(237 days)
No
The description refers to a "diagnostic analysis algorithm" and mentions it is the same algorithm used in predicate devices from the early 1990s. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No.
The device is used for diagnostic purposes by analyzing ECG waveforms and monitoring cardiac rhythms, not for treating conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option provides a means for performing diagnostic ECG analysis." The "Device Description" also mentions it is "designed to acquire, analyze and display up to twelve ECG vectors in a standard diagnostic ECG analysis format."
Yes
The device description explicitly states that the "SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a softwareonly option added to the 90492 module software" and that "There is no additional hardware required for this option." While it works in conjunction with a hardware module, the described device itself is solely the software component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples outside the body. The text clearly states that this device acquires and analyzes ECG signals directly from the patient's body surface using electrodes. This is an in vivo measurement, not an in vitro one.
- The intended use is for monitoring and diagnostic analysis of electrical activity of the heart. This is a physiological measurement, not the analysis of a biological specimen like blood, urine, or tissue.
Therefore, the SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a medical device used for physiological monitoring and diagnostic analysis, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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Product codes
74 DSI
Device Description
The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a software-only option added to the 90492 module software, and is designed to acquire, analyze and display up to twelve ECG vectors in a standard diagnostic ECG analysis format and to work exclusively within the SpaceLabs Medical 90492 12lead ECG module. The diagnostic analysis algorithm is that used in the Mortara Instruments ELI 100 (K920627), ELI 200 (K920626A) and ELI 300 (K933143) and is provided by Mortara Instruments as object code. There is no additional hardware required for this option.
The SpaceLabs Medical Model 90492 ECG module is designed to acquire, process and display up to twelve ECG leads and one respiratory effort signal using standard ECG electrodes. The twelve ECG leads consist of the standard twelve ECG leads, I, II, III, aVR, aVL, aVF, V1 - V6.
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
Used to monitor patients in the operating room, recovery rooms, intensive care units, in the emergency room, in research settings, or other units where additional ECG leads are desired.
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 SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option has been subjected to extensive safety and performance testing. Final testing for the system includes various bench and performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have been performed to ensure the device complies to all applicable industry and safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
MAR 2 5 1997
Image /page/0/Picture/2 description: The image shows the logo for SpaceLabs Medical. The logo consists of the letters SL in a box on the left, and the words SpaceLabs Medical on the right. The letters SL are in bold, and the words SpaceLabs Medical are in a sans-serif font.
dmond, Washington 98073-9713
510(k) Summary
SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option
- Submitter's Name SpaceLabs Medical Inc. 1. 15220 N.E. 40th Street Redmond. WA 98073 (206) 882-3913 Telephone: Facsimile: (206) 867-3550
- SpaceLabs Medical 12-Lead Diagnostic ECG Analysis 2. Name of Device Option
Classification: Arrhythmia Detector and Alarm; 21 CFR 870.1025
- The SpaceLabs Medical 12 Lead Diagnostic ECG 3. Predicate Analysis Option is a modification to the existing Device(s) SpaceLabs Medical 12 Lead ECG Module, as described in K942058. As a result of a business relationship between Mortara Instruments and SpaceLabs Medical, the diagnostic ECG algorithm used in the Diagnostic ECG Analysis Option are identical to those found in the Mortara Instrument ELI300, as described in K933143.
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- The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a softwareonly option added to the 90492 module software, and is designed to acquire, analyze and display up to twelve ECG vectors in a standard diagnostic ECG analysis format and to work exclusively within the SpaceLabs Medical 90492 12lead ECG module. The diagnostic analysis algorithm is that used in the Mortara Instruments ELI 100 (K920627), ELI 200 (K920626A) and ELI 300 (K933143) and is provided by Mortara Instruments as object code. There is no additional hardware required for this option.
The SpaceLabs Medical Model 90492 ECG module is designed to acquire, process and display up to twelve ECG leads and one respiratory effort signal using standard ECG electrodes. The twelve ECG leads consist of the standard
1
twelve ECG leads, I, II, III, aVR, aVL, aVF, V1 - V6. The 90492 ECG module is used to monitor patients in the operating room, recovery rooms, intensive care units, in the emergency room, in research settings, or other units where additional ECG leads are desired.
ECG data is displayed as an analog moving waveform or as various static waveforms. The analog ECG is passed through digital filters to eliminate unwanted signals. Standard ECG electrodes are used to interface the patient to the 90492 ECG module. Clinicians will position the electrodes in the customary locations. The electrodes are connected to shielded leadwires which are connected to a shielded cable. The cable is connected to the front of the 90492 module.
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- The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option provides a means for performing diagnostic ECG analysis in conjunction with the monitoring functions of the SpaceLabs Medical Model 90492 ECG module. Diagnostic ECG analyzes detailed ECG waveforms in each cardiac cycle and the beat-to-beat variability in order to determine the cardiac rhythm. When used in conjunction with a SpaceLabs Medical Patient Care Management System (PCMS) monitor the SpaceLabs Medical Model 90492 ECG module provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events.
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- The SpaceLabs Medical Model 90492 ECG module with the 12 Lead Diagnostic ECG Analysis Option provides multiple lead monitoring and ECG analysis from electrodes placed on the body surface. Electrical activity of the heart is measured via multiple electrodes placed at various locations on the patient's body. The design, material used, and energy source are similar to its predicate devices.
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- The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option has been subjected to extensive safety and performance testing. Final testing for the system includes various bench and performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have been performed to ensure the device complies to all applicable industry and safety standards.
In conclusion, the SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is as safe and effective as the predicate device and raises no new issues.