(150 days)
No
The summary explicitly states "ApneaTrak is NOT intended to perform automatic diagnosis" and describes the device as acquiring, recording, storing, and transmitting data for viewing and review by qualified medical personnel. There is no mention of AI/ML in the device description, performance studies, or key metrics.
No
The device is described as a "sleep diagnostic system" intended for "home sleep testing" and to "acquire, record, store, and transfer" physiological data. It explicitly states, "ApneaTrak is NOT intended to perform automatic diagnosis." There is no indication that it provides any form of treatment.
Yes
The device is intended for home sleep testing, including the acquisition of physiological and environmental data, and helps in the diagnosis of sleep disorders, specifically Sleep Disordered Breathing (SDB).
No
The device description explicitly states that the system consists of acquisition hardware, a host electronic device (PC), and software. The performance studies also detail testing of hardware components like ExG, Pulse Oximetry, and various airflow/respiratory channels.
Based on the provided information, the Cadwell ApneaTrak 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 to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing substances like blood, urine, tissue, etc.
- ApneaTrak's Function: The ApneaTrak device acquires physiological and environmental data from the patient's body (ExG, respiratory effort, thermistor, pressure, snore, oximetry). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for home sleep testing and the acquisition of data for review by qualified medical personnel to assess sleep disorders. This is a diagnostic process, but it's based on in vivo (within the body) measurements, not in vitro analysis of specimens.
Therefore, the Cadwell ApneaTrak is a medical device used for physiological data acquisition and monitoring, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cadwell ApneaTrak device is intended for home sleep testing, including the acquisition of physiological and environmental data. The recorded signals are then transmitted to a PC so that they can be viewed. ApneaTrak is intended for use on patients older than 2 years of age.
ApneaTrak is intended for use in hospitals, sleep centers and other sleep testing environments, including the patient's home. ApneaTrak is intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel. ApneaTrak is NOT intended to perform automatic diagnosis.
Product codes
OLV, MNR
Device Description
Cadwell's ApneaTrak is a sleep diagnostic system consisting of: (1) acquisition hardware that can acquire, record, store, and transfer up to 3 channels of ExG (including EEG, EMG, ECG, and EOG signals) data, 2 respiratory effort channels, 1 thermistor channel, 1 pressure channel, 1 snore channel, and 1 oximetry channel; (2) a host electronic device (typically a PC) capable of running the software as well as charging and interfacing with the acquisition device; and (3) software that allows for device configuration and data download.
ApneaTrak is connected, by a clinical user, to a host device via USB cable for initialization. After initialization and having been given instruction on correct clinical use of the device, ApneaTrak is then used by the patient at home. The device acquires and stores physiological and/or environmental data to onboard memory. After use, the device is returned to the clinical user, who connects the device to the host PC. The software downloads and stores data from the device in European Data Format (EDF).
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
patients older than 2 years of age
Intended User / Care Setting
Intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel.
Intended for use in hospitals, sleep centers and other sleep testing environments, including the 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: The ApneaTrak was tested in accordance with internal software requirements, system requirements, and usability requirements as a result of the risk analysis External tests have been completed for electrical safety and EMC as indicated above. In addition, bench testing results are summarized below to demonstrate the ApneaTrak complies with its predetermined specifications and accurately captures each biologically relevant signal being collected by the predicate devices.
- ExG: ExG functionality of the subject device is validated by complying with essential performance requirements from the following standards: IEC 60601-2-26 and IEC 60601-2-40. All tests results demonstrate compliance with the standards.
- Pulse Oximetry: The pulse oximetry functionality of the subject device is validated by complying with ISO 80601-2-61 Particular requirements for pulse oximeters. All tests results demonstrate compliance with the standard.
- Respiratory Effort: A known oscillating input signal was injected into the respiratory channel of the subject device. The input and output data were plotted and quantitatively compared. Passing result based on high measure of equivalence between input and output signals.
- Airflow - Pressure: A known oscillating input signal was input to the airflow pressure channel of the subject device. The input and output data were plotted and quantitatively compared. Passing result based on high measure of equivalence between input and output signals.
- Airflow - Thermal: A known oscillating input signal was input to the airflow thermal channel of the subject device. The input and output data were plotted and quantitatively compared. Passing result based on high measure of equivalence between input and output signals.
- Snore: A known oscillating input signal was input to the snore channel of the subject device. The input and output data were plotted and quantitatively compared. Passing result based on high measure of equivalence between input and output signals.
All tests confirm the ApneaTrak meets the requirements for both the external tests and performance bench tests. Cadwell Industries, Inc has determined the ApneaTrak is Substantially Equivalent to the predicate devices.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the ApneaTrak. The results of these activities demonstrate that the ApneaTrak is as safe, as effective, and performs as well as or better than the predicate devices. Therefore, the ApneaTrak is considered substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cadwell Industries, Inc. Mr. James Blevins Product Manager - Sleep 909 N. Kellogg Street Kennewick, Washington 99336
Re: K192624
Trade/Device Name: ApneaTrak Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV, MNR Dated: January 7, 2020 Received: January 21, 2020
Dear Mr. James Blevins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192624
Device Name ApneaTrak
Indications for Use (Describe)
The Cadwell ApneaTrak device is intended for home sleep testing, including the acquisition of physiological and environmental data. The recorded signals are then transmitted to a PC so that they can be viewed. ApneaTrak is intended for use on patients older than 2 years of age.
ApneaTrak is intended for use in hospitals, sleep centers and other sleep testing environments, including the patient's home. ApneaTrak is intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel. ApneaTrak is NOT intended to perform automatic diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter: | Cadwell Industries, Inc.
909 N. Kellogg Street
Kennewick, Washington 99336
509-735-6481 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Blevins
Email: jamesbl@cadwell.com |
| Date Prepared: | September 20, 2019 |
| Trade Name: | ApneaTrak |
| Regulation Name: | Standard Polysomnograph with Electroencephalograph |
| Regulation Number: | 21 CFR 882.1400 |
| Regulatory Classification: | Class II |
| Product Codes: | OLV, MNR |
| Classification Panel: | Neurology |
| Predicate Device: | Primary Predicate:
Zmachine Synergy Sleep Monitoring System from Consolidated Research of Richmond, Inc.
Product Code: OLV, OMC, MNR
510(k) Number: K172986
Reference Predicate:
Nox T3 Sleep Recorder from Nox Medical
Product Code: MNR
510(k) Number: K082113 |
| Device Description: | Cadwell's ApneaTrak is a sleep diagnostic system consisting of: (1) acquisition hardware that can acquire, record, store, and transfer up to 3 channels of ExG (including EEG, EMG, ECG, and EOG signals) data, 2 respiratory effort channels, 1 thermistor |
channel, 1 pressure channel, 1 snore channel, and 1 oximetry channel; (2) a host electronic device (typically a PC) capable of running the software as well as charging
510(k) Summary
4
VELL
510(k) Summary
and interfacing with the acquisition device; and (3) software that allows for device configuration and data download.
ApneaTrak is connected, by a clinical user, to a host device via USB cable for initialization. After initialization and having been given instruction on correct clinical use of the device, ApneaTrak is then used by the patient at home. The device acquires and stores physiological and/or environmental data to onboard memory. After use, the device is returned to the clinical user, who connects the device to the host PC. The software downloads and stores data from the device in European Data Format (EDF).
Indications for The Cadwell ApneaTrak device is intended for home sleep testing, including the Use: acquisition of physiological and environmental data. The recorded signals are then transmitted to a PC so that they can be viewed. ApneaTrak is intended for use on patients older than 2 years of age.
ApneaTrak is intended for use in hospitals, sleep centers and other sleep testing environments, including the patient's home. ApneaTrak is intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel. ApneaTrak is NOT intended to perform automatic diagnosis.
5
510(k) Summary ு இ
The ApneaTrak employs the same technological characteristics as the predicate devices. Technology Comparison:
| | Zmachine Synergy
(K172986, Primary
Predicate) | Nox T3 Sleep Recorder
(K082113, Reference
Predicate) | Cadwell ApneaTrak
(Proposed Device) | Discussion of Differences |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General | | | |
| Product Codes | OLV, OMC, MNR | MNR | OLV, MNR | Equivalent |
| Classification
Regulation | 21 CFR 882.1400 | 21 CFR 868.2375 | 21 CFR 882.1400 | Equivalent |
| Population | Adults | Greater than 2 years of
age | Greater than 2 years of age | Differences in patient
population do not raise
concerns of safety or
effectiveness. |
| Prescription Use | Yes | Yes | Yes | Equivalent |
| Intended
Environments | Home or clinical
environment | Home or clinical
environment | Home or clinical environment | Equivalent |
| Indication for Use | The Zmachine Synergy
is an EEG and
respiratory signal
recorder. The device is
intended for use by
adult patients in the
home or clinical
environment, under the
direction of a qualified | 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 | The Cadwell ApneaTrak device
is intended for home sleep
testing, including the
acquisition of physiological and
environmental data. The
recorded signals are then
transmitted to a PC so that they
can be viewed. ApneaTrak is | The indications for use
between the proposed
device and the predicate
have no substantive
differences. |
| | healthcare practitioner,
to aid in the diagnosis
of sleep disorders. | (Nocturnal). 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 centers, sleep
clinics, or other test
environments,
including patient's
home. | intended for use on patients
older than 2 years of age.
