(55 days)
Medilog MR63 K943862
Not Found
No
The description focuses on digital signal acquisition, storage, and analysis on a separate system, with no mention of AI or ML algorithms for interpretation or diagnosis. The performance studies compare the device's recording capabilities to a predicate device, not its analytical capabilities using AI/ML.
No
Explanation: The device is a diagnostic tool used for recording ECG data to aid in the diagnosis of cardiac disorders, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used in the diagnosis of various cardiac disorders."
No
The device description clearly outlines hardware components including electrodes, leads, patient cable, recorder with digital acquisition module, and a PCMCIA Flash ATA card for data storage. The software component is for analysis of the data collected by the hardware.
Based on the provided information, the Medilog FD4 Holter monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Medilog FD4 Function: The Medilog FD4 records electrical signals directly from the patient's body (ECG) via electrodes attached to the chest. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "recording of ECG in an ambulatory mode" and the data is used by a physician as an "aid in the diagnosis." This is a direct measurement of a physiological signal, not an analysis of a biological sample.
Therefore, the Medilog FD4 falls under the category of a medical device that measures physiological parameters, but it is not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, hospitalised patients
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
A total of 29 recordings, 17 of which were performed in undern with an MR63, were carried out from a variety of sources, with a view to establishing that the FD4 recorder was equivalent to its predicate device, the Medilog MR63. The recording sources were: a programmable simulator (giving researchiseble EKGs); an EKG generator (providing real patient data from a database of recordings); and human volunteers. The recordings were checked for signal quality, reliability of recording and download, detection of patient events and recording duration. In addition the heart rate variability was monitored and logged for comparison with the predicate device. All recordings were archived to optical disk.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance bench tests have been carried out on FD4 in accordance with American National Standard EC38 "Ambulatory electrocardiographs" and draft British Standard Electrical Equipment- part 2: Particular requirements for safety- section 2.47: specification for ambulatory electrocardiographic monitors. The performance parameters tested were; input dynamic range, gain accuracy, system noise, multichannel crosstalk, frequency response, and minimum feature size. The FD4 was found to meet all requirements.
A total of 29 recordings, 17 of which were performed in undern with an MR63, were carried out from a variety of sources, with a view to establishing that the FD4 recorder was equivalent to its predicate device, the Medilog MR63. The recording sources were: a programmable simulator (giving researchiseble EKGs); an EKG generator (providing real patient data from a database of recordings); and human volunteers. The recordings were checked for signal quality, reliability of recording and download, detection of patient events and recording duration. In addition the heart rate variability was monitored and logged for comparison with the predicate device. All recordings were archived to optical disk.
All recordings met the criteria for a successful recording as defined below.
- Recording lasted for its intended duration ●
- Patient events detected 0
- Signal quality and gain comparable with the predicate device, where applicable
- No problems with either the recording or the replay ●
- Successful review by Oxford Instruments clinical specialist .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Medilog MR63 K943862
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.
Not Found
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).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the word "OXFORD" in a stylized, sans-serif font. The letter "O" is a perfect circle, and the "X" is formed by two intersecting lines. The "F" is a straight line with a curved shape attached to the right side. The second "O" has a crescent shape inside of it. The "R" and "D" are more traditional sans-serif letters.
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
MAY - 5 1997 - 5 1997
:
1
Image /page/1/Picture/0 description: The image shows the word "OXFORD" in a stylized font. Each letter is distinct and bold. The letters are evenly spaced and the word is horizontally aligned.
Oxford Instruments Modical Systems Division 1 1 526 53rd Street N Clearwater, Florida 34620 Telephone (813) 573-4500 Fax (813) 572-6836
510(k) Summary
Date of summary :
Contact : Charles Holz Regulatory Affairs Manager
Name of device : Medilog FD4 Classification name : Monitor - Electrocardiograph Name of predicate : Medilog MR63 K943862
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.
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.
FD4 performance testing.
Performance bench tests have been carried out on FD4 in accordance with American National Standard EC38 "Ambulatory electrocardiographs" and draft British Standard Electrical Equipment- part 2: Particular requirements for safety- section 2.47: specification for ambulatory electrocardiographic monitors. The performance parameters tested were; input dynamic range, gain accuracy, system noise, multichannel crosstalk, frequency response, and minimum feature size. The FD4 was found to meet all requirements.
Summary of FD4 trial results
A total of 29 recordings, 17 of which were performed in undern with an MR63, were carried out from a variety of sources, with a view to establishing that the FD4 recorder was equivalent to its predicate device, the Medilog MR63. The recording sources were: a programmable simulator (giving researchiseble EKGs); an EKG generator (providing real patient data from a database of recordings); and human volunteers. The recordings were checked for signal quality, reliability of recording and download, detection of patient events and recording duration. In addition the heart rate variability was monitored and logged for comparison with the predicate device. All recordings were archived to optical disk.
