(97 days)
Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.
Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.
The provided text describes the Biomerix Composite Surgical Mesh, a medical device, and its journey through FDA 510(k) clearance. However, the document does not contain information about "acceptance criteria" in the format of specific performance metrics (e.g., sensitivity, specificity, accuracy) or details about a study designed to prove the device meets these criteria in the context of an AI-powered diagnostic or decision support system.
The content focuses on demonstrating substantial equivalence to predicate devices through various tests relevant to a surgical mesh, rather than the performance of a software algorithm.
Here's a breakdown of the available information given the context of the provided text, and where specific requested information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, or specific thresholds for biomechanical properties). The acceptance criteria are broadly implied by the tests performed to establish substantial equivalence.
- Reported Device Performance:
Test Category Performance Outcome Material Testing Demonstrates material properties are suitable for intended use. Bench Testing Demonstrates that manufactured devices meet performance specifications. Test results show the device meets specifications and is acceptable for clinical use. Biocompatibility Testing Performed per ISO 10993-1. Demonstrates the material is safe and biostable. Animal Testing Exhibits a well-tolerated long-term histomorphologic response with good integration, minimal foreign body response, and no evidence of device degradation or adjacent tissue necrosis.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "material testing," "bench testing," "biocompatibility testing," and "animal testing" but does not provide specific sample sizes for these tests.
- Data Provenance: Not specified. The studies are described as lab-based (material, bench, biocompatibility) and animal studies. There is no mention of human clinical data or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not applicable/not specified. The "ground truth" for a surgical mesh involves physical, chemical, and biological properties, not a diagnostic interpretation by human experts. The assessment of animal study results would likely be done by veterinary pathologists or similar experts, but the number and qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. This concept typically applies to the resolution of discrepant readings in medical image analysis or similar diagnostic tasks, which is not the focus of this device's testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is a surgical mesh, not an AI-powered diagnostic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical surgical mesh, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this device's performance would be established through:
- Physical/Chemical Standards: For material and bench testing (e.g., tensile strength, pore size, degradation rate under specific conditions).
- Biological Standards/Pathology: For biocompatibility and animal testing (e.g., tissue integration, foreign body response, inflammation levels assessed via histopathology).
- ISO Standards: For biocompatibility (ISO 10993-1).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. As there is no AI/machine learning component, there is no training set or associated ground truth.
Summary:
The provided 510(k) summary for the Biomerix Composite Surgical Mesh details the regulatory pathway for a conventional medical device (surgical mesh) by demonstrating substantial equivalence to predicate devices. The performance data presented consists of material, bench, biocompatibility, and animal testing results, all aimed at proving the safety and effectiveness of the physical implant. The questions about AI, algorithms, expert consensus, and reader studies are not relevant to this type of device or the information contained in this 510(k) document.
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510(K) SUMMARY
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Page (1) of (2)
| Applicant Name: | Biomerix Corporation47757 Fremont BoulevardFremont, CA 94538Phone: (510) 933-1222Fax: (510) 933-3451JAN - 7 2005 |
|---|---|
| Contact Person: | Christina L KichulaSr. Director, RA/QA/CA |
| Date Prepared: | October 1, 2008 |
| Device Trade Name:Device Common Name:Classification Name: | Biomerix Composite Surgical MeshPolymeric surgical meshMesh, surgical, polymeric |
| Predicate Devices: | Ethicon Prolene Soft Mesh (K001122)Ethicon Mersilene Polyester Fiber Mesh (pre-amendment)Biomerix Surgical Mesh (K070961)Bard Composix L/P Mesh (K061754)W.L. Gore GORETEX® DualMesh® Biomaterial(K992189)AMS InteMesh™ (K042592) |
| Device Description | Biomerix Composite Surgical Mesh is a non-absorbableporous polymer scaffold (polycarbonate polyurethaneurea) incorporating knitted polypropylene monofilamentfibers. |
| Intended Use | Biomerix Composite Surgical Mesh is intended to assistin the repair and/or reinforcement of hernia and othersoft tissue defects requiring additional support of anonabsorbable implant during and after wound healing. |
| 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 the above characteristics have beenadequately tested to support 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 clinical |
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Biomerix Composite Surgical Mesh Traditional 510(k)
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use.
Extensive biocompatibility testing per ISO 10993-1 was performed to demonstrate that the material is safe and biostable.
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.
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, clutching a staff with a snake wrapped around it. The eagle and staff are stylized and simplified.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomerix Corporation % Ms. Christina L. Kichula Sr. Director, RA, QA & CA 47757 Fremont Boulevard Fremont, California 94538
JAN - 7 2009
Re: K082941
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 16, 2008 Received: December 17, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
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Page 2 – Ms. Christina L. Kichula
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRI's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities inder the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sponsor: Biomerix
INDICATIONS FOR USE 4.0
Indications for Use
510(k) Number (if known):
Device Name: Biomerix Composite Surgical Mesh
Indications for Use:
Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.
Prescription Use × (Part 21 CFR 801 Subpart D)
人类
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 (QDE)
CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number
§ 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.