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.

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).

AI/ML Overview

The provided document does not contain an acceptance criteria table detailing specific performance metrics and a study describing how the device meets those criteria with clinical data. Instead, it details that the ApneaTrak device underwent performance testing against recognized electrical safety, electromagnetic disturbance, and performance standards for its various signal acquisition functionalities.

The document indicates that the device's technical specifications and intended use are similar to predicate devices (Zmachine Synergy and Nox T3 Sleep Recorder). The testing primarily focuses on demonstrating compliance with standards and equivalence in signal acquisition performance through bench testing rather than a comparative effectiveness study involving human readers or a standalone algorithm-only performance study.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific performance thresholds for diagnostic accuracy (e.g., sensitivity, specificity for identifying sleep disorders) that the device must meet against a ground truth. Instead, it lists the following performance tests and their outcomes:

Test	Test Method Summary	Reported Device Performance (Results)
ExG	ExG functionality validated by complying with essential performance requirements from IEC 60601-2-26 and IEC 60601-2-40.	All test results demonstrate compliance with the standards.
Pulse Oximetry	Pulse oximetry functionality validated by complying with ISO 80601-2-61 Particular requirements for pulse oximeters.	All test 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.
Electrical Safety	Compliance with 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.	All test results demonstrate compliance with the applicable standards.
Electromagnetic	Compliance with IEC 60601-1-2:2014.	All test results demonstrate compliance with the applicable standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes "performance bench tests" where "a known oscillating input signal was injected" or "tested in accordance with internal software requirements, system requirements, and usability requirements." This implies laboratory-based testing with simulated data or controlled inputs rather than a clinical test set with patient data. Therefore, there is no sample size of patients or information on data provenance (country, retrospective/prospective) for a clinical test set provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Given the nature of the bench testing described (injecting known signals), the concept of "experts establishing ground truth for a test set" as typically understood in AI/clinical validation studies does not apply here. The ground truth for these tests was the "known oscillating input signal" or the performance requirements of the standards themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is mentioned, as the testing described focuses on device functionality and signal accuracy against known inputs or standards, not on diagnostic interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or reported in the provided document. The device is described as a data acquisition system for home sleep testing, and it "is NOT intended to perform automatic diagnosis." The focus is on accurate signal acquisition, not AI-assisted interpretation or improvement of human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe a standalone algorithm performance study. The device's purpose is to acquire and transmit physiological data for review by qualified medical personnel. It explicitly states, "ApneaTrak is NOT intended to perform automatic diagnosis."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench tests, the ground truth was known oscillating input signals or the defined specifications and requirements of the relevant IEC/ISO standards. For the purpose of regulatory substantial equivalence, the ground truth for the device's claims implicitly relies on the predicate devices and their established performance for similar data acquisition.

8. The sample size for the training set

No training set is mentioned as the document does not describe a machine learning or AI-based diagnostic algorithm that would require a training set. The device is an electrophysiological signal acquisition system.

9. How the ground truth for the training set was established

As no training set is discussed, this question is not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K192624

Device Name ApneaTrak

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the Cadwell logo. The logo consists of a circle with a stylized waveform inside, followed by the word "CADWELL" in bold, sans-serif font. A registered trademark symbol is present to the right of the word.

Submitter:	Cadwell Industries, Inc.909 N. Kellogg StreetKennewick, Washington 99336509-735-6481
Contact Person:	James BlevinsEmail: 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, MNR510(k) Number: K172986Reference Predicate:Nox T3 Sleep Recorder from Nox MedicalProduct Code: MNR510(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

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VELL

510(k) Summary

and interfacing with the acquisition device; and (3) software that allows for device configuration and data download.

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.

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510(k) Summary ு இ

The ApneaTrak employs the same technological characteristics as the predicate devices. Technology Comparison:

	Zmachine Synergy(K172986, PrimaryPredicate)	Nox T3 Sleep Recorder(K082113, ReferencePredicate)	Cadwell ApneaTrak(Proposed Device)	Discussion of Differences
	General
Product Codes	OLV, OMC, MNR	MNR	OLV, MNR	Equivalent
ClassificationRegulation	21 CFR 882.1400	21 CFR 868.2375	21 CFR 882.1400	Equivalent
Population	Adults	Greater than 2 years ofage	Greater than 2 years of age	Differences in patientpopulation do not raiseconcerns of safety oreffectiveness.
Prescription Use	Yes	Yes	Yes	Equivalent
IntendedEnvironments	Home or clinicalenvironment	Home or clinicalