K Number
K960379
Device Name
ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
Date Cleared
1996-04-25

(90 days)

Product Code
Regulation Number
870.4875
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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. 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.
More Information

Not Found

Not Found

No
The device description focuses on mechanical components and control systems without mentioning any AI/ML algorithms or data processing for decision-making or analysis.

Yes
The device is intended to treat occlusive atherosclerotic disease and restore luminal patency by ablating occlusive material, which represents a direct therapeutic intervention.

No

This device is designed to treat occlusive atherosclerotic disease by ablating material and restoring luminal patency, which is a therapeutic function rather than a diagnostic one.

No

The device description details numerous hardware components including a burr, drive shaft, air turbine, guide wire, sheath, advancer, console, foot pedal, and compressed gas system. This clearly indicates it is a hardware-based medical device, not software-only.

Based on the provided information, the Rotablator system is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states that the system is for "percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease." This describes a procedure performed on a living patient, not a test performed on a sample taken from a patient outside the body.
  • Device Description: The description details a mechanical system with a rotating burr designed to physically ablate material within blood vessels. This is a therapeutic intervention, not a diagnostic test.
  • Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample analysis, or the generation of diagnostic information from biological samples.

In summary, the Rotablator system is a medical device used for a therapeutic procedure (angioplasty) performed directly on a patient, not a device used to perform diagnostic tests on samples outside the body.

N/A

Intended Use / Indications for 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.

Product codes

Not Found

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.
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vessels

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Tensile strength (grams)
a) weld joint
b) solder joint
Torque Strength (oz.- in.)
Torqueability (proximal to distal turns)
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

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

K960379

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

(

1

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: (206) 556-1541
Fax: (206) 558-1400 |
| 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, 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.

2

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

3

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.

FeatureType CRotaWire
Wire ProfileLinear taper in the distal
1.60"Support - Compound
tapered profile in the distal
18.0"
Rail - Taper in the distal
3.1"
Wire Material304 Stainless Steel304 Stainless Steel
Spring Tip MaterialPt-8%W alloyPt-8%W alloy or
Pt-10%Ni alloy
Spring Tip Length1.40"1.10"
Spring Tip Inner
Diameter.0090".0055 to .0060"
Spring Tip Outer
Diameter0.017"0.014"

Table 1. Design Comparison of Type C and RotaWire Guide Wires

4

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.

5

Support RotaWireRail RotaWireType C
Tensile strength (grams)
a) weld joint
b) solder jointa) minimum 472
nominal 685
maximum 808

b) minimum 2337
nominal 2390
maximum 2276 | No Test1 | No Test |
| Torque Strength (oz.- in.) | minimum .076
nominal .105
maximum .143 | minimum .077
nominal .107
maximum .153 | .185 |
| Torqueability2 (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

b) 1.49

c) 3.95 | a) .79

b) 1.29

c) 3.27 | a) .71

b) 1.00

c) 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.