(29 days)
The Stealth 360° Orbital PAD 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 Stealth 360™ Orbital PAD System 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 Stealth 360° uses an electrically driven shaft to apply 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 Stealth 360° Orbital PAD System consists of the following components:
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- Orbital atherectomy device
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- Atherectomy guide wire
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- Externally operated saline pump
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- Atherectomy Lubricant (e.g. ViperSlide)
The provided document describes the Stealth 360™ Orbital PAD System, a peripheral atherectomy device. This 510(k) summary focuses on validating the device's substantial equivalence to previously cleared predicate devices through extensive bench testing and biocompatibility studies, rather than clinical performance studies involving human subjects or AI algorithms. As such, many of the requested criteria, such as MRMC comparative effectiveness studies, ground truth establishment for training sets, or expert adjudication, are not applicable to the information provided.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO MEM Elution Assay | Met established specifications; non-toxic and non-sensitizing. |
| ASTM Hemolysis Assay | Met established specifications; non-toxic and non-sensitizing. | |
| Material Mediated Rabbit Pyrogenicity | Met established specifications; non-toxic and non-sensitizing. | |
| ISO Guinea Pig Maximization Sensitization | Met established specifications; non-toxic and non-sensitizing. | |
| ISO Acute Systemic Injection Test | Met established specifications; non-toxic and non-sensitizing. | |
| ISO Intracutaneous Reactivity Test | Met established specifications; non-toxic and non-sensitizing. | |
| Complement Activation C3a and SC5b-9 Assay | Met established specifications; non-toxic and non-sensitizing. | |
| Partial Thromboplastin Time | Met established specifications; non-toxic and non-sensitizing. | |
| Performance Bench Testing | System Life Testing | Met established specifications for consistent performance. |
| Stall Testing | Met established specifications for consistent performance. | |
| Introducer Compatibility Testing | Met established specifications for consistent performance. | |
| Temperature Testing | Met established specifications for consistent performance. | |
| Tensile Testing | Met established specifications for consistent performance. | |
| Flexibility Testing | Met established specifications for consistent performance. | |
| Delivered Torque Testing | Met established specifications for consistent performance. | |
| Orbit Testing | Met established specifications for consistent performance. | |
| Device User Interface Controls Testing | Met established specifications for consistent performance. | |
| Switch Logic Testing | Met established specifications for consistent performance. | |
| Guide Wire Brake Testing | Met established specifications for consistent performance. | |
| Flow Testing | Met established specifications for consistent performance. | |
| AV Graft Testing | Met established specifications for consistent performance. | |
| Motor Control Board Testing | Met established specifications for consistent performance. | |
| Track Testing | Met established specifications for consistent performance. | |
| Package Testing (Handle and Pump) | Met established specifications for consistent performance. | |
| EN 60601-1 Electrical Testing (Handle and Pump) | Met established specifications for consistent performance. | |
| EN 60601-1-2 EMC Testing (Handle and Pump) | Met established specifications for consistent performance. | |
| Saline Pump Functional Testing | Met established specifications for consistent performance. | |
| Saline Pump Physical Testing | Met established specifications for consistent performance. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of biocompatibility assays and comprehensive performance bench tests. The report concludes that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Stealth 360° Orbital PAD System met the established specifications necessary for consistent performance during its intended use."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "bench testing" and "test results" but does not provide precise sample sizes for each specific test.
- Data Provenance: The data provenance is from laboratory and bench testing performed by the manufacturer, Cardiovascular Systems, Inc. This is not derived from human patient data, therefore, it cannot be classified as retrospective or prospective in that context, nor does it have a country of origin in terms of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device submission relies on engineering specifications, material science, and safety standards rather than clinical expert consensus for establishing ground truth. The "ground truth" here is adherence to these predefined technical and safety standards.
4. Adjudication Method for the Test Set
- Not Applicable. As the evaluation is based on objective measurements against engineering and safety specifications, an adjudication method for a test set (as typically seen in clinical studies with human interpretative components) is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with vs. without AI Assistance
- No. This type of study is not relevant to the clearance of this mechanical atherectomy device, which does not involve AI or human interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a mechanical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context refers to pre-defined engineering specifications, international and national biocompatibility standards (e.g., ISO, ASTM, EN 60601), and the performance characteristics of the predicate devices. The device's performance was compared against these established technical criteria to demonstrate safety and effectiveness.
8. The Sample Size for the Training Set
- Not Applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is a mechanical device, not an AI model, so there is no training set or associated ground truth establishment process in that context.
§ 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).