(161 days)
The CapSure ™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
The CapSure™ Permanent Fixation System is a sterile single use device that delivers either 15 or 30 permanent fasteners via a straight shaft. The CAPSURE™ Permanent Fixation System is 37 cm in length. The fasteners are designed with a 316L Stainless steel helical coil and polyetheretherketone (PEEK) cap on the proximal end to support mesh or tissue.
The provided text describes the acceptance criteria and performance data for the CapSure™ Permanent Fixation System, a medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conforms to FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." Specific tests to include Cytotoxicity, Sensitization, Irritation, Pyrogen Testing (for device); Cytotoxicity, Maximization Sensitization Study, Intracutaneous Study, Acute Systemic Toxicity Study, Pyrogenicity, Hemolysis, Complement Activation Assay, Intramuscular Implant (12 weeks), Rabbit Femoral Bone Implant (12 & 26 weeks), Bacterial Reverse Mutation (Ames) Assay, In Vitro Mouse Lymphoma Mutation Assay, Mouse Peripheral Blood Micronucleus Test, Subacute (14-Day) Intraperitoneal Toxicity Study Mice, Subchronic (14-Day) Intravenous Toxicity Study Mice, Subchronic (13-Week) Toxicity Study in Rats, In Vivo Neurotoxicity, Non-Volatile Residue, Residue on Ignition, Turbidity, UV Absorption (for implant materials). Implantable fastener material conforms to ASTM F138 (316L Stainless Steel) and ASTM F2026 (PEEK). | All samples tested met the acceptance criteria. |
| Mechanical Testing | Not explicitly stated in quantitative terms but implied to demonstrate substantial equivalence to the predicate device (ProTack™). Specific tests include Trigger Force, Mesh Compatibility, Deployment Reliability, MR Compatibility, Burst Testing. | CapSure™ passed all the test requirements and showed substantial equivalence to the results of the predicate device - ProTack™. |
| Animal Studies | Not explicitly stated in quantitative terms but implied to demonstrate substantial equivalence to the predicate device. Specific study: Porcine implantation strength study. | CapSure™ passed all the test requirements and showed substantial equivalence to the results of the predicate device - ProTack™. |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the mechanical and animal studies. For biocompatibility, it refers to "All samples tested," but the specific number is not provided. The data provenance is from internal company testing conducted by Davol Incorporated. It is retrospective in the sense that it's reported after the tests were performed to support the 510(k) submission. No information about the country of origin of the data is specified beyond "the company."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable as the studies described are performance and safety tests (biocompatibility, mechanical, animal studies) for a medical device that performs a mechanical function, not an AI or diagnostic device that requires expert-established ground truth from images or clinical data.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
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:
This is not applicable. The device is a surgical fixation system, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical surgical tool; there is no "algorithm only" performance to be evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed can be characterized as follows:
- Biocompatibility: Established by adherence to ISO 10993 standards and the expected biological responses (e.g., absence of cytotoxicity, irritation, sensitization).
- Mechanical Testing: Established by engineering specifications, physical measurements, and comparison to the performance of the legally marketed predicate device (ProTack™).
- Animal Studies: Established by anatomical and physiological assessment in the animal model, and comparison to the performance of the predicate device.
8. The Sample Size for the Training Set:
This is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This is not applicable as there is no training set for this type of device.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.