(85 days)
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 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 Peripheral Orbital Atherectomy System (OAS) 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 Diamondback 360 uses an eccentrically orbiting sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.
The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:
- Orbital Atherectomy Device (OAD)
- Atherectomy Guide Wire (e.g., ViperWire Advance)
- Saline Pump (OAS Pump)
- Atherectomy Lubricant (e.g., ViperSlide)
Additional 1.25 Solid, 1.50 Solid, and 1.75 Solid Diamondback 360 Peripheral Orbital Atherectomy Devices (OADs) with increased drive shaft lengths of 180 cm and 200 cm are proposed as additional length options to accommodate patient vessel anatomy and physicians preferred access methodology, for example radial access. The proposed OADs are designed to maintain 5Fr compatibility. Additional accessories to accommodate the increased drive shaft lengths were necessitated such as additional saline sheaths with increased lengths and additional lengths of ViperWire Advance Peripheral guide wires to accommodate the working length of the proposed OADs. The proposed 0.014 in core guide wires are 475 cm in length and compatible with the 180 cm and 200 cm length drive shafts. The proposed 0.014 in core guide wires are designed with a 0.014 in or 0.018 in distal spring tip options. The proposed dimensions of the 1.75 Solid crown are configured to accommodate the smaller diameter drive shaft while maintaining 5Fr compatibility. Packaging dimensions were increased in comparison to that of the predicate packaging to accommodate for the increased OAD and guide wire lengths.
The provided document describes a 510(k) premarket notification for a medical device, the Diamondback 360® Peripheral Orbital Atherectomy System. This submission is for modifications to an already cleared predicate device, specifically offering additional lengths for the Orbital Atherectomy Devices (OADs) and guide wires.
Since this is a submission for modifications to an existing device, and not a de novo review for a novel AI device, the information typically requested for AI-powered diagnostic or comparative effectiveness studies (like sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance) is not directly applicable or present in this document. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical study outcomes.
Therefore, for aspects related to AI performance metrics, ground truth establishment, or clinical study designs (MRMC, standalone), the document would state "Not Applicable" or "Information Not Provided in Document" because these are not within the scope of a 510(k) for device modifications confirmed by bench testing.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Life Testing (including guide wire) | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Stall Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Introducer Compatibility Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Switch Logic Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Dimensional Analysis | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Tactile Feedback | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Temperature Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Tensile Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Flexibility Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Delivered Torque Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Orbit Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Guide Wire Brake Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Saline Flow Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Track Testing | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Packaging/Simulated Distribution Testing for Guide Wire | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Guide Wire Tip Flexibility | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Guide Wire Trackability | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Guide Wire Torque Transfer | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Guide Wire Torque Strength | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Particulate Inspection | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Effluent Particulate Analysis | Met established specifications necessary for consistent performance during its intended use. | The device met all established specifications. |
| Overall Conclusion | Met all predetermined acceptance criteria of design verification and validation testing. | All test results demonstrate that the materials, manufacturing process, and design utilized...met the established specifications necessary for consistent performance during its intended use. |
Description of the Study:
The study conducted was a series of performance bench tests designed to confirm that the modified Diamondback 360 Peripheral Orbital Atherectomy System (with increased drive shaft lengths) met its established specifications and was substantially equivalent to the predicate device. The tests evaluated various mechanical, physical, and operational characteristics of the device and its components (OADs and guide wires).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in the provided document. The document refers to "bench testing" which typically involves a number of units tested to satisfy engineering specifications and statistical requirements for device validation, but the exact number is not included here.
- Data Provenance: Not applicable in the context of clinical data. This refers to laboratory and bench testing results conducted by the manufacturer, Cardiovascular Systems, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. Ground truth, in this context, would be defined by engineering specifications and objective measurements from the bench tests, not by expert clinical interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The tests are objective measurements against predefined specifications.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. This document does not describe an AI-powered diagnostic device or a study involving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
- Standalone Study: No, a standalone algorithm performance study was not done.
- This device is a mechanical medical device, not an AI algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for this device's performance is based on pre-established engineering specifications, material properties, and functional performance requirements as demonstrated through bench testing. These specifications ensure the device operates as intended and is safe and effective.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This document does not describe an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable. This document does not describe an AI algorithm that requires a training set.
§ 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).