ApneaTrak is intended for use
in hospitals, sleep centers and
other sleep testing
environments, including the
patient's home. ApneaTrak is
intended to be used when
prescribed by a qualified
healthcare provider for use on
patients suspected of sleep
disorders, specifically Sleep
Disordered Breathing (SDB)
and requires review by
qualified medical personnel.
ApneaTrak is NOT intended to
perform automatic diagnosis. | |
| | Physical | | | |
| Case Material | ABS Plastic | ABS Plastic | ABS Plastic | Equivalent |
| Dimension | 61mm (2.40") W
120mm (4.72) H
24mm (0.94") D | 80mm (2.5") W
111mm (4.9") H
18.5mm (0.8") D | 73mm (2.87") W
115mm (4.52") H
25mm (0.98") D | Differences in physical
dimension do not raise
concerns of safety or
effectiveness. |
| Weight | 86g | 280g | 143.5g | Differences in physical
dimension do not raise
concerns of safety or
effectiveness. |
| Functional | | | | |
| Acquisition Units | One unit | One unit | One unit | Equivalent |
| Number of Channel
Inputs | 6 | 7 | 8 | The proposed device has
2 additional EXG channel
inputs. These additional
EXG channels are
composed of the same
hardware and are
controlled in the same
manner as the other EXG
channels. As such,
whether the overall
number of EXG channels
is 2 or 3, the risk profile
of the device does not
change. Therefore, this
difference does not raise
concerns of safety or
effectiveness. |
| Recording Time | Up to 30 hours | Up to 24 hours | Up to 24 hours | Differences in recording
time do not raise concerns
of safety or effectiveness. |
| Data Storage | On-board storage | On-board storage | On-board storage | Equivalent |
| Data Interface (PC) | USB | USB | USB | Equivalent |
| Connections to
Patient | RIP belt for respiratory
effort | RIP belt for respiratory
effort | RIP or PVDF belts for
respiratory effort | All accessories are
previously cleared,
widely available medical
devices.
Differences do not raise
questions of safety and
effectiveness. |
| | Probes or Flexi wrap for
oximetry | Probes or Flexi wrap
for oximetry | Probes for oximetry | |
| | Plastic tubing and cannula
for pressure sensing | Plastic tubing and
cannula for pressure
sensing | Plastic cannula for pressure
sensing
Plastic snore microphone | |
| Display Type | LEDs on device for signal
check and device status | LCD on device for
signal check and device
status | LEDs on device for signal
check and device status | Equivalent |
| Signals and Sensors | | | | |
| Signals Recorded | Respiratory Effort
Body position
Activity
Oxygen Saturation
Pulse
Airflow
Snore
EEG | Respiratory Effort
(Abdomen and Thorax)
Body position
Activity
Oxygen Saturation
Pulse
Nasal/mask pressure
Airflow
Snore
EEG, EOG, EMG,
ECG
Respiratory sound | Respiratory Effort (Abdomen
and Thorax)
Body position
Activity
Oxygen Saturation
Pulse
Nasal/mask pressure
Airflow (Pressure and Thermal)
Snore
EEG, EOG, EMG, ECG | The addition of an
independent snore sensor
(both sensors derive snore
from the cannula as well)
and additional ExG inputs
(3 vs 1) do not raise
questions of safety or
effectiveness as the
channels are just
multiplied to meet clinical
user's needs.
Nasal/mask pressure is
the same as pressure-
based airflow and would
be equivalent in the
predicate despite not
being listed. |
| Sensor Technology | Solid state pressure
sensor
Solid state
position/activity sensor
Respiratory effort sensors
(RIP Technology)
Oximetry
Zmachine EEG
Technology | Solid state pressure
sensor
Solid state
position/activity sensor
Respiratory effort
sensors (RIP
technology)
Oximetry
Microphone
Gold cup electrodes
Ag/AgCL electrodes | Solid state pressure sensor
Solid state position/activity
sensor
Respiratory effort sensors (RIP
or PVDF technology)
Oximetry
Snore Microphone
Gold cup electrodes
Ag/AgCL electrodes | Equivalent
ApneaTrak uses common
ExG technology using
gold or Ag/AgCL cup
electrodes.
The predicate device uses
a snap style connector.
Electrode connection
styles do not raise
questions of safety or
effectiveness as they are |
| | | | | both used commonly in
the industry. |
| Power and Isolation | | | | |
| Power Source | Internally powered using
li-ion rechargeable battery | Internally powered
using AA disposable
battery | Internally powered using li-ion
rechargeable battery | Equivalent |
| Patient Isolation | Device has no galvanic
connections to mains
during operation as it is a
battery-operated device
Not possible to connect
auxiliary devices to the
device | Device has no galvanic
connections to mains
during operation as it is
a battery-operated
device
Not possible to connect
auxiliary devices to the
device | Device has no galvanic
connections to mains during
operation as it is a battery-
operated device
Not possible to connect
auxiliary devices to the device | Equivalent |
| | | Transmitter | | |
| RF Data transfer | None | Bluetooth wireless
technology | Bluetooth Transmitter
Equipped, but disabled | Bluetooth transmitter has
been included as part of
the ApneaTrak Hardware
but is disabled by
firmware/software at this
time and is not available
to the user. Bluetooth
functionality is subject to
future 510(k) clearance.
