(172 days)
No
The description focuses on data synchronization, calculation of basic metrics (desaturations, pulse events), and report generation from pre-existing data. There is no mention of algorithms that learn or adapt from data.
No
The device is intended for reviewing and interpreting sleep data, not for providing treatment or therapy. It explicitly states that it does not suggest a course of treatment or generate a diagnosis.
No
The device is explicitly stated to not generate a diagnosis: "The report requires clinician interpretation of the results; it does not suggest a course of treatment or generate a diagnosis."
Yes
The device is explicitly described as "a software-only device" and "a standalone desktop software application" that processes data from separate hardware devices (Night Shift and pulse oximeter). While it interacts with hardware for data transfer and device settings, its core function and regulatory classification are based on the software component.
Based on the provided information, the Positional Sleep Assessment System (PoSAS) Software 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 (like blood, urine, or tissue) to provide information about a person's health.
- PoSAS Function: The PoSAS Software processes data from external devices (Night Shift and pulse oximeter) that measure physiological parameters (position, movement, sound, SpO2, pulse rate) directly from the patient's body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for accessing and interpreting previously recorded data related to sleep, snoring, and positional breathing events. This data is acquired non-invasively from the patient.
Therefore, the PoSAS Software falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Positional Sleep Assessment System (PoSAS) Software is a software-only device intended for use by healthcare professionals to access previously recorded data for review and interpretation of sleep length, sleep disruptions, snoring, and positional sleep disordered breathing events in adults. The PoSAS Software is used in healthcare facilities to generate sleep study reports from data obtained with the Night Shift and pulse oximeter devices; reports include sleep/wake, position, snoring, SpO2, pulse rate, pulse event (6 bpm change), and/or desaturation event information. The report requires clinician interpretation of the results; it does not suggest a course of treatment or generate a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The Positional Sleep Assessment System (PoSAS) Software is a standalone desktop software application that provides the capability to generate reports from the data acquired with the Advanced Brain Monitoring (ABM) Night Shift (K140190) and/or a pulse oximeter. The PoSAS Software is currently compatible with the Nonin WristOx> (model 3150) cleared in K102350.
The Night Shift is a small neck-worn device with software indicated for use in reporting position, movement, and sound so that positional changes in sleep quality and snoring can be assessed for adult patients only. The Nonin WrisOx₂ is a small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of adults and pediatric patients. The PoSAS Software is intended to be used in healthcare facilities (e.g. Clinician's office) to transfer and analyze data obtained with the Night Shift and WristOx2 by adult patient's in the home or sleep lab. The Night Shift uses a USB 2.0 data cable to transfer data via Standard USB 2.0 flash drive and the WristOx₂ uses a proprietary USB 2.0 data cable to transfer data via USB 2.0 Virtual COM Port.
Once the devices are recognized, the PoSAS Software graphical user interface (GUI) enables the user to synchronize the devices by writing the same computer date/time (down to the second) to each of the devices. The PoSAS Software also allows for the data to be erased from both the Night Shift and WristOx2 devices, and allows for the Night Shift device settings (I.e. Vibration feedback on, Vibration feedback off, or Trial mode) to be updated prior to recording.
Once the clock times from the two devices are synchronized, and the user has set the desired settings of the Night Shift device (i.e., identical to features available using Night Shift software), the Night Shift and WristOx2 are worn by a patient to record sleep study data. The PoSAS Software reads the study files and recognizes the respective clock times within each file, and aligns the data for generation of a PoSAS report.
The PoSAS Software report presents the Night Shift data, analyzed pulse oximeter data, and combines the positional data from the Night Shift with the analyzed results from the pulse oximetry data.
A PoSAS Software report can be generated either from the data saved on the connected Night Shift and pulse oximeter devices or from data saved to the hard disk of the personal computer. Data from the Night Shift is displayed on the PoSAS Software report without modification. The PoSAS Software calculates oximetry data based on the once per second SpO₂ and pulse data acquired by the pulse oximeter. 3% or 4% desaturations and pulse events (6 bpm change) are also calculated. The PoSAS software combines Night Shift position information with calculated oximetry data to present metrics based on the patient's position (supine or non-supine). A clinician's assessment of his/her patient's "Sleep Quality" is enabled by the PoSAS Report's inclusion of the following study metrics:
- recording time
- Sleep Time
- % Efficiency
- Wake After Sleep Onset (WASO)
- Awakenings
- Supine Time
- % Supine Time
- Overall Snoring > 50dB
- Supine Snoring > 50dB
- Non-supine Snoring > 50dB
- No. Supine Attempts
- Typical Feedbacks
- Minimum Feedbacks
- Maximum Feedbacks
- Graphical presentation of:
- Sleep/wake o
- о Position
- Snoring o
- Mean SpO2 O
- Minutes SpO2
§ 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
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: March 6, 2018
SUBMITTER:
Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 F 760.720.3337
PRIMARY CONTACT PERSON:
Daniela Soll Director, Regulatory Affairs & Quality Assurance Advanced Brain Monitoring, Inc.
SECONDARY CONTACT PERSON:
Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.
