(69 days)
The CLiRpath® Turbo and TURBO elite™ Excimer laser catheters: For use in the treatment of infrainguinal stenoses and occlusions.
The CLiRpath® Turbo excimer laser catheters and the TURBO elite™ excimer laser catheters consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted guidewire, allowing the operator to deliver laser energy fargeted to a lesion in the vasculature. The CLiRpath® Turbo and TURBO elite™ excimer laser catheters are provide in models designed for "over-the-wire" (OTW) or "rapid exchange" (RX) interventional techniques. Laser energy photoablates or debulks the lesion material re-establishing blood flow within the vessel and permits placement of other interventional devices if needed.
The provided text describes a 510(k) summary for the CLiRpath® Turbo and TURBO elite™ Excimer Laser Catheters and a subsequent correction letter. It details the device, its intended use, and a clinical study conducted to support its safety and efficacy.
Here's an analysis of the acceptance criteria and the study, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | No major adverse events |
| Efficacy | Successful facilitation of peripheral excimer laser catheters in 96.8% of trial cases |
Note on "Acceptance Criteria": The document does not explicitly state pre-defined quantitative acceptance criteria in percentages or thresholds for clinical outcomes. Instead, it reports the observed performance and uses qualitative statements like "No major adverse events" and "successfully facilitated." This is common in 510(k) submissions where substantial equivalence to a predicate device is the primary goal, and clinical data serves to support safety and similar performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 61 patients
- Data Provenance: The study, called the CELLO Study (CLiRpath Excimer Laser System to Enlarge Lumen Openings), was an approved IDE #G060015. This strongly suggests it was a prospective clinical trial conducted under an Investigational Device Exemption. The country of origin is not explicitly stated, but given the submission to the FDA, it is highly likely to have been conducted in the United States or with oversight that aligns with US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given text. The text only mentions "Clinical data were collected" in the context of the CELLO Study. Details about expert involvement in establishing ground truth (e.g., for lesion assessment or outcome verification) are absent.
4. Adjudication Method for the Test Set
- This information is not provided in the given text. The text does not describe any specific adjudication methods (like 2+1 or 3+1 consensus) used for clinical outcomes reported in the CELLO study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The study described (CELLO Study) appears to be a single-arm study evaluating the safety and efficacy of the device itself, not comparing human readers with and without AI assistance. The device is a medical catheter, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable. The device, CLiRpath® Turbo and TURBO elite™ Excimer Laser Catheters, is a physical interventional medical device, not a standalone algorithm or AI. Its performance is intrinsically tied to human operation to deliver laser energy to a lesion.
7. The Type of Ground Truth Used
- The ground truth for "safety" would be based on the absence of major adverse events, likely determined through direct observation and reporting during the clinical trial.
- The ground truth for "efficacy" (successful facilitation of peripheral excimer laser catheters) would likely be based on procedural success outcomes, which are objective clinical observations and measurements during the interventional procedure (e.g., successful catheter placement, re-establishment of blood flow). This would potentially involve angiographic evidence or other direct clinical assessments.
8. The Sample Size for the Training Set
- Not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The CELLO Study was a clinical trial to evaluate the device in patients, not to train an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no AI training set for this device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).