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The Diamondback 360® Peripheral 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 system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360® Peripheral 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 system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems (OAS) are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown.

The OAS consists of the following main components:

1. Reusable Saline Pump (provided non-sterile)
2. Single-use Orbital Atherectomy Device (OAD) (provided sterile)
3. Single-use Atherectomy lubricant (provided sterile)
4. Single-use Atherectomy guide wire (provided sterile)

Mechanism of Action
The Diamondback and Stealth OAS mechanism of action is identical to the predicate device and is defined by:
• Centrifugal force
• Orbital rotation
• Differential sanding
• Bi-directional sanding

The rapidly rotating eccentric crown creates a centrifugal force that presses the diamond-coated crown against the calcified plaque. With each pass of the crown, plaque is reduced, and the diameter of the orbit increases.

This document is a 510(k) premarket notification for the Diamondback 360 Peripheral Orbital Atherectomy System and Stealth 360 Peripheral Orbital Atherectomy System. It compares the proposed device to a predicate device (K152694 - Diamondback 360 Peripheral Orbital Atherectomy System).

The information provided in the document refers to physical and mechanical performance testing of the device, rather than a clinical study evaluating its diagnostic or therapeutic effectiveness using AI. Therefore, most of the requested points regarding acceptance criteria and study details for an AI/device performance study (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device submission as described.

The performance data listed (Bench Testing, Track Verification Testing, Stall / Life and Tight Stenosis Verification Testing, etc.) are primarily engineering and hardware verification tests, not clinical performance or AI algorithm performance assessments. The conclusion explicitly states that the device has the "same technological characteristics as the predicate device" and that "testing results demonstrate that the devices perform as intended under the specified use conditions." This focuses on demonstrating equivalence to an existing device through non-clinical means.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided document. The document describes a medical device with mechanical action for atherectomy, not an AI-powered diagnostic or therapeutic device.

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