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510(k) Data Aggregation
(70 days)
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
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 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.
The Diamondback 360° Orbital Atherectomy System with ViperSlide is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.
The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.
The Diamondback 360° Orbital Atherectomy System consists of the following components:
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- Orbital atherectomy device (OAD, air or electric powered)
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- Atherectomy guide wire
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- Atherectomy saline pump or controller
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- Atherectomy lubricant
The provided text describes a 510(k) premarket notification for the "Diamondback 360® Orbital Atherectomy System with ViperSlide® Lubricant", focusing on the addition of an alternate ViperSlide lubricant formulation. The study conducted to prove the device meets acceptance criteria is a performance bench testing and biocompatibility testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Bench Testing | Established specifications | All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360° Orbital Atherectomy System with ViperSlide met the established specifications necessary for consistent performance during its intended use. |
| - System Life Testing | Established specifications | Met established specifications for consistent performance during its intended use. |
| - Emulsion Admixture Stability | Established specifications | Met established specifications for consistent performance during its intended use. |
| Biocompatibility Testing | Biocompatible with biological tissue consistent with intended use | The biocompatibility test results show that the materials used in the design and manufacture of ViperSlide are biocompatible with the biological tissue consistent with its intended use. |
| - ISO MEM Elution Assay | Biocompatible | Biocompatible |
| - Hemolysis – Direct Contact Method | Biocompatible | Biocompatible |
| - In-vitro Hemocompatibility Assay | Biocompatible | Biocompatible |
| - ISO Acute Systemic Injection Test | Biocompatible | Biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the test set used in the performance bench testing or biocompatibility testing. These appear to be laboratory-based tests rather than human clinical trials. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of patient data, as no patient data is mentioned in relation to these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for bench testing and biocompatibility is typically based on predefined engineering specifications, material standards (like ISO for biocompatibility), and established scientific methods, rather than expert consensus on patient cases.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for the type of bench and biocompatibility testing described. Adjudication methods are typically used in clinical studies involving multiple readers or assessors of subjective outcomes.
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
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study and no discussion of AI or human reader improvement. The submission pertains to a medical device (orbital atherectomy system and lubricant), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance bench testing appears to be based on established engineering specifications, material properties, and functionality requirements. For biocompatibility, the ground truth is established by international standards (e.g., ISO) for material biocompatibility.
8. The Sample Size for the Training Set
There is no mention of a training set sample size. This document describes testing for a physical medical device, not a machine learning or AI model that typically involves training sets.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set, this information is not applicable.
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