(108 days)
Not Found
No
The description focuses on electrical stimulation parameters and a standard CPU-based workstation with a graphical interface, with no mention of AI, ML, or related concepts.
No
The device is used for diagnostic cardiac stimulation and electrophysiological testing, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Z6 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation electrophysiological testing of the human heart."
No
The device description explicitly states it is an "electrical stimulus generator" and a "cardiac pulse generator" with "four independent output channels" capable of generating current and voltage. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Z6 Stimulator System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Z6 Stimulator System directly interacts with the human heart by delivering electrical stimulus.
- The intended use is for diagnostic cardiac stimulation electrophysiological testing of the human heart. This is an in-vivo procedure, meaning it is performed on a living organism.
- The device description clearly states it delivers electrical stimulus to the patient's heart.
Therefore, the Z6 Stimulator System is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Z6 Stimulator is intended to be used for diagnostic electrical stimulation of the purpose of electrical.
The Z6 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation electrophysiological testing of the human heart.
Product codes
JOQ
Device Description
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 protocol and allows for storage of patient and study data and 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 mA 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Electrophysiology Laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: 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 found to be with in the specifications.
Non-clinical Testing Conclusions: The Z6 Stimulator output pulses were found to be with in the published specifications of the EPS320 Stimulator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 |
| 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
1
Premarket Notification March 13, 2007
Z6 Súmulator Page 5-2
| Comparative Element | Micropace EP320
(Predicate Device) | Z6 Stimulator |
|-------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K011826 | pending |
| Isolated Stimulus
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
Stimuli | 6 | 8 |
| Display | 15" LCD monitor | 19" LCD monitor |
| Hardware Platform | Standard Personal Computer with
custom Stimulus Generator Unit | Standard Personal Computer with Pulse
Generation circuit board and custom
Signal Conditioning Hardware. |
| Software Platform | Custom Application, Custom Real
Time Operating System and Off the
Shelf operating system Daylight ROM | Custom Application, Off the Shelf
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.
2
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.
3
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
4
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