(204 days)
The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:
- upper and lower extremity peripheral arteries > 1.5mm in diameter and
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
AngioJet Solent Dista Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Dista Thrombectomy Set is used with the AngioJet Ultra Console.
The provided text describes a 510(k) premarket notification for the AngioJet Solent Dista Thrombectomy Set. While it lists various performance tests conducted, it does not provide specific acceptance criteria or detailed results of those tests. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study with defined acceptance criteria for a novel AI/medical imaging device.
Therefore, the requested information, which is typically associated with the evaluation of AI/medical imaging devices against specific performance metrics and acceptance criteria, cannot be fully extracted from this document.
However, based on the information provided, here's what can be inferred or stated about the testing performed:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document lists "Performance Data" which includes various types of testing, but it does not specify quantitative acceptance criteria or the reported performance metrics against those criteria.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each test. The document mentions "GLP Animal acute and chronic safety studies" but does not give the number of animals or the species.
- Data Provenance: Not specified, but given the nature of the tests (biocompatibility, hemocompatibility, operational characteristics, animal studies), the data would likely be from laboratory and animal testing, not human patient data (retrospective or prospective) in the context of clinical efficacy for an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes physical and biological testing of a thrombectomy device, not an AI or imaging device requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
Not applicable, as there is no mention of expert review or consensus for establishing ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is relevant for imaging devices or AI tools that assist human readers in interpretation, which is not the case for this thrombectomy set.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The AngioJet Solent Dista Thrombectomy Set is a physical medical device, not an algorithm.
7. The type of ground truth used:
The concept of "ground truth" as typically applied to AI/imaging devices (e.g., pathology, outcomes data) is not directly relevant here. The "truth" in these tests would be established through objective measurements against design specifications and established biological safety standards. For example:
- Biocompatibility: Conformance to ISO 10993 standards (e.g., no cytotoxicity, no sensitization).
- Hemocompatibility: Conformance to ASTM F2382-04 and ISO 10993-4 (e.g., acceptable hemolysis rates, minimal complement activation).
- Mechanical Integrity: Meeting predetermined tensile strengths, compression limits, etc.
- Clot Removal: Demonstrated effectiveness in removing clots in an in-vitro or animal model.
- Animal Studies: Observation of no adverse events or unacceptable tissue reactions/injury in animal models.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
Summary of available information regarding performance data:
The document lists the following types of performance data collected to support substantial equivalence:
- Biocompatibility:
- Cytotoxicity (ISO 10993-5)
- Intracutaneous Reactivity (ISO 10993-10)
- Sensitization (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Material Mediated Pyrogen (ISO 10993-11)
- Physiochemical (ISO 10993-18)
- Hemocompatibility:
- ASTM Hemolysis (ISO 10993-4)
- Partial Thromboplastin Time Assay (ASTM F2382-04)
- C3a Complement Activation (ISO 10993-4)
- SC5b-9 Complement Activation (ISO 10993-4)
- Thromboresistance (ISO 10993-4)
- Catheter operational characteristics
- Leak testing
- Corrosion
- Dimensional verification
- Guidewire compatibility tests
- Particulate generation
- Tracking/function in tortuosity
- Extended use
- Clot removal
- Hemolysis
- Thermal dose
- Mechanical integrity (tensile strengths, compression/buckling, torque testing)
- GLP Animal acute and chronic safety studies.
The "Conclusion" states that "Testing (bench, biocompatibility testing, and animal testing) verified that the new device is substantially equivalent to the predicate devices." This implies that the results of these tests met the necessary standards for safety and performance required for a 510(k) clearance, demonstrating equivalence to the predicate devices.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).