(646 days)
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No
The summary describes standard signal processing techniques for ECG, NIBP, and SpO2, and does not mention AI, ML, or related concepts. There is no description of training or test sets, which are typical for AI/ML devices.
No
The device is described as a monitor that acquires, processes, and displays physiological parameters (ECG, blood pressure, SpO2, respiratory effort) and detects arrhythmias and ST segment deviations. It does not provide any therapy or treatment.
Yes
The device detects conditions such as "premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia" and "ST segment deviations." Detection of abnormal physiological states is a characteristic of a diagnostic device.
No
The device description explicitly states it is a "Module" designed to acquire, process, and display physiological signals using standard hardware components like ECG electrodes, NIBP cuffs, and SpO2 sensors. It also mentions being exclusively used with a "PCMS Monitor," indicating a hardware dependency.
Based on the provided information, 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 SpaceLabs Medical Integrated Multi-Parameter Module is a patient monitoring device that measures physiological parameters directly from the patient's body surface using electrodes, cuffs, and sensors. It monitors ECG, respiratory effort, non-invasive blood pressure, and pulse oximetry.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It acquires signals and measurements from the body itself.
Therefore, the device's function falls under the category of patient monitoring equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SpaceLabs Medical Integrated Multi-Parameter Module is intended for use as a ECG monitor and an arrhythmia detector, which monitors the electrocardiogram and is designed to produce a visible and audible signal (via a SpaceLabs Medical PCMS monitor) when an arrhythmia, such as premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia, exists. In addition, ST segment deviations are detected.
The SpaceLabs Medical Integrated Multi-Parameter Module is also intended for use as a non-invasive blood pressure system, a pulse oximeter, and a monitor of respiratory effort.
The SpaceLabs Medical Integrated Multi-Parameter Module is intended for use on both adult and neonatal patient populations in all clinical settings. The SpaceLabs Medical Integrated Multi-Parameter Module is not intended for home use. The intended uses of this device are substantially equivalent to its predicate devices.
Product codes
74DSI, 74DXN, 74DQA
Device Description
The SpaceLabs Medical Integrated Multi-Parameter Module is designed to acquire, process, and display electro-cardiogram vectors (ECG), respiratory effort, non-invasive blood pressure (NIBP), and pulse oximetric oxygen saturation (SpO2) using standard ECG electrodes, NIBP cuffs, and SpO2 sensors and be exclusively used with the SpaceLabs Medical Integrated Multi-Parameter Module along with the PCMS Monitor. Operation, set-up, and alarm limit settings are all controlled by simple menu choices via the PCMS Monitor.
The SpaceLabs Medical Integrated Multi-Parameter Module is designed to acquire, process and display up to two ECG vectors and the respiratory effort signal using standard ECG electrodes plus one channel of noninvasive blood pressure and one channel of pulse oximetry.
The SpaceLabs Medical Integrated Multi-Parameter Module provides multiple lead ECG monitoring 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.
Non-invasive blood pressure measurements are acquired through a conventional inflatable cuff mechanism that is considered to be standard of care. The SpO2 channel is designed to noninvasively and continuously monitor functional oxygen saturation by the standard photoelectric pulse oximetric technique.
The design, material used, and energy source are similar to its predicate devices.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Body surface (for ECG and SpO2), Upper arm (for NIBP)
Indicated Patient Age Range
adult and neonatal patient populations
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K945429, K942058, K922510, K941167, K913695, K901209, K882609, K900032, Kaoo 2005 8
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
APR - 2 1997
510(k) Summary SpaceLabs Medical Integrated Multi-Parameter Module K952912
- Submitter's Name SpaceLabs Medical Inc. 1. 15220 N.E. 40th Street Redmond, WA 98073 (206) 882-3913 Telephone (206) 867-3550 Facsimile
- SpaceLabs Medical Integrated Multi-Parameter Module 2. Name of Device:
SpaceLabs Medical Integrated Multi-Parameter Module Classification: is classified under Arrhythmia Detector and Alarm (No. 74DSI) which has been classified as a Class III device, in accordance to 21 CFR 870.1025.
SpaceLabs Medical Integrated Multi-Parameter Module is also classified under Noninvasive Blood Pressure Measurement System (No. 74DXN) which has been classified as a Class II device, in accordance to 21 CFR 870.1130.
SpaceLabs Medical Integrated Multi-Parameter Module is also classified under Oximeter (No. 74DQA)_which has been classified as a Class II device, in accordance to 21 CFR 870.2700.
- SpaceLabs Medical 90352 PC Scout Expansion 3. Predicate Devices: a. Housing, as described in K945429.
- SpaceLabs Medical 90492 ECG Module, as b. described in K942058;
- SpaceLabs Medical 90478 Telemetry Receiver, as C. described in K922510;
- SpaceLabs Medical 90553 NIBP Monitor, as ರ. described in K941167;
- Nellcor N-180 pulse oximeter, as described in e. K913695:
- f. SpaceLabs Medical 90489 SpO2 Module, as described in K901209;
- Hewlett Packard CMS and M1175A, as described ு. in K882609 and K900032; and
- h. Marquette Tramscope System, as described in Kaoo 2005 8
1
- The SpaceLabs Medical Integrated Multi-Parameter Module is designed to ব acquire, process, and display electro-cardiogram vectors (ECG), respiratory effort, non-invasive blood pressure (NIBP), and pulse oximetric oxygen saturation (SpO2) using standard ECG electrodes, NIBP cuffs, and SpO2 sensors and be exclusively used with the SpaceLabs Medical Integrated Multi-Parameter Module along with the PCMS Monitor. Operation, set-up, and alarm limit settings are all controlled by simple menu choices via the PCMS Monitor.
- The SpaceLabs Medical Integrated Multi-Parameter Module is designed to ട. acquire, process and display up to two ECG vectors and the respiratory effort signal using standard ECG electrodes plus one channel of noninvasive blood pressure and one channel of pulse oximetry.
The SpaceLabs Medical Integrated Multi-Parameter Module is intended for use as a ECG monitor and an arrhythmia detector, which monitors the electrocardiogram and is designed to produce a visible and audible signal (via a SpaceLabs Medical PCMS monitor) when an arrhythmia, such as premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia, exists. In addition, ST segment deviations are detected.
The SpaceLabs Medical Integrated Multi-Parameter Module is also intended for use as a non-invasive blood pressure system, a pulse oximeter, and a monitor of respiratory effort.
The SpaceLabs Medical Integrated Multi-Parameter Module is intended for use on both adult and neonatal patient populations in all clinical settings. The SpaceLabs Medical Integrated Multi-Parameter Module is not intended for home use. The intended uses of this device are substantially equivalent to its predicate devices.
- The SpaceLabs Medical Integrated Multi-Parameter Module provides multiple ട. lead ECG monitoring 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.
Non-invasive blood pressure measurements are acquired through a conventional inflatable cuff mechanism that is considered to be standard of care. The SpO2 channel is designed to noninvasively and continuously monitor functional oxygen saturation by the standard photoelectric pulse oximetric technique.
The design, material used, and energy source are similar to its predicate devices.