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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."

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.

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The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal vasculature.

The SilverHawk™ Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk™ Peripheral Catheter and SilverHawk™ Cutter Driver.

The SilverHawk™ Peripheral Plaque Excision System will be provided sterile for singleuse. The catheter will be sterilized by Ethylene Oxide (ANSVAAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 106, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is identical in material of construction, overall design, intended use, and safety and efficacy to the predicate device.

The provided text is a 510(k) summary for the SilverHawk™ Peripheral Plaque Excision System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study demonstrating the device meets such criteria.

The document states: "The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is identical in material of construction, overall design, intended use, and safety and efficacy to the predicate device." This indicates that the new device's safety and efficacy are established by its similarity to the already-approved predicate device (K053460), rather than a new standalone study with specific acceptance criteria.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them because this information is not present in the provided text. The submission relies on substantial equivalence to a predicate device, which typically means a new clinical study to establish acceptance criteria for the new device is not required or presented in the 510(k) summary.

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Indications for Use: The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectorny of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System is provided sterile for single-use.

The provided text is related to a 510(k) submission for a medical device called the "SilverHawk™ Peripheral Plaque Excision System." It describes the classification, predicate device, and confirms its substantial equivalence for marketing. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a summary of the 510(k) notification and the FDA's clearance letter, which focuses on regulatory aspects such as substantial equivalence to a predicate device and adherence to general controls. It does not detail the technical studies, performance metrics, or clinical trial data that would typically be included in a full submission to demonstrate safety and efficacy.

Therefore, I cannot provide the requested information based on the input text.

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The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System will be provided sterile for singleuse. The catheter will be sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 ". The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 10°, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

The provided text is a 510(k) summary for the SilverHawk Peripheral Plaque Excision System. It details the device name, predicate device, a general summary, and indications for use. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document. The summary focuses on regulatory substantial equivalence based on prior device characteristics and sterilization methods, not on new performance study data against specific acceptance criteria.

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The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature and is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System will be provided sterile for single-use.

The SilverHawk Peripheral Plaque Excision System is a medical device intended for atherectomy of the peripheral vasculature. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth for a de novo study is not directly available in this summary.

However, based on the provided text, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and detailed performance metrics are not explicitly stated in this 510(k) summary, as the submission is based on demonstrating substantial equivalence to a predicate device rather than a de novo approval requiring a set of performance benchmarks. The "performance" reported is primarily in the context of being substantially equivalent to the predicate.

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

The provided document does not detail a specific clinical test set for the SilverHawk Peripheral Plaque Excision System. The "performance" is assessed based on comparison to the predicate device, which would involve engineering, bench, and potentially animal testing data, but the specific sample sizes for these tests are not provided. The data provenance is not mentioned as this is a regulatory submission rather than a clinical study report.

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

Not applicable. As this is a 510(k) submission based on substantial equivalence, the "ground truth" for device performance is largely established through comparison to the predicate device's known performance characteristics and regulatory clearances, not through expert consensus on a new clinical test set for the SilverHawk device itself in this document.

4. Adjudication Method for the Test Set

Not applicable. There is no described "test set" in the context of a prospective clinical trial requiring an adjudication method.

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

No. This document does not describe a MRMC comparative effectiveness study involving human readers or AI.

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

This device is not an AI algorithm. It is a physical medical device (atherectomy catheter system). Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (ReFORM Peripheral Catheter System, K024243), as determined by its previous FDA clearance and market performance. The goal of this 510(k) is to demonstrate that the SilverHawk system is "substantially equivalent" to this established ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

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