EASY RIDER MICRO CATHETER

K974473 · Micro Therapeutics, Inc. · KRA · Jun 17, 1998 · Cardiovascular

Device Facts

• Record ID: K974473
• Device Name: EASY RIDER MICRO CATHETER
• Applicant: Micro Therapeutics, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Jun 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The catheter is intended to be used for the controlled infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.

Device Story

EASY RIDER® Micro Catheter is a single-lumen infusion catheter for distal vasculature navigation. Device features hydrophilic coating for lubricity; radiopaque marker at tip for fluoroscopic visualization; standard luer lock adapter at proximal hub for accessory attachment. Operated by physicians in clinical settings; introduced over steerable guide wire. Facilitates targeted delivery of therapeutic agents and contrast media. Benefits include precise, controlled infusion into neurovascular and peripheral systems.

Clinical Evidence

No clinical data. Evidence consists of bench testing including biocompatibility (ISO 10993-1:1992(E)), dimensional inspection, tensile strength, burst pressure, flow rate, torque, and performance under simulated conditions.

Technological Characteristics

Single-lumen infusion catheter with hydrophilic coating and radiopaque tip marker. Standard luer lock proximal hub. Biocompatibility per ISO 10993-1:1992(E).

Indications for Use

Indicated for controlled infusion of therapeutic agents and contrast media into neurovascular and peripheral systems in patients requiring such delivery.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• FasTracker™ -10 Infusion Catheter (Target Therapeutics, Inc.)
• RapidTRANSIT™ Infusion Catheters (Cordis Endovascular Systems, Inc.)
• JetStream™ Infusion Catheter (Micro Interventional Systems, Inc.)

Submission Summary (Full Text)

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JUN 17 1998
MITI MICRO THERAPEUTICS, INC.
K111173

# 510(k) Summary of Safety and Effectiveness

## EASY RIDER® Micro Catheter

Prepared November 21, 1997

### General Information

| Classification | Class II |
| --- | --- |
| Trade Name | EASY RIDER® Micro Catheter |
| Generic Name | Percutaneous Catheter |
| Submitted By | Micro Therapeutics, Inc.
1062-F Calle Negocio
San Clemente, CA 92673
Phone: [phone] FAX [phone] |
| Contact | Tom Daughters
Regulatory Affairs |

### Predicate Devices

1. FasTracker™ -10 Infusion Catheter
Target Therapeutics, In.

2. RapidTRANSIT™ Infusion Catheters
Cordis Endovascular Systems, Inc.

3. JetStream™ Infusion Catheter
Micro Interventional Systems, Inc.

### Device Description

The EASY RIDER® Micro Catheter is a single lumen infusion catheter designed to be introduced over a steerable guide wire into distal vasculature. The EASY RIDER® Micro Catheter has a hydrophilic coating to provide lubricity for navigation of vessels. A standard luer lock adapter on the proximal hub is used for the attachment of accessories. The catheter tip is indicated by a radiopaque marker to facilitate fluoroscopic visualization.

Exhibit 7 Page 2

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Micro Therapeutics, Inc.
Premarket Notification 510(k) - EASY RIDER® Micro Catheter

## Intended Use

The catheter is intended to be used for the controlled infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.

## Testing

Biocompatibility testing was performed on the EASY RIDER Micro Catheter in accordance with the International Standard for the Biological Evaluation of Medical Devices, Part 1: Guidance on Selection of Tests (ISO 10993-1:1992(E)). Results of the tests showed that the device passed biocompatibility testing and is suitable for its application.

Physical testing of the product included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests and performance under simulated conditions. All testing of the product yielded acceptable results.

## Summary of Substantial Equivalence

The EASY RIDER Micro Catheter is substantially equivalent to the predicate devices in intended use and principles of operation.

Exhibit 7 Page 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 17 1998

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Tom Daughters
Regulatory Affairs
Micro Therapeutics, Inc.
1062-F Calle Negocio
San Clemente, CA 92673

Re: K974473
Trade Name: EASY RIDER® Micro Catheter
Regulatory Class: II
Product Code: KRA
Dated: June 6, 1998
Received: June 21, 1998

Dear Mr. Daughters:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the

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Page 2 - Tom Daughters

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 [phone]. Additionally, for questions on the promotion and advertising 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,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:
EASY RIDER® Micro Catheter

Indications for Use:
The catheter is intended to be used for the controlled infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ OR Over the Counter Use ☐
(Per 21 CFR 801.109) TWA
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K974473

Exhibit 8 Page 3