FLEXCATH STEERABLE SHEATH & DILATOR

K070357 · Cryocath Technologies, Inc. · DRA · Dec 28, 2007 · Cardiovascular

Device Facts

• Record ID: K070357
• Device Name: FLEXCATH STEERABLE SHEATH & DILATOR
• Applicant: Cryocath Technologies, Inc.
• Product Code: DRA · Cardiovascular
• Decision Date: Dec 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1280
• Device Class: Class 2

Intended Use

The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

Device Story

FlexCath™ Steerable Sheath & Dilator is a deflectable catheter introducer used to facilitate percutaneous catheter placement into the vasculature and heart chambers. The device consists of a shaft and a handle; it includes a dilator. Used in clinical settings by physicians to assist in positioning catheters. The sheath's steerable mechanism allows for deflection, aiding in the navigation and placement of diagnostic or therapeutic catheters within the heart. It is not intended for performing transseptal punctures.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design, material, and biocompatibility testing.

Technological Characteristics

Deflectable catheter introducer consisting of a shaft and handle, supplied with a dilator. Materials and design are substantially equivalent to predicate devices. Class II device (21 CFR 870.1280).

Indications for Use

Indicated for percutaneous catheter introduction into the vasculature and heart chambers. Contraindicated for left atrial or ventricular placement in patients with intra-atrial septal patches or prior surgical intervention in/adjacent to the septum, patients with embolic events from the left heart within 2 months, or patients with known/suspected atrial myxoma. Not for use in transseptal puncture.

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• Agilis Steerable Catheter introducer
• Enpath Deflectable Catheter

Submission Summary (Full Text)

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K070357

## 510(k) Summary

CryoCath Technologies Inc.

# FlexCath™ Steerable Sheath & Dilator

- SPONSOR/MANUFACTURER 1. CryoCath Technologies Inc. 16771 Chemin Ste-Marie Kirkland, Quebec H9H 5H3 CANADA
DEC 28 2007

Official Correspondence Chief Scientific Officer Jean Pierre Desmarais (Telephone: [phone], Ext. 226) E-mail: [e-mail]

- 2. DEVICE NAME FlexCath™ Steerable Sheath & Dilator Proprietary Name:
Common/Usual Name: Introducer Classification Name: Catheter Introducer

### 3. PREDICATE DEVICES

The Agilis Steerable Catheter introducer and the Enpath Deflectable Catheter

#### 4. DEVICE DESCRIPTION

The FlexCath™ Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.

CryoCath Technologies Inc., Traditional 510(k) FlexCath™ Steerable Sheath & Dilator

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### 5. INTENDED USE

The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Technological characteristics such as product design and materials of the FlexCath™ Steerable Sheath are substantially equivalent to the predicate devices. Where dimensional and slight material differences exist between the proposed device and the predicate devices, biocompatibility testing demonstrated that these differences do not adversely affect safety and effectiveness.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.

DEC 2 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CryoCath Technologies, Inc. c/o Dr. Fred Miller U.S. Agent for CryoCath Technologies Applied Physics 10B Tano Road Santa Fe, NM 87506

Re: K070357

FlexCath ™ Steerable Sheat & Dilator Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II (two) Product Code: DRA Dated: December 19, 2007 Received: December 20, 2007

Dear Mr. Desmarais:

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.

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Page 2 - Dr. Fred Miller

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. 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/industry/support/index.html.

Sincerely yours,

Bhimimmar for

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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Image /page/4/Picture/0 description: The image shows the word "CryoCath" in black letters next to a black symbol. The symbol is made up of three curved lines that are stacked on top of each other. The word "CryoCath" is written in a simple, sans-serif font. The image is simple and clear, with a focus on the text and symbol.

CrvoCath Technologies Inc 16771 Chemin Ste-Marie, Kirkland, Québec, Canada H9H 5H3

# Premarket Notification

Indications for Use Statement

510(k) Number (if known): K070357

Device Name: FlexCath™ Steerable Sheath & Dilator

Indications for Use: The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The FlexCath™ Steerable sheath is contraindicated for Contraindications: placement in the left atrium or ventricle if:

- The patient has an intra-atrial septal patch or has had . other surgical intervention in or adjacent to the intra-atrial septum.
- The patient has had previous embolic event from the left . side of the heart within 2 months of the procedure
- The patient has known or suspended atrial myxoma. .

FlexCath™ Steerable sheath should not be used to perform the transseptal puncture.

Prescription Use: × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use: (Part 21 CFR 801 Subpart C)

(Please do not write Below this line-continue on another page if needed) CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Bhim
(Division Sign-Off)

CryoCath Technologies Inc., Traditional 510(k) FlexCath™ Steerable Sheath & Dilator

ardiovascular Devices