ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066

K024118 · Micro Therapeutics, Inc. · KRA · Feb 3, 2003 · Cardiovascular

Device Facts

• Record ID: K024118
• Device Name: ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
• Applicant: Micro Therapeutics, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Feb 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraFlow™ HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.

Device Story

UltraFlow™ HPC is a single-lumen, endhole micro catheter for subselective infusion of pharmacologic agents or contrast media into distal peripheral and neuro vasculature. Device features semi-rigid proximal shaft and highly flexible distal shaft for navigation in tortuous anatomy; includes radiopaque distal marker for fluoroscopic visualization and lubricious outer coating. Accompanied by a stylet to increase distal rigidity during introduction into a guiding catheter. Operated by physicians in clinical settings. Output is the delivery of fluids/agents to target sites; clinical benefit is precise, controlled infusion in distal vessels.

Clinical Evidence

Bench testing only. In-vitro performance testing verified minor product changes, including biocompatibility, angiographic visualization, dimensional verification, and functional performance.

Technological Characteristics

Single-lumen, endhole catheter; semi-rigid proximal shaft; flexible distal shaft; radiopaque distal marker; lubricious outer coating; includes stylet. Class II device (21 CFR 870.1210).

Indications for Use

Indicated for controlled selective infusion of physician-specified pharmacologic agents or contrast media into distal peripheral and neuro vasculature. Contraindicated for use in coronary vasculature.

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

• Modified FlowRider™ Flow Directed Micro Catheter (K010004)

Submission Summary (Full Text)

{0}------------------------------------------------

K024118

## Micro Therapeutics, Inc.

Special 510(k) (modifications to K010004) Special 510(tr) (modifications to No 10001)
UltraFlow™ HPC Flow Directed Micro Catheter
December 13, 2002

FEB 0 3 2003

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

## 4. 510(k) Summary

| Prepared December 13, 2002 | | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------|
| TRADE NAME | UltraFlow™ HPC Flow Directed Micro Catheter | | |
| GENERIC NAME | Flow Directed Micro Catheter | | |
| CLASSIFICATION | Class II (21 CFR 870.1210) | | |
| SUBMITTED BY | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, CA 92618 | CONTACT | Bill Hyatt<br>Regulatory Affairs<br>[phone] |
| PREDICATE<br>DEVICE(S) | Modified FlowRider™ Flow Directed Micro Catheter (K010004), cleared<br>February 13, 2001. | | |
| DEVICE<br>DESCRIPTION | The UltraFlow™ HPC Flow Directed Micro Catheters are single-lumen, endhole<br>catheters designed for the subselective infusion of physician-specified<br>pharmacologic agents or contrast media in tortuous, distal vessels. The catheters<br>have a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the<br>advancement of the catheter in the anatomy. The proximal end of the catheter<br>incorporates a standard luer adapter to facilitate the attachment of accessories.<br>The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic<br>visualization. The outer surfaces of the catheter are coated to increase lubricity.<br>The stylet accompanying the catheter is used to increase the rigidity of the distal<br>section during introduction into the guiding catheter. | | |
| INDICATIONS FOR<br>USE | The UltraFlow™ HPC Flow Directed Micro Catheter is intended for the<br>controlled selective infusion of physician-specified pharmacologic agents or<br>contrast media into the distal vasculature of the peripheral and neuro anatomy. It<br>is not intended for use in the coronary vasculature. | | |
| TESTING | Selected in-vitro performance testing of the MTI UltraFlow™ HPC Micro<br>Catheter were performed to verify the minor product changes. These tests<br>included the following:<br>BiocompatibilityAngiographic visualizationDimensional verificationFunctional performance. | | |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The UltraFlow™ HPC Flow Directed Micro Catheter is the same device as the<br>Modified FlowRider™ Flow Directed Micro Catheter (K010004). This<br>submission has been made to change the device name as it appears on the CDRH<br>database for Premarket Notification decisions. | | |
| | Minor enhancements to the design would normally have required letters to file<br>based upon FDA's guidance document "Deciding When To Submit a 510(k) for a<br>change to an Existing device", January 10, 1997 and are being presented here for<br>information purposes only. | | |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the USA. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 3 2003

Mr. Bill Hyatt Manager, Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618

Re: K024118

Trade/Device Name: UltraFlow™ HPC Flow Directed Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: January 14, 2003 Received: January 16, 2003

Dear Mr. Hyatt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{2}------------------------------------------------

Page 2 - Mr. Bill Hyatt

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Kelleher

am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Micro Therapeutics, Inc. Special 510(k) (modifications to K010004) UltraFlow™ HPC Flow Directed Micro Catheter December 13, 2002

## Indications for Use Statement 6.

510(k) Number (if known): _________

Device Name:

MTI UltraFlow™ HPC Flow Directed Micro Catheter

Indications for Use:

The UltraFlow™ HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physicianspecified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:center;">OR</div> | Over the Counter Use |
|----------------------|------------------------------------------|----------------------|
| (Per 21 CFR 801.109) | | |

| (Division Sign-Off) |
|------------------------------------|
| Division of Cardiovascular Devices |

| 510(k) Number | K084118 |
|---------------|---------|
|---------------|---------|