MODIFICATION TO MIRA-FLEX 18 MICROCATHETER

K060224 · Cook Incorporated · KRA · Mar 6, 2006 · Cardiovascular

Device Facts

• Record ID: K060224
• Device Name: MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
• Applicant: Cook Incorporated
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 6, 2006
• 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. Supplied sterile in peel-open packages. Intended for one-time use.

Device Story

Mira-Flex 18 is an infusion microcatheter; 2.5 French shaft; compatible with 0.018" embolization coils and particles. Used in small vessel or superselective anatomy for diagnostic and interventional procedures (neuro, peripheral, coronary). Operated by physicians in clinical settings. Device facilitates delivery of thrombolytic therapy or embolic devices. Supplied sterile for single-use. Benefits include access to tortuous anatomy for targeted therapy.

Clinical Evidence

Bench testing included tensile, burst, pressure, and leakage tests. Acute animal study performed. No human clinical trial data provided.

Technological Characteristics

Infusion microcatheter with hydrophilic coating; 2.5 French shaft; 100, 110, 135, and 150 cm lengths. Compatible with 0.018" coils/particles. Sterile, single-use. No electronic or software components.

Indications for Use

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

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.

Submission Summary (Full Text)

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

K 060224

MAR 6 2006

## 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

27 January 2006

#### 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 technological characteristics to 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, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including neuro, peripheral, or coronary use. This device will be available with a 2.5 French shaft, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be supplied sterile, 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 Assurance Program. The 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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mar 6 2006

2006

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

Re: K060224 Mira-Flex™ 18 Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: February 16, 2006 Received: February 17, 2006

Dear Ms. Brine:

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, F12A may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Thalia Brine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DTT 8 local.org complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any redelal statutes and regulations and using, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It I art 007); adoling (21 CFR Part 820); and if application (21 CFR Part 820); and if application (200 forth in the quarty by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) I mis letter wif anow you to ough finding of substantial equivalence of your device to a legally premarket notification. "The PDF and on 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 If you desire specific ac no and [phone]. Also, please note the regulation entitled, Connact the Office of Ocharket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international 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,

surve R. V. Amer

GA_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): _ KOGO224

Mira-Flex™ 18 microcatheter Device Name:

Indications for 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. Supplied sterile in peel-open packages. Intended for one-time use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

______________________________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 807 Subpart C)

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