MIRAFLEX HIGH FLOW MICROCATHETER

K080737 · Cook, Inc. · KRA · Aug 8, 2008 · Cardiovascular

Device Facts

• Record ID: K080737
• Device Name: MIRAFLEX HIGH FLOW MICROCATHETER
• Applicant: Cook, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MiraFlex™ High Flow Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Device Story

Infusion catheter for small vessel/superselective anatomy; diagnostic and interventional procedures. Features 2.8 French shaft; available in 100, 110, 135, 150 cm lengths; hydrophilic coating. Sterile, single-use device. Operated by physicians in clinical settings. Provides access for diagnostic/interventional agents; facilitates navigation in complex vasculature.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included tensile, burst/pressure, kink/stiffness, torque, flow rate, embolic particle, leakage, shelf life, and biocompatibility assessments.

Technological Characteristics

Infusion catheter; 2.8 French shaft; hydrophilic coating; lengths 100-150 cm. Sterile, single-use. Mechanical device; no software or energy source.

Indications for Use

Indicated for diagnostic and interventional procedures in small vessel or superselective anatomy, including neuro, peripheral, or coronary applications.

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

• MiraFlex™ 18 Microcatheter (K060224)

Submission Summary (Full Text)

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becial 510(k) Premarket Notification iraFlexTM High Flow Microcatheter OK INCORPORATED

# 510(k) Summary

AUG - 8 2008

## Submitted By:

Nathan Simon Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812.339.2235

14 March 2008

## Device:

Trade Name: Proposed Classification: MiraFlex™ High Flow Microcatheter Catheter, Continuous Flush KRA

#### Indications for Use:

The MiraFlex™ High Flow Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

#### Predicate Devices:

The MiraFlex™ High Flow Microcatheter is similar in terms of intended use, materials, and technological characteristics to the predicate MiraFlex™ 18 Microcatheter cleared under 510(k) number K060224.

#### Device Description:

The MiraFlex™ High Flow Microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures. The device is available with a 2.8 French shaft and is available in 100, 110, 135, and 150 cm lengths. The device is supplied sterile and intended for one-time use.

## Substantial Equivalence:

The MiraFlex™ High Flow Microcatheter is substantially equivalent to the predicate MiraFlex™ Microcatheter cleared under 510(k) number K060224.

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K080737 pg 2 of 2

Special 510(k) Premarket Notification MiraFlex™ High Flow Microcatheter COOK INCORPORATED

#### Test Data:

The MiraFlex™ High Flow Microcatheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were:

- 1. Tensile tests
- 2. Burst and pressure tests
- 3. Kink radius and stiffness tests
- 4. Torque response tests
- 5. Flow rate tests
- 6. Embolic particle tests
- 7. Leakage tests
- 8. Shelf life tests
- 9. Biocompatibility tests

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure with three curved lines, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Incorporated c/o Mr. Nathan Simon 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

110 - 8

Re: K080737

> Trade/Device Name: MiraFlex™ High Flow Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: July 10, 2008 Received: July 11, 2008

Dear Mr. Simon:

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 mov publish further announcements concerning your device in the Eederal 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 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.

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Page 2 - Mr. Nathan Simon

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and my of substantial equivalence of your device of your device to a legally premarket nedicate 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 11 Joa at the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket [phone]. TRBS) pro 807.97). For questions regarding postmarket surveillance, please contact nouncention (21 er er and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device 240-276-3411: 1 t the division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Shaall oomin other general mional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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1

Special 510(k) Premarket Notification MiraFlex™ High Flow Microcatheter COOK INCORPORATED

510(k) Number (if known): _KOB6737

MiraFlex™ High Flow Microcatheter Device Name:

Indications for Use:

The MiraFlex™ High Flow Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

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