GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E

K012520 · Cardiac Assist Devices, Inc. · DRF · Mar 27, 2002 · Cardiovascular

Device Facts

• Record ID: K012520
• Device Name: GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
• Applicant: Cardiac Assist Devices, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Mar 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Gyro Tip Lariat Deflectable Loop Mapping Catheter is indicated for multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure.

Device Story

Diagnostic electrophysiology catheter used for mapping, recording, and temporary stimulation of cardiac structures. Device features braided outer tube and distal portion with up to 20 platinum electrodes for radiopacity under fluoroscopy. Physician operates manual steering mechanism in handle to actuate pre-formed distal bend, creating a "halo-shaped" loop perpendicular to the catheter shaft. Input consists of electrical signals from cardiac tissue; output is electrical data for cardiac mapping/recording. Used in clinical electrophysiology settings. Benefits include improved visualization and circumferential mapping capability compared to standard linear catheters. Device connects to external recorder/monitor via accessory cables.

Clinical Evidence

Bench testing only. Performance characteristics evaluated per FDA's 'Electrode Recording Catheter preliminary Guidance' and compared to predicate devices. Results indicate the device is as safe and effective as the named predicates.

Technological Characteristics

Diagnostic electrophysiology catheter; up to 20 platinum electrodes; braided outer tube; stainless steel actuating wires (0.012" diameter); manual steering mechanism; pre-formed distal bend for halo-shaped configuration; compatible with UL 544 safety standards for accessory cables.

Indications for Use

Indicated for multi-electrode electrophysiological mapping, recording, and/or temporary stimulation of cardiac structures along circumferential paths in patients requiring cardiac electrophysiology procedures.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

• Gyro Tip EP Catheter, Delta Series (K955847)
• Cordis Webster A20 Diagnostic Deflectable Tip Catheter (K953768)
• Cordis Webster T20 Diagnostic Deflectable Tip Catheter (K953663)

Submission Summary (Full Text)

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

K012520

p. 1/5

510(k) Submission

Gyro Tip Lariat Deflectable Loop Mapping Catheter

Cleveland, Ohio 44106 Phone: [phone] [phone] Fax:

# MAR 2 7 2002

# 510(k) Summary

#### [1] Submitter's Information:

Cardiac Assist Devices, Inc. 11000 Cedar Avenue, Suit 451 Cleveland, Ohio 44106 Phone: [phone] [phone] Fax: E-mail: [e-mail]

## Contact Person: Rassoll Rashidi, President

Date Summary Prepared: 7-1-2001

- [2] _Device Names:

| Proprietary Device Name: | Gyro-Tip Lariat Deflectable Loop Mapping<br>Catheter |
|--------------------------|------------------------------------------------------|
| Classification name: | Diagnostic Electrophysiology catheter |
| Common Device Name: | Electrode Recording Probe |

Class II [3] Device Classification:

# [4] Predicate Devices:

- Gyro Tip EP Catheter, Delta Series. K955847 1
- Cordis Webster A20 Diagnostic Deflectable Tip Catheter, K953768 1
- Cordis Webster T20 Diagnostic Deflectable Tip Catheter, K953663 해

1

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

5100k) Suhmission Gyro Tip Lariat Deflectable Loop Mapping Cathe

012520

une, Suite 44 leveland, Ohio 44106 Phone: [phone] [phone]

## 510(k) Summary (continue)

#### [5] Device Description:

The Gyro-Tip Lariat Deflectable Loop Mapping Catheter of Cardiac Assist Devices, Inc. has been designed and developed as a diagnostic catheter for electrophysiological mapping of cardiac structures. The catheter has a braided outer tube that exhibits similar torsional stiffness, under a clockwise and counterclockwise-applied torque directions, to those of the named predicate devices. The distal portion of the subject catheter has up to 20 platinum electrodes that offer radiopacity under fluoroscopy for the required visibility during the cardiac electrophysiology mapping procedures. The accessory cables used to connect the subject device to a recorder/monitor comply with Section 12A of the Underwriters Laboratories UL 544 Standard for safety.

A schematic view of the Gyro-Tip Lariat Deflectable Loop Mapping Catheter is shown in Figure 1.

#### [6] Indication for Use:

Gyro-Tip lariat Deflectable Loop Mapping Catheter is indicated for multi electrode electrophysiological mapping, recording and/or temporary stimulation, of cardiac structures along circumferential paths.

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

Cardiac Assist Devices, Inc. 11000 Cedar Avenue, Suite 451 Cleveland, Ohio 44106 [phone] Phone: [phone] Fax:

Kol2520 R315

# 510(k) Summary

Image /page/2/Figure/4 description: This image shows a catheter handle with a multi-pole end connector. The distal portion of the catheter is shown before and after actuation of the manual actuator. The catheter has a pre-formed bent shape.

