(331 days)
Not Found
No
The description mentions "automated analysis" and "waveform measurements" but does not use terms like AI, ML, deep learning, or neural networks. The analysis described appears to be based on predefined algorithms for detecting specific ECG features and calculating standard measurements, which is typical of traditional signal processing rather than AI/ML.
No
The device is described as a recorder and analyzer of ECG data, intended to assist physicians in interpretation for diagnosis and assessment, rather than directly treating a condition.
Yes
The device is intended to assist the physician in the interpretation of recorded ECG data for the diagnosis and assessment of patients, despite the disclaimer that it is not a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.
No
The device description explicitly states "SEER MC is a Holter Recorder designed to be used in conjunction with an ambulatory ECG system" and "The SEER MC acquires, digitizes, stores and analyzes data". This indicates it is a hardware device that performs data acquisition and storage, in addition to analysis.
Based on the provided information, the SEER MC Ambulatory Digital Analysis Recorder is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The SEER MC records electrical signals from the heart on the body (ECG data).
- The intended use clearly states it records and analyzes ECG data. This is a physiological measurement, not an analysis of a biological sample.
- The device description reinforces that it acquires, digitizes, stores, and analyzes ECG data.
Therefore, the SEER MC falls under the category of a medical device that measures physiological signals, not an IVD.
N/A
Intended Use / Indications for Use
The SEER MC Ambulatory Digital Analysis Recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded ECG data. Results of the automated analysis, when used in conjunction with an ECG review system, are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECC data. In addition, the SEER MC can record and analyze 12-lead ambulatory ECG data for definition of morphology shape and measurements, heart rate, rhythm, and ST segment trending. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) patients in a clinical setting by qualified medical personnel.
The SEER MC in its 2 or 3 channel mode of operation detects the following: normal beats, ventricular beats, supraventricular beats, paced beats and artifact. This information with an ECG review system, documents the following: fastest and slowest heart rate, runs of ventricular beats, runs of supraventricular beats, pauses, ST segment changes, areas of atrial fibrillation, percentage of paced beats, prolonged QT, T-Wave Alternans, Heart Rate Turbulence, Heart Rate Variability and ECG strips associated with patient events and/or symptoms.
The SEER MC in its 12-lead mode of operation, in conjunction with a ECG Review system, documents the afforementioned information and also measures and trends the following 12 lead parameters: PR interval, QT interval, QRS diration, ST measurements at J point plus 40, 60 and 80 mseconds for all 12 leads and displays the Ventricular rate, and P, R and T axis for each 12-lead segment.
The SEER MC is not intended to be used as a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.
Product codes (comma separated list FDA assigned to the subject device)
MLO
Device Description
SEER MC is a Holter Recorder designed to be used in conjunction with an ambulatory ECG system to assist in the diagnosis and assessment of patients. The SEER MC acquires, digitizes, stores and analyzes data for scanning and review by an ambulatory ECG review system. SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze 12 lead ambulatory ECG data periodically or on demand. This analysis performs waveform measurements. These measurements are performed during recording for use in analysis and review within the ambulatory ECG review system.
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
adult and pediatric (greater than 10Kg) patients
Intended User / Care Setting
qualified medical personnel in a clinical setting
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 SEER MC complies with the voluntary standards as detailed in Section 9 Test Summary: of this submission. The following quality assurance measures were applied to the development of the device: . Requirements specification review, Risk analysis, Software and hardware testing, Performance testing, Safety testing, Environmental testing, Clinical use evaluation, Final validation. The results of these measurements demonstrated that the SEER MC is as safe, as effective, and performs as well as the predicate devices.
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.
SEER® (K882818), Mortara H12+ Holter Recorder (K021373)
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
SEP 0 2 2005
Section 2 Summary
510(k) Summary of Safety and Effectiveness
| Date: | October 4, 2004 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Grace LeMieux |
| Regulatory Affairs Manager | |
| GE Medical Systems Information Technologies | |
| Phone: (262) 293-1609 | |
| Fax: (262) 293-1460 | |
| Device: | |
| Trade Name: | SEER MC |
| Common/Usual Name: | Holter Recorder |
| Classification Names: | 21 CFR 870.2800 Electrocardiograph, ambulatory, with analysis algorithm |
| Predicate Devices: | SEER® (K882818) |
| Mortara H12+ Holter Recorder (K021373) | |
| Device Description: | SEER MC is a Holter Recorder designed to be used in conjunction with an |
| ambulatory ECG system to assist in the diagnosis and assessment of patients. | |
| The SEER MC acquires, digitizes, stores and analyzes data for scanning and | |
| review by an ambulatory ECG review system. SEER MC can collect and store | |
| up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In | |
| addition, the SEER MC can record and analyze 12 lead ambulatory ECG data | |
| periodically or on demand. This analysis performs waveform measurements. | |
| These measurements are performed during recording for use in analysis and | |
| review within the ambulatory ECG review system. |
The SEER MC recorder is intended to provide ambulatory ECG signal and Intended Use: automated analysis of the recorded data. Results of the automated analysis when used in conjunction with an ECG review system are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze12-lead ambulatory ECG data periodically or on demand. This analysis performs waveform measurements. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) human patients in a clinical setting by qualified medical personnel. Ambulatory ECG monitoring is useful for the following indications:
- Evaluation of symptoms that may be caused by cardiac arrhythmia . and/or conduction disturbances
- Evaluation of symptoms that may be due to myocardial ischemia .
- Detection of ECG events that alter prognosis in certain forms of heart ● disease
- Detection and analysis of pacemaker function and failure .
- Determination of cardiac response to lifestyle .
- Evaluation of therapeutic interventions .
Investigations in epidemiology and clinical trials
SEER MC is not intended to be used as a substitute for a standard, diagnostic-
1