(90 days)
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
The Rotablator Rotational Angioplasty System uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The burr is driven by a flexible helical drive which has a central lumen through which a guide wire passes. The drive shaft is connected to an air turbine which is powered by compressed air or nitrogen. The guide wire that is used with this system can be separately advanced and steered past an occlusive lesion. The guide wire has a radiopaque spring tip that facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes its progress visible. The sheath covering the drive shaft protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the spinning drive. The advancer functions as a housing for the air turbine and as a guide for the sliding elements that control burr extension. The console monitors and controls the rotational speed of the burr and continuously provides the operator with performance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange. The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting rapid stopping of the burr. The foot pedal also has a toggle switch for activating and deactivating the lower speed catheter exchange. The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.
The provided text describes a 510(k) submission for new guide wires (Support and Rail RotaWire™) for the Rotablator® Rotational Angioplasty System. The study is an in-vitro bench test comparison of the new guide wires against an existing predicate device (Type C guide wire).
Here's a breakdown of the requested information based on the provided text, with "N/A" for information not present:
Acceptance Criteria and Device Performance Study
The study performed was a series of in vitro bench tests designed to characterize the performance of the new RotaWire guide wires and compare them to the predicate Type C guide wire. The objective was to demonstrate that the RotaWire design is robust and capable of performing satisfactorily with the Rotablator system, serving as an alternative to the Type C guide wires. The implicit acceptance criterion is that the RotaWire guide wires perform comparably or better than the predicate device in the tested engineering parameters.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds against a numerical value for each test. Instead, the performance of the new RotaWire guide wires is presented alongside the predicate device (Type C) for direct comparison. The implicit acceptance is that the RotaWire performance is equivalent or acceptable relative to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied: Comparable to or acceptable relative to Type C) | Support RotaWire Performance (Reported) | Rail RotaWire Performance (Reported) | Type C Performance (Predicate) |
|---|---|---|---|---|
| Tensile Strength (grams) | ||||
| a) weld joint | N/A (Only Support RotaWire tested as dimensionally identical to Rail) | minimum 472, nominal 685, maximum 808 | No Test (due to dimensional identity with Support RotaWire) | No Test |
| b) solder joint | N/A (Only Support RotaWire tested as dimensionally identical to Rail) | minimum 2337, nominal 2390, maximum 2276 | No Test (due to dimensional identity with Support RotaWire) | No Test |
| Torque Strength (oz.-in.) | N/A | minimum 0.076, nominal 0.105, maximum 0.143 | minimum 0.077, nominal 0.107, maximum 0.153 | 0.185 (single value, likely a nominal or minimum from predicate) |
| Torqueability (proximal to distal turns) | Desirable: 1 to 1 (one-to-one response for proximal/distal rotation) | minimum 1.75 to 1, nominal 1.75 to 1, maximum 2.25 to 1 | minimum 2.75 to 1, nominal 2.75 to 1, maximum 3 to 1 | 3.25 to 1 (single value, likely nominal) |
| Tip Flexibility (in.) | N/A | |||
| a) cantilevered 1.5"; force = 0.20 gm | N/A | 0.79 | 0.79 | 0.71 |
| b) cantilevered 3.1"; force = 0.20 gm | N/A | 1.49 | 1.29 | 1.00 |
| c) cantilevered 6.1"; force = 0.20 gm | N/A | 3.95 | 3.27 | 3.27 |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The exact sample size for each individual test is not specified. For tensile strength, "minimum," "nominal," and "maximum" values are provided, implying multiple measurements. For other parameters, ranges or single values are given.
- Data Provenance: The study consists of in vitro (bench) tests, not human or animal data. The location of testing is implied to be within Heart Technology, Inc. or an associated lab in Redmond, WA, USA. It is prospective testing for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- N/A. This was an in vitro engineering study measuring physical properties, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set:
- N/A. As an in vitro engineering study, no human adjudication was involved in establishing ground truth. The results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- N/A. This was an in vitro engineering study, not a clinical study involving human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- N/A. This is a medical device (guide wire), not a software algorithm. The "standalone" performance refers to the physical properties of the guide wires themselves as tested on the bench.
7. The Type of Ground Truth Used:
- Objective Engineering Measurements: The "ground truth" for this study comes from direct, objective measurements of physical properties (tensile strength, torque strength, torqueability, flexibility) in a controlled laboratory setting.
8. The Sample Size for the Training Set:
- N/A. This is an in vitro device performance study, not a machine learning study that would have a distinct training set. The "training" for the device design would have been part of the product development process, but not in the context of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- N/A. See point 8.
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APR 2 5 1996
510(k) for Peripheral Rotablator® Rotational Angioplasty System with the Support Page 1 and Rail RotaWire™ Guide Wires
TABLE OF CONTENTS
510(k) SUMMARY
| A. | Introduction | |
|---|---|---|
| B. | Device Description | |
| C. | Intended Use | |
| D. | Comparison to Predicate Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . | |
| E. | In Vitro Tests |
(
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510(k) SUMMARY
A. Introduction
... ... ... ..
