(58 days)
The Diamondback 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerosis disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS SOLID, CLASSIC and MICRO crowns support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. *The 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).
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 SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenotic materiovenous dialysis fistulae (AV shunt).
The Diamondback 360® Peripheral Orbital Atherectorny System Exchangeable Series 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 SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).
The OAS is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The document lists the main components of the OAS, including a reusable saline pump, a single-use orbital atherectomy device, a single-use atherectomy lubricant, and a single-use atherectomy guide wire.
The provided text (K220568 510(k) Summary) describes a medical device, the Diamondback 360® Peripheral Orbital Atherectomy System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria related to AI or algorithmic performance.
The document outlines:
- Device Description: A percutaneous orbital atherectomy system designed to remove occlusive material from peripheral arteries and arteriovenous dialysis fistulae.
- Comparison to Predicate Device: The current device is "identical" to the predicate device in terms of indication for use, vessel diameter range, principles of operation, sterilization methods, single-use nature, and performance specifications. The only described difference is a change in the diamond size used in the crown coating (from 30-micron to 70-micron diamonds). A minor update to the Indications for Use is mentioned, stating that the 2.00 Max Crown has not been tested for removal of stenotic material from AV shunts.
- Testing Conducted: Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility) and bench testing (stall, tight stenosis, life, coating integrity, tensile verification, orbit characterization, temperature and flow verification, particulate testing, corrosion testing, GLP animal testing). These tests are stated to "verify that the design meets all product specifications and address the potential safety hazards."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving algorithmic performance because the document does not discuss:
- Acceptance criteria for an AI/algorithmic medical device.
- A test set, training set, or data provenance for an AI/algorithmic study.
- Expert involvement for ground truth establishment or adjudication for an AI/algorithmic study.
- MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used in the context of AI/algorithmic performance.
The document is a 510(k) submission for a physical medical device (atherectomy system) that functions mechanically, not through an AI/algorithmic component. The testing described is typical for a mechanical medical device to demonstrate safety and effectiveness and substantial equivalence to a predicate device.
§ 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).