The Z6 Stimulator is a cardiac pulse generator designed for use in an Electrophysiology Laboratory during electrophysiological studies. The system operates in conjunction with ECC Recording devices to deliver electrical stimulus to the patient's heart through up to four simultaneously operable output channels. The Z6 Stimulator is controlled by a CPU based Workstation with Windows XP. This provides programmability and flexibility with regard to the stimulus program and allows access to system users. Additionally, the system features a graphical interface with a Windows XP look and feel.

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

AI/ML Overview

The provided document, K070743, is a 510(k) premarket notification for the Z6 Stimulator, a programmable cardiac electrophysiological stimulator. The purpose of this notification is to demonstrate that the Z6 Stimulator is substantially equivalent to a legally marketed predicate device, the Micropace Pty Ltd. EPS320 Clinical Stimulator.

Here's an analysis of the acceptance criteria and the study presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document uses the specifications of the predicate device, the Micropace EP320 Stimulator, as the acceptance criteria for the Z6 Stimulator's performance. The "Non-clinical Testing" section explicitly states that the Z6 Stimulator's output pulses were compared to these specifications and "found to be within the specifications."

Acceptance Criteria (Based on Micropace EP320)	Z6 Stimulator Reported Performance
Output Pulse Timing Accuracy	Within specifications
Output Pulse Amplitude Accuracy	Within specifications
Isolated Stimulus Channels: 2	4 (Improved, exceeding criteria)
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 (Improved)
Number of Extra Stimuli: 6	8 (Improved, exceeding criteria)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for the test set. The non-clinical testing appears to be a technical verification comparing the Z6 Stimulator's output characteristics against the published specifications of the predicate device.
The data provenance is not explicitly stated as country of origin or retrospective/prospective. As it's a technical verification of the device itself rather than patient data, these categories might not be applicable in the traditional sense. It's an internal validation of the Z6 Stimulator's hardware and software performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable to this type of submission. The ground truth for this technical verification is the published specifications of the predicate device, which are objective engineering parameters. Clinical expert consensus is not used for this.

4. Adjudication Method for the Test Set:

This is not applicable. The "test set" here refers to the device's output parameters which are objectively measured and compared to numerical specifications. There is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on the substantial equivalence of device specifications, not on clinical effectiveness in human readers. The Z6 Stimulator is a tool used by clinicians, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in spirit. The non-clinical testing for the Z6 Stimulator is inherently a "standalone" evaluation of the device's functional performance (timing, amplitude accuracy) against established specifications. It's the performance of the device itself, independent of a human operator's cognitive input in interpreting results.

7. The Type of Ground Truth Used:

Engineering specifications and published data of the predicate device. The Z6 Stimulator's output pulses (timing and amplitude accuracy) were compared against the "specifications of the EP320 Stimulator output pulses."

8. The Sample Size for the Training Set:

Not applicable. This submission is for a medical device (a stimulator), not an AI algorithm that requires a "training set" in the machine learning sense. The device is designed based on engineering principles and validated against specifications.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As stated above, there is no "training set" in the context of this device and submission.

Summary

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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 CircleBroomfield, 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

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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(Predicate Device)	Z6 Stimulator
510(k) Number	K011826	pending
Isolated StimulusChannels	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 ExtraStimuli	6	8
Display	15" LCD monitor	19" LCD monitor
Hardware Platform	Standard Personal Computer withcustom Stimulus Generator Unit	Standard Personal Computer with PulseGeneration circuit board and customSignal Conditioning Hardware.
Software Platform	Custom Application, Custom RealTime Operating System and Off theShelf operating system Daylight ROM	Custom Application, Off the Shelfoperating 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

5.8 Non-clinical Testing Conclusions

DOS

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 870.1750 External programmable pacemaker pulse generator.

(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).