ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE

K011847 · Zynergy Cardio Vasular (Zcv), Inc. · DRF · Jul 13, 2001 · Cardiovascular

Device Facts

• Record ID: K011847
• Device Name: ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
• Applicant: Zynergy Cardio Vasular (Zcv), Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Jul 13, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is indicated for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording.

Device Story

The Zynergy Z5000 is an electrophysiology catheter used for intracardiac stimulation and ECG signal recording. It consists of a radiopaque, stainless steel-braided tubing with a soft tip containing multiple electrodes and a back-end electrical connector. The device is used by physicians in a clinical setting during electrophysiology studies. It functions by being inserted into the heart to record electrical signals or provide stimulation, which are then transmitted via the Z9000 accessory cable to external monitoring equipment. The output allows clinicians to map cardiac electrical activity and diagnose arrhythmias, facilitating clinical decision-making regarding patient treatment. The device is provided sterile and pyrogen-free.

Clinical Evidence

No clinical data. Safety and effectiveness were established through functional, performance, and biocompatibility bench testing.

Technological Characteristics

Catheter with radiopaque stainless steel-braided tubing and soft tip with electrodes. Sterilized via ETO. Connectivity via Z9000 accessory cable to external recording/stimulation equipment. No software or electronic processing components.

Indications for Use

Indicated for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording in patients undergoing 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

• Zynergy Zolution Electrophysiology Catheter Model Z5000 and Cable Model Z9000 (K991060)

Submission Summary (Full Text)

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# K011847

# JUL 1 3 2001

# Attachment 10

#### 510(k) Summary

### June 1, 2001

1. Submission Applicant & Correspondent:

| Name: | Zynergy CardioVascular, Inc. |
|-----------------|------------------------------|
| Address: | 298 Fernwood Ave. |
| | Edison, NJ 08837 |
| Phone No.: | [phone] |
| Contact Person: | Ms. Jing Zhang |

- 2. Name of Device:
Trade/Proprietary/Model Name: Zynergy Z5000 Electrophysiology Catheter With

Common or Usual Name: Classification Names:

Z9000 Accessory Cable Electrophysiology Catheter Electrode Recording Catheter

- 3. Devices to Which New Device is Substantially Equivalent: Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is substantially equivalent to Zynergy Zolution Electrophysiology Catheter Model Z5000 and Cable Model Z9000 as described in 510(k) K991060, which is cleared by the FDA on April 6, 2000.
- 4. Device Description:

Same as the predicate Zynergy Zolution Electrophysiology catheter, the Zynergy Z.5000 Electrophysiology catheter is comprised of a radiopaque tubing reinforced with stainless steel braiding. The soft tip is fitted with electrodes in varying sizes and configurations. The back end of the catheter is comprised of an electrical connector.

- 5. Intended Use of the Device:
Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is indicated for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording.

- 6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
The Zynergy Z5000 Electrophysiology Catheters have identical indicated use, use the same operating principle, have similar size ranges, incorporate the same basic catheter design and technological characteristics, and are packaged and sterilized using the same materials and processes (ETO sterile and pyrogen free) as the predicate Zynergy Zolution catheters.

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K011847 p.2/2

The major differences between the Z5000 catheter and the predicate device are in the catheter's main body tube material and electrode material. These changes do not raise any new issues of safety or effectiveness as demonstrated by the biocompatibility test results and comparable results from the design verification testing.

## 7. Tests and Conclusions:

Extensive functional and performance testing, and biocompatibility testing were conducted to assess the safety and effectiveness of the Zynergy Z5000 Electrophysiology Catheter. All results are satisfactory.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2001

Mr. Jing Zhang Manager, Regulatory Affairs Zynergy CardioVascular, Inc. 298 Fernwood Avenue Edison, NJ 08837-3839

Re: K011847

Trade Name: Zynergy Z5000 Electrophysiology Catheters with Z9000 Accessory Cables Regulation Number: 870.1200 Regulatory Class: II (Two) Product Code: DRF Dated: June 1, 2001 Received: June 13, 2001

Dear Mr. Zhang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 -- Mr. Jing Zhang

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and hype a ding 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 11 you done opening 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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| Attachment 3 | Indications for Use Statement |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number<br>(if known) | |
| Device Name | Zynergy Z5000 Electrophysiology Catheter With Z9000Accessory Cable |
| Indications for Use | Identical to the indications of the predicate Zynergy Zolutioncatheters and cables cleared through 510(k) K991060,Zynergy Z5000 Electrophysiology Catheter With Z9000Accessory Cable is indicated for temporary use inelectrophysiology studies for intracardiac simulation and/orECG recording. |

K011847

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21 CFR 801.109) | |
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| Over-The Counter Use | |
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Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K011847 |
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