(223 days)
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.
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.
The Biomerix Ventral Hernia Repair Mesh is a medical device, and the provided text describes its acceptance criteria and the studies performed to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria as would be typical for an AI/software device. Therefore, a direct mapping to the requested table and sections for AI/software is not fully possible. However, I will extract the relevant information from the document as best as the content allows.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Bench Testing | Device meets performance specifications of surgical meshes (as per FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, issued March 2, 1999). | "Test results demonstrate that the device meets the specifications, performs comparably to predicate devices and is acceptable for clinical use." |
| Biocompatibility | Device is biocompatible according to ISO 10993-1 standards. | "Biocompatibility testing in accordance ISO 10993-1 standards was conducted, and results demonstrate that the device is biocompatible according to these standards." |
| Animal Testing | Device performs equivalently to a predicate device regarding minimization of tissue attachment and histological response. | "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." |
| Overall Conclusion | Substantial equivalence to identified predicate devices in terms of intended use, safety, and effectiveness. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data for an AI/software device. The studies mentioned are:
- Bench testing: Involves physical testing of the mesh material. No data provenance or sample size for a "test set" is applicable in the AI sense.
- Biocompatibility testing: Involves evaluating the biological response to the material. No data provenance or sample size for a "test set" is applicable in the AI sense.
- Animal testing: Used to assess tissue attachment and histological response. The sample size for the animal study is not specified, nor is the "provenance" in the geographical sense. It is a prospective study using animal models.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a physical surgical mesh, not an AI/software device that relies on expert interpretation for its ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for a physical medical device. The "ground truth" for the performance of this device is established through objective physical, chemical, biological, and animal model testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable as the device is a physical surgical mesh, not an AI/software device intended to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical surgical mesh, not an AI algorithm. Its performance is inherent to the material and design.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" for its performance is established by:
- Bench test specifications: Objective engineering and material properties.
- ISO 10993-1 standards: Objective biological safety criteria.
- Comparative animal study results: Histological and tissue attachment observations in animal models, compared to a predicate device.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical surgical mesh and does not involve AI model training.
9. How the Ground Truth for the Training Set was Established
This is not applicable as the device is a physical surgical mesh and does not involve AI model training.
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510(K) SUMMARY 1.0
| Applicant Name: | Biomerix Corporation47757 Fremont BoulevardFremont, CA 94538Phone: (510) 933-1222Fax: (510) 933-3451 | MAY 13 2010 |
|---|---|---|
| Contact Person: | Christina L KichulaSr. Director, RA/QA/CA | |
| Date Prepared: | May 11, 2010 | |
| Device Trade Name:Device Common Name:Classification Name: | Biomerix Ventral Hernia Repair MeshPolymeric surgical meshMesh, 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 BioresorbableSheet (K050332) | ||
| • Polyganics VivoSorb Sheet (K042811) | ||
| Device Description | The Biomerix Ventral Hernia Repair Mesh is a sterile,composite mesh comprised of three layers: 1) a thinsheet of the Biomerix Biomaterial™, 2) a layer of knittedpolypropylene monofilament fibers and 3) a resorbablelactide-caprolactone film. | |
| The resorbable film separates the permanent mesh fromunderlying tissues and organ surfaces, and it is designedto minimize the risk of a tissue attachment to the deviceduring the wound healing period. | ||
| The Biomerix Ventral Hernia Repair Mesh is providedsterile for single use and is available as individuallypackaged thin sheets in various shapes and sizes. | ||
| Intended Use | The Biomerix Ventral Hernia Repair Mesh is intended forthe reconstruction of hernias and soft tissue deficienciesand for the temporary bridging of fascial defects. Theresorbable protective film minimizes tissue attachment tothe device in case of direct contact with the viscera. | |
| Device TechnologicalCharacteristics and | The Biomerix Ventral Hernia Repair Mesh is similar inmaterials, design, performance and intended use to | |
| Comparison toPredicate Device(s): | other surgical meshes. Any differences in the abovecharacteristics have been adequately tested to supportsubstantial equivalence. | |
| Performance Data: | Bench testing, conducted in accordance with FDA'sGuidance for the Preparation of a Premarket NotificationApplication for a Surgical Mesh (issued March 2, 1999),was performed to demonstrate that the device asmanufactured meets the performance specifications.Test results demonstrate that the device meets thespecifications, performs comparably to predicate devicesand is acceptable for clinical use. | |
| Biocompatibility testing in accordance ISO 10993-1standards was conducted, and results demonstrate thatthe device is biocompatible according to thesestandards. | ||
| Animal testing demonstrates that the Biomerix VentralHernia Repair Mesh performs equivalently to a predicatedevice in terms of minimization of tissue attachment tothe device and histological response. | ||
| Conclusion: | Based on the material, biocompatibility, bench, andanimal testing, and the proposed device labeling, theBiomerix Ventral Hernia Repair Mesh is substantiallyequivalent to the identified predicate devices in terms ofintended use, safety, and effectiveness. |
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KOG3123 of 2 2
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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
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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
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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
§ 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.