(203 days)
No
The description details standard signal processing and a software algorithm for identifying QRS complexes, which is not indicative of AI/ML. There is no mention of AI, ML, or related concepts.
No.
The device's intended use is solely for monitoring various physiological parameters (oxygen saturation, pulse rate, ECG, heart rate, blood pressure), not for treating or providing therapy.
No.
The device is a patient monitor, which measures and displays physiological parameters (SpO2, pulse rate, ECG, heart rate, blood pressure). While these measurements provide information about a patient's condition, the device itself does not interpret the data to make a diagnosis. It provides data for a clinician to use in diagnosis.
No
The device description explicitly mentions hardware components like ECG leads, cables, an ECG processing module, and a front panel display. It also describes the collection of intrinsic electrocardiac signals via surface electrodes. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device noninvasively monitors physiological parameters (oxygen saturation, pulse rate, ECG, heart rate, blood pressure) using external sensors (SpO2 sensor, ECG leads, blood pressure cuffs). It does not involve testing samples taken from the body (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description details how the device collects and processes electrical signals from the body surface (ECG) and uses optical methods (pulse oximetry) and pressure measurements (blood pressure) to derive physiological data. This is consistent with in vivo monitoring, not in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device monitors physiological signals directly from the patient's body.
N/A
Intended Use / Indications for Use
The purpose and function of the N-3000E Patient Mcnitor is to: - noninvasively and continuously monitor functional arterial oxygen saturation and . pulse rate (using an accessory SpO2 sensor); - noninvasively and continuously monitor ECG and heart rate (using accessory . ECG leads). When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to: - display and print out associated ECG and Plethysmograhic waveforms, SpO2, . pulse rate and heart rate. When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000E/N-3100/N-3200 is aiso to: - noninvasively and automatically measure systclic, diastolic and mean arterial . blood pressure and to derive pulse rate from these measurements (using accessory blood pressure cuffs); and display and print out systolic, diastolic and mean arterial blood pressure (on the N-3200 disclay/printer) When the N-3100 is connected to the N-3200 Display/Printer, the purpose and function of the combined device (compared to K945947) is expanded to: - display and print out associated. pulse rate and systolic, diastolic and mean . arterial blood pressure. The N-3000E Patient Monitor is intended for use in hospital-type and hospital transport environments as a "standalone" product and when connected to the N-3200 display/printer and/or the N-3100 blocd pressure monitor. It is also intended for use to monitor neonatal, pediatric, or adult patients. The N-3000E. N-3200 and N-3100 are for prescription use only. The N-3000E, the N-3000E connected to the N-3200, the N-3000E connected to the N-3100 and the N-3000E connected to both the N-3200 and N-3100 have the following similar intended uses to the precicate devices, in terms of function/purpose, environment of use and patient population: Datascope PASSPORT - pulse oximetry, ECG, NIBP, display/printing functions; hospital and hospital-type environments; adult/pediatric patients Protocol Systems PROPAQ 104 - pulse oximetry, ECG, NIBP, display/printing functions; hospital, hospital-type, environments; aduit/pediatric patients NELLCOR SYMPHONY™ N-3000 Pulse Oximeter - pulse oximetry function; hospital, hospital-type; adult/pediatric/reonate patients NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor, standalone and in combination with the NELLCOR SYMPHONY™ N-3000 Pulse Oximeter, pulse oximetry, NIBP functions; hospital, hospital-type environments; adult/pediatric/ neonate patients. The N-3000E. N-3200 and N-3100 differ from the Datascope PASSPORT and Protocol Systems PROPAQ 104 in having fewer measurement/monitoring parameters available. They also differ in that they include neonates in their intended patient population but do not include home or mobile environments. The N-3000E/N-3200/N-3100 devices have the same patient population as the predicate N-3000 pulse oximeter and predicate N-3100 blood pressure monitor, including adult, pediatric and neonate patients. They differ only in that they feature ECG as an additional measurement parameter and include a display/printer function, but do not include home or mobile environments.
Product codes
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Device Description
Intrinsic electrocardiac signals are collected by conventional patient surface electrodes and conducted via a 3-lead ECG lead set and cable to the N-3000E's ECG processing module. These signals then undergo amplification and noise filtering. A software algorithm operates on the processed ECG signal to identify sequential QRS complexes and, hence, determine heart rate for numerical presentation on the N-3000E's front panel display. The processed ECG signal may also be supplied to the N-3200 Display/Printer for graphical presentation and printout. The ECG module is designed to comply with the AAMI/ANSI EC-13 standard, with the exception of clause 3.2.6.1. Test results confirming compliance with this standard have been included in the 510(k) submission. The technological characteristics of the pulse oximetry function of the N-3000E are identical to those in the predicate N-3000 pulse oximeter. The same algorithm is used in both products. Testing has been conducted to confirm that modification of the N-3000 pulse oximeter to add an ECG function and access to the N-3200 display/printer have not affected the safety or effectiveness of the oximetry function of the N-3000E.
