(115 days)
The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery.
Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Properties | Material testing was performed to demonstrate that the material properties are suitable for the intended use. |
| Device Performance | 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 | Biocompatibility testing in accordance with ISO 10993-1 recommended standards was conducted, and results demonstrated that the device is biocompatible according to these standards. |
| In-vivo Response (Animal) | 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. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for the material testing, bench testing, biocompatibility testing, or animal testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for any of these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The studies described are focused on material, mechanical, and biological properties of the device, not on diagnostic or clinical interpretation by human experts.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document, as the studies are not based on human interpretation or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided in the document. The device is a surgical mesh, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used
- Material Properties: The ground truth would be established by industry standards and engineering specifications for material strength, elasticity, porosity, etc.
- Device Performance (Bench Testing): The ground truth would be established by the device's pre-defined performance specifications (e.g., tensile strength, burst strength, suture retention strength as relevant for a surgical mesh).
- Biocompatibility: The ground truth is established by the criteria outlined in ISO 10993-1 standards (e.g., absence of cytotoxicity, sensitization, irritation).
- In-vivo Response (Animal Testing): The ground truth is established through histological examination and expert pathology assessment for parameters like tissue integration, foreign body response, and degradation, relative to expected normal healing and established safety benchmarks for implantable materials.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. The device is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided in the document.
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510(K) SUMMARY 3.0
| Applicant Name: | Biomerix Corporation47757 Fremont BoulevardFremont, CA 94538Phone: (510) 933-3450Fax: (510) 933-3451 | DEC 23 2011 |
|---|---|---|
| Contact Person: | Maybelle JordanVP of Regulatory Affairs & Business Development | |
| Date Prepared: | December 22, 2011 | |
| Device Trade Name:Device Common Name:Classification Name: | Biomerix Composite Surgical MeshPolymeric surgical meshMesh, 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-absorbableporous polymer scaffold (polycarbonate polyurethaneurea) incorporating knitted polypropylene monofilamentfibers. | |
| Intended Use | The Biomerix Composite Surgical Mesh is intended forrepair and/or reinforcement of soft tissues whereweakness exists in plastic and reconstructive surgery. | |
| Device TechnologicalCharacteristics andComparison toPredicate Device(s): | The Biomerix Composite Surgical Mesh is similar inmaterials, design, performance and intended use toother surgical mesh devices. Any differences in theabove characteristics have been adequately tested tosupport substantial equivalence. | |
| Performance Data: | Material testing was performed to demonstrate that thematerial properties are suitable for the intended use.Bench testing was performed to demonstrate that thedevices as manufactured meet the performancespecifications. Test results demonstrate that the devicemeets the specifications and is acceptable for clinicaluse.Biocompatibility testing in accordance to ISO 10993-1recommended standards was conducted, and resultsdemonstrated that the device is biocompatible accordingto these standards.Animal testing demonstrates that the mesh exhibits a |
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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.
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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
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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
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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
§ 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.