorbable
Sheet (K050332) | |
| | • Polyganics VivoSorb Sheet (K042811) | |
| Device Description | The Biomerix Ventral Hernia Repair Mesh 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 a tissue attachment to the device
during the wound healing period. | |
| | The Biomerix Ventral Hernia Repair Mesh is provided
sterile for single use and is available as individually
packaged thin sheets in various shapes and sizes. | |
| Intended Use | The Biomerix Ventral Hernia Repair Mesh is intended for
the reconstruction of hernias and soft tissue deficiencies
and for the temporary bridging of fascial defects. The
resorbable protective film minimizes tissue attachment to
the device in case of direct contact with the viscera. | |
| Device Technological
Characteristics and | The Biomerix Ventral Hernia Repair Mesh is similar in
materials, design, performance and intended use to | |
| Comparison to
Predicate Device(s): | other surgical meshes. Any differences in the above
characteristics have been adequately tested to support
substantial equivalence. | |
| Performance Data: | Bench testing, conducted in accordance with FDA's
Guidance for the Preparation of a Premarket Notification
Application for a Surgical Mesh (issued March 2, 1999),
was performed to demonstrate that the device as
manufactured meets the performance specifications.
Test results demonstrate that the device meets the
specifications, performs comparably to predicate devices
and is acceptable for clinical use. | |
| | Biocompatibility testing in accordance ISO 10993-1
standards was conducted, and results demonstrate that
the device is biocompatible according to these
standards. | |
| | Animal testing demonstrates that the Biomerix Ventral
Hernia Repair Mesh 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 Ventral Hernia Repair Mesh is substantially
equivalent to the identified predicate devices in terms of
intended use, safety, and effectiveness. | |
1
KOG3123 of 2 2
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomerix Corporation % Ms. Christina L. Kichula Senior Director, RA, QA & CA 47757 Fremont Boulevard
MAY 1 3 2010
Re: K093123
Fremont, California 94538
Trade/Device Name: Biomerix Ventral Hernia Repair Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 29, 2010 Received: April 30, 2010
Dear Ms. Kichula:
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 nov 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. Christina L. Kichula
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark M. Milburn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4.0 INDICATIONS FOR USE
Indications for Use
KOG3123 510(k) Number (if known):
Device Name: Biomerix Ventral Hernia Repair Mesh
Indications for Use:
The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.
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 Keane for MXM
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093123