(310 days)
No
The description explicitly states the device is "totally passive" and "offers no diagnosis or perform any signal analysis," indicating no AI/ML processing of the ECG data.
No.
The device is used for monitoring and recording ECG data in occasionally symptomatic patients, not for providing therapy or treatment.
Yes
The device records ECG data when activated by the patient during symptomatic episodes, and this data is then transmitted to a qualified technician or the patient's physician for "interpretation," which is a step in the diagnostic process for identifying arrhythmias.
No
The device description explicitly states it is a "portable ECG memory loop recorder" and describes hardware components like electrodes, amplifiers, digitizers, a microprocessor, RAM, a speaker, and batteries. It is a physical device that records and transmits ECG data.
Based on the provided text, 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.
- Device function: The description clearly states the device's sole intended use is for the long term monitoring of ECG by recording electrical signals from the heart via surface electrodes. It is a passive device that records and transmits data for interpretation by a qualified technician.
- No analysis or diagnosis: The text explicitly states the device "takes no action and advises none to the patient," "offers no diagnosis or perform any signal analysis." This is a key distinction from many IVD devices which perform analysis on the sample.
- No sample analysis: The device does not analyze any biological samples from the patient. It collects electrical signals from the body surface.
Therefore, the Retrospective II-Elite, as described, falls under the category of a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The sole intended use for the device or its predicate is for the long term monitoring of ECG in occasionally symptomatic patients. The purpose of both devices is to record occasional short-lived arrhythmia. Their usage is usually confined to otherwise healthy individuals on an out-patient basis. These recorders are not meant for use in life support or ICU situations. Their normal function is to record all ECG data and save a particular episode only when activated by the patient. The stored episode contains data before and after the activation so that the actual arrhythmia will be captured. The data is then saved for transmission to a qualified technician for interpretation. The recorders take no action and advises none to the patient other than to call the receiving station. They are totally passive devices and offers no diagnosis or perform any signal analysis.
Product codes
74DXH
Device Description
The Retrospective II is a portable ECG memory loop recorder. It is a non-critical Type II device. The device, as well as its predicate, continuously record ECG and store several minutes of the most recent data. When the patient experiences a symptom he/she presses a button which saves this stored data. The patient then calls a receiving service and transmits the data over the telephone. The service is then able to interpret or forward the data to the patient's physician. Both the Retrospective and the Retrospective II-Elite have this same operational sequence. Both devices obtained ECG data via 3 or 5 disposable surface electrodes. The ECG signals are amplified and then digitized. A microprocessor controls the sampling of the data and then stores the data in RAM. When the symptom button is pressed the most recent stored data is then saved. When the send button is presses the saved data is recalled by the microprocessor The data is then frequency modulated and used to drive a speaker. This audio data is transmitted over a voice grade telephone line to the receiving hardware. Both devices accomplish this entire process using solid-state techniques, that is no magnetic media or moving parts are employed. Both devices are powered by alkaline batteries and have no AC power connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Retrospective II-Elite was designed to meet the specifications suggested by the Association for the Advancement of Medical Instrumentation (AAMI) for Ambulatory ECG Monitors. Verification testing on a sample device has shown that the Retrospective II-Elite complies with applicable AAMI performance requirements.
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
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
K954163 L
JUL 11 1986
510(K) SUMMARY Retrospective II-Elite
CEC Medical Systems, Inc. 2063 South 116th Street Milwaukee, WI 53227 Voice: (414) 545-6777 FAX: (414) 545-4126
Date of Summary: August 25, 1995
Contact for this submission: John Ellenz, Director of Engineering
| Device Trade Name: | Retrospective II-Elite |
|---|---|
| Device Common Name: | ECG Memory Loop Recorder |
| Device Classification: | Transmitters and Receivers, Electrocardiographic, |
| Telephone. | |
| Classification Number: | 74DXH |
| Claimed Predicate Device: | Retrospective ECG Memory Loop Recorder |
| Manufacturer: | CEC Medical Systems |
Description of Device
510(K) Document #:
The Retrospective II is a portable ECG memory loop recorder. It is a non-critical Type II device. The device, as well as its predicate, continuously record ECG and store several minutes of the most recent data. When the patient experiences a symptom he/she presses a button which saves this stored data. The patient then calls a receiving service and transmits the data over the telephone. The service is then able to interpret or forward the data to the patient's physician. Both the Retrospective and the Retrospective II-Elite have this same operational sequence
Both devices obtained ECG data via 3 or 5 disposable surface electrodes. The ECG signals are amplified and then digitized. A microprocessor controls the sampling of the data and then stores the data in RAM. When the symptom button is pressed the most recent stored data is then saved. When the send button is presses the saved data is recalled by the microprocessor The data is then frequency modulated and used to drive a speaker. This audio data is transmitted over a voice grade telephone line to the receiving hardware. Both devices accomplish this entire process using solid-state
File:c.\usr\john\rem\elite\summary.doc
1
techniques, that is no magnetic media or moving parts are employed. Both devices are powered by alkaline batteries and have no AC power connection.
Intended Use of Device
The sole intended use for the device or its predicate is for the long term monitoring of ECG in occasionally symptomatic patients. The purpose of both devices is to record occasional short-lived arrhythmia. Their usage is usually confined to otherwise healthy individuals on an out-patient basis. These recorders are not meant for use in life support or ICU situations. Their normal function is to record all ECG data and save a particular episode only when activated by the patient. The stored episode contains data before and after the activation so that the actual arrhythmia will be captured. The data is then saved for transmission to a qualified technician for interpretation. The recorders take no action and advises none to the patient other than to call the receiving station. They are totally passive devices and offers no diagnosis or perform any signal analysis.
Summary of Comparison to Predicate Device
The Retrospective II-Elite is an evolution of the original Retrospective. Both were designed with the same intended use. Improvements in technology over the past decade allow the Retrospective II-Elite to be smaller, lighter, and have longer battery life than the original device. However the underlying principal of operation is identical for both devices. Both amplify and digitize ECG data, store that data digitally in static RAM, and transmit the data via acoustic FM.
Additional features of the Elite model include the simultaneous transmission of two channels of ECG data, automatic baseline centering, multiple events, and digital time/date stamps. These features do not alter the intended use of the device, rather they allow the device to be competitive with others on the market. The quality of transmitted ECG data is not compromised by the additional features. In fact the Elite is designed to conform with ECG quality specifications suggested by The Association for the Advancement of Medical Instrumentation (AAMI) which are more rigorous than those used in the original Retrospective.
Both devices are powered by alkaline (or other standard consumer types such as carbon zinc) batteries. There is no provision for the connection of either device to any external supply. No AC risk currents exist. Data is transmitted to a receiving station over normal telephone lines. No electrical connection is made with the telephone system, as the coupling method is acoustic. Therefore the Retrospective II-Elite presents no additional èlectrical risks to the patient.
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Test Results
The Retrospective II-Elite was designed to meet the specifications suggested by the Association for the Advancement of Medical Instrumentation (AAMI) for Ambulatory ECG Monitors. Verification testing on a sample device has shown that the Retrospective II-Elite complies with applicable AAMI performance requirements.