REBAR MICRO CATHETER, MODELS 105-5080, 105-5086

K993672 · Micro Therapeutics, Inc. · KRA · Jan 4, 2000 · Cardiovascular

Device Facts

• Record ID: K993672
• Device Name: REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
• Applicant: Micro Therapeutics, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Jan 4, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

Device Story

Rebar Micro Catheter is a single-lumen, steerable infusion catheter; introduced over guidewire into distal vasculature. Features semi-rigid proximal shaft tapering to flexible distal shaft; lubricious hydrophilic coating; radiopaque distal marker for fluoroscopic visualization. Proximal end includes standard luer adapter for accessory attachment. Used by physicians in clinical settings for targeted delivery of therapeutic agents or contrast media. Benefits include precise, controlled infusion within peripheral and neuro anatomy.

Clinical Evidence

Bench testing only. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, short duration (<24 hr) device. Performance testing conducted per ISO 10555 included dimensional verification, tensile/burst/torque strength, flexibility, trackability, and coating integrity.

Technological Characteristics

Single-lumen catheter; semi-rigid proximal shaft, flexible distal shaft; hydrophilic coating; radiopaque marker. Complies with ISO 10555 (sterile, single-use intravascular catheters) and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for controlled selective infusion of therapeutic agents or contrast media into peripheral and neuro vasculature in patients requiring such procedures.

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

• Micro Therapeutics, Inc. Easy Rider Micro Catheter (K974473)

Submission Summary (Full Text)

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## Rebar™ Micro Catheter

### Prepared December 2, 1999

| TRADE NAME: | Rebar™ Micro Catheter | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-------------------------------------------------------|
| GENERIC NAME: | Infusion Catheter | CLASSIFICATION: | Class II |
| SUBMITTED BY: | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, CA 92618 | CONTACT: | Tom Daughters<br>Regulatory Affairs<br>[phone] |
| PREDICATE<br>DEVICE | Micro Therapeutics, Inc. Easy Rider Micro Catheter, K974473 | | |
| DEVICE<br>DESCRIPTION | The Rebar Micro Catheter is a single-lumen catheter designed to be introduced over a<br>steerable guidewire into the distal vasculature. The proximal end of the catheter<br>incorporates a standard luer adapter to facilitate the attachment of accessories. The<br>catheter has a semi-rigid proximal shaft which tapers into the flexible distal shaft to<br>facilitate the advancement of the catheter in the anatomy. The outer surface of the<br>catheter has a lubricious hydrophilic coating. The catheter has a radiopaque marker at<br>the distal end to facilitate fluoroscopic visualization. Select catheter models (.0165"<br>lumen) have a secondary marker 3 cm proximal of the distal tip marker. | | |
| INDICATIONS<br>FOR USE | The Rebar Micro Catheter is intended for the controlled selective infusion of physician-<br>specified therapeutic agents or contrast media into the vasculature of the peripheral and<br>neuro anatomy. | | |
| SAFETY AND<br>PERFORMANCE<br>TESTS | Biocompatibility of the Rebar catheter was verified in accordance with ISO 10993-1,<br>Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of<br>the Rebar catheter when tested as an external communicating, blood contact, short<br>duration device (<24 hr).<br>Performance testing of the Rebar catheter was conducted in accordance with ISO 10555<br>Sterile, single use intravascular catheters - Part 1. Verification tests included:<br>dimensional verification; catheter tensile, burst and torque strength; flexibility,<br>trackability, and coating integrity. Test results demonstrate that the device meets or<br>exceeds the requirements of these standards and performs substantially equivalent to<br>the predicate device. | | |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The Rebar Micro Catheter is substantially equivalent to the predicate device in intended<br>use and principle of operation. | | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 4 2000

Mr. Tom Daughters Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618

Re: K993672 Rebar™ Micro Catheter Trade Name: Regulatory Class: II Product Code: KRA December 2, 1999 Dated: Received: December 6, 1999

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 requlatory 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 Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Tom Daughters

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,

Clintoplu.th.

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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# Indications for Use Statement

| 510(k)<br>Number<br>(if known) | K993672 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Rebar™ Micro Catheter |
| Indications<br>for Use | The Rebar Micro Catheter is intended for the controlled selective<br>infusion of physician-specified therapeutic agents or contrast media<br>into the vasculature of the peripheral and neuro anatomy. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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× Prescription Use_ (Per 21 CFR 801. 109)

Over-The-Counter Use_

Christopher for Witter

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