PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE

K021421 · Tz Medical, Inc. · DRF · Apr 18, 2003 · Cardiovascular

Device Facts

• Record ID: K021421
• Device Name: PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
• Applicant: Tz Medical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.

Device Story

PadTac system consists of fixed electrophysiology (EP) catheters (5-8 Fr, 4-14 pole), junction box cable connectors, and cables. Catheters are inserted into the heart to record intracardiac electrograms (EGM) and provide cardiac stimulation during diagnostic EP studies. Used in high right atrium, right ventricular apex, and HIS bundle. Cables and junction box serve as passive interface between catheter and external recording system. Operated by clinicians in a clinical setting. Device facilitates cardiac mapping and stimulation to assist in diagnosis of cardiac arrhythmias.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated via compliance with FDA guidance for electrode recording catheters and UL 2601 (IEC 60601-1) standards for medical equipment.

Technological Characteristics

Fixed EP catheters (5-8 Fr, 4-14 pole); passive electrical connectivity; cables and junction box interface. Electrical safety per UL 2601 (IEC 60601-1).

Indications for Use

Indicated for patients undergoing diagnostic electrophysiology studies requiring intracardiac electrogram recording and cardiac stimulation in the high right atrium, right ventricular apex, and HIS bundle (recording only).

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

• IBI 1100 Electrophysiology Catheter System (K961924)
• IBI 1000 Electrophysiology Catheter System (K946333)

Submission Summary (Full Text)

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K02142

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## 510(k) SUMMARY of Safety and Effectiveness

(Persuant to 21 CFR 807.92)

APR 1 8 2003

#### l. GENERAL

11.

C.

| A. | Submitted By: | TZ Medical Inc.<br>7272 S.W. Durham Road #800<br>Portland, Oregon 97724 |
|----------------------------|----------------------|-------------------------------------------------------------------------------------------------|
| B. | Contact Person | Madalyn C. Duncan<br>Regulatory Specialist |
| C. | Proprietary Name: | PadTac Electrophysiology Recording Catheters<br>PadTac Junction Cable Connector<br>PadTac Cable |
| D. | Classification Name: | Electrode Recording Catheter |
| E. | Classification: | Class II, Cardiovascular DRF,<br>CFR 870.1220 |
| DEVICE INFORMATION SUMMARY | | |
| A. | Predicate Device | IBI 1100 Electrophysiology Catheter System<br>K961924 |

IBI 1000 Electrophysiology Catheter System K946333

- Device Description The PadTac Electrophysiology catheters are between 5 and 8 french (fr), 4, 10, 12 and 14 pole, fixed, monitoring and recording.
The multi-electrode electrophysiology catheters are used for electrophysiology electrocardiograph recording and cardiac stimulation during diagnostic procedures. The cables and box serve as an extension between the catheter and the pin block.

#### B. Device Intended Use

The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.

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#### SUBSTANTIAL EQUIVQALENCE TESTING SUMMARY lll.

The TZ Medical PadTac EP Catheters have been tested and are considered safe and effective per "Electrode Recording Catheter Preliminary Guidance", Mark Massi, Pacing and Electrophysiology Device Branch, Division of Cardiovascular, Respiratory and Neurological Devices, Office of Device Evaluation FDA,CDRH, 1995.

The TZ medical PadTac cables have been tested and are considered safe and effective per "Standard for Medical Equipment; Part 1: General Requirements, UL 2601 (IEC 60601-1).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2003

TZ Medical Inc. c/o Ms. Madalyn C. Duncan RA/OA Specialist 7272 S.W. Durham Rd., #800 Portland, OR 97224

Re: K021421

Trade Name: PadTac Electrophysiology Recording Catheters, Junction Box Cable Connector, and Electrophysiology Connector Cables Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: January 17, 2003 Received: January 21, 2003

Dear Ms. Duncan:

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 - Ms. Madalyn Duncan

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/dsma/dsmamain.html

Sincerely yours.

Kala Gill

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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# 510(k) Number (if known) (((() 2 /4 2

PadTac Mapping and Recording EP Catheters: Device Name:

### Indications for Use:

The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.

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

Concurrence Of CDRH, Office OF Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional P

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K02142