ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER

K993648 · Boston Scientific Corporation Northwest Technology · MCW · Nov 24, 1999 · Cardiovascular

Device Facts

• Record ID: K993648
• Device Name: ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
• Applicant: Boston Scientific Corporation Northwest Technology
• Product Code: MCW · Cardiovascular
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The peripheral 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 system performs rotational atherectomy to restore luminal patency in peripheral vessels. System components include advancer, catheter with diamond-coated burr, console, foot pedal, and guide wire. During operation, burr rotates at 140,000-190,000 RPM to ablate occlusive atherosclerotic material into fine particles; particles are carried distally and cleared via reticuloendothelial system. Used by physicians in clinical settings. Device provides mechanical intervention to treat peripheral arterial disease, offering an alternative to bypass surgery or standard angioplasty.

Clinical Evidence

Bench testing only.

Technological Characteristics

System comprises advancer, catheter with diamond-coated burr, console, foot pedal, and guide wire. Operates via high-speed rotational ablation (140,000-190,000 RPM). Materials and construction are similar to the predicate device.

Indications for Use

Indicated for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease 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

• Peripheral Rotablator® Rotational Angioplasty System with the RotaLink® Exchangeable Catheter (K970296)

Submission Summary (Full Text)

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Special 510(k): Device Modificatio Rotablator® Angioplasty System with RotaLink® Exchangeable Catheter for Peripheral Use

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| Section III - 510(k) Summary | NOV 24 1999 |
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### General Information

| Submitter | Boston Scientific Corporation Northwest Technology<br>Center, Inc.<br>17425 N.E. Union Hill Road<br>Redmond, WA 98052 |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Cyndy Adams<br>425-556-1570 (phone)<br>425-558-1400 (fax) |
| Classification Name | Catheter, Peripheral, Atherectomy<br>(per 21 CFR 870.4875) |
| Common or Usual Name | Rotational Angioplasty System<br>Rotablator® Rotational Angioplasty System with the<br>RotaLink® Exchangeable Catheter |
| Classification Panel | Cardiovascular |

# Name of Predicate Device

Predicate Device 510(k) Reference No. K970296 Peripheral Rotablator® Rotational Angioplasty System with the RotaLink® Exchangeable Catheter

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### 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 Rotablator System with Exchangeable Catheter comprises four main components: advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.

### Intended Use

The peripheral 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.

### Summary of Technological Characteristics

The proposed Rotablator system is similar in construction and materials to the currently marketed Rotablator system.

### Test Summary

The proposed Rotablator system is considered to be substantially equivalent to the previously marketed Rotablator system based on a comparison of the intended uses and designs and results of the testing and evaluations performed.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1999

Ms. Cyndy Adams Sr. Regulatory Affairs Specialist Boston Scientific Corporation 17425 N.E. Union Hill Road Redmond, WA 98052-3376

Re: K993648

> Peripheral Rotablator® Rotational Angioplasty System Trade Name: With the RotaLink™ Exchangeable Catheter Regulatory Class: II Product Code: MCW Dated: October 28, 1999 Received: October 29, 1999

Dear Ms. Adams:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to

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Page 2 - Ms. Cyndy Adams

your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ohto M. Mth for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Section I - Indications for Use

510(k) Number (if known)

| Device Name | Peripheral Rotablator® Rotational Angioplasty System with the RotaLink™ Exchangeable Catheter |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The peripheral 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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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over The Counter Use

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993648
(Optional Format 1-2-96)