(117 days)
The Turbo Elite devices are indicated for use in the treatment of infrainguinal stenosis and occlusions. When used in conjunction with the Turbo Booster and/or as an accessory to the Turbo Tandem System, the devices are indicated for atherectomy of infrainguinal arteries.
The 0.014" and 0.018" Over-the-wire (OTW) Turbo Elite laser catheters are also indicated for use as an accessory to the use of the Turbo Tandem System in the treatment of femoropoplited artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).
Spectranetics Turbo Elite Laser Ablation Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen for Over-the-Wire (OTW) configurations, and bundled together for Rapid-Exchange (Rx) versions. Turbo Elite Laser Ablation Catheters are available in an Over the Wire (OTW) configuration and a Rapid Exchange (RX) configuration. The Turbo Elite laser catheters in the OTW configuration are available in six different catheter tip sizes (0.9mm, 1.4mm, 1.7mm, 2.0mm, 2.3mm, and 2.5mm) and three different guide-wire compatibilities (0.014", 0.018", and 0.035"). New indication clearance is only being requested for the OTW configurations of Turbo Elite catheters compatible with 0.014" and 0.018" quidewires.
The Turbo-Tandem Laser Guide Catheter with Laser Atherectorny Catheter (Turbo-Tandem System) is a laser atherectomy catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser atherectomy catheter. The Turbo-Tandem System is designed to be used to directionally ablate infrainguinal concentric lesions in vessels 5mm or greater at or above the knee. The Turbo Tandem Laser Guide Catheter with Laser Atherectorny Catheter is available in two sizes; a 7F and 8F with a 2.0mm equivalent laser catheter embedded in the system. New indication clearance is only being requested for the Turbo-Tandem 7F catheters.
The multifiber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to an obstruction in the patient's artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate fibrous, calcific, and atheromatous lesions, 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.
Acceptance Criteria and Study Details for Spectranetics Turbo-Tandem System and Turbo Elite Laser Catheters
1. Table of Acceptance Criteria and Reported Device Performance
The provided document focuses on seeking a new Indication for Use (IFU) based on clinical evidence, rather than presenting specific numerical acceptance criteria for a device performance test where the device's output is measured against a predefined standard. The clinical study (EXCITE trial) compared the device combination (ELA+PTA) against another treatment (PTA alone) to demonstrate non-inferiority for safety and superiority for effectiveness for the new indication.
Device Effectiveness (Primary Effectiveness Hypothesis):
| Acceptance Criteria | Reported Device Performance (EXCITE Trial) |
|---|---|
| Freedom from Target Lesion Revascularization (TLR) through 6 months with ELA+PTA superior to PTA alone. | The primary effectiveness hypothesis was met. |
Device Safety (Primary Safety Hypothesis):
| Acceptance Criteria | Reported Device Performance (EXCITE Trial) |
|---|---|
| Freedom from a Major Adverse Event (MAE) through 30 days with ELA+PTA non-inferior to PTA alone. MAE defined as all-cause death, major amputation in the target limb, or target lesion revascularization (TLR). | The primary safety hypothesis was met. |
| (Additional analysis) Superiority for the safety endpoint. | Met (implicitly supported by the statement "Analysis of the data has shown superior safety and effectiveness results compared to PTA."). |
| No statistical difference in major amputation rates, mortality, serious adverse events, or adverse events between groups. | Met. |
Note: The document does not provide specific numerical thresholds or percentages for "superiority" or "non-inferiority" for these clinical endpoints. It only states that the hypotheses were met.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data): The EXCITE trial
- Sample Size: Not explicitly stated as a number of patients, but referenced as "a prospective randomized controlled trial performed respectively in a 2:1 randomization scheme."
- Data Provenance: Prospective, randomized controlled trial. The country of origin of the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is generally not applicable to clinical trials comparing medical device efficacy and safety directly in patients. The "ground truth" in this context is based on clinical outcomes (e.g., freedom from TLR, occurrence of MAE) observed in patients following treatment, as assessed by clinical investigators and defined trial endpoints, rather than expert consensus on a diagnostic image or interpretation. The trial would have been monitored by a Data Safety Monitoring Board (DSMB) and events adjudicated by independent committees, but the roles and qualifications of such individuals are not detailed here.
4. Adjudication Method for the Test Set
The document mentions that the EXCITE trial involved a "primary safety hypothesis" and "primary effectiveness hypothesis" and that "freedom from a major adverse event (MAE)" was defined. Clinical trials typically have independent clinical events committees (CECs) to adjudicate endpoints like MAE and TLR to ensure consistency and minimize bias. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not detailed in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the performance of diagnostic devices or imaging interpretation by different human readers. The EXCITE trial was a clinical trial comparing the effectiveness and safety of a treatment device (laser atherectomy with PTA) against another treatment (PTA alone), not a study of human readers' performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (algorithm only) was not done. The "device" in question is a physical medical device (laser ablation catheter and system) used by a physician during a procedure, not a diagnostic algorithm or AI system. The EXCITE trial evaluated the performance of the device in conjunction with human intervention (the procedure).
7. Type of Ground Truth Used for the Test Set
The ground truth for the clinical effectiveness and safety endpoints in the EXCITE trial was based on clinical outcomes data from patients, specifically:
- Freedom from Target Lesion Revascularization (TLR): A clinical outcome representing the need for a repeat revascularization procedure of the treated lesion.
- Freedom from Major Adverse Events (MAE): A composite clinical outcome including all-cause death, major amputation in the target limb, or target lesion revascularization (TLR).
These are direct patient-level clinical events, not expert consensus on images or pathology results in the typical sense of AI/image analysis studies.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here, as the device is a physical medical instrument, not a machine learning algorithm that underwent a training phase. The EXCITE trial was a clinical validation study to support a new indication for use.
9. How the Ground Truth for the Training Set Was Established
As noted above, there was no "training set" in the context of developing an algorithm. Therefore, the establishment of ground truth for a training set is not relevant to this submission.
§ 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).