All recordings met the criteria for a successful recording as defined below.
- Recording lasted for its intended duration ●
- Patient events detected 0
- Signal quality and gain comparable with the predicate device, where applicable �
- No problems with either the recording or the replay ●
- Successful review by Oxford Instruments clinical specialist .
2
Comparison table of FD4/MR63 features & specification
..
| | MIR63 | FD4 | Impact on
effectiveness | Impact on safety | | | | | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------|--|------|--|
| Type of device | Holter ECG recorder | Holter ECG recorder | N/A | N/A | | | | | |
| Device class | non-critical
Regulatory Class II | non-critical
Regulatory Class II | no change | no change | | | | | |
| designed to
comply with..... | IEC 601-1, UL 544,
93/42/EEC (MDD) | IEC 601-1, UL 2601-1,
AAMI EC38,
93/42/EEC (MDD) | Improved, updated
standards including
EC38 performance. | none | | | | | |
| EMC | IEC 601-1-2 | IEC 601-1-2 | no change | no change | | | | | |
| Environmental | 5 °C to 40 °C
10 to 95% RH | 0 °C to 45 °C
10 to 95% RH | Improved operating
range. | none | | | | | |
| Recording duration | 24 hours | 24 hours | no change | no change | | | | | |
| Mounting method | Belt-mounted pouch | Belt-mounted pouch | no change | no change | | | | | |
| Case | Polycarbonate / ABS | Polycarbonate / ABS | no change | no change | | | | | |
| Power source | 2xAA 1.5v primary
alkaline or 1.2v NiMh
rechargeable | 2xAA 1.5v primary
alkaline or 1.2v NiMh
rechargeable | no change | no change | | | | | |
| Electrode system | 3/5/7 lead
configurations using
yoke cable and
individual electrode
leads | 3/5/7 lead
configurations using
yoke cable and
individual electrode
leads | no change | no change | | | | | |
| Recording medium | C-60 cassette | 20Mb flash ATA card | improved frequency
response (no tape
variations) | none | | | | | |
| Recording method | Direct | Digitised and
compressed without
loss. | Improved (no replay
variations) | none | | | | | |
| Display | 4 digit + colon 7
segment LCD displays
time | 4 digit + colon 7
segment LCD displays
time and additional
error codes | More effective use of
display to show
useful information | none | | | | | |
| Audible sounder | 4kHz bleeper used to
provide feedback
during time/date
setting and patient
events | Frequency of
bleeping variable | Provide more
effective feedback
and to distinguish
between various
sounds | none | | | | | |
| Patient event
marking | encoded onto data
track of cassette.
Resolution 1 second | Stored in file header.
Resolution 1/128 th
sec | Higher resolution
patient event timing
an advantage | none | | | | | |
| External controls | Patient event button
(also used for
time/date setting).
Head arm switch | Patient event button
(also used for
time/date setting)
plus ON/OFF slide
switch under
recorder lid | Need ON/OFF switch
to replace head arm
switch of tape
mechanism. | none | | | | | |
| Signals recorded | 3 x analogue ECG | 3 x digitised ECG | improved | none | | | | | |
| Setting up | Analogue monitor
socket (not isolated)
for all 3 ECG channels | Fibre optic output
producing ECG
signals in digital
format at real-time | Attaches directly to
existing OXFORD
replay systems. No
need for separate
write-out unit. | Provides patient
isolation by virtue of
plastic optical fibre. | | | | | |
| Method of
isolation during
monitoring | XE-45 write-coupler | Automatically
provided by plastic
fibre optic cable | none | Plastic fibre optic
inherently safer than
relying on use of safe
writer coupler. | | | | | |
| Data recorded | Time/Date & patient
events | Time/date & patient
events | no change | no change | | | | | |
| Data format | Pulse width
modulated | Digital format in file
header. | Better reliability-not
sensitive to tape
variations | none | | | | | |
| Channel gain
adjustment | | Hardware gain
adjustment using
digital | | Software gain
adjustment to give
optimum signal | | Ensures high fidelity
reproduction of small
& large ECG signals | | none | |
| Dynamic range | potentiometers.
50 μV to 10 mV | optimum signal amplitude
10 μV to 10 mV | Improved. Allows accurate recording of larger range of ECG signals & large ECG signals amplitudes. | none | | | | | |
3
| | MR63 | FD4 | Impact on
effectiveness | Impact on safety |
|------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------|
| Overall
recorder/replay
bandwidth | 0.5Hz - 25Hz | 0.05Hz - 40 Hz | No frequency
response limitation
due to tape
recording/replay.
Frequency response
only due to hardware
filters. | none |
| Typical pk-pk noise
over input
bandwidth |