(102 days)
No
The document describes "automatic scoring performed by the Noxturnal application" and compares it to manual scoring, but it does not explicitly mention the use of AI or ML algorithms for this automatic scoring. The focus is on signal recording and analysis, which can be done with traditional algorithms.
No.
The device is intended for ambulatory recording and analysis of physiological signals during sleep, specifically for patients suspected of Sleep Disordered Breathing or Periodic Limb Movement Disorder, but it is explicitly stated that it is "NOT intended for any patient monitoring or automatic diagnosis." This indicates it's a diagnostic tool, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "The Nox T3 device is intended for ambulatory recording of physiological signals during sleep." It also clarifies that "The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 application (Noxturnal)." This process of recording and analyzing physiological signals for the purpose of identifying conditions like Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD) is an act of diagnosis. While it states that the system is "NOT intended for any patient monitoring or automatic diagnosis," the ability to record signals for analysis by a clinician or trained technician ultimately serves a diagnostic purpose.
No
The device description explicitly states that the Nox T3 system includes a recording device, respiratory effort sensors, clip straps, filter tube connector, and a USB cable, in addition to the Nox T3 application (Noxturnal). This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the Nox T3 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing substances like blood, urine, tissue, etc.
- Nox T3 Function: The Nox T3 device is an ambulatory recording system that records physiological signals from the patient's body during sleep. It measures things like respiratory effort, pressure, acceleration, and audio.
- Intended Use: The intended use is for recording physiological signals for viewing and analysis to help identify patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD). This is a diagnostic aid based on in vivo (within the body) measurements, not in vitro analysis of specimens.
- No Specimen Analysis: The description does not mention the collection or analysis of any biological specimens.
Therefore, the Nox T3 device falls under the category of a medical device that performs physiological measurements in vivo, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 application (Noxturnal). The Nox T3 system is indicated for use in patients greater than 2 years of age.
The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis.
The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home.
The Nox T3 system is used for patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD).
Product codes
MNR
Device Description
The Nox T3 is an ambulatory recording system. It includes a recording device, respiratory effort sensors, clip straps, filter tube connector and an USB cable for data download and the Nox T3 application (Noxturnal).
The Nox T3 device is a pocket size battery powered digital recorder that incorporates electronics to record and store up to three nights of physiological parameters. The Nox T3 device is worn on the patient's chest by snapping it to the thoracic respiratory effort sensor belt and securing its position with the clip straps. It has a display for status indication, signal integrity and preliminary results, and buttons for control.
The Nox T3 device records signals from five external sensors and three built-in sensors. The external sensors that can be used with the device are abdominal and thoracic respiratory effort sensors, oximeter (via wireless transmission), and two leads of the following: ECG, EMG, EEG or EOG. The built-in sensors include a pressure transducer allowing either recording of nasal pressure (via nasal cannula) or mask pressure and measuring of snoring, a three dimensional acceleration sensor for measure of patient's position and activity, and a microphone for true audio recording capabilities.
The Nox T3 device includes a class II Bluetooth transmitter/receiver to allow for wireless transmission of data from Nonin’s Model 4100 Patient Oximeter Module.
The Nox T3 application (Noxturnal) is used to configure the device for recording, and downloading, viewing and analyzing of recorded data on a PC.
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
The Nox T3 system is indicated for use in patients greater than 2 years of age.
Intended User / Care Setting
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home.
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
The recordings used consisted of 1057 Embla N7000 recordings which had all gone through the process of being manually scored by Sleep Technicians with RPSGT certification, and then reviewed by a Physician.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Nox T3 system has been tested and verified in various phases to include internal testing, verification and validation as well as external testing to assure product safety, effectiveness and reliability.
The design was verified and validated throughout the design process according to requirement specifications and intended use. Risk analysis was performed according to ISO 14971:2007, appropriate measures were implemented and their effectiveness verified and validated.
External test house was used to conduct testing needed to comply with applicable standards reqarding EMC and patient safety as well as additional RF testing to assure compliance to FCC requirements for R&TTE (The Radio and Telecommunications Terminal Equipment Directive) approval.
The general process from configuration of device to reading out the results and generating report was validated by having untrained person perform this actions. The results demonstrates that the Nox T3 system has meet its objective of being easy to operate, the Noxturnal interface guides the user appropriately, minimizing the likelihood of errors and lapses, and the design of the Nox T3 components and user instruction allows the hook-up to be performed by untrained people.
