The intended use of the Prucka Engineering, Inc. CardioLab EP 4.2 System is to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators.

The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

Device Description

The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to accquire ECG, intracardiac, pressure, and digital data from other devices such as RF generators and fluoro video systems. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. The software has three major functions: data acquisition and display, data storage, and reporting of data. The system is able to acquire signal data in the presence of pacing pulses. In addition to signal waveform display and basic caliper-type measurement, the system allows the user to create isopotential and isochronal activation maps of waveform timing information. The system can also be used to accept video input from a fluoroscopy system for either single frame capture or full motion video display. The system can also acquire data from an RF generator via standard computer RS-232 serial port. The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

AI/ML Overview

Here's an analysis of the provided text regarding the Prucka Engineering, Inc. CardioLab EP System's performance testing:

The document does not describe acceptance criteria for the device's performance in analyzing physiological data or detecting arrhythmias, as the device explicitly states it "does not analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities."

Instead, the non-clinical tests described focus on electrical safety, EMC (Electromagnetic compatibility), and basic functional validation of the system's ability to acquire, filter, digitize, amplify, display, and record various physiological signals and data from other medical devices.

Therefore, the table for "acceptance criteria and the reported device performance" will focus on these aspects related to the system's operational integrity and safety, rather than diagnostic performance on a specific medical condition.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Electrical Safety Standards Compliance	The device is certified to meet IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-2-27, and IEC 601-2-34 standards by SEMKO (an Inchcape Testing Services Company), and ETL Testing Laboratories performed tests conforming to FDA Reviewer Guidance for Premarket Notification Submissions, November 1993. This means the device's electrical design, construction, and operation comply with internationally recognized safety requirements for medical electrical equipment, including general safety, collateral standards (e.g., safety requirements for medical electrical systems), electromagnetic compatibility, particular requirements for electrocardiographs, and particular requirements for medical record imaging devices.
Functional Aspect Validation	An in-house validation was performed on the system. The results met acceptance criteria, confirming the safety and efficacy of each functional aspect of the system. This indicates that functions such as signal acquisition, filtering, digitization, amplification, display, recording, data storage, basic measurement (caliper-type), and report generation operate as intended and safely. The system's ability to acquire signal data in the presence of pacing pulses, create isopotential/isochronal maps, and integrate with external devices (e.g., fluoroscopy, RF generators, cardiac stimulators) were implicitly validated.
Substantial Equivalence	The device was determined by the FDA to be substantially equivalent to legally marketed predicate devices, meaning its safety and efficacy profile is comparable. This acts as an overarching acceptance criterion met through the combination of technical characteristics and non-clinical testing.

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set in the context of physiological signal analysis or diagnostic performance.
- The tests described are primarily non-clinical (electrical safety, EMC, and functional validation).
- The data provenance is not relevant in the typical sense (e.g., country of origin of patient data) as these are engineering and safety tests on the device itself. The tests were performed by SEMKO and ETL Testing Laboratories, and in-house validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study concerns technical and safety compliance, not diagnostic performance requiring expert interpretation of medical images or signals. The "ground truth" for electrical safety tests are the defined limits and parameters in the international standards (IEC 601 series) and FDA guidance, as assessed by accredited testing laboratories and internal engineering teams.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the tests are objective measures against technical standards (e.g., leakage current, resistance to interference) and functional checks, not subjective interpretations requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. The device explicitly states it "does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities." Therefore, there is no AI component or diagnostic assistance for human readers to evaluate.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm-only performance study was conducted. As stated above, the device does not perform analysis or detection, thus no algorithm for such tasks exists in this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is based on engineering specifications, international electrical safety and EMC standards (IEC 601 series), and FDA guidance. For the in-house functional validation, the ground truth would be the expected operational parameters and outputs of the system according to its design specifications.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied by the device's capabilities.

Summary

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APR 7 2000

K993414

Image /page/0/Picture/2 description: The image shows the logo for Prucka Engineering, Inc. The logo consists of a black geometric shape on the left, resembling a stylized building or structure. To the right of the shape is the text "Prucka Engineering, Inc." in a slanted, sans-serif font. The word "Engineering" is slightly smaller than "Prucka", and "Inc." is even smaller and set off by a comma.

Advanced Technology for Cardiology

Section C - 510(k) Summary

October 8, 1999

A. Contact Information:

Matthew W. Prucka Prucka Engineering, Inc. 13000 Executive Drive Sugar Land, TX 77478

Phone: (281) 275-5011 Fax: (281) 275-5001

B. Device names:

Trade Name: Prucka Engineering, Inc. CardioLab EP System Common Name: Electrophysiology lab system Classification Names: Electrocardiograph Biopotential Amplifier and Signal Conditioner Programmable Diagnostic Computer Blood Pressure Computer

C. Substantial equivalence is claimed to the following devices:

Quinton EP System (K971570) EP Medsystem EP System (K935186) Biosense Carto System (K954395)

D. Description of device:

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devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. The software has three major functions: data acquisition and display, data storage, and reporting of data. The system is able to acquire signal data in the presence of pacing pulses. In addition to signal waveform display and basic caliper-type measurement, the system allows the user to create isopotential and isochronal activation maps of waveform timing information. The system can also be used to accept video input from a fluoroscopy system for either single frame capture or full motion video display. The system can also acquire data from an RF generator via standard computer RS-232 serial port. The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

E. Intended use of device:

The intended use of the Prucka Engineering, Inc. CardioLab EP 4.2 System is to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators.

