(144 days)
The SilverHawk and TurboHawk Peripheral Plaque Excision System are intended for use in atherectomy of the peripheral vasculature. The SilverHawk and TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.
The TurboHawk Catheter (THS-LS-C, THS-LX-C) is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions.
The SilverHawk and TurboHawk Peripheral Plaque Excision System consists of a Catheter and Cutter Driver, which are packaged separately, but shipped and used together during the plaque excision procedure. The catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the catheter is a small cutting assembly comprised of a rotating inner blade contained within a tubular housing. The proximal end of the Catheter contains a connector and positioning lever designed to fit into a small, disposable, battery driven Cutter Driver, which powers the device.
The SilverHawk and TurboHawk Peripheral Plaque Excision System each have two switches: 1) the Cutter Driver main power switch and 2) the Catheter thumb switch. The Cutter Driver main power switch supplies power to the device when turned ON. When the thumb switch is fully forward (OFF), the cutting blade is closed and stored in the cutter housing with the motor off. This position is used during delivery of the device to the target lesion. Once the device has been positioned the Catheter thumb switch is pulled proximally to the ON position to activate the drive shaft and engage the cutter. Pulling back on the Catheter thumb switch simultaneously turns on the motor and causes the distal portion of the cutter housing to deflect, forcing the device against the target lesion. At the same time, this motion exposes the inner rotating blade, preparing the device for lesion treatment. With the blade spinning, the Catheter is slowly advanced across the lesion, "shaving" occlusive material from the artery. The excised tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the Catheter thumb switch distally, deactivating the drive shaft, disengaging the cutter, and aligning the cutter and housing. The Catheter thumb switch is fully advanced distally to the OFF position in order to move the cutter forward within the tip and pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.
The SilverHawk and TurboHawk Peripheral Plaque Excision System uses the following materials: stainless steel, platinum/iridium, carbide w/ 12% nickel binder, titanium, delrin, polyimide, PET lined tecothane, pebax, nylon, Teflon, tungsten carbide, ABS, PVC, silicone, Santoprene, polycarbonate, polypropylene and hydrophilic coating.
The provided document is a 510(k) summary for the Medtronic SilverHawk and TurboHawk Peripheral Plaque Excision Systems. It describes changes made to the device and the testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting.
Therefore, many of the requested data points related to clinical study design, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable or available in this document. The document focuses on performance testing in a bench setting to support a 510(k) clearance.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes "Test Methods Used to Evaluate Change" and concludes that "The results from these tests demonstrate that the technological and performance characteristics of the proposed SilverHawk and TurboHawk devices perform in a manner equivalent to the predicate devices currently on the market."
| Test Method Used to Evaluate Change | Reported Device Performance |
|---|---|
| General Bench Tests (applicable to most models after changes): | |
| • Device Inspections | |
| • Cutter Height | |
| • Cycle and Life | |
| • Carbide Edge Attachment | |
| • Repeated Cutter Spin Down and Packing | |
| • Coating Integrity | |
| • Simulated Use (trackability, rotational fatigue, cycling and cutting) | |
| • Shaft Torque Test | |
| • Device Tensile Test | Performed in a manner equivalent to the predicate devices currently on the market. |
| Specific Bench Tests for certain models: | |
| • Flush Test (SilverHawk SXL, EXL, SS+, ES+) | |
| • Tissue Removal Cycle Test (SilverHawk SXL, SS+, ES+, TurboHawk LS-M, LX-M) | |
| • Tissue Flushing Tool Deployment (TurboHawk LS-M, LX-M) | |
| • Tissue Distal Flushing Tool (DFT) Deployment (TurboHawk LS-C, LX-C) | |
| • Driveshaft Compression (TurboHawk SX-C, SS-C, SS-CL) | Performed in a manner equivalent to the predicate devices currently on the market. The specific quantitative results or acceptance thresholds for each test are not provided in this summary. The overarching "performance" is that the devices maintained equivalence to their predicates despite the specified component changes. |
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: Not explicitly stated for any of the individual bench tests. The document refers to "testing" or "tests" but does not give the number of units or replicates tested.
- Data provenance: Bench testing results. This implies the data was generated in a laboratory or engineering setting, likely within Medtronic. No geographical origin is specified beyond Medtronic Vascular, Inc. is located in Plymouth, MN, USA. The testing is prospective in the sense that it was conducted on the modified devices before market clearance.
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)
Not applicable. The "ground truth" for bench testing of a medical device's physical and functional properties is typically defined by engineering specifications, material properties, and comparative performance against predicate devices, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication for expert consensus in clinical data, which is not present in this document.
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
Not applicable. This document describes a 510(k) submission for a peripheral plaque excision system (a physical device for atherectomy), not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device. The described tests evaluate the physical device's performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For this type of device and testing, the "ground truth" is defined by established engineering and material science principles, manufacturing specifications, and the performance characteristics of the predicate devices. The objective is to demonstrate that the modified device performs similarly to or within acceptable limits compared to the original/predicate design.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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).