The signals recorded with the Nox T3 system were compared to signals recorded with the predicate device Embla N7000. The result demonstrates the reliability and usability of all signals recorded with the Nox T3 system.
Analysis comparison was performed to validate the quality of the automatic scoring performed by the Noxturnal application compared to manual scoring of full PSG data. The validation study focused on the comparison of the Apnea Hypopnea Index (AHI) values and the Oxygen Desaturation Index (ODI) values. The recordings used consisted of 1057 Embla N7000 recordings which had all gone through the process of being manually scored by Sleep Technicians with RPSGT certification, and then reviewed by a Physician.
The analysis comparison result demonstrates that the Noxturnal application scores AHI and ODI events in a substantially equivalent manner to the manual scoring on full PSG recordings obtained using Embla N7000 recorders.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Embla N7000 from Medcare Flaga K024322, Compass M10 from Medcare Flaga K041724, 4100 Patient Oximeter Module from Nonin Medical Inc. K043359
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains a sequence of characters that appear to be handwritten. The characters are 'K0821113'. The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses. The overall impression is that of a handwritten code or identifier.
Nox Medic
Nox Medical • Impra Keldnaholti • It 112 Reykjavik • Iceland • Tel.: • 354 570 7111 • www.noxmedical.com
510(k) Summary
Submitter
NOV - 7 2008
Nox Medical Keldnaholti IS-112 Reykjavik Iceland
Tel: 011 354 522 9000 Fax: 011 354 522 9111
Registration Number: Nox Medical will register following FDA clearance
Contact person
Kolbrun E Ottosdottir Keldnaholti IS-112 Reykjavik Iceland Email: keo@noxmedical.com Direct tel: 011 354 522 9140
Preparation Date
July 25, 2008
Device
| Trade Name: | Nox T3 |
|---|---|
| Common Name: | Sleep Recorder |
| Classification Name: | Ventilatory Effort Recorder |
| Regulation Number: | 868.2375 |
| Product Code: | MNR |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |
Predicate Devices
Embla N7000 from Medcare Flaga Product Code: MNR 510(k) Number: K024322
Compass M10 from Medcare Flaga Product Code: MNR 510(k) Number: K041724
4100 Patient Oximeter Module from Nonin Medical Inc. Product Code: DQA 510(k) Number: K043359
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K082113". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.
nox Medical
Nox Medical・Impra Keldnaholti・IS 112 Reykjavík・Iceland・Tel.: +354 570 7100・Fax: +354 570 711 ・www.noxmedical.com
Device Description
The Nox T3 is an ambulatory recording system. It includes a recording device, respiratory effort sensors, clip straps, filter tube connector and an USB cable for data download and the Nox T3 application (Noxturnal).
The Nox T3 device is a pocket size battery powered digital recorder that incorporates electronics to record and store up to three nights of physiological parameters. The Nox T3 device is worn on the patient's chest by snapping it to the thoracic respiratory effort sensor belt and securing its position with the clip straps. It has a display for status indication, signal integrity and preliminary results, and buttons for control.
The Nox T3 device records signals from five external sensors and three built-in sensors. The external sensors that can be used with the device are abdominal and thoracic respiratory effort sensors, oximeter (via wireless transmission), and two leads of the following: ECG, EMG, EEG or EOG. The built-in sensors include a pressure transducer allowing either recording of nasal pressure (via nasal cannula) or mask pressure and measuring of snoring, a three dimensional acceleration sensor for measure of patient's position and activity, and a microphone for true audio recording capabilities.
The Nox T3 device includes a class II Bluetooth transmitter/receiver to allow for wireless transmission of data from Nonin´s Model 4100 Patient Oximeter Module.
The Nox T3 application (Noxturnal) is used to configure the device for recording, and downloading, viewing and analyzing of recorded data on a PC.
Intended Use
The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 application (Noxturnal). The Nox T3 system is indicated for use in patients greater than 2 years of age.
The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis.
The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home.
The Nox T3 system is used for patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD).
Technological Characteristics
The comparison table below is provided as a summary of the most relevant characteristics of the Nox T3 system relative to the predicate devices. The comparison table demonstrates that the Nox T3 system has no significant differences from the predicate devices for the intended use that would adversely affect product safety and effectiveness.
