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Turbo-Power™ Laser Atherectomy Catheted for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy.

Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5mm or greater in diameter. Turbo-Power Laser Atherectomy Catheter is comprised of 2 subassemblies:

• 1. Catheter Subassembly
• 2. 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 guidewire 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 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 is used to photoablate multiple morphology lesions which mav 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.

This document, a 510(k) summary for the Spectranetics Turbo-Power Laser Atherectomy Catheter (K152181), does not contain information about the device's acceptance criteria or a study directly proving the device meets specific acceptance criteria in the format requested.

Instead, it focuses on demonstrating substantial equivalence to predicate devices (Turbo-Tandem and Turbo-Elite) based on various performance data and existing clinical studies of the predicate devices.

Here's an breakdown of the information that is available and a note on what is missing based on your request:

Missing Information:

• A table of acceptance criteria and the reported device performance: This document does not provide a table specifying predefined quantifiable acceptance criteria (e.g., specific thresholds for success, failure rates, accuracy) for the Turbo-Power device itself, nor does it present its performance against such criteria. The "Performance Data" section lists types of tests conducted but not the results or the criteria for those results.
• Sample size used for the test set and the data provenance: While a "pre-clinical GLP study" is mentioned, details about its sample size, specific test set, and data provenance are not provided. The clinical data leveraged are from studies of the predicate devices.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no direct acceptance criteria study with expert ground truth is described for the Turbo-Power device.
• Adjudication method for the test set: Not applicable for the same reason as above.
• 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 device is a laser atherectomy catheter, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the predicate device studies (EXCITE, PATENT, CELLO), outcomes data (MAE, TLR, restenosis reduction, acute procedural success) were used as endpoints, which can be considered a form of ground truth for assessing clinical effectiveness. However, no ground truth is explicitly described for the Turbo-Power device's direct performance against acceptance criteria.
• The sample size for the training set: Not applicable, as this is not an AI device.
• How the ground truth for the training set was established: Not applicable.

Information that is available (or can be inferred) from the document, relevant to the spirit of your request, but focused on substantial equivalence rather than direct acceptance criteria fulfillment:

The document states that the following testing was conducted to validate and verify that the subject device met all specifications:

• Simulated Use Testing
• Functional Testing
• Physical Testing
• Laser Testing
• Software Testing
• Sterility/Biocompatibility/Physiochemical Testing

Pre-clinical Data:

• Study Type: A pre-clinical GLP study was conducted to compare the usability and procedural safety of the Turbo-Power and Turbo-Tandem laser catheters.
• Purpose: To support the premarket notification and demonstrate similarity to the predicate device.
• Sample Size/Data Provenance: Not specified in this document.
• Ground Truth: Usability and procedural safety endpoints, likely determined by direct observation and measurement in the GLP study, but the specific metrics are not detailed.

Clinical Data (Leveraged from Predicate Devices to Support Indications for Use):

The document explicitly states: "New clinical data was not required to demonstrate substantial equivalence." Instead, the following clinical studies of the predicate devices were leveraged:

1. The EXCITE Trial:

   • Device: Spectranetics Turbo Elite Laser Ablation Catheter and Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter.
   • Focus: Safety and efficacy of Excimer Laser Atherectomy (ELA) with adjunctive PTA vs. PTA alone for femoropopliteal bare nitinol in-stent restenosis (ISR) in vessels ≥5mm.
   • Study Design: Prospective randomized controlled trial (2:1 randomization).
   • Endpoints/Ground Truth:
     • Primary Safety: Freedom from Major Adverse Event (MAE) through 30 days (all-cause death, major amputation in target limb, Target Lesion Revascularization (TLR)).
     • Primary Efficacy: Freedom from TLR through 6 months.
   • Results: Both primary safety and efficacy hypotheses were met. No statistical difference in major amputation rates, mortality, serious adverse events, or adverse events between groups.
   • Sample Size/Provenance: Not specified in this document, but implied to be a multi-center trial.

2. The PATENT Study:

   • Device: Spectranetics peripheral atherectomy laser catheters (Turbo Elite) used with Turbo-Booster catheters.
   • Focus: Safety and performance for in-stent restenosis of nitinol stents in femoropopliteal arteries.
   • Study Design: Multicenter prospective registry.
   • Endpoints/Ground Truth: Safety and performance (specific metrics not detailed in this summary).
   • Sample Size/Provenance: Involved 5 EU centers (specific sample size not detailed).

3. The CELLO (CLiRpath Excimer Laser System to Enlarge Lumen Openings) Study:

   • Device: Turbo-Elite used with Turbo-Booster catheters.
   • Focus: Safety and performance for treatment of Peripheral Artery Disease (PAD).
   • Endpoints/Ground Truth:
     • Primary Effectiveness: ≥ 20 percent reduction in percent diameter stenosis (assessed by angiographic core lab).
     • Secondary Effectiveness: Acute procedural success (visual assessment of final residual stenosis).
     • Primary Safety: Occurrence of major adverse events (clinical perforation, major dissection requiring surgery, major amputation, CVA, MI, death) at procedure time and through six months.
   • Results: Demonstrated safety for the treatment of patients with stenoses and occlusions crossable by a guidewire in SFA and popliteal artery, with no occurrence of major adverse events through six-month follow-up.
   • Sample Size/Provenance: Not specified in this document.

Conclusion for Substantial Equivalence:

The document concludes that the Turbo-Power System is substantially equivalent to the Turbo-Tandem and Turbo-Elite based on:

• Similarities in design.
• Performance data (referring to the listed testing).
• Pre-clinical data (GLP study).
• Leveraged clinical data from the predicate devices.

The implication is that the Turbo-Power device, having successfully completed its internal specifications and pre-clinical testing, is expected to perform similarly to the predicate devices whose clinical safety and effectiveness have already been established by the EXCITE, PATENT, and CELLO trials against their respective clinical endpoints.

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