MIRA-FLEX 18 MICROCATHETER

K052841 · Cook, Inc. · KRA · Dec 8, 2005 · Cardiovascular

Device Facts

• Record ID: K052841
• Device Name: MIRA-FLEX 18 MICROCATHETER
• Applicant: Cook, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Dec 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mira-Flex™ 18 microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. This device is intended for one-time use.

Device Story

Mira-Flex™ 18 is an infusion microcatheter for diagnostic and interventional procedures in small vessel or superselective anatomy (neuro, peripheral, coronary). Device features hydrophilic coating and is compatible with 0.018" embolization coils and particles. Used by physicians in clinical settings to deliver thrombolytic therapy or embolic devices. Operates as a manual delivery tool; physician navigates catheter to target site under imaging guidance to deliver therapeutic agents or devices. Benefits include access to tortuous anatomy for targeted treatment. Single-use device.

Clinical Evidence

Bench testing included tensile, burst, pressure, and leakage tests. Biocompatibility testing performed. Acute animal study conducted to confirm performance in tortuous/superselective anatomy. No human clinical trial data provided.

Technological Characteristics

Infusion microcatheter with hydrophilic coating. Compatible with 0.018" embolization coils/particles. Available in 100, 110, 135, and 150 cm lengths. Manual operation. Sterilization method not specified.

Indications for Use

Indicated for diagnostic and interventional procedures in small vessel or superselective anatomy, including neuro, peripheral, or coronary applications. No specific age or gender restrictions provided. Contraindications not specified.

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

• Mira-Flex 18 microcatheter (K052841)

Submission Summary (Full Text)

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K052841

Special 510(k) Premarket Notification Mira-Flex microcatheter COOK INCORPORATED

2005 DEC 8

# 510(k) Summary

### Submitted By:

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

5 October 2005

### Device:

Trade Name: Proposed Classification: Mira-Flex™ 18 Microcatheter Catheter, Continuous Flush KRA

### Predicate Devices:

The Mira-Flex™ 18 microcatheter is similar in terms of intended use, materials, and The Milla-Fica - 10 mirrocans the predicate device reviewed as a device for the delivery of thrombolytic therapy or embolic devices in tortuous or superselective anatomy.

## Device Description:

The Mira-Flex™ 18 microcatheter is an infusion catheter with a hydrophilic coating, The Mira-1 lex - To inferesanteer superselective anatomy for diagnostic and interventional designed for use in small volser of eapon or coronary use. This device with a saal procedures, moturing nower possible the tip, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be cilloonzation cons and is intended for one-time use. The Mira-Flex™ 18 will be available in 100, 110, 135, and 150 cm lengths.

## Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality This device will bo maxe device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to devices currently marketed and distributed as well. Being similar with respect to indications for use, materials, and physical construction to the predicate device, this device meets the requirements for section 510(k) substantial equivalence.

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# Test Data:

The Mira-Flex™ 18 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. Biocompatibility tests
- 4. Leakage tests
- 5. Acute animal study

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an infusion catheter in tortuous or superselective anatomy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of human form, with three figures connected at the top and flowing downward.

DEC 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook, Incorporated c/o Ms. Thalia Brine Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489

> K052841 Mira-Flex™ 18 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: KRA Dated: November 8, 2005 Received: November 17, 2005

## Dear Ms. Brine:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications ferenced a o re and and sure) to legally marketed predicate devices marketed in interstate for associated in the enactment date of the Medical Device Amendments, or to commerce provision of they 2012) 2011 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 I va raly) and sprovisions 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanted other requirements of the Act
that FDA has made a determination that your device also about one one . You must that FDA has made a determination that your as read by other Federal agencies. You must and listing or any Federal statutes and regulations adminiser of registration and listing (2)
comply with all the Act's requirements, including, but not the requirements as set comply with all the Act s requirements, including, barufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if capped if capolicable, the ele CFR Part 807), labeling (21 CFR Fall on ), good manastali: gdd if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 820); and if applicable forth in the quality systems (QS) regulation (21 -51 x 4 x 8 x 8 x 8 x 1 0 x 1 x 1 000-1050.
product radiation control provisions (Sections 53 1-542 of the Action Section 5 product radiation control provisions (Scettons 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leval This letter will allow you to begin makemig your article as walnee of your device to a legally
premarket notification. The FDA finding of substantial equipacioned thus, perm premarket notification. The FDA inding of substanced by 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
r the results of the man and 120 m the support the reculation entitled If you desire specific advice for your ac not on on on on Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. ↑ Also, please note t contact the Office of Comphalled at (2 t of 2 t 8 and (21CFR Patt 807.97). You may obtain "Misbranding by relerence to prematict nonlineaus. The Act from the Division of Small
other general information on your responsibilities under the 4 this from pumber (800) 63 other general information on your responsion.com its toll-free number [phone] or 1 Manufacturers, International and Consumer Assistance as to very industry/support/index.html.

Sincerely yours,

Duna R. Vochner

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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Special 510(k) Premarket Notification Mira-Flex microcatheter COOK INCORPORATED

510(k) Number (if known): __ KOSZ84 |

Mira-Flex™ 18 microcatheter Device Name:

Indications for Use:

The Mira-Flex™ 18 microcatheter is designed for use in small vessel or superselective I he Mira-Fiex™ To increatically is designed for and uding neuro, peripheral, or
anatomy for diagnostic and interventional procedures including and time vec anatomy for diagnostic and mich ventional provenance intended for one-time 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)

| | <div style="text-decoration: overline;">Muna R. Vochner</div> |
|------------------------------------|---------------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) number | <div style="text-decoration: overline;">K052841</div> |