(214 days)
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
The Rotablator Rotational Angioplasty system uses a high speed, rotating, diamond-coated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The A21 Rotablator system comprises four main components: advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.
The provided document is a 510(k) summary for a medical device called the "Peripheral Rotablator® Rotational Angioplasty System with the RotaLink™ Exchangeable Catheter" (A21 Rotablator system). This document details device description, intended use, and comparison to a predicate device (A19 Rotablator system). It also describes various tests performed to demonstrate substantial equivalence but explicitly states that clinical studies were NOT conducted for the A21 design.
Therefore, many of the requested criteria related to clinical studies, human performance, and AI-specific evaluations cannot be answered from this document. The device is a mechanical system, not an AI/ML-driven diagnostic tool.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance |
|---|---|
| Conforms to product specifications | Bench testing showed A21 system conforms to product specifications. |
| Safe and effective as the current peripheral A19 system | Bench testing showed A21 system is as safe and effective as the A19 system. |
| 95% confidence, 99% probability that dynamic stall torque will be met | Met. |
| 95% confidence, 99% probability that steady state stall torque will be met | Met. |
| 95% confidence, 99% probability that distal flow rate will be met | Met. |
| 95% confidence, 99% probability that functional life of the catheter will be 20 minutes | Met. |
| Lesion crossing time not statistically significantly different from A19 | No statistically significant difference observed between A19 and A21. |
| Biocompatibility: Safe for human use | Biological evaluation (material characterization, cytotoxicity, pyrogenicity, hemocompatibility assays under GLP) found the A21 Rotablator system compatible with biological systems. |
| Sterility: Sterility Assurance Level (SAL) of $10^{-6}$ | Achieved a SAL of $10^{-6}$ through ethylene oxide (EtO) sterilization. Device is non-pyrogenic based on LAL assay. |
| Patient Safety: Biocompatibility of fluid contact path, device sterility, interaction between burr and vessel wall, infusion of saline, functionality of brake system | All these aspects of the A21 have been tested and show the device to be safe and the clinically relevant parameters unchanged from those of the A19. The parts in contact with the patient (burr, drive shaft, sheath material) are the same as the A19 system. |
| Performance specifications (speed, infusate flow, torque) identical or more stringent than A19 | All performance specifications for A21 are identical or more stringent than A19. A21 runs slower and delivers less torque at console pressures below 50 PSI compared to A19, but maximum suggested operational speed (180 KRPM) can still be attained and higher operational pressures for A21 offset lower torques, so these differences are not significant to the user. |
Study Proving Acceptance Criteria:
The device meets the acceptance criteria through "Bench testing" (in vitro tests) and "Biological evaluation" described in sections E and F of the 510(k) summary. These tests aimed to demonstrate that the performance of the peripheral A21 system conforms to product specifications and that it is as safe and effective as the current peripheral A19 system for relevant performance characteristics, biocompatibility, and sterility.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for performance tests: "Statistically valid sample sizes" were used for tests on dynamic stall torque, steady state stall torque, and distal flow rate, and catheter functional life.
- Sample Size for comparative performance tests: Five A19 1.5 mm burrs, five A19 3.0 mm burrs, one A21 advancer, and five A21 catheters (one burr size, as they use the same turbine nozzle) were used for speed versus console pressure and stall torque versus console pressure tests.
- Data Provenance: The tests were "Bench testing" and "In Vitro Tests," indicating laboratory settings rather than human clinical data. The document does not specify country of origin for the data but the submitter and manufacturing facilities are listed in Redmond, WA, USA. The tests are retrospective in the sense that they are comparing a new design to an existing one.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This was a mechanical device performance and biocompatibility study, not an AI/ML-driven diagnostic study requiring expert ground truth for imaging or other clinical data.
4. Adjudication Method for the Test Set:
Not applicable. See 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:
Not applicable. This device is not an AI-assisted diagnostic tool and no MRMC study was performed. The document explicitly states: "Clinical studies were not conducted on the A21 design."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a mechanical device, not an algorithm. Bench tests characterized the device's standalone performance.
7. The Type of Ground Truth Used:
- For performance metrics (stall torque, flow rate, functional life, lesion crossing time), the "ground truth" was established by the specified product specifications and direct physical measurements under controlled laboratory conditions, compared against the predicate device (A19).
- For biocompatibility, the "ground truth" was established by standard biological evaluation methods (material characterization, cytotoxicity, pyrogenicity, hemocompatibility assays) conducted under Good Laboratory Practices (GLP) and compliance with relevant biological safety standards.
- For sterility, the "ground truth" was established by validated ethylene oxide (EtO) sterilization processes and Limulus Amebocyte Lysate (LAL) assay for pyrogenicity, demonstrating a SAL of $10^{-6}$.
8. The Sample Size for the Training Set:
Not applicable. There was no "training set" as this is a mechanical device, not an AI/ML system.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).