(161 days)
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:
| Acceptance Criteria Category | Specific Criterion / Test Performed | Reported Device Performance / Conclusion |
|---|---|---|
| Reprocessing Effectiveness | Cleaning Validation | Demonstrated effective cleaning. |
| Sterilization Validation | Demonstrated effective sterilization. | |
| Drying Validation | Demonstrated effective drying. | |
| Reprocessing Cycle Limit Enforcement (1 cycle max) | Device is reprocessed no more than once; marked and rejected from further reprocessing after this limit. | |
| Restriction on Reprocessing Devices from Other Reprocessors | Northeast Scientific restricts its reprocessing to exclude devices previously reprocessed by other reprocessors. | |
| Device Integrity & Functionality | Visual Inspection | Inspected prior to packaging and labeling. (Implies meeting visual quality standards for a reprocessed device.) |
| Dimensional Verification | Verified prior to packaging and labeling. (Implies meeting specified dimensional tolerances.) | |
| Mechanical Characteristics (e.g., integrity, strength) | Tested to ensure maintained mechanical properties after reprocessing. | |
| Hydrophilic Coating (application & performance) | Proprietary lubricious hydrophilic coating applied to facilitate movement through arteries. (Implies meeting performance standards for lubricity.) | |
| System Compatibility (with Spectranetics CVX-300 Excimer Laser) | Tested to ensure continued compatibility with the specified laser system. | |
| Solarization (related to laser energy transmission degradation) | Tested. (Implies meeting standards for maintaining acceptable laser energy transmission.) | |
| Tissue Ablation (effectiveness of laser function) | Tested. (Implies demonstrated ability to photoablate lesions effectively.) | |
| Biocompatibility | Biocompatibility Testing | Demonstrated acceptable biocompatibility for patient contact. |
| Packaging Integrity | Packaging Validation | Demonstrated effective packaging to maintain sterility and device integrity. |
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.
§ 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).