(24 days)
The 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 Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V grafts).
The Diamondback 360°™ Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral artery and A-V graft stenosis.
OAS provides a method of removing stenotic material from peripheral arteries and A-V Graft. OAS applies a diamond coated, eccentrically rotating cutting 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:
- Orbital Atherectomy Device,
- Orbital Atherectomy Controller, and
- Guidewire.
This 510(k) is for the same device with modifications to the orbital atherectomy controller for ergonomics and ease of use.
The provided text is a 510(k) summary for a medical device called the Diamondback 360°™ Orbital Atherectomy System. It describes the device, its intended use, and states that it has been found substantially equivalent to predicate devices.
However, the document does not contain information about acceptance criteria, specific device performance metrics, or the details of any studies (like sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) typically associated with proving a device meets acceptance criteria.
The 510(k) states: "Laboratory test data were provided to support the safety of the modification to the Diamondback 360°TM Orbital Atherectomy System. No new questions of safety or effectiveness are raised." This implies that some testing was done to support the modification, but the details of those tests, including specific acceptance criteria and performance results, are not included in this summary.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided text. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices for a modified version of the same system, rather than presenting detailed clinical or performance study results for this specific 510(k) submission.
§ 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).