Z6 STIMULATOR

K070743 · St Cardio Technologies, LLC · JOQ · Jul 2, 2007 · Cardiovascular

Device Facts

• Record ID: K070743
• Device Name: Z6 STIMULATOR
• Applicant: St Cardio Technologies, LLC
• Product Code: JOQ · Cardiovascular
• Decision Date: Jul 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1750
• Device Class: Class 2

Intended Use

The Z6 Stimulator is intended to be used for diagnostic electrical stimulation of the purpose of electrical measurements of electrical conduction. Z6 Stimulator is intended for prescription use only. Z6 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation electrophysiological testing of the human heart.

Device Story

Z6 Stimulator is a programmable cardiac pulse generator for use in electrophysiology laboratories. Device delivers electrical stimuli to the patient's heart via up to four independent output channels. System operates in conjunction with ECG recording devices. Controlled by a CPU-based workstation running Windows XP; provides graphical user interface for programming stimulus parameters. Output parameters include pulse amplitude (0.1-25 mA), duration (0.5-10 ms), and interstimulus intervals. Healthcare providers (electrophysiologists) use the device to perform diagnostic electrical stimulation to measure cardiac conduction. Output affects clinical decision-making by facilitating electrophysiological studies to assess heart rhythm and conduction properties.

Clinical Evidence

Bench testing only. Testing compared timing and amplitude accuracy of Z6 Stimulator output pulses against the specifications of the predicate EP320 Stimulator. Results confirmed Z6 output pulses were within published specifications.

Technological Characteristics

External programmable pacemaker pulse generator. Features four independent output channels. Hardware includes a standard PC with a pulse generation circuit board and custom signal conditioning hardware. Operates on Windows XP. Graphical user interface with 19" LCD monitor. Pulse amplitude: 0.1-25 mA; pulse duration: 0.5-10 ms; interstimulus interval: 30-10000 ms.

Indications for Use

Indicated for diagnostic cardiac stimulation and electrophysiological testing of the human heart. Prescription use only.

Predicate Devices

• Micropace Pty Ltd. EPS320 Clinical Stimulator (K011826)

Submission Summary (Full Text)

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K070743

Premarket Notification March 13, 2007

26 Stimulator Page 5-1

# Section 5 -- 510(k) Summary

JUL - 2 2007

## 510(k) Owner 5.1

| Name: | ST Cardio Technologies, LLC |
|-----------------|-------------------------------------------|
| Address: | 3901 Troon Circle<br>Broomfield, CO 80020 |
| Phone: | 303-324-9417 |
| Fax: | 303-648-5338 |
| Contact Person: | William Abboud |
| Date: | March 13, 2007 |

## Device Name 5.2

| Trade Name: | Z6 Stimulator |
|----------------------|------------------------------------------------------|
| Common Name: | Programmable Cardiac Electrophysiological Stimulator |
| Classification Name: | External Programmable Pacemaker Pulse Generator |

## Predicate Device 5.3

Company Name: Micropace Pty Ltd. EPS320 Clinical Stimulator Device Name:

### Device Description 5.4

The Z6 Stimulator is a cardiac pulse generator designed for use in an Electrophysiology Laboratory during The Z6 Stimulator is a cardias pulse generator designed in ECC Reporting devices to deliver.
electrophysiological studies. The system operates in onjunction with ECC Recordin electrophysiological studies . The system one included with the simultaneously operable output
electrical stimulus to the patient's heart through up to finultaneously operati electrical stimulus to the patient's beat through to tour and with the wines with with Wisdows XP. This
channels. The Z6 Stimulator is controlled by a CPU based Workstand wo channels. The Z6 Stimulator is controlled by a CPU oaked voor operamage on and alle to system users.
provides programmability and flexibility with regard to the stimulas pro provides programmability and flexibility with regard to the simular p
Additionally, the system features a graphical interface with a Windows XP look and feel.
Additionally, t

Each of the four independent output channels of the Z6 Stimulator is capable of generating between 0.1 and 25
0 all Each of the four independent output channels of the system is apable of delivering pulses on all
e As of current to the patient, with voltages up to 20 Yourse 0.5 and 10 ms, mAs of current to the patient, with voltages up to 20 Volts. "The System is apples
channels simultaneously. The duration of the pulses can be programmed to be between 0.5 a maintaining timing accuracy ( > +/- 0.15 ms).

#### 5.5 Intended Use

The Z6 Stimulator is intended to be used for diagnostic electrical stimulation of the purpose of electrical The Z6 Stimulator is intended to be used for thaghostic checked that the surements of electrical conduction

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Premarket Notification March 13, 2007

Z6 Súmulator Page 5-2

| Comparative Element | Micropace EP320<br>(Predicate Device) | Z6 Stimulator |
|-------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K011826 | pending |
| Isolated Stimulus<br>Channels | 2 | 4 |
| Pulse Amplitude | 0.1-25 mA | 0.1-25 mA |
| Pulse Duration | 0.5-10 ms | 0.5 to 10 ms |
| Interstimulus Interval | 30-9900 ms | 30-10000 ms |
| Number of Extra<br>Stimuli | 6 | 8 |
| Display | 15" LCD monitor | 19" LCD monitor |
| Hardware Platform | Standard Personal Computer with<br>custom Stimulus Generator Unit | Standard Personal Computer with Pulse<br>Generation circuit board and custom<br>Signal Conditioning Hardware. |
| Software Platform | Custom Application, Custom Real<br>Time Operating System and Off the<br>Shelf operating system Daylight ROM | Custom Application, Off the Shelf<br>operating system Windows XP |

## Technological Characteristics ફ, ઈ

### 5.7 Non-clinical Testing

User Interface Preview Window

Sensing

Catheter Tip IECG

Testing of the timing and amplitude accuracy of the Z6 Stimulator output pulses was compared to the specifications of the EP320 Stimulator output pulses. The Z6 Stimulator output pulses were fourd to be with in the specifications.

Graphical windowed display

Yes

No

### 5.8 Non-clinical Testing Conclusions

DOS

No

Limited

Graphical windowed display

The Z6 Stimulator output pulses were found to be with in the published specifications of the EPS320 Stimulator.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2007

ST Cardio Technologies, LLC c/o Mr. William J. Abboud President and CEO 3901 Troon Circle Broomfield, CO 80020

Re: K070743

> Trade Name: Z6 Stimulator System Regulation Number: 21 CFR 870.1750 Regulation Name: External Programmable Pacemaker Pulse Generator Regulatory Class: Class II (two) Product Code: JOQ Dated: June 14, 2007 Received: June 15, 2007

Dear Mr. Abboud:

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- Mr. William J. Abboud

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.

uma R. be dumes

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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## tion 4 -- Indications for Use Statement

Z6 Stimulator is intended for prescription use only.

**RENSSELAER**

## dications for Use:

go Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation electrophysiological testing of the human heart.

buna R. Valnes

IMsion Signifon of Cardiovascular Devices

:(k) number k070743