(79 days)
Not Found
No
The device description focuses on manual control, pre-programmed patterns, and remote display duplication, with no mention of AI or ML capabilities.
No
The device is used for diagnostic electrical stimulation of the heart to initiate and terminate tachyarrhythmias, take refractory measurements, and measure electrical conduction, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used for diagnostic electrical stimulation of the heart".
No
The device description explicitly states that the system consists of a "manually controllable pulse generator" and a "remote bedside touch monitor," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic electrical stimulation of the heart" for purposes like initiating/terminating tachyarrhythmias and measuring electrical properties. This is a direct interaction with the patient's body (in vivo) to gather information, not an analysis of samples taken from the body (in vitro).
- Device Description: The description clearly states it's a "cardiac stimulator" that issues "cardiac pacing pulses." This is a therapeutic and diagnostic device that works by applying electrical signals to the heart.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the StimLab Cardiac stimulator is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The StimLab cardiac stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electrical conduction.
Product codes
JOQ
Device Description
The StimLab™ is an EPS320 cardiac stimulator modified by the addition of a remote bedside touch monitor. The system consists of a manually controllable pulse generator issuing standard cardiac pacing pulses, normally controlled by a separate computer containing a graphic touch user interface and pre-programmed complex stimulation patterns suited to electrophysiology (EP) studies. In the StimLab™, a second remotely locatable beside control touch screen duplicates the video display and touch controls allowing verification and control of stimulator settings from two locations, one typically located in an electrophysiology laboratory central control room and the second at the operating table. The device is not a life support device and makes no diagnoses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Appropriate risk-analysis driven product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows a handwritten text string that appears to be "K072200". The text is written in a somewhat stylized manner, with some characters resembling symbols or stylized numbers. Below the handwritten text, there is a printed line that reads "Aug 2007. V2.1", indicating a date and version number.
6. 510(k) SUMMARY
007 26 2007
General Information
| Classification | Class II |
|---|---|
| Trade Name | StimLab™ Dual Control Computerized Diagnostic |
| Programmable Cardiac Stimulator | |
| Manufacturer | Micropace Pty Ltd |
| Suite 7, 186-188 Canterbury Rd, | |
| Canterbury | |
| NSW 2193 Sydney Australia | |
| Contact | Dr Michael Cejnar |
| Managing Director |
Intended Use / Indications for use (unaltered from predicate device):
The StimLab cardiac stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electrical conduction. This is the same intended use as previously cleared for the EPS320, K011826.
Predicate Device
The predicate devices is the Micropace EPS320 Cardiac Stimulator - K011826, 24 Jan 2002
Device Description
The StimLab™ is an EPS320 cardiac stimulator modified by the addition of a remote bedside touch monitor. The system consists of a manually controllable pulse generator issuing standard cardiac pacing pulses, normally controlled by a separate computer containing a graphic touch user interface and pre-programmed complex stimulation patterns suited to electrophysiology (EP) studies. In the StimLab™, a second remotely locatable beside control touch screen duplicates the video display and touch controls allowing verification and control of stimulator settings from two locations, one typically located in an electrophysiology laboratory central control room and the second at the operating table. The device is not a life support device and makes no diagnoses.
Materials
The materials in the StimLab™ Cardiac stimulator are suitable for their intended use and have been used in previously cleared products. The device is not patient contacting and therefore no biocompatibility testing was required.
Testing
Appropriate risk-analysis driven product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device.
Summary of Substantial Equivalence
The StimLab™ Cardiac Stimulator is equivalent to the predicate product. The indications for use, basic overall function, and materials used are equivalent.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 7007
Micropace PTY LTD c/o Dr. Michael Cejnar Founding Managing Director Canterbury, NSW Australia 2193
Re: K072200
StimLab™ Programmable Cardiac Electrophysiological Stimulator Regulation Number: 21 CFR 870.1750 Regulation Name: External programmable pacemaker pulse generator Regulatory Class: Class II (two) Product Code: JOQ Dated: October 17, 2007 Received: October 19, 2007
Dear Dr. Cejnar:
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.
2
Page 2 - Dr. Michael Cejnar
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,
B. Summerfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
10. Indications for Use Statement
510(k) Number (if known): ИО72200
Device Name:
StimLab™ Programmable Cardiac Electrophysiological Stimulator
Indications For Use:
The StimLab Cardiac stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electrical conduction.
B.B. Emmons
ascular Devices