ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE

K960379 · Heart Technology Mfg., Inc. · MCW · Apr 25, 1996 · Cardiovascular

Device Facts

• Record ID: K960379
• Device Name: ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
• Applicant: Heart Technology Mfg., Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Apr 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Rotablator Rotational Angioplasty System uses high-speed (140,000-190,000 RPM) diamond-coated burr to ablate occlusive atherosclerotic material in peripheral vessels; burr driven by flexible helical drive shaft connected to air turbine (compressed air/nitrogen). System includes console for speed monitoring/control, foot pedal for turbine activation, and guide wires (Support/Rail RotaWire) for navigation. Guide wires feature radiopaque spring tips for visualization and vessel trauma reduction. Sheath protects arterial tissue and delivers saline for lubrication/cooling. Used in clinical settings by physicians. Console provides performance feedback; high-speed mode for ablation, low-speed for catheter exchange. Ablated material removed via reticuloendothelial system. Benefits include restoration of luminal patency.

Clinical Evidence

Bench testing only. Engineering tests compared tensile strength, torque strength, torqueability, and tip flexibility between Support RotaWire, Rail RotaWire, and Type C guide wire. Toxicity testing performed on Pt-10%Ni alloy spring tip material. No clinical data provided.

Technological Characteristics

Materials: 304 Stainless Steel wire, Pt-8%W or Pt-10%Ni alloy spring tips. Principle: Mechanical rotational ablation via diamond-coated burr. Energy: Compressed air/nitrogen turbine. Connectivity: None. Sterilization: Not specified. Software: None (mechanical/pneumatic control).

Indications for Use

Indicated for patients with occlusive atherosclerotic disease in peripheral vessels who are candidates for bypass graft surgery or percutaneous transluminal angioplasty.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Type C guide wire

Reference Devices

• Type A guide wire

Submission Summary (Full Text)

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K960379
APR 25 1996

510(k) for Peripheral Rotablator® Rotational Angioplasty System with the Support and Rail RotaWire™ Guide Wires
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## TABLE OF CONTENTS

### 510(k) SUMMARY

A. Introduction ... 2
B. Device Description ... 2
C. Intended Use ... 3
D. Comparison to Predicate Device ... 4
E. *In Vitro* Tests ... 5

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510(k) for Peripheral Rotablator® Rotational Angioplasty System with the Support and Rail RotaWire™ Guide Wires
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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 Road
Redmond, WA 98052

Contact: Diane Johnson
Phone: [phone]
Fax: [phone]

Device Common Name: Rotational Angioplasty System
Guide 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 Road
Redmond, WA 98052

## B. Device Description

The Rotablator Rotational Angioplasty System uses a high speed, rotating, diamond-coated 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
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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.

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510(k) for Peripheral Rotablator® Rotational Angioplasty System with the Support and Rail RotaWire™ Guide Wires
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## D. Comparison to Predicate Device

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 distal 1.60" | Support - Compound tapered profile in the distal 18.0"
Rail - Taper in the distal 3.1" |
| Wire Material | 304 Stainless Steel | 304 Stainless Steel |
| Spring Tip Material | Pt-8%W alloy | Pt-8%W alloy or Pt-10%Ni alloy |
| Spring Tip Length | 1.40" | 1.10" |
| Spring Tip Inner Diameter | .0090" | .0055 to .0060" |
| Spring Tip Outer Diameter | 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
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## E. In Vitro Tests

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 A and 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 joint
b) solder joint | a) minimum 472
nominal 685
maximum 808 | No Test^{1} | No Test |
| | b) minimum 2337
nominal 2390
maximum 2276 | No Test^{1} | No Test |
| Torque Strength (oz.- in.) | minimum .076
nominal .105
maximum .143 | minimum .077
nominal .107
maximum .153 | .185 |
| Torqueability^{2} (proximal to distal turns) | 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 |
| Tip Flexibility (in.)
a) cantilevered 1.5°; force =0.20 gm
b) cantilevered 3.1°; force =0.20 gm
c) cantilevered 6.1°; force =0.20 gm | a) .79 | .79 | .71 |
| | b) 1.49 | 1.29 | 1.00 |
| | c) 3.95 | 3.27 | 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.

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.