(79 days)
Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal atteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).
The Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheter are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System and Philips Laser System. The Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The Turbo-Power (2.0mm) and (2.3mm) are used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are comprised of 2 subassemblies:
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- Catheter Subassembly
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- Motor Drive Unit (MDU) Subassembly
The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) quidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System or Philips Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system or Philips Laser System is used to photoablate multiple morphology lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.
- Motor Drive Unit (MDU) Subassembly
This document is a 510(k) premarket notification for the Turbo-Power (2.0mm and 2.3mm) Laser Atherectomy Catheters. It describes a modification to an existing device (a new Printed Circuit Board Assembly and firmware) and aims to demonstrate substantial equivalence to a predicate device.
Therefore, the study design described is a design verification and validation testing for the modified device, rather than a clinical trial or large-scale comparative effectiveness study typical for new medical device approvals. The acceptance criteria and the study performed are focused on confirming that the modified device functions as intended and meets the safety and performance requirements established for the original device.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document broadly states that "Functional testing was performed to confirm the devices with the new PCBA meet the relevant product requirements." and "The following testing was conducted to verify that the subject device met all acceptance criteria as required by the risk analysis that was performed." However, a specific table detailing individual acceptance criteria and corresponding reported device performance values (e.g., pass/fail for specific tests, quantitative measurements within certain tolerances) is not provided in this summary. The categories of testing performed are listed:
| Acceptance Criteria (General Categories) | Reported Device Performance |
|---|---|
| Functional Performance (relevant product requirements) | Confirmed to meet relevant product requirements (Pass) |
| Software Performance | Software testing was performed (Pass) |
| Medical Electrical Safety | Medical Electrical Safety Testing was performed (Pass) |
| Sterilization | Assessment concluded additional sterilization testing not required (Deemed Acceptable) |
| Risk Analysis Requirements | Met all acceptance criteria as required by risk analysis (Pass) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size (number of modified devices) used for the functional, software, and medical electrical safety testing. It mentions "devices with the new PCBA" in plural, implying more than one unit, but no specific number.
- Data Provenance: The testing was conducted by The Spectranetics Corporation, based in Colorado Springs, Colorado, USA. The data is prospective as it involves new testing on the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving subjective human interpretation, such as image reading in AI/diagnostic device studies. For this submission, which focuses on engineering verification of a physical device modification, the "ground truth" is established by the device's technical specifications and engineering requirements. Therefore, no external experts (like radiologists) were used to establish a "ground truth" in the diagnostic sense. The "experts" would be the internal engineers and quality personnel responsible for defining and executing the test protocols and assessing compliance. Their qualifications are implicitly assumed to be appropriate for device testing and validation.
4. Adjudication method for the test set:
Not applicable in the context of this device modification verification. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple human readers when establishing ground truth for diagnostic studies. For engineering and safety testing, passing or failing a test is typically based on predefined objective criteria, not subjective interpretation requiring adjudication.
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:
No, an MRMC comparative effectiveness study was not done. This document is for a medical device modification (a laser atherectomy catheter) and not an AI/CADe device where human reader improvement with AI assistance would be relevant. The submission aimed to demonstrate substantial equivalence of the modified device to its predicate, focusing on maintaining existing performance and safety.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic device. The "performance" here refers to the physical and electrical function of the catheter and its associated components, not the output of a diagnostic algorithm.
7. The type of ground truth used:
The "ground truth" for this device modification is based on engineering specifications, functional requirements, and safety standards. The tests performed verify that the modified device continues to meet these objective, predefined criteria. It does not involve "expert consensus, pathology, or outcomes data" in the traditional sense of validating a diagnostic or AI-based device.
8. The sample size for the training set:
Not applicable. This is a medical device modification, not a machine learning or AI algorithm development. Therefore, there is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
Not applicable, as there is 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).