2
■ ПОХ 【 П Ре С | C | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
able 1 Substantial Equivalence Summ
| Characteristic | Embla N7000
(K024322) | Compass M10 System
(K962865) | 4100 Patient Oximeter Module
(K043359) | Nox T3 System |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Embla N7000 is intended for use
by a physician or trained technician
for the acquisition of EEG and
polysomnography (PSG) signals and
transmission of these signals to a PC
during neurophysiologic or sleep
examinations. | General
The intended use of the Compass
M10 system is to record physiological
signals during sleep, scan the signals
for abnormalities and represent the
count of abnormal events in a form
of a summary report. The results of
the scan may be manually
overwritten or corrected by the
physician. The device is intended for
use as a screening device to
determine the need for clinical
diagnosis and evaluation by
polysomnography based on the
patient's count of abnormal events.
It is not intended for any diagnosis.
It is not intended to be a monitor. | The Nonin's Bluetooth® enabled
Model 4100 Patient Oximeter Module
is indicated for use in measuring and
transmitting functional oxygen
saturation of arterial hemoglobin
(SpO2), pulse rate, and
plethysmographic data to a
compatible Bluetooth® enabled
device. | The Nox T3 device is intended for
ambulatory recording of physiological
signals during sleep. The recorded
signals are then downloaded to a PC
where the signals can be viewed and
analyzed by use of the Nox T3
application (Noxturnal).
The Nox T3 system is NOT intended
for any patient monitoring or
automatic diagnosis. |
| Intended Environments | The intended environments are
hospitals, institutions, sleep centers,
sleep clinics, or other test
environments. | Not defined | Not defined | The Intended environments are
hospitals, institutions, sleep centers,
sleep clinics, or other test
environments, including patient's
home. |
| Patient Population | Not defined | The Compass M10 system is intended
to be used for adult and pediatric
patients. | Not defined | The Nox T3 system is indicated for
use in patients greater than 2 years
of age. |
| Prescription Use | Yes | Yes | Yes | Yes |
| Standards/Listing/Registrations | | | | |
| IEC60601-1:1988 | Yes | Yes | Yes | Yes |
| IEC60601-1-2:2001 | Yes | Yes | Yes | Yes |
| IEC 60601-2-25:1993 | Yes | NA | NA | Yes |
| IEC 60601-2-26: 2002 | Yes (1994 version) | NA | NA | Yes |
| IEC 60601-2-40: 1998 | Yes | NA | NA | Yes |
| Characteristic | Embla N7000
(K024322) | Compass M10 System
(K962865) | 4100 Patient Oximeter Module
(K043359) | Nox T3 System |
| 47 CFR Part 15 | NA | NA | Yes | Yes |
| FCC registration | NA | NA | Yes | Yes |
| Bluetooth EPL | NA | NA | Yes | Yes |
| Case Material | ABS Plastic (Patient Unit) | ABS Plastic and Aluminum | NA | ABS Plastic |
| RIP Belts Material | Polyester, latex free | Polyester, latex free | NA | Polyester, latex free |
| Dimension | 80mm (2.5") W
111mm (4.9") H
18.5mm(0.8") D
(Patient Unit) | 65mm (2.5") W
124mm (4.9") H
20mm(0.8") D | NA | 79mm (3.11") W
63mm (2.48")H
21mm(0.83") D |
| Weight | 280g (Patient Unit) | 100g | NA | 65g |
| Disposable Components | Disposable respiratory effort
sensor/RIP belts.
Nasal cannula
Remaining components require
cleaning. | Disposable respiratory effort
sensor/RIP belts.
Remaining components require
cleaning. | NA | Disposable respiratory effort
sensor/RIP belts.
Filter tube connector
Remaining components require
cleaning. |
| Acquisition units | Three units | One unit | NA | One unit |
| Number of channels | Seven channels (Patient Unit).
40 channels (Bedside Unit).
Eight auxiliary channels
(Communication Unit). | Five channels. | NA | Eight channels. |
| Recording time | Unlimited | Up to 12 hours | NA | Up to 24 hours |
| Control | Data acquisition and data storage
microprocessor controlled
Acquisition parameters set from
application SW | Data acquisition and data storage
microprocessor controlled
Acquisition parameters set from
application SW | NA | Data acquisition and data storage
microprocessor controlled
Acquisition parameters set from
application SW |
| Device Data Storage | No | Yes | NA | Yes |
Section 5 - Page 3 of 8
510(k) Summary
3
Nox Medical.
