(30 days)
The TigerPaw® System II is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
The TigerPaw® System II consists of an implantable Fastener and Delivery Tool designed for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The Fastener is composed of linearly spaced connectors overmolded with a soft silicone. The spacing between the connectors along with the silicone gives the Fastener an ability to conform to the anatomy and exclude the LAA. The TigerPaw System II also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with two triggers that when separately actuated, close opposing jaws thus mating the two sides of the permanently implanted Fastener, and, then allowing release of the Fastener and opening of the jaws for Delivery Tool removal.
The provided text describes a 510(k) premarket notification for the TigerPaw® System II, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical or AI-driven study.
Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established) are not applicable to this type of submission. This 510(k) is for a modification to an existing device, and the evaluation focuses on bench testing and biocompatibility to show that the modifications do not alter the safety or effectiveness of the device compared to its predicate.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of acceptance criteria with specific quantitative thresholds and corresponding device performance data in a clinical context. Instead, it relies on a comparison to the predicate device and in vitro bench testing for verification.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Design Specifications Met | "Verification testing provided proof that the modifications met all design specifications." (Specific specifications are not detailed in this summary) |
| Mechanical Performance | "Extensive bench evaluations were performed on the TigerPaw® II System. This testing consisted of in vitro bench testing, including connector tensile testing and pressure leak testing of fasteners." (Specific results or thresholds for these tests are not provided in this summary, but the implication is they met internal benchmarks equivalent to the predicate.) |
| Biocompatibility | "Biocompatibility testing provided evidence of continued biocompatibility of the revised device." (This confirms the material changes did not negatively impact biocompatibility compared to the predicate.) |
| Substantial Equivalence | "Based upon the intended use, product technical information, performance testing and biocompatibility information provided in this pre-market notification, the TigerPaw System II has been shown to be substantially equivalent to the currently cleared predicate device in terms of design, performance and intended use." (This is the overarching conclusion, indicating the device performs as expected and similarly to the previously cleared version, and thus meets the safety and effectiveness profile for its intended use.) The FDA's letter (K111064) confirms this determination: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". |
Evaluation of Sections Not Applicable to a 510(k) for Device Modification:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission details in vitro bench testing and biocompatibility assessments, not a clinical study involving human patient data.
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)
- Not Applicable. No human-interpreted "ground truth" was established as there was no clinical study or diagnostic imaging component. The evaluation relied on engineering and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or subjective interpretation requiring adjudication was involved.
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
- Not Applicable. This is a hardware medical device (implantable fastener and delivery tool), not an AI-based diagnostic tool. No human reader or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for the engineering tests would be derived from physical measurements against defined engineering specifications, not clinical outcomes or expert consensus. For biocompatibility, it's adherence to relevant standards.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved a limited number of devices for bench evaluations.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set.
§ 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.