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
neonatal, pediatric, or adult patients
Intended User / Care Setting
hospital-type and hospital transport environments
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)
Safety and effectiveness of the N-3000E, alone and in combination with the N-3200 display/printer and/or the N-3100 blood pressure monitor, have been confirmed by complying with the requirements of the Reviewer Guidance for Premarket Notification Submissions, November 1993, through design, testing and labeling.
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.
Not Found
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
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
ATTACHMENT 7
1 2 1906
510(k) SUMMARY, REVISED
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(f) Intended Use:
The purpose and function of the N-3000E Patient Mcnitor is to: -
noninvasively and continuously monitor functional arterial oxygen saturation and . pulse rate (using an accessory SpO2 sensor);
-
noninvasively and continuously monitor ECG and heart rate (using accessory . ECG leads).
When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to:
-
display and print out associated ECG and Plethysmograhic waveforms, SpO2, . pulse rate and heart rate.
When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000E/N-3100/N-3200 is aiso to: -
noninvasively and automatically measure systclic, diastolic and mean arterial . blood pressure and to derive pulse rate from these measurements (using accessory blood pressure cuffs); and display and print out systolic, diastolic and mean arterial blood pressure (on the N-3200 disclay/printer)
When the N-3100 is connected to the N-3200 Display/Printer, the purpose and function of the combined device (compared to K945947) is expanded to: -
display and print out associated. pulse rate and systolic, diastolic and mean . arterial blood pressure.
The N-3000E Patient Monitor is intended for use in hospital-type and hospital transport environments as a "standalone" product and when connected to the N-3200 display/printer and/or the N-3100 blocd pressure monitor. It is also intended for use to monitor neonatal, pediatric, or adult patients. The N-3000E. N-3200 and N-3100 are for prescription use only.
The N-3000E, the N-3000E connected to the N-3200, the N-3000E connected to the N-3100 and the N-3000E connected to both the N-3200 and N-3100 have the following similar intended uses to the precicate devices, in terms of function/purpose, environment of use and patient population:
Datascope PASSPORT - pulse oximetry, ECG, NIBP, display/printing functions; hospital and hospital-type environments; adult/pediatric patients
Protocol Systems PROPAQ 104 - pulse oximetry, ECG, NIBP, display/printing functions; hospital, hospital-type, environments; aduit/pediatric patients
NELLCOR SYMPHONY™ N-3000 Pulse Oximeter - pulse oximetry function; hospital, hospital-type; adult/pediatric/reonate patients
1
NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor, standalone and in combination with the NELLCOR SYMPHONY™ N-3000 Pulse Oximeter, pulse oximetry, NIBP functions; hospital, hospital-type environments; adult/pediatric/ neonate patients.
The N-3000E. N-3200 and N-3100 differ from the Datascope PASSPORT and Protocol Systems PROPAQ 104 in having fewer measurement/monitoring parameters available. They also differ in that they include neonates in their intended patient population but do not include home or mobile environments.
The N-3000E/N-3200/N-3100 devices have the same patient population as the predicate N-3000 pulse oximeter and predicate N-3100 blood pressure monitor, including adult, pediatric and neonate patients. They differ only in that they feature ECG as an additional measurement parameter and include a display/printer function, but do not include home or mobile environments.
(g) Technological Characteristics
Intrinsic electrocardiac signals are collected by conventional patient surface electrodes and conducted via a 3-lead ECG lead set and cable to the N-3000E's ECG processing module. These signals then undergo amplification and noise filtering. A software algorithm operates on the processed ECG signal to identify sequential QRS complexes and, hence, determine heart rate for numerical presentation on the N-3000E's front panel display. The processed ECG signal may also be supplied to the N-3200 Display/Printer for graphical presentation and printout. The ECG module is designed to comply with the AAMI/ANSI EC-13 standard, with the exception of clause 3.2.6.1. Test results confirming compliance with this standard have been included in the 510(k) submission.
The technological characteristics of the pulse oximetry function of the N-3000E are identical to those in the predicate N-3000 pulse oximeter. The same algorithm is used in both products. Testing has been conducted to confirm that modification of the N-3000 pulse oximeter to add an ECG function and access to the N-3200 display/printer have not affected the safety or effectiveness of the oximetry function of the N-3000E.
Safety and effectiveness of the N-3000E, alone and in combination with the N-3200 display/printer and/or the N-3100 blood pressure monitor, have been confirmed by complying with the requirements of the Reviewer Guidance for Premarket Notification Submissions, November 1993, through design, testing and labeling.