(43 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 grafts. 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
- Atherectomy guidewire.
This 510(k) is for the same device with modifications to the crown assembly of the orbital atherectomy device for a more consistent design and performance.
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 technology, and states that laboratory test data was provided to support the safety of a modification to the device. However, this document does not contain information about acceptance criteria, detailed device performance, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K071350 and K071427) based on modifications to the crown assembly for "a more consistent design and performance." The conclusion 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 the testing performed was likely focused on technical aspects related to the modification rather than a clinical performance study with predefined acceptance criteria as typically seen for AI/ML device evaluations.
Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory submission for a medical device modification, not a study report detailing performance metrics against specific acceptance criteria.
§ 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).