(333 days)
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No
The document describes a standard physiological monitor using respiration detection and ECG, with no mention of AI or ML in the device description, performance studies, or key metrics.
No.
The device is indicated for continuous monitoring of heart rate and respiration rate, not for providing therapy or treatment.
No
The device is a continuous monitor for heart rate and respiration rate, indicated for monitoring infants whose condition may lead to instability in these vital signs. It is designed to track physiological parameters, not to diagnose a particular disease or condition. While the information it provides can be used to inform diagnostic decisions, the device itself performs monitoring, not diagnosis.
No
The device description explicitly mentions hardware components such as electrodes, auxiliary inputs, and power sources (battery/AC), indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ami Infant Central Apnea/Heart Rate Monitor directly monitors physiological signals (heart rate and respiration rate) from the infant's body using electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use is for continuous monitoring of vital signs, not for analyzing biological samples.
Therefore, this device falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Use of the Ami Infant Central ApnealHeart Rate Monitor is indicated for the continuous monitoring of an infant's heart rate and respiration rate in a home, hospital or portable environment. Continuous monitoring is indicated for infants whose physical condition may result or has resulted in an instability in heart rate or respiration which may become detrimental to the infant. Conditions which may require monitoring include (not all inclusive):
- Prematurity
- Respiratory dysfunction
- Neurologic dysfunction
- Maternal drug abuse
- Cardiovascular dysfunction
Product codes
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Device Description
The Ami Infant Central ApnealHeart Rate Monitor is capable of monitoring an infant's respiratory and heart rates. The device utilizes respiration detection technology for respiratory effort detection and also detects ECG rate through the same two electrodes. The device also incorporates auxiliary inputs for recording stand-alone oximeter output parameters and/or other devices' signal outputs within specified parameters. The device operates off either battery of AC power.
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
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Indicated Patient Age Range
infant
Intended User / Care Setting
Home, hospital or portable environment
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
The Ami Infant Central AonealHeart Rate Monitor was subjected to detailed laboratory testing designed to fully exercise and evaluate device functionality, performance, safety and effectiveness under conditions such as the presence of electrostatic discharge (ESD), electric and magnetic field interference (EMI), mechanical vibration and shock, high and low temperature and humidity conditions.
Performance validation protocols and checklists were derived directly from the device specification to develop the test plan including all monitoring parameters. This laboratory testing utilized physiologic test simulators, test meters and other sophisticated electronic and mechanical measurement which was maintained under strict calibration control.
The user interface was also tested during this phase. The Ami Infant Central ApnealHeart Rate Monitor was found to meet all of the validation requirements verifying performance to the design specification.
Clinical evaluations were also conducted. The design of these studies assessed the performance and functionality of the Ami Infant Central Apnea/Heart Rate Monitor as compared to the predicate device, Aequitron Model 9550 and other reference monitors.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Laboratory Testing and Clinical Evaluations
Key Results: The Ami Infant Central ApnealHeart Rate Monitor was found to meet all of the validation requirements verifying performance to the design specification. The results of clinical studies further demonstrated the proper functionality, safety and effectiveness and substantial equivalence to the predicate device.
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.
Aequitron Medical, Inc. Model 9550 Cardiorespiratory Monitor
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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§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
1 4300 250 Ausmin North Minneapolis. Minnesota 55117 800.107.1979 612.557.8200 Fax 612.55, 9200
APR 1 8 1997
Image /page/0/Picture/3 description: The image shows the logo for Aequitron Medical. The logo is in black and white, with the word "AEQUITRON" in large, bold letters. Below the word "AEQUITRON" is the word "MEDICAL" in smaller letters. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
Contact Individual:
Robert C. Samec Vice President, Quality Assurance/Regulatory Affairs
Robert. Sauer
5-13-96 Date
510(k) SUMMARY
This summary of 510(k) Promarket Notification safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) and 21 CFR 807.92.
Device Name:
The proprietary name of the device to be introduced into interstate commerce by Aequitron Medical, Inc. is the Ami Infant Central AnnealHeart Rate Monitor.
Classification:
The Ami Infant Central Apnea/Heart Rate Monitor is classified as a "Breathing Frequency Monitor" (21 CFR 868.2375).
The device classification is Class II.
Predicate Device(s):
The Ami Infant Central Apnea/Heart Rate Monitor is substantially equivalent to the Aequitron Medical, Inc. Model 9550 Cardiorespiratory Monitor.
Device Description:
The Ami Infant Central ApnealHeart Rate Monitor is capable of monitoring an infant's respiratory and heart rates. The device utilizes respiration detection technology for respiratory effort detection and also detects ECG rate through the same two electrodes. The device also incorporates auxiliary inputs for recording stand-alone oximeter output parameters and/or other devices' signal outputs within specified parameters. The device operates off either battery of AC power.
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1
Indications for Use:
Use of the Ami Infant Central ApnealHeart Rate Monitor is indicated for the continuous monitoring of an infant's heart rate and respiration rate in a home, hospital or portable environment. Continuous monitoring is indicated for infants whose physical condition may result or has resulted in an instability in heart rate or respiration which may become detrimental to the infant. Conditions which may require monitoring include (not all inclusive):
Prematurity ●
- Respiratory dysfunction ●
- Neurologic dysfunction .
- Maternal drug abuse ●
- Cardiovascular dysfunction .
Description of Laboratory and Clinical Testing:
The Ami Infant Central AonealHeart Rate Monitor was subjected to detailed laboratory testing designed to fully exercise and evaluate device functionality, performance, safety and effectiveness under conditions such as the presence of electrostatic discharge (ESD), electric and magnetic field interference (EMI), mechanical vibration and shock, high and low temperature and humidity conditions.
Performance validation protocols and checklists were derived directly from the device specification to develop the test plan including all monitoring parameters. This laboratory testing utilized physiologic test simulators, test meters and other sophisticated electronic and mechanical measurement which was maintained under strict calibration control.
The user interface was also tested during this phase. The Ami Infant Central ApnealHeart Rate Monitor was found to meet all of the validation requirements verifying performance to the design specification.
Clinical evaluations were also conducted. The design of these studies assessed the performance and functionality of the Ami Infant Central Apnea/Heart Rate Monitor as compared to the predicate device, Aequitron Model 9550 and other reference monitors.
The results of these studies further demonstrated the proper functionality, safety and effectiveness and substantial equivalence to the predicate device.
Thomas J. Callister
(Division Sign-O
Division of Cardiovascular, Respiratory,
*Neurological Devices K961972