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K Number
K212351
Device Name
Revolution Peripheral Atherectomy System
Manufacturer
Rex Medical, L.P.
Date Cleared
2021-12-15

(139 days)

Product Code
MCW
Regulation Number
870.4875
Type
Traditional
Panel
CV
Reference & Predicate Devices
K191419
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

Device Description

The Revolution Peripheral Atherectomy System is sterile, single-use device designed for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

The Revolution device incorporates a flexible drive shaft designed to track over the Revolution guidewire. Attached to the distal end of the drive shaft is a diamond coated spheroid shaped burr which rotates at high speed to ablate occlusive material and restore luminal patency. Power is derived from a mains source and converted using the reusable power supply. During treatment, the rotating burr ablates material into fine particles. This particulate is conveyed proximally by a mechanical means through the catheter and handle into a collection receptacle that resides outside the patient. The device is available in 145cm, 200cm, and 60cm lengths with burr diameters of 1.33mm, 1.66mm, 2.00mm, and 2.33mm.

The Revolution Peripheral Atherectomy System consists of the following components:

  1. Single-use Revolution Device (provided sterile)
  2. Single-use Revolution .014" Guidewire (provided sterile)
  3. Single-use infusion assembly (provided sterile)
  4. Single-use collection receptacle (provided sterile)
  5. Single-use guidewire clip (provided sterile)
  6. Reusable power supply (provided non-sterile)
AI/ML Overview

The provided document is a 510(k) summary for the Revolution™ Peripheral Atherectomy System. It describes the device, its intended use, and compares it to a predicate device (K191419). However, it does not contain any information regarding clinical studies, AI/algorithm performance, or human reader effectiveness with or without AI assistance.

The document details non-clinical performance data and testing methods used to demonstrate substantial equivalence, focusing on the physical and functional aspects of the device in simulated environments. It does not provide the kind of information requested in points 1-9, which are typically associated with AI/ML device approval studies.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
  2. Sample sizes used for a test set, or data provenance.
  3. Number of experts or their qualifications for ground truth establishment.
  4. Adjudication method for a test set.
  5. MRMC comparative effectiveness study results or effect sizes for human reader improvement with AI.
  6. Standalone algorithm performance.
  7. Type of ground truth used (expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document pertains to the clearance of a mechanical medical device (Atherectomy System), not an AI-powered diagnostic or assistive tool.

§ 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).