(29 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 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.
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 Flex Tip 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.
This document is a 510(k) premarket notification for a medical device called the "Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System," specifically addressing a modification to a component: the ViperWire Advance Flex Tip Peripheral Guide Wire.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical table of acceptance criteria with specific numerical targets and matching device performance values. Instead, it lists the types of performance bench tests conducted and states that "All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance Flex Tip Guide Wire met the established specifications necessary for consistent performance during its intended use." And "The ViperWire Advance Flex Tip Guide Wire met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."
Here's a summarized table based on the provided text, indicating the types of tests performed:
| Test Category | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Mechanical/Physical Tests | Established specifications necessary for consistent performance during its intended use. | Met established specifications and predetermined acceptance criteria. Performs as well or better than the predicate device. |
| Corrosion Testing | (Implied: No unacceptable corrosion) | Met established specifications and predetermined acceptance criteria. |
| Life Testing | (Implied: Device maintains integrity and function for intended duration) | Met established specifications and predetermined acceptance criteria. |
| Tensile Strength | (Implied: Meets required strength for intended use) | Met established specifications and predetermined acceptance criteria. |
| Tip Flexibility | (Implied: Demonstrates appropriate flexibility) | Met established specifications and predetermined acceptance criteria. |
| Trackability | (Implied: Device tracks smoothly through血管) | Met established specifications and predetermined acceptance criteria. |
| Orbit Testing | (Implied: Crown maintains proper orbital function) | Met established specifications and predetermined acceptance criteria. |
| Torque Transfer | (Implied: Efficient transfer of torque for device operation) | Met established specifications and predetermined acceptance criteria. |
| Combined Load Testing | (Implied: Device integrity under various loads) | Met established specifications and predetermined acceptance criteria. |
| Packaging/Simulated Distribution Testing | (Implied: Packaging protects device during distribution) | Met established specifications and predetermined acceptance criteria. |
| Biocompatibility Tests | As per ISO 10993 standards (5, 10, 11, 4) | Met established specifications and predetermined acceptance criteria. |
| Cytotoxicity (ISO 10993-5) | (Implied: Non-cytotoxic) | Met established specifications and predetermined acceptance criteria. |
| Systemic Toxicity (ISO 10993-11) | (Implied: No unacceptable systemic toxicity) | Met established specifications and predetermined acceptance criteria. |
| Sensitization (ISO 10993-10) | (Implied: Non-sensitizing) | Met established specifications and predetermined acceptance criteria. |
| Irritation (ISO 10993-10) | (Implied: Non-irritating) | Met established specifications and predetermined acceptance criteria. |
| Pyrogenicity (ISO 10993-11) | (Implied: Non-pyrogenic) | Met established specifications and predetermined acceptance criteria. |
| Hemocompatibility (ISO 10993-4) | (Implied: Compatible with blood, minimal undesirable interactions) | Met established specifications and predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "performance bench testing" and "design verification and validation testing," using phrases like "All test results demonstrate..." which implies that a test set was used. However, specific sample sizes for any of these tests are not provided.
The data provenance is not explicitly stated as country of origin, but these are bench tests conducted by the manufacturer, Cardiovascular Systems, Inc., which is based in Saint Paul, MN, USA. The tests are described as retrospective in the sense that they are laboratory evaluations of the modified device, not clinical trials on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The study described is bench testing of a device component's physical and biocompatibility properties, not a study involving human diagnosis or interpretation where expert ground truth would be established. The "ground truth" for these tests would be the established engineering specifications and ISO standard requirements.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies to resolve discrepancies among multiple expert readers. This document describes bench testing, not a reader study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document describes bench testing of a guide wire component, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device is a physical medical device (atherectomy system component), not an AI algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance are not relevant concepts for this type of device submission. The performance described is purely device-only (standalone physical device component) performance.
7. The Type of Ground Truth Used:
For the bench testing described, the "ground truth" is defined by:
- Established engineering specifications: Performance requirements set by the manufacturer for the guide wire (e.g., tensile strength, flexibility).
- Applicable standards: Specifically, ISO 10993 series for biocompatibility (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation, ISO 10993-11 for systemic toxicity and pyrogenicity, ISO 10993-4 for hemocompatibility).
- Test protocols: Documented procedures detailing how each test was to be performed and what constituted a successful outcome.
- Customer inputs: (Implied: requirements derived from user needs and clinical application).
8. The Sample Size for the Training Set:
This information is not applicable. The document describes a 510(k) submission for a physical medical device component, which involves bench testing and comparison to a predicate device. It does not involve machine learning or AI, and therefore there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above (no training set for an AI algorithm).
§ 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).