Equivalent currently. |
| Recorded Data | | | | |
| Access to recorded
data | Recorded data is stored in
the device. When the
device is connected to a
PC via USB cable the
device provides access to
its internal memory. | Recorded data is stored
in the device. When the
device is connected to a
PC via USB cable the
device provides access
to its internal memory. | Recorded data is stored in the
device. When the device is
connected to a PC via USB
cable the device provides
access to its internal memory. | Equivalent |
| Recorded data
format | Each channel of recorded
data is stored in an
individual file of the
GCS2 data format. | All channels of
recorded data are
stored in proprietary
data format. | All channels of recorded data
are stored in EDF data format. | GCS2 appears to be the
predicate device's
proprietary data format.
EDF is non-proprietary.
Data format does not
raise new concerns of
safety or effectiveness. |
| Device Initialization | Yes | Yes | Yes | Equivalent |
| Data Download | Yes | Yes | Yes | Equivalent |
6
TELL 510(k) Summary
7
VELL 510(k) Summary S
8
VELL 510(k) Summary S
9
VELL 510(k) Summary S
10
VELL 510(k) Summary
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Image /page/11/Picture/0 description: The image shows the logo for Cadwell. The logo consists of a stylized graphic to the left of the word "CADWELL" in all caps. To the right of the word "CADWELL" is a circled "R" which indicates that the name is a registered trademark. The number 5 is to the right of the logo.
510(k) Summary
Electrical The ApneaTrak was tested for safety and essential performance in accordance with the Safety: following safety standards:
- IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012 ●
- AAMI ES60601-1:2005 +C1+A2 [R2012] ●
- IEC 60601-2-40:2016
- IEC 60601-2-26:2012 ●
- ISO 80601-2-61:2017 ●
- IEC 60601-1-11:2015 ●
- IEC 60601-1-6:2013 ●
- IEC 62304:2006 + A1:2015 ●
Test results indicate that the ApneaTrak complies with the applicable standards.
Electromagnetic The ApneaTrak was tested for performance in accordance with the following Disturbances: standards:
- . IEC 60601-1-2:2014
Test results indicate that the ApneaTrak complies with the applicable standards.
Performance The ApneaTrak was tested in accordance with internal software requirements, system Testing: requirements, and usability requirements as a result of the risk analysis External tests have been completed for electrical safety and EMC as indicated above. In addition, bench testing results are summarized below to demonstrate the ApneaTrak complies with its predetermined specifications and accurately captures each biologically relevant signal being collected by the predicate devices.
| Test | Test Method Summary | Results |
|---|---|---|
| ExG | ExG functionality of the | |
| subject device is validated by | ||
| complying with essential | ||
| performance requirements from | ||
| the following standards: IEC | ||
| 60601-2-26 and IEC 60601-2- |
- | All tests results demonstrate
compliance with the
standards. |
| Pulse Oximetry | The pulse oximetry
functionality of the subject
device is validated by
complying with ISO 80601-2-
61 Particular requirements for
pulse oximeters | All tests results demonstrate
compliance with the standard. |
12
510(k) Summary
| Respiratory
Effort | A known oscillating input
signal was injected into the
respiratory channel of the
subject device. The input and
output data were plotted and
quantitatively compared. | Passing result based on high
measure of equivalence
between input and output
signals. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Airflow -
Pressure | A known oscillating input
signal was input to the airflow
pressure channel of the subject
device. The input and output
data were plotted and
quantitatively compared. | Passing result based on high
measure of equivalence
between input and output
signals. |
| Airflow -
Thermal | A known oscillating input
signal was input to the airflow
thermal channel of the subject
device. The input and output
data were plotted and
quantitatively compared. | Passing result based on high
measure of equivalence
between input and output
signals. |
| Snore | A known oscillating input
signal was input to the snore
channel of the subject device.
The input and output data were
plotted and quantitatively
compared | Passing result based on high
measure of equivalence
between input and output
signals. |
All tests confirm the ApneaTrak meets the requirements for both the external tests and performance bench tests. Cadwell Industries, Inc has determined the ApneaTrak is Substantially Equivalent to the predicate devices.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the ApneaTrak. The results of these activities demonstrate that the ApneaTrak is as safe, as effective, and performs as well as or better than the predicate devices.
Therefore, the ApneaTrak is considered substantially equivalent to the predicate devices.