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K Number
K970902
Device Name
MEDILOG FD4
Manufacturer
OXFORD INSTRUMENTS MEDICAL SYSTEMS
Date Cleared
1997-05-05

(55 days)

Product Code
DSH
Regulation Number
870.2800
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Medilog FD4 Hoher monitor is intended to be used in the diagnosis of various cardiac disorders by the recording of ECG in an ambulatory mode. These disorders principally include cardiac arrhythmia's and myocardial ischeamia.

The ECG data is used by the physician as an aid in the diagnosis of the patients condition. In some circumstances the patient may be hospitalised as part of the medical evaluation and Holter monitoring may be performed in conjunction with other non-invasive or invasive procedures. In such cases there is no interaction between the FD4 and other equipment.

Device Description

Decer poton it looks like an MR63. The difference being the analogue cassette mechanism has been replaced with a digital acquisition module containing a slot for a PCMCIA Flash ATA card.

The patient is connected to the FD4 via disposable electrodes attached to the chest. These detect the electrical signals generated by the heart, which are then transferred to the recorder via the electrode leads and patient cable. In the recorder, these signals are amplified, filtered, digitised and compressed without loss before being stored on a removable PCMCIA Flash ATA card. At the completion of recording the flash memory card is removed and the recorded ECG data is replayed and analysed on the Oxford Instruments ECG Analysis System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria CategorySpecific CriteriaReported Device Performance (FD4)
Performance Bench TestsInput dynamic range meets American National Standard EC38 requirements.FD4 meets all requirements of American National Standard EC38.
Gain accuracy meets American National Standard EC38 requirements.FD4 meets all requirements of American National Standard EC38.
System noise meets American National Standard EC38 requirements.FD4 meets all requirements of American National Standard EC38.
Multichannel crosstalk meets American National Standard EC38 requirements.FD4 meets all requirements of American National Standard EC38.
Frequency response meets American National Standard EC38 requirements.FD4 meets all requirements of American National Standard EC38.
Minimum feature size meets American National Standard EC38 requirements.FD4 meets all requirements of American National Standard EC38.
Meets draft British Standard Electrical Equipment - part 2: Particular requirements for safety - section 2.47: specification for ambulatory electrocardiographic monitors.FD4 meets all requirements of the draft British Standard.
Trial PerformanceRecording lasted for its intended duration.All recordings (29 total) met this criterion.
Patient events detected.All recordings (29 total) met this criterion.
Signal quality and gain comparable with the predicate device (Medilog MR63), where applicable.All recordings (29 total) met this criterion.
No problems with either the recording or the replay.All recordings (29 total) met this criterion.
Successful review by Oxford Instruments clinical specialist.All recordings (29 total) met this criterion.
Technical SpecificationsImproved, updated standards including EC38 performance (compared to MR63).FD4 complies with IEC 601-1, UL 2601-1, AAMI EC38, 93/42/EEC (MDD). The MR63 complied with older standards (IEC 601-1, UL 544, 93/42/EEC).
Improved operating range (temperature).FD4: 0 °C to 45 °C (compared to MR63: 5 °C to 40 °C).
Improved frequency response (due to digital recording).FD4: 0.05Hz - 40 Hz (compared to MR63: 0.5Hz - 25Hz).
Lower typical peak-to-peak noise over input bandwidth.FD4:

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).