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K Number
K090521
Device Name
DIAMONDBACK 360 DBX
Manufacturer
CARDIOVASCULAR SYSTEMS, INC.
Date Cleared
2009-03-20

(22 days)

Product Code
MCW
Regulation Number
870.4875
Type
Special
Panel
CV
Reference & Predicate Devices
K071350,K071427,K072748,K081944
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The 3X Solid Crown Diamondback 360°™ Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

Device Description

The Diamondback 360°TM Orbital Atherectomy System (OAS) with 3X Solid Crown is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. OAS applies a diamond coated, eccentrically rotating sanding surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.

The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:

    1. Orbital atherectomy device
    1. Orbital atherectomy controller, and
    1. Atherectomy guidewire.

This 510/k) is for the same device with modifications to the crown ,shaft and guidewire for improved sanding efficiency.

AI/ML Overview

The provided text is a 510(k) summary for the 3X Solid Crown Diamondback 360°™ Orbital Atherectomy System. This document does not describe a study involving acceptance criteria for device performance in the context of an AI/algorithm-driven medical device, nor does it contain information about AI performance metrics, sample sizes for test or training sets, expert adjudication, or MRMC studies.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. The "study" mentioned is laboratory and animal tests performed to support the safety profile of modifications made to an existing device, not a performance study as typically understood for AI-driven devices.

Here's how the requested information maps to the provided text:

  1. A table of acceptance criteria and the reported device performance:

    • Not applicable. The document does not define specific performance acceptance criteria or report device performance in a quantitative manner (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/algorithm. The "performance" assessment is based on demonstrating that the modified device's safety profile is consistent with earlier versions and predicate devices.

  2. Sample sizes used for the test set and the data provenance:

    • Not applicable. No test sets for algorithm performance are mentioned. The document refers to "laboratory and animal tests" but does not specify sample sizes or data provenance for these engineering/biological validation tests.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. Ground truth in the context of AI device performance is not relevant to this document. The "ground truth" for this regulatory submission is established through engineering principles, preclinical testing (lab and animal), and comparison to existing, cleared devices.

  4. Adjudication method for the test set:

    • Not applicable. No adjudication method for a test set 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. No MRMC study is mentioned. This device is a physical medical instrument, not an AI-assisted diagnostic or therapeutic tool for human readers.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is not an algorithm-only device. It is a physical atherectomy system.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not applicable in the AI context. For this physical device, the "ground truth" for its safety and effectiveness is established through engineering design, material properties testing, bench testing, and animal studies to confirm its ability to ablate stenotic material without adverse effects and its substantial equivalence to predicate devices.

  8. The sample size for the training set:

    • Not applicable. No training set for an algorithm is mentioned.

  9. How the ground truth for the training set was established:

    • Not applicable. No training set ground truth is mentioned.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence for a physical medical device (an atherectomy system), not a performance study for an AI-driven device. Therefore, most of the requested information regarding AI acceptance criteria and studies is not present.

§ 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).