F. Summary of the technological characteristics of the CardioLab EP System compared to the predicate devices:

Technological characteristics of the Prucka Engineering, Inc. CardioLab EP System are the same as predicate devices with the following exceptions:

Comparison TableReference*	Summary of differences
2	Amplifier leakage current data not available for Biosense Carto System
3	Amplifier input channel types data not available for Biosense Carto System
4	Amplifier output channel types data not available for Biosense Carto System
6	The amplifier in the CardioLab EP System sends digital data to the computer via fiber optic cable which provides complete electrical isolation between the computer and amplifier unit. The predicate devices use an electrical connection between the amplifier and computer, and electrical isolation is provided by an opto isolator inside the amplifier.
7 and 8	The CardioLab EP System, the Quinton EP System and the EP Medsystems EP System use standard personal computers to control the amplifier and use it as the main data processing unit. The Biosense Carto System uses a Sun workstation computer for these functions.
9	The CardioLab EP System, the Quinton EP System and the EP Medsystems EP System have independently controlled monitors which display real-time data, review information, and images. The Biosense Carto System has only one computer monitor.
10	The CardioLab EP System, the EP Medsystems EP System, and the Biosense Carto System store data on read/write optical media. The Quinton EP System stores data on "write once" media.
12	The CardioLab EP System, the Quinton EP System and the EP Medsystems EP System have the ability to print data on a strip chart recorder. The Biosense Carto System does not have this feature.
13	The CardioLab EP System and the Quinton EP System have input for a third party cardiac stimulator which will connect the stimulator to the intracardiac signal inputs with no control over the function of the third party cardiac stimulator. The EP Medsystems EP System has the same properties, except it controls the function of the external stimulator. Third party stimulator input capability data not available for the Biosense Carto System.
15	The CardioLab EP System, the Quinton EP System and the EP Medsystems EP System have the ability to record from intracardiac signal at the same time a third party cardiac stimulator is pacing to the intracardiac signal. Biosense Carto System data not available with respect to this feature.
16	The CardioLab EP System, the Quinton EP System and the EP Medsystems EP System can connect to third party RF generators using a standard RS-232 serial port in order to acquire, display, store and print data from the third party RF generators. The Biosense Carto System does not have this feature.
17	The CardioLab EP System, the Quinton EP System and the EP Medsystems EP System have standard video frame grabber board that operates in the personal computer and digitizes standard video images for display on the computer monitor and storage with the patient information. The Biosense Carto System does not have this feature.
18	The CardioLab EP System and the Biosense Carto System have the ability to display waveform timing information in a two dimensional color map that indicates either the isocronal or isopotential timing information. The Quinton EP System and EP Medsystems EP System do not have this feature.

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See corresponding number in comparison table in Section F.

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Each technological characteristic of the CardioLab EP System is found in at least one predicate device used in the same type of procedure as the CardioLab EP System is intended to be used in. The technological differences listed above are minor and do not raise new issues of safety and efficacy. The technological characteristics of the CardioLab EP System are substantially equivalent to technological characteristics found in predicate devices.

G. Brief discussion of the nonclinical tests and how their results support a determination of substantial equivalence:

The equipment has been tested and certified to meet the following national and international safety stadards by SEMKO which is an Inchcape Testing Services Company.

IEC 601-1 IEC 601-1-1 IEC 601-1-2 IEC 601-2-27 IEC 601-2-34

The equipment has also been tested by ETL Testing Laboratories with the applicable requirements of the FDA Reviewer Guidance for premarket Notification Submissions, November 1993.

In addition, an in-house validation has been performed on the system with results that meet acceptance criteria, confirming the safety and efficacy of each functional aspect of the system.

These tests conducted by outside laboratories together with system level validation testing conducted in-house provide complete confirmation that the system is safe and effective for its intended use. This demonstrates that the Prucka Engineering. Inc. CardioLab EP 4.2 System has a substantially equivalent level of safety and efficacy as predicate devices.

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Public Health Service

APR 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matthew Prucka President Prucka Engineering, Inc. 13000 Executive Drive Sugar Land, TX 77478

Re: K993414 Prucka Engineering, Inc. CardioLab EP System, Version 4.2 Regulatory Class: II (two) Product Code: DPS Dated: February 3, 2000 Received: February 4, 2000

Dear Mr. Prucka:

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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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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Paqe 2 - Mr. Matthew W. Prucka

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CTegarlmgneher

for

James E. Dillard III Director

Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K993414 510(k) Number (if known): __

Device Name: CardioLab EP System, Version 4.2

Indications For Use:

(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) scular, Respiratory,

(Optional Format 3-10-98)

000-55

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).