Search Results

The Turbo-Elite devices are indicated for use in treatment, including atherectomy, of infrainguinal stenoses and occlusions.

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 femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Turbo-Elite laser atherectomy catheters are percutaneous intravascular devices constructed of multiple optical fibers in a concentric array around a guidewire lumen. The optical fibers are enclosed in an outer jacket and the working length of the device is coated with a hydrophilic coating. The distal tip of the catheter includes a Platinum Iridium outer Marker Band which is visible under fluoroscopy. The proximal end consists of a tail tube and a coupler which connects the device to the CVX-300 or PLS laser systems.

Turbo-Elite is designed and intended to be used exclusively with Spectranetics' CVX-300 Excimer Laser System and Philips Laser System (PLS).

The catheters transmit ultraviolet energy from the laser system to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate 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.

During a laser atherectomy, and under fluoroscopic guidance, a physician advances the introducer sheath to the target lesions. The Turbo-Elite catheters are then advanced to the proximal end of the lesion to be treated.

The provided text is a 510(k) summary for the Spectranetics Turbo-Elite Laser Atherectomy Catheter. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, especially not regarding performance in terms of AI/algorithm effectiveness.

The document states:

• "The subject device has the same technological characteristics as the predicate device with no significant updates to device design, specification, or performance."
• "Other minor changes related to component suppliers and certain adhesives used were supported via applicable design verification and validation testing and related rationales."

These statements imply that testing was performed to demonstrate that the minor changes did not negatively impact performance, and that the device performs equivalently to the predicate. However, it does not provide any specific quantitative acceptance criteria or the results of any clinical or analytical studies proving such performance, nor does it mention any AI or algorithmic components. The device described is a physical medical device (laser atherectomy catheter), not a software or AI-driven diagnostic tool.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving an AI device meets them based on the provided text. The questions are largely centered around AI/algorithm performance and ground truth, which are not relevant to the content of this 510(k) summary.

In summary, the provided document does NOT contain the information requested in your prompt regarding acceptance criteria and algorithmic performance studies.

Ask a specific question about this device

The NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter (0.014" guidewire compatible and over-the-wire configuration) is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The 0.014" 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 femoropopliteal artery in-stent restenosis (ISR) in bare nutinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

The NES Reprocessed Spectranetics Turbo-Elite Laser Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen. Catheter sizing identification is printed on the catheters.

For NES Reprocessed Spectranetics Turbo-Elite Laser Catheters, Over-The-Wire (OTW) catheters, a Luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriately sized guidewire.

This document describes the NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter and its substantial equivalence to a predicate device, focusing on functional and safety testing rather than an AI/ML device. Therefore, many standard questions about acceptance criteria and studies for AI/ML devices (e.g., sample sizes for test/training sets, expert consensus, MRMC studies) are not applicable in this context.

However, I can extract the acceptance criteria and the type of studies performed to demonstrate the device's safety and effectiveness.

1. Table of Acceptance Criteria (from the perspective of a reprocessed medical device) and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the given text. For a reprocessed medical device, the "test set" would typically refer to the number of devices subjected to each specific functional and safety test (e.g., how many catheters were used for cleaning validation, how many for tissue ablation testing, etc.) and the number of reprocessing cycles they underwent. The provenance would be the manufacturing facility of Northeast Scientific, Inc., and the studies would be prospective bench and laboratory tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm requiring expert interpretation to establish ground truth. The "ground truth" for this device is established through physical and chemical measurements, functional performance, and biological safety testing against established standards.

4. Adjudication Method for the Test Set:

This is not applicable for a physical medical device. Decisions are based on objective measurements and compliance with predetermined specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms where human reader performance is being evaluated with and without AI assistance. This document describes a physical laser atherectomy catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this reprocessed device is established through:

• Engineering specifications and design requirements: For dimensional checks, mechanical characteristics, and system compatibility.
• Chemical and microbiological standards: For cleaning, sterilization, and biocompatibility validations.
• Performance metrics: For hydrophilic coating efficacy, solarization, and tissue ablation effectiveness, compared against the original predicate device's performance or established clinical benchmarks.
• Regulatory standards: All testing is performed to meet FDA and international standards for medical devices.

8. The Sample Size for the Training Set:

This is not applicable as the document is for a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of reprocessed medical devices; rather, there are manufacturing and process validation runs.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable. As mentioned above, there is no "training set" for this type of device. The ground truth for validating the reprocessing process and the final device's performance is based on established engineering principles, scientific standards, and regulatory requirements specific to medical device manufacturing and reprocessing.

Ask a specific question about this device

The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

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 femoropopliteal 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" guidewires.

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 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.

The provided text is a 510(k) summary for a medical device (Spectranetics Turbo-Elite Laser Atherectomy Catheters). It focuses on establishing substantial equivalence to a predicate device and expanding indications for use. While it mentions a clinical study (ABLATE), it does not provide acceptance criteria in the form of a table with specific device performance numbers, nor does it detail all the specific information requested in the prompt regarding the study's methodology for acceptance testing as if it were an AI/ML device.

However, I can extract the information that is present and indicate where information is missing based on the prompt's requirements.

Missing Information Acknowledgment:
The document does not include details typically found in studies proving an AI/ML device meets acceptance criteria, such as:

• A table of specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy thresholds for an AI/ML diagnostic device).
• Information on test set sample size for AI validation.
• Data provenance for AI training/test sets.
• Number/qualifications of experts for AI ground truth.
• Adjudication methods for AI ground truth.
• MRMC comparative effectiveness study results (AI vs. without AI).
• Standalone performance for an algorithm.
• Ground truth type for AI (e.g., pathology, outcomes data).
• Training set sample size for AI.
• How ground truth for the training set was established for AI.

This is because the device described, the "Spectranetics Turbo-Elite Laser Atherectomy Catheters," is a physical medical device (a laser catheter) and not an AI/ML software device. The clinical study mentioned (ABLATE) is designed to demonstrate the safety and effectiveness of the physical device for its intended use in treating infrainguinal stenosis and occlusions, not to validate an AI/ML algorithm's performance against specific metrics.

Based on the provided text, here is the available information related to the clinical study and device performance, rephrased to fit the prompt's structure where possible, and explicitly noting missing AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the primary safety and effectiveness endpoints of the ABLATE clinical study for the physical device, not an AI/ML algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not explicitly stated numbers of patients in the ABLATE clinical study.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: The ABLATE study is referred to as a "clinical study," which typically implies a prospective design for gathering safety and effectiveness data for device approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not specified.
• Qualifications of Experts: The "Angiographic Core Lab" is mentioned for assessing reduction in percent stenosis, implying expert (likely interventional cardiologists or radiologists specializing in vascular imaging) review, but no specific qualifications or numbers are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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. This is a physical device, not an AI/ML system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not conducted. The study evaluated the direct impact of the laser atherectomy catheter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a physical device, not an AI/ML algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the physical device, the "ground truth" for effectiveness and safety endpoints included:

• Clinical Outcomes Data: Major Adverse Events (MAE) and Target Lesion Revascularizations (TLR) are clinical outcomes.
• Angiographic Assessment: "Mean reduction in percent stenosis at the time of the procedure by Angiographic Core Lab assessment" serves as a measure of the device's immediate effectiveness against a measurable anatomical change.

8. The sample size for the training set

• Not applicable. This is a physical device undergoing a clinical trial for safety and effectiveness, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is a physical device approval, not an AI/ML algorithm.

Ask a specific question about this device