Figure 1 Schematic View of the Gyro Tip Lariat Deflectable Loop Mapping Catheter

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

KO12520

# veland, Ohio 44106

Phone: [phone] [phone] Fax:

# 510(k) Summary (continue)

#### [7] Technological Characteristics of the Subject Device:

The Gyro-Tip Lariat Deflectable Loop Mapping Catheter is technologically similar to the primary named predicate device, namely the Gyro Tip EP catheter of Cardiac Assist Devices, Inc. that is cleared for marketing under K955847. The subject device has more platinum electrodes (up to 20 electrodes) at its distal portion compared to the primary predicate device that has 4 electrodes. This total number of electrodes is however the same as the number of electrodes of the secondary predicate devices that are cleared for marketing under K953768 (Cordis Webster A20 Diagnostic Deflectable Tip Catheter) and K953663 (Cordis Webster T20 Diagnostic Deflectable Tip Catheter). Each of these secondary predicate devices has 20 electrodes at its distal portion.

The distal portion of the subject device has a pre-formed bend at its distal portion. This pre-formed bend causes formation of a deflectable loop at the catheter's distal portion in response to the actuation of the steering mechanism located in the catheter handle of the subject device. The steering mechanism of the subject device is exactly similar to the steering mechanism of the primary predicate device, namely the Gyro Tip EP Catheter of Cardiac Assist Devices, Inc. The actuating wires that transmit the actuation forces from the steering mechanism of the catheter handle to the distal portion of the subject device are stainless steel wires having generally circular crosssection with a diameter in the order of 0.012". These actuating wires are the same as the actuating wires of the primary predicated device (cleared under K955847). The distal portion of the actuating wires of the subject device has rectangular crosssection, having the same effective cross-sectional area as that of the circular crosssection portion. This better determines the plane of loop formation at the distal portion of the subject device. The geometric plane, in which the distal loop of the subject device is formed, upon the manual actuation of the steering mechanism, is generally perpendicular to the elongated shaft of the catheter. Therefore the subject device can assume a "halo-shaped" configuration at its distal portion, similar to the "halo-shaped" configuration of the distal portion of the secondary predicate device, namely Cordis Webster T20 Diagnostic Deflectable Tip Catheter that is cleared under K953663.

A

{4}------------------------------------------------

Cleveland, Ohio 44106 Phone: [phone] Fax:

## 510(k) Summary (continue)

#### 171 Technological Characteristics of the Subiect Device (continued):

The halo-shaped configuration of the distal portion of the subject device, and the process of assuming this final halo-shaped configuration, in response to the manual actuation of its steering mechanism, has shown to be safe and effective through a series of non-clinical testing. The descriptions and results of these tests are included in Appendices A , B, and C of this 510K, with a brief discussion presented next.

#### [8] Brief Discussion of the Non-Clinical Tests:

The subject device, (The Gyro-Tip Lariat Deflectable Loop Mapping Catheter) has gone under a series of non-clinical testing in order to determine its performance characteristics as they relate to its safety and effectiveness. These tests were performed according to FDA's "Electrode Recoding Catheter preliminary Guidance". The results of these non-clinical tests were compared to results of the same tests on predicate devices. The comparison of the results indicates that the subject device is as safe, and as effective, as the named predicate devices.

#### 191 Conclusion Drawn From Non-Clinical and Clinical Tests:

The results of the non-clinical tests. presented in Appendices A. B. C. D, and E of this 510(k) indicates that the subject device (The Gyro-Tip Lariat Deflectable Loop Mapping Catheter) performs as well as the named predicate devices, and any minute differences in the test results are not significant to influence the safety and effectiveness of the subject device. Therefore, Cardiac Assist Devices, Inc. presents the Gvro-Tip Lariat Deflectable Loop Mapping Catheter વડ substantially equivalent to the named predicate devices in this 510(k).

5

#### [10] Additional Information:

Available upon request

{5}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 7 2002

Mr. Rassoll Rashidi President Cardiac Assist Devices, Inc. 11000 Cedar Avenue, Suite 451 Cleveland, OH 44106-3052

Re: K012520

Trade Name: Gyro-Tip Lariat Deflectable Loop Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: December 20, 2001 Received: December 27, 2001

#### Dear Mr. Rashidi:

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.

{6}------------------------------------------------

#### Page 2 - Mr. Rassoll Rashidi

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Dealla Tellh

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

Enclosure

{7}------------------------------------------------

## 510(k) Number (if known): K012520

Device Name: Gyro Tip Lariat Deflectable Loop Mapping Catheter

Indications For Use:

The Gyro Tip Lariat Deflectable Loop Mapping Catheter is indicated for multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

of Cardiovascular & Respiratory Devices 510(k) Number

Image /page/7/Picture/8 description: The image shows the words "Prescription Use" with a check mark above the word "Use". Below that, the text "(Per 21 CFR 801.109)" is shown. The check mark indicates that the prescription use is confirmed. The text below indicates that the prescription use is in accordance with the Code of Federal Regulations.

OR

Over-The-Counter Use_

(Optional Format 1-2-96)