(49 days)
The Aspiron(TM) Aspiration Catheter is used for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature system.
The Aspiron™ Aspiration Catheter is a dual lumen, rapid exchange catheter consisting of a distal tip, distal shaft, and proximal shaft with luer hub at the proximal end. The smaller of the two lumens is the Guide wire lumen (distal tip) and is compatible with 0.014" (0.36mm) guide wires. The larger diameter lumen is the extraction lumen and when used with the Aspiron™ accessories, allows for removal of thrombus. The extraction lumen is provided pre-loaded with a stylet that resists kinking during delivery. A hydrophilic coating is applied to the distal shaft. The Aspiron™ is compatible with 6F guide catheters and has a working length of 140cm. The Aspiron™ accessories include 30ml suction syringes, a one way stopcock, an extension tube, a flushing needle and 70μm filter caps.
The provided text describes the Aspiron™ Aspiration Catheter and its 510(k) summary, which outlines the device's comparison to a predicate device and its non-clinical performance data. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria based on human-in-the-loop performance or diagnostic accuracy metrics.
Here's a breakdown of the information that is available, and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document states: "The Aspiron™ Aspiration catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols." However, it does not provide a table with specific acceptance criteria (e.g., numerical thresholds for performance like extraction rate or tensile strength) or their corresponding individual reported device performance values. It only lists the types of tests performed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The non-clinical performance data describes bench testing, not a clinical test set with 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)
This information is not provided as the document details non-clinical, bench testing, not studies requiring expert interpretation of medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the document details non-clinical, bench 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
This information is not provided. The document describes a medical device (aspiration catheter) and its non-clinical performance, not an AI or imaging device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device described is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" would be the established engineering specifications, standards (like ISO 10993-1 for biocompatibility), and test protocols. The document states the device "met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols."
8. The sample size for the training set
This information is not provided as the document details non-clinical, bench testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not provided as the document details non-clinical, bench testing, not a machine learning model.
Summary of available information related to acceptance criteria and study:
The device is the Aspiron™ Aspiration Catheter. The study described is a series of non-clinical, bench performance tests and biocompatibility tests.
Acceptance Criteria (General Statement):
"The Aspiron™ Aspiration catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols."
Reported Device Performance (General Statement):
"Comparative testing between the Aspiron™ Aspiration Catheter and Export Advance™ Aspiration Catheter found similar performance characteristics with respect to Catheter Extraction Rate, Tensile strength and Radiopacity."
List of Non-Clinical Performance Tests Performed:
- Dimensional verification
- Tensile Strength
- Flexibility and kink
- Torque strength
- Radiopacity
- Catheter Preparation, Extraction and Removal
- Catheter Extraction Rate (Aspiration Rate)
- Aspiration Catheter Leak
- Coating Integrity & Acute Particulate Evaluation
Biocompatibility Testing (in compliance with ISO 10993-1):
- In Vitro Cytotoxicity Study
- Skin Sensitization Study
- Intracutaneous reactivity test
- Acute Systemic Toxicity Study
- In vitro Hemolysis test Study
- Material Mediated Pyrogen Test
- In vitro C3a and SC5b-9 complement activation Test
- In Vivo Thromboresistance
Biocompatibility Testing for Accessories:
- In Vitro Cytotoxicity Study
- Skin Sensitization Study
- Intracutaneous reactivity test
- Acute Systemic Toxicity Study
- In vitro Hemolysis test Study
- Material Mediated Pyrogen Test
Conclusion of the study: The Aspiron™ Aspiration catheter met all predetermined acceptance criteria and no safety and efficacy issues were raised. It was found substantially equivalent to the predicate Export Advance™ Aspiration Catheter.
§ 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).