This 510(k) is for two new guide wires that are designed for use with the Rotablator® Rotational Angioplasty System.
| Submitter: | Heart Technology, Inc.17425 N.E. Union Hill RoadRedmond, WA 98052 |
|---|---|
| Contact: | Diane JohnsonPhone: (206) 556-1541Fax: (206) 558-1400 |
| Device Common Name: | Rotational Angioplasty SystemGuide Wires |
| Device Proprietary Name: | Rotablator® System's Guide Wire Line: Support RotaWire™;Rail RotaWire™ |
| Classification Name: | Catheter, Peripheral, Atherectomy (per 21 CFR 870.4875)Guide Wire, Angiographic, Accessory |
| Classification Panel: | Cardiovascular |
| Manufacturing Facility: | Heart Technology Manufacturing, Inc.17425 N.E. Union Hill RoadRedmond, WA 98052 |
B. Device Description
The Rotablator Rotational Angioplasty System uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The burr is driven by a flexible helical drive which has a central lumen through which a guide wire passes. The drive shaft is connected to an air turbine which is powered by compressed air or nitrogen.
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510(k) for Peripheral Rotablator® Rotational Angioplasty System with the Support and Rail RotaWire™ Guide Wires Page 3
The guide wire that is used with this system can be separately advanced and steered past an occlusive lesion. The guide wire has a radiopaque spring tip that facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes its progress visible.
The sheath covering the drive shaft protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the spinning drive.
The advancer functions as a housing for the air turbine and as a guide for the sliding elements that control burr extension.
The console monitors and controls the rotational speed of the burr and continuously provides the operator with performance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange.
The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting rapid stopping of the burr. The foot pedal also has a toggle switch for activating and deactivating the lower speed catheter exchange.
The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.
C. Intended Use
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
11:52
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510(k) for Peripheral Rotablator® Rotational Angioplasty System with the Support : and Rail RotaWire™ Guide Wires Page 4
Comparison to Predicate Device D.
The Rotablator system's new RotaWire guide wires are substantially equivalent to the currently marketed Type C guide wire. The differences in the RotaWire wires compared to the Type C are summarized in Table 1. The indications for use remain the same. No change to the Rotablator advancer/catheter or the console is being proposed.
| Feature | Type C | RotaWire |
|---|---|---|
| Wire Profile | Linear taper in the distal1.60" | Support - Compoundtapered profile in the distal18.0"Rail - Taper in the distal3.1" |
| Wire Material | 304 Stainless Steel | 304 Stainless Steel |
| Spring Tip Material | Pt-8%W alloy | Pt-8%W alloy orPt-10%Ni alloy |
| Spring Tip Length | 1.40" | 1.10" |
| Spring Tip InnerDiameter | .0090" | .0055 to .0060" |
| Spring Tip OuterDiameter | 0.017" | 0.014" |
Table 1. Design Comparison of Type C and RotaWire Guide Wires
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510(k) for Peripheral Rotablator® Rotational Angioplasty System with the Support and Rail RotaWire™ Guide Wires Page 5
In Vitro Tests ய்
្រី ន
A series of bench tests were done to characterize the performance of the RotaWire guide wires in a clinical setting. The results of these tests demonstrate that the design of the RotaWire guide wires is robust, and that these guide wires are capable of performing satisfactorily with the Rotablator system in the treatment of lesions as an alternative to the Type C guide wires that are currently used. Test results are summarized in Table 2.
In addition to the tests summarized in Table 2, toxicity tests were completed on a Pt-10%Ni alloy because this material was chosen as an alternative to the Pt-8%W alloy currently used for the spring tips in HTI's guide wires.
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| Support RotaWire | Rail RotaWire | Type C | |
|---|---|---|---|
| Tensile strength (grams)a) weld jointb) solder joint | a) minimum 472nominal 685maximum 808b) minimum 2337nominal 2390maximum 2276 | No Test1 | No Test |
| Torque Strength (oz.- in.) | minimum .076nominal .105maximum .143 | minimum .077nominal .107maximum .153 | .185 |
| Torqueability2 (proximal to distal turns) | minimum 1.75 to 1nominal 1.75 to 1maximum 2.25 to 1 | minimum 2.75 to 1nominal 2.75 to 1maximum 3 to 1 | 3.25 to 1 |
| Tip Flexibility (in.)a) cantilevered 1.5"; force =0.20 gmb) cantilevered 3.1"; force =0.20 gmc) cantilevered 6.1"; force =0.20 gm | a) .79b) 1.49c) 3.95 | a) .79b) 1.29c) 3.27 | a) .71b) 1.00c) 3.27 |
Table 2. Engineering Test Comparison of Type C and RotaWire Guide Wires
1 Weld and solder joints for the Support and Rail RotaWires are dimensionally identical, therefore, only the
Support RotaWire was tested. Support RotaWire was tested.
2 A one-to-one torque response is desirable, that is, for one revolution of the proximal end (outside the body), the distal spring tip in the vessel should also rotate once.
§ 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).