(87 days)
The Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus is intended to ablate occlusive material and restore luminal patency in the peripheral vasculature.
The Rotablator™ Rotational Atherectomy System is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.
The Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus is a catheter based angioplasty device that utilizes a high speed, rotating, diamond-coated burr to ablate occlusive material and restore luminal patency. The burr spins at up to 190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. There are three main components that comprise the Rotablator Rotational Atherectomy: 1) the Peripheral RotaLink Plus, 2) Peripheral RotaWire Guidewire with the wireClip Torquer, and 3) Rotablator Console with Dynaglide foot pedal. Rotaglide, a lubricant is also available as an accessory.
The provided document is a 510(k) submission for the Rotablator™ Rotational Atherectomy System. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through bench testing and biocompatibility testing, rather than clinical efficacy studies with specific performance metrics against acceptance criteria that are typically associated with AI/ML devices.
Therefore, many of the requested elements (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) are not directly applicable or available in this type of submission.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria in terms of quantitative performance metrics for a specific clinical outcome. Instead, it relies on demonstrating that the device's technological characteristics, safety, and performance are substantially equivalent to its predicate devices through a series of in-vitro and biocompatibility tests.
| Acceptance Criteria Category | Specific Tests Performed by Manufacturer | Reported Device Performance Summary |
|---|---|---|
| Material Biocompatibility | For Rotablator Rotational Atherectomy System; Peripheral RotaLink Plus: | Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. |
| - Natural Rubber Latex | ||
| - Hemolysis Assay: Extract Method | ||
| - Hemolysis Assay: Direct Contact Method | ||
| - Complement Activation C3a and SC5b-9 Assay | ||
| - Partial Thromboplastin Time (PTT) | ||
| - In vitro Hemocompatibility Assay | ||
| - Guinea Pig Maximization Sensitization Test: Method for Biomaterial Extracts | ||
| - Intracutaneous Reactivity Test (Irritation) | ||
| - Acute Systemic Injection Test | ||
| - Materials Mediated Rabbit Pyrogen Test | ||
| - USP Physicochemical Test for Plastics | ||
| - In vitro Cytotoxicity Test: MEM Elution | ||
| - FTIR Analysis | ||
| For Peripheral RotaWire Guidewire: | ||
| - Natural Rubber Latex | ||
| - Hemolysis Assay: Direct Contact Method | ||
| - Complement Activation C3a and SC5b-9 Assay | ||
| - Partial Thromboplastin Time (PTT) | ||
| - In vitro Hemocompatibility Assay | ||
| - Guinea Pig Maximization Sensitization Test: Method for Biomaterial Extracts | ||
| - Intracutaneous Reactivity Test (Irritation) | ||
| - In vitro Cytotoxicity Test: MEM Elution | ||
| - Materials Mediated Rabbit Pyrogen Test | ||
| - USP Physicochemical Test for Plastics | ||
| - Acute Systemic Injection Test | ||
| For Rotaglide: | ||
| - Hemolysis Assay: Direct Contact Method | ||
| - In vitro Cytotoxicity Test: MEM Elution | ||
| - Partial Thromboplastin Time (PTT) | ||
| - Materials Mediated Rabbit Pyrogen Test | ||
| Device Performance (In-vitro) | For Peripheral RotaLink Plus: | The results from these tests supported the conclusion of substantial equivalence. |
| - Strain Relief | ||
| - Operational Speeds | ||
| - Stall Torque | ||
| - Infusate Temperature Generation | ||
| - Catheter Advancement | ||
| - Component Interface Compatibility | ||
| - Burr Cutting Ability | ||
| - Tensile Strength | ||
| - Brake Engagement | ||
| - Infusate Flow Rate | ||
| - Lumen Patency | ||
| - Functional Life | ||
| For Peripheral RotaWire Guidewire and wireClip Torquer: | ||
| - Corrosion | ||
| - Radiodetectability | ||
| - Fracture | ||
| - Flexure | ||
| - Tensile Strength | ||
| - Tip Formability | ||
| - Torque Transmission | ||
| - Pushability | ||
| - Tip Deflection | ||
| - Stiffness | ||
| - Torque to Fail | ||
| - Functional Life |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission relies on bench testing and biocompatibility testing, not a clinical "test set" in the context of an AI/ML study. The sample sizes for each specific in-vitro or biocompatibility test would be contained within the full test reports, which are not detailed in this summary.
- Data Provenance: The data comes from internal bench testing and biocompatibility assessments conducted by Boston Scientific Corporation. This is not clinical data, so country of origin or retrospective/prospective classification isn't relevant to the summary provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. There is no "ground truth" derived from expert consensus on medical images or clinical outcomes, as this is not an AI/ML diagnostic device. The "ground truth" for the engineering and biocompatibility tests would be the established scientific and regulatory standards/protocols against which the device performance is measured (e.g., ISO standards for biocompatibility tests).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC study was not done. This device is a mechanical atherectomy system, not a diagnostic AI/ML tool that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical device, not an algorithm, so the concept of standalone performance isn't relevant. Its performance is demonstrated through its physical and material properties and how it functions as intended.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the biocompatibility and in-vitro performance tests, the "ground truth" is established by adherence to recognized standards (e.g., ISO standards for biocompatibility, internal engineering specifications for performance tests) and the comparison to previously cleared predicate devices. It is not clinical outcome data, pathology, or expert consensus in the diagnostic sense.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a medical device submission, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable.
§ 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).