Search Results

The Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus is intended to ablate occlusive material and restore luminal patency in the peripheral vasculature.

The Rotablator Rotational Atherectory System is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.

The Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus consists of an Advancer pre-connected to a Catheter. The advancer functions as a guide for the sliding elements that control burr advancement and the catheter portion of the device guides the burr through the vasculature to the treatment site. The Peripheral RotaLink Plus devices are provided sterile and non-pyrogenic. It is intended for one procedure use only. The Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus currently offers burr sizes 1.5, 1.75, 2.00, 2.15, 2.25, 2.38 and 2.5mm, with 1.25mm being introduced in this submission.

The provided text is a 510(k) summary for the Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed results of a study designed to prove the device meets specific acceptance criteria in the way one would expect for a deep learning algorithm or diagnostic AI tool.

Instead, the submission focuses on demonstrating substantial equivalence of a modified medical device to previously cleared predicate devices through a series of in-vitro performance tests and biocompatibility/chemical characterization tests. These tests ensure the new device iteration (with a new burr size) performs safely and effectively in a manner consistent with its predecessors.

Therefore, many of the requested elements (like "reported device performance" against acceptance criteria for a diagnostic measure, sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to the type of device and submission described.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests but does not provide specific numerical acceptance criteria or detailed performance results in the format of a typical diagnostic study. The "reported device performance" is essentially that the device passed these tests, affirming its safety and function consistent with predicate devices.

2. Sample size used for the test set and the data provenance:
* Sample Size: Not specified in the summary. Performance tests for medical devices typically involve testing a statistically representative sample of units.
* Data Provenance: Not applicable in the context of diagnostic data. These are engineering and biological tests conducted on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. The ground truth for these performance and biocompatibility studies would be established by validated test methods and industry standards, not expert consensus on diagnostic images.

4. Adjudication method for the test set:
* Not applicable. No image review or diagnostic adjudication is mentioned.

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 not an AI/diagnostic software device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is not an AI/diagnostic software device.

7. The type of ground truth used:
* For performance tests: Engineering specifications, validated test methodologies, and established industry standards for mechanical, electrical, and functional properties.
* For biocompatibility tests: International standards (e.g., ISO 10993 series) and recognized test methods for assessing biological responses to medical devices.

8. The sample size for the training set:
* Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:
* Not applicable.

Summary of the Study:

The "study" described in the 510(k) summary is a comprehensive set of in-vitro performance tests and biocompatibility/chemical characterization tests. These tests were conducted to demonstrate that the modified Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus (specifically, the introduction of a new 1.25mm burr size) is substantially equivalent to its predicate devices (K901206 and K121774) in terms of safety and effectiveness.

The conclusion states that "Based on the indications for use, technological characteristics, and safety and performance testing, the Peripheral Rotablator Atherectomy System with the Peripheral RotaLink Plus has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Peripheral Rotablator Rotational Angioplasty System as submitted in K901206 and K121774." This implies that the device passed all listed tests and met the internal acceptance criteria for each test, which would be consistent with the performance of the predicate device and established engineering/biological safety standards.

Ask a specific question about this device