(246 days)
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.
Spectranetics' laser atherectorny catheters, including the 2,5 mm Turbo CLiRoath catheter for peripheral use, 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 medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. The 2.5 mm Turbo catheter is designed for "over-the-wire" interventional techniques. Laser energy impinged on a blockage ablates, or debulks, the lesion material re-establishing blood flow within the vessel, and permitting placement of devices used in vascular interventions. The Spectranetics Turbo laser catheter is supplied with a tip diameter of 2.5 mm, appropriate for interventional use in the peripheral vasculature of the leg.
The provided text describes the Spectranetics 2.5 mm Turbo CLiRpath Excimer Laser Catheter and its substantial equivalence to a predicate device. However, it does not explicitly define acceptance criteria in a table format or present a comparative study with numerical performance metrics against those criteria. The study described focuses on safety and performance in a porcine model rather than a detailed, quantitative analysis against pre-defined acceptance criteria for efficacy in humans.
Here's an attempt to extract the relevant information based on the typical content of a 510(k) summary, acknowledging the limitations of the provided document in explicitly defining "acceptance criteria" and "device performance" in a quantitative, human-centric way:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit, quantitative acceptance criteria for efficacy in the manner of a clinical trial. Instead, the "acceptance criteria" are implied by the demonstration of safety and equivalent functionality to a predicate device. The "device performance" is described qualitatively.
| Acceptance Criteria (Implied) | Reported Device Performance (Qualitative) |
|---|---|
| Safety: No deleterious tissue damage, no complications. | Confirmed safety in a porcine model. No complications were noted during treatment of the illiac and femoral arteries. Histological evaluation of harvested arterial segments showed no deleterious tissue damage after exposure to maximum energy parameters. |
| Functionality/Efficacy (Equivalence to Predicate): Ablates or debulks lesion material, re-establishes blood flow, facilitates placement of other devices, equivalent to the predicate device. | The device disrupts occlusive material plaque, permitting its removal and re-establishing blood flow within the diseased vessel. The pathway opened facilitates subsequent placement of other devices. Comparisons to the predicate device indicated that the 2.5 mm Turbo catheter was equivalent with respect to both safety and functionality. In vitro laboratory tests, qualification and validation studies confirmed manufacturing and design specifications met. |
| Biocompatibility: Meets ISO 10993 standards. | Confirmed in accord with the ISO 10993 series of standards. |
| Sterilization: Meets ISO 11135 standards. | Conducts and maintains valid ethylene oxide sterilization processes in accord with ISO 11135. |
| Packaging: Validated and visually verified for integrity. | Initially validated and visually verified for 100% of devices. |
| Device Integrity and Functionality: Meets Spectranetics in-house and ISO 10555-1 requirements. | Qualified and/or validated using samples produced under routine manufacturing conditions. Meets or exceeds both Spectranetics in-house requirements and requirements listed in ISO 10555-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of animals, but refers to "a porcine model."
- Data Provenance: The study was conducted on a porcine model (animals), making it pre-clinical and prospective (conducted specifically for this submission). The country of origin of the data is not specified, but the company is based in Colorado Springs, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study was a pre-clinical animal study, and while a GLP (Good Laboratory Practices) compliant protocol was followed, there's no mention of experts establishing a "ground truth" in the diagnostic sense (e.g., radiologists interpreting images). Histological evaluation would typically be performed by veterinary pathologists, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given it was an animal study focused on safety (complications, tissue damage observed histologically) and device functionality, formal adjudication by a panel of experts for diagnostic accuracy (as might be seen in a clinical trial for an imaging device) is unlikely to have been applied in this context.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical catheter, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study of an algorithm was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the animal study was based on:
- Direct observation of complications during the procedure in the porcine model.
- Histological evaluation of harvested arterial segments (pathology) to assess tissue damage.
- Functional assessment of the device's ability to "disrupt occlusive material plaque" and "re-establish blood flow," implicitly compared to the predicate device's known performance.
8. The Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not a machine learning model requiring a training set. The device design and manufacturing processes were likely developed and refined through engineering tests and validation, but these are not "training sets" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).