DEVICE:
TRADE NAME: Positional Sleep Assessment System (PoSAS) Software COMMON/USUAL NAME: PoSAS, PoSAS Software CLASSIFICATION NAMES: 868.2375 Breathing frequency monitor REVIEW PANEL: Anesthesiology PRODUCT CODE: MNR
PREDICATE DEVICE(S):
Apnea Risk Evaluation System (ARES) K112514
REFERENCE DEVICE(S):
1
Night Shift Software K140190
Sleep Profiler K153412
nVISION Data Management software K033307
DEVICE DESCRIPTION:
The Positional Sleep Assessment System (PoSAS) Software is a standalone desktop software application that provides the capability to generate reports from the data acquired with the Advanced Brain Monitoring (ABM) Night Shift (K140190) and/or a pulse oximeter. The PoSAS Software is currently compatible with the Nonin WristOx> (model 3150) cleared in K102350.
The Night Shift is a small neck-worn device with software indicated for use in reporting position, movement, and sound so that positional changes in sleep quality and snoring can be assessed for adult patients only. The Nonin WrisOx₂ is a small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of adults and pediatric patients. The PoSAS Software is intended to be used in healthcare facilities (e.g. Clinician's office) to transfer and analyze data obtained with the Night Shift and WristOx2 by adult patient's in the home or sleep lab. The Night Shift uses a USB 2.0 data cable to transfer data via Standard USB 2.0 flash drive and the WristOx₂ uses a proprietary USB 2.0 data cable to transfer data via USB 2.0 Virtual COM Port.
Once the devices are recognized, the PoSAS Software graphical user interface (GUI) enables the user to synchronize the devices by writing the same computer date/time (down to the second) to each of the devices. The PoSAS Software also allows for the data to be erased from both the Night Shift and WristOx2 devices, and allows for the Night Shift device settings (I.e. Vibration feedback on, Vibration feedback off, or Trial mode) to be updated prior to recording.
Once the clock times from the two devices are synchronized, and the user has set the desired settings of the Night Shift device (i.e., identical to features available using Night Shift software), the Night Shift and WristOx2 are worn by a patient to record sleep study data. The PoSAS Software reads the study files and recognizes the respective clock times within each file, and aligns the data for generation of a PoSAS report.
The PoSAS Software report presents the Night Shift data, analyzed pulse oximeter data, and combines the positional data from the Night Shift with the analyzed results from the pulse oximetry data.
A PoSAS Software report can be generated either from the data saved on the connected Night Shift and pulse oximeter devices or from data saved to the hard disk of the personal computer. Data from the Night Shift is displayed on the PoSAS Software report without modification. The
2
PoSAS Software calculates oximetry data based on the once per second SpO₂ and pulse data acquired by the pulse oximeter. 3% or 4% desaturations and pulse events (6 bpm change) are also calculated. The PoSAS software combines Night Shift position information with calculated oximetry data to present metrics based on the patient's position (supine or non-supine). A clinician's assessment of his/her patient's "Sleep Quality" is enabled by the PoSAS Report's inclusion of the following study metrics:
- Recording Time ●
- Sleep Time
- % Efficiency
- Wake After Sleep Onset (WASO)
- Awakenings
- Supine Time
- % Supine Time
- Overall Snoring > 50dB
- Supine Snoring > 50dB
- Non-supine Snoring > 50dB
- No. Supine Attempts
- Typical Feedbacks
- Minimum Feedbacks
- Maximum Feedbacks
- Graphical presentation of:
- Sleep/wake o
- о Position
- Snoring o
- Mean SpO2 O
- Minutes SpO2 50dB
• Supine Snoring > 50dB
• Non-supine Snoring > 50dB
• No. Supine Attempts
• Typical Feedbacks
• Minimum Feedbacks
• Maximum Feedbacks
Graphical presentation of:
• Sleep/wake
• Position
• Snoring | Calculated and reported:
• Recording time
• Sleep Time
• % Sleep Efficiency
• Measures of sleep/wake
• Supine Time
• % Supine Time
• % time by sleep stage
• % Time Snoring > 30dB,
40dB, and 50dB
• Overall, Supine, Non-
Supine, and REM Apnea
Index and AHI
Graphical presentation of:
• Sleep/wake
• Head position
• Snoring
• Sleep disordered breathing
events
• Pulse rate with arousal
indicators
• SpO₂ | Equivalent. The PoSAS Software
reports are similar in content to
the ARES predicate device and
identical to that of the reference
Night Shift software for display
of data calculated by Night Shift
firmware. |
7
| Specification | Proposed Device: | Predicate Device: | Discussion Differences |
|---|---|---|---|
| PoSAS Software (K172799) | ARES (K112514) | ||
| Data Analyzed | |||
| and Displayed | |||
| on Report | Transfer pulse and SpO2 data | ||
| file from oximeter via USB and | |||
| process and analyze data for | |||
| report. | Equivalent. PoSAS analyzes and | ||
| reports on the SpO2 and pulse | |||
| rate signals in the same manner | |||
| as the ARES. The analysis and | |||
| reporting of SpO2 and pulse rate | |||
| use identical algorithms to the | |||
| reference Sleep Profiler | |||
| software. The PoSAS uses the | |||
| sleeping position from the Night | |||
| Shift to derive positional-related | |||
| SpO2 and Pulse measures. | |||
| • Mean SpO2 | |||
| • Minutes SpO2 |