■ NOX 【 】 LE di C 【 】 【 】 【 】 【 】 】 】 【 】 】 】 】 】 【 】 】 】 【 】 【 】 】 】 【 】 【 】 】 【 】 】 【 】 】 】 【 】 】 】 【 】 】 】 【 】 】 】 【 】 】 】 【 】 】 】 【 】 】 】 【 】 】 】 】 【 】 】 】 【 】 】 】 】 【 】
KO82113
510(k) Summary
4
| medicar | |
|---|---|
| ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | |
| X | |
| ﻟ | |
| l |
Nox Medical · Impra Keldnaholti · Is 112 Reykjavik · Iceland · Tel. +354 570 7111 · www.noxmedical.com
| Characteristic | Embla N7000
(K024322) | Compass M10 System
(K962865) | 4100 Patient Oximeter Module
(K043359) | Nox T3 System |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interface (PC) | Ethernet | USB v1.1 | NA | USB v2.0 |
| Connection to Patient | RIP belts for respiratory effort
Probes or Flexi Wrap for oximetry
Plastic tubing and cannula for
pressure sensing
Touch proof electrode cables
Thermistor
Snore Sensor
Piezo belts for respiratory effort
Elastic cloth material for support of
device | RIP belts for respiratory effort
Probes or Flexi Wrap for oximetry
Elastic cloth material for support of
device | NA | RIP belts for respiratory effort
Probes or Flexi Wrap for oximetry
Plastic tubing and cannula for
pressure sensing
Touch proof electrode cables
RIP belts for attaching of device and
clip straps to secure position of
device |
| Signals Recorded | Respiratory Effort (Abdomen and
Thorax)
Body position
Activity
Oxygen Saturation
Pulse
Nasal/mask pressure
Airflow
Snore
Respiratory sound
EEG, EOG, EMG, ECG | Signals and Sensors
Respiratory Effort (Abdomen and
Thorax)
Body position
Activity
Oxygen Saturation
Pulse | NA | Respiratory Effort (Abdomen and
Thorax)
Body position
Activity
Oxygen Saturation
Pulse
Nasal/mask pressure
Airflow
Snore
Respiratory sound
EEG, EOG, EMG, ECG |
| Sensor Technology used
in/with the system | Solid state pressure sensor
Solid state position/activity sensor
Respiratory Effort Sensors (RIP
technology)
Oximetry | Solid state position/activity sensor
Respiratory Effort Sensors (RIP
technology)
Oximetry | NA | Solid state pressure sensor
Solid state position/activity sensor
Respiratory Effort Sensors (RIP
technology)
Oximetry |
| Characteristic | Embla N7000
(K024322) | Compass M10 System
(K962865) | 4100 Patient Oximeter Module
(K043359) | Nox T3 System |
| Microphone | Gold cup electrodes
Ag/AgCL electrodes
Piezobelts for respiratory effort
Thermistor
Piezo snoring sensor | | | Microphone
Gold cup electrodes
Ag/AgCL electrodes |
| Power Source | 115/230V AC | Power and Isolation
3V by 2 AA batteries (Data
Acquisition) | Two 1.5V AA batteries | 1.5V by 1 AA battery (Data
Acquisition) |
| Patient Isolation | Isolation between mains and applied part | Host PC (Data Transfer)
Device has no galvanic connections
to mains as it is a battery operated
device | Device has no galvanic connections
to mains as it is a battery operated
device | Host PC (Data Transfer)
Device has no galvanic connections
to mains as it is a battery operated
device |
| | | Not possible to connect auxiliary
devices to the device | Not possible to connect auxiliary
devices to the device | Not possible to connect auxiliary
devices to the device |
| | | Transmitter | | |
| RF Data Transfer | No | No | Bluetooth wireless technology | Bluetooth wireless technology |
| Bluetooth Specification | NA | NA | Version 1.1 | Version 2.0 |
| RF Operating frequency | NA | NA | 2.4-2.4835 GHz | 2.4-2.4835 GHz |
| RF Emissions CISPR 11 | NA | NA | Group 2 | Group 2 |
| | | | Class B | Class B |
| Output power | NA | NA |