(212 days)
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No
The description focuses on data acquisition, digitization, storage, display, and basic signal processing (measurements, filtering). There is no mention of AI, ML, or any algorithms that learn or adapt from data. The system is described as microprocessor-based with graphical user interfaces, which are standard features and do not imply AI/ML.
No
The device is a data acquisition unit for recording and displaying physiological signals, not for treating or diagnosing a condition.
No
This device records and displays physiological signals and pressure recordings for the user to analyze, but it does not inherently provide a diagnosis.
No
The device description explicitly states it is a "multi-channel pressure and electrocardiograph system that digitizes, and stores pressure and electrical signal information" and is a "data acquisition unit which connects to the patient to collect both electrical ECG and intracardiac signals as well as pressure waveforms acquired by various pressure transducers." This indicates the presence of hardware components for signal acquisition and digitization, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside the body.
- Device Function: The CardioCath system is described as a data acquisition unit that connects directly to the patient to record electrical and pressure signals from the patient's body. It measures physiological parameters in real-time.
- Intended Use: The intended use is in a cardiac catheterization laboratory to record signals directly from the patient during a procedure.
The system is designed for in vivo (within the living body) measurement and monitoring, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
The system is used in a cardiac catheterization laboratory where ECG, intracardiac signals, and pressure recordings need to be recorded from a patient.
Product codes (comma separated list FDA assigned to the subject device)
74 DPS
Device Description
The CardioCath system is a multi-channel pressure and electrocardiograph system that digitizes, and stores pressure and electrical signal information on magnetic media.
System Configuration: The CardioCath system is a data acquisition unit which connects to the patient to collect both electrical ECG and intracardiac signals as well as pressure waveforms acquired by various pressure transducers. The data is digitized and stored in a computer which displays the data on video monitors. The system allows the user to archive, perform signal measurements and to print out signals on both continuous paper recorder or on a laser printer.
Function: The system provides isolation of biopotential signals from the patient to ground, high impedance inputs, high gain and variable filtering capabilities required for measuring bioelectric potentials. The system provides isolation, conditioning and amplifications of electrical signals from strain gage blood pressure transducers.
Design: The system incorporates defibrillation protection and is designed to comply with IEC 601-1 and U.L. 544 electrical safety standards.
Operation: The system is microprocessor based and feature graphical user interfaces. The system allows the user to acquire, display, measure and printout various biopotential waveforms.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Cardiologists or trained medical professionals in a cardiac catheterization laboratory.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivty, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
AUG 21 1996
Pr
Engineering, Inc. K960321
Technology at Work
Section 2: Safety and Effectiveness Summary (510K Summary)
- A. Trade Name: CardioCath Catheterization Lab System
- B. Common Name: Cardiac Cath Lab System
- C. Establishment Registration Number: 1643488
- D. Address of Manufacturing Site: Prucka Engineering, Inc. 8050 El Rio Houston, Texas 77054 713-746-1000 713-747-8451 Fax
- E. Classification:
The CardioCath system is a multi-channel pressure and electrocardiograph system that digitizes, and stores pressure and electrical signal information on magnetic media. Prucka Engineering, Inc. considers the CardioCath system to be a Class II device within FDA classification 74 DPS. The CardioCath is designed to comply with FDA, UL 2601, IEC 601-1 and AAMI guidelines for patient leakage current.
- F: Predicate Devices:
Prucka Engineering believes the CardioLab Catheterization Lab System to be substantially equivalent to several devices currently in commercial distribution, including Quinton Q-Cath Computerized Cath Lab Recording System. The device is manufactured by:
Quinton Instrument Co. 2121 Terry Avenue Seattle, WA 98121
Marquette Electronics Inc. also manufactures and distributes a computerized cath lab recording system called MAC-Lab. This product is also substantially equivalent to the PECA system. The device is manufactured by:
Marquette Electronics, Inc.
1
8200 W. Tower Ave. Milwaukee, Wisconsin 53223
Similar Characteristics:
Both the Ouinton O-cath system and Marquette MAC-Lab system contain similar physical characteristics and specifications as the CardioCath system. All of the systems begin with a data acquisition unit which connects to the patient to collect both electrical ECG and intracardiac signals as well as pressure waveforms acquired by various pressure transducers. The data is digitized and stored in a computer which displays the data on video monitors. The systems allow the user to archive, perform signal measurements and to print out signals on both continuous paper recorder or on a laser printer.
All the systems provide isolation of biopotential signals from the patient to ground, high impedance inputs, high gain and variable filtering capabilities required for measuring bioelectric potentials. All systems provide isolation, conditioning and amplifications of electrical signals from strain gage blood pressure transducers.
All systems are microprocessor based and feature graphical user interfaces. The systems allow the user to acquire, display, measure and printout various biopotential waveforms,
System Differences:
Marquette Electronics, Inc. MAC-Lab. The CardioLab system uses 21" monitors instead of 16" monitors. The maximum resolution of the monitors for the CardioCath system is 1600 x 1280. The resolution on the MAC-Lab is 800 x 600. The MAC-Lab system records from up to 4 ECG, 4 Blood Pressure (BP), and 4 BP Mean signals simultaneous. The CardioCath system will record up to 32 signals simultaneously. The user may select a combination of signals from a 12 lead ECG, 6 blood pressure channels, 6 BP mean channels, 4 high level DC signals, and 32 intracardiac signals, for a total of 32 signals to be acquired simultaneously. The MAC-Lab system uses a Motorola 68000 and an Intel 80286 based computer, while the CardioCath system uses an Intel 80486 based system. The MAC-Lab system archives data on floppy disks whereas the CardioCath system archives data on optical disk.
Quinton Instruments Q-Cath. The Q-Cath system uses either 16" or 14" color monitors whereas the CardioCath system uses 21" monitors. The O-Cath system can record up to 6 channels simultaneously from 3 ECG, 4 BP, 4 BP, mean, 4 dP/dt, 3 intracardiac and 2 High Level DC signals. The CardioCath system can record up to 32 signals simultaneous where the user can choose from a 12 lead ECG, 6 BP, 6 BP Mean, 4 High Level DC signals, and 32 intracardiac signals. The Q-Cath system archives data on floppy disks whereas the CardioCath system archives data on optical disk.
G: System Description and Intended Use
(
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System Configuration: The CardioCath system is a data acquisition unit which connects to the patient to collect both electrical ECG and intracardiac signals as well as pressure waveforms acquired by various pressure transducers. The data is digitized and stored in a computer which displays the data on video monitors. The system allows the user to archive, perform signal measurements and to print out signals on both continuous paper recorder or on a laser printer.
Intended Use: The system is used in a cardiac catheterization laboratory where ECG, intracardiac signals, and pressure recordings need to be recorded from a patient.
Function: The system provides isolation of biopotential signals from the patient to ground, high impedance inputs, high gain and variable filtering capabilities required for measuring bioelectric potentials. The system provides isolation, conditioning and amplifications of electrical signals from strain gage blood pressure transducers.
Design: The system incorporates defibrillation protection and is designed to comply with IEC 601-1 and U.L. 544 electrical safety standards.
Operation: The system is microprocessor based and feature graphical user interfaces. The system allows the user to acquire, display, measure and printout various biopotential waveforms.
H: Safety Standards
The CardioCath system was designed to meet IEC 601-1 which applies to the safety of medical electrical equipment and the reliable operation where it is connected with safety and IEC 601-2-27 which applies to the particular safety requirements for electrocardiographic (ECG) monitoring equipment and IEC 601-2-34 which applies to the particular safety requirements for invasive pressure monitoring equipment.
IEC 601-1 covers the following safety aspects of the device:
Environmental conditions during transportation and storage, operation and use of the power supply. Enclosures and protective covers Insulation and protective impedances Protective earthing, functional earthing and potential equalization. Continuous leakage currents and patient auxiliary currents Dielectric strength Mechanical strength Moving parts Stability in Normal Use Expelled Parts Protection against excessive temperatures Overflow, spillage, leakage, humidity, ingress of liquids and cleaning. Interruption of the power supply Abnormal operation and fault conditions
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IEC 601-2-27 covers the following safety aspects of the device as they relate to ECG monitoring:
Protection against the effects of a cardiac defibrillator discharge Continuous leakage currents and patient auxiliary currents Dielectric strength
Accuracy of operating data and protection against hazardous output
IEC 601-2-34 covers the following safety aspects of the device as they relate to the invasive blood pressure monitoring:
Protection against the effects of a cardiac defibrillator discharge
Continuous leakage currents and patient auxiliary currents
Dielectric strength
Mechanical strength
Accuracy of operating data and protection against hazardous output
The equipment has been tested and certified to meet the above specifications by SEMKO which is an Inchcape Testing Services Company.