(61 days)
The Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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 atherectomy guide wire is a component that is part of the Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System. The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) are 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 Stealth 360 and the Diamondback 360 use an eccentrically rotating 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. In addition to the atherectomy guide wire, the Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System consists of the following components: Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant (e.g., ViperSlide). The ViperWire Advance FlexTip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. These extended length guide wires use the same technology as the previously cleared Stealth 360® Orbital PAD.
The provided text describes a 510(k) premarket notification for a medical device called the "ViperWire Advance Flex Tip Peripheral Guide Wire" and its associated atherectomy systems. The submission seeks to prove substantial equivalence to a predicate device, rather than demonstrate meeting specific acceptance criteria in a clinical study with performance metrics like sensitivity, specificity, etc. This is a common regulatory pathway for devices that are similar to already approved ones.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics like those typically associated with AI/software devices (e.g., sensitivity, specificity, accuracy) is not applicable in the context of this 510(k) submission for a guide wire and atherectomy system.
Instead, the submission focuses on bench testing to demonstrate that the modified device performs similarly to its predicate and meets established engineering specifications for safety and effectiveness.
Here’s a breakdown of the information that is available, reframed to address the spirit of your request where possible, and clearly indicating when information is not present:
Acceptance Criteria and Device Performance (Based on Bench Testing for Substantial Equivalence)
The "acceptance criteria" for this device are its ability to meet established specifications through a series of bench tests, confirming its safety and performance is comparable to the predicate device. The "reported device performance" is that it met these criteria. Specific quantitative performance metrics (e.g., specific failure loads, deviation tolerances) are not provided in this summary but would have been part of the detailed 510(k) submission.
| Acceptance Criterion Category | Reported Device Performance |
|---|---|
| Mechanical Performance | - Manual Track Testing: Met established specifications. |
- Torque Transfer Testing: Met established specifications.
- Torque Strength Testing: Met established specifications.
- Life Testing: Met established specifications.
- Orbit Testing: Met established specifications.
- Tensile Testing (ISO 11070): Met established specifications.
- Tip Flexibility Testing: Met established specifications.
- Transfer Force Test: Met established specifications. |
| Material & Durability | - ISO Corrosion, Flex, and Fracture Test (ISO 11070): Met established specifications. - Particulate (USP ): Met established specifications. |
| Biocompatibility | - Biocompatibility (ISO 10993): Met established specifications. |
| System Functionality | - OAS Flow Tests: Met established specifications. - OAS Pump Functional Tests: Met established specifications. |
| Electrical Safety | - IEC 60601-1-2:2014 (4th edition) Compliance: Met established specifications (for the OAS pump updates). |
| Overall Conclusion | All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance FlexTip Guide Wire and OAS pump met the established specifications necessary for consistent performance during its intended use. The device met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Performance is substantially equivalent to the predicate. |
Additional Requested Information:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for a clinical study with human data in this 510(k) summary. The testing described is bench testing of physical devices. The "sample size" would refer to the number of individual guide wires or pump units tested according to engineering protocols. This specific number is not disclosed in the summary, but it would have been defined in the test protocols.
- Data Provenance: Not specified, but generally, bench testing data for FDA submissions is generated within the manufacturing and testing facilities of the submitting company or certified contract labs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This submission is not based on expert-adjudicated ground truth from clinical data. Performance is assessed through engineering tests against predefined specifications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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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
- Not applicable. This is a hardware medical device (guide wire and atherectomy system), not an AI/software device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering specifications and standards: The "ground truth" for this type of submission is the predefined engineering specifications derived from relevant industry standards (e.g., ISO 11070, ISO 10993, IEC 60601-1-2), internal design requirements, and performance data from the legally marketed predicate device.
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The sample size for the training set
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are validated through the described bench testing.
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How the ground truth for the training set was established
- Not applicable. See point 7.
§ 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).