(284 days)
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No
The description focuses on remote viewing and analysis of ECG data using mathematical computations and a proprietary algorithm, without mentioning AI or ML.
No
The device is described as a system to remotely view and analyze patient ECG data, which is a diagnostic function, not a therapeutic one. It facilitates monitoring and analysis but does not treat or cure a disease.
Yes
The device is designed to "remotely view and analyze patient ECG data," which directly relates to diagnosing a patient's cardiac condition by interpreting their electrocardiogram.
No
The device description explicitly mentions hardware components such as a "remote user input device that retains the ECG signal and transmits it over the telephone lines," a "modern at the Host site," and a "DOS based Computer." While software is a key component, the system relies on specific hardware for data acquisition, transmission, and display.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- CardioView analyzes electrical signals generated by the heart (ECG data) from the body.
The device's function is to remotely view and analyze ECG data, which is a physiological measurement, not an in vitro analysis of a biological sample.
N/A
Intended Use / Indications for Use
CardioView is a computerized, enhanced electronic Transtelephonic System designed for clinical andications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software.
Product codes
74FYW
Device Description
CardioView is a computerized, enhanced electronic Transtelephonic System designed for clinical andications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software.
Both devices use a remote user input device that retains the ECG signal and transmits it over the telephone lines. Both devices can use a switched telephone network. Both devices use a modern at the Host site to communicate with the remote device and uplink the data into the Computer. Both devices use a DOS based Computer which runs in Windows "" to display data.
Both devices: output a display that resembles a conventional ECG display. Both devices retain a electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a Windows "" environment.
Neither device have claims or, are offered as, laboratory analysis equipment. Both are for remote convenience and easy response.
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
physicians or other health care providers / small to medium health care monitoring facilities.
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)
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
OCT - 8 1996
Exhibit 14 Summary of Safety & Effectiveness for CardioView *** Transtelephonic Software, Part Number 268-400-004
CardioView is a computerized, enhanced electronic Transtelephonic System designed for clinical andications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software.
As such, this device is a Class II device, having Classification Name: Monitor, Electrograph, Product Code: 74FYW as described in 21 CFR Part 870.2340. MICROMEDICAL INC. has determined that this device is substantially equivalent to a predicate medical device which is currently in commerce and has been submitted to the FDA via K925639 as an electronic Transtelephonic Software and is identified as CardioMagic™ Software, marketed by Instromedix.
A determination of substantial equivalence is based upon:
Both the CardioView and CardioMagic are electronic Transelechonic Software for clinical applications to allow physicians or other health care providers to remotely view and analyze patient ECG data.
Both devices use a remote user input device that retains the ECG signal and transmits it over the telephone lines. Both devices can use a switched telephone network. Both devices use a modern at the Host site to communicate with the remote device and uplink the data into the Computer. Both devices use a DOS based Computer which runs in Windows "" to display data.
Both devices: output a display that resembles a conventional ECG display. Both devices retain a electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a Windows "" environment.
Neither device have claims or, are offered as, laboratory analysis equipment. Both are for remote convenience and easy response.
The CardioView has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy MICROMEDICAL INC. continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION:
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
M/ba
Mr. Malcom Castle President MICROMEDICAL INC. 255 Revere Drive, Suite 111 Northbrook, IL 60062 Tel 708 205 0099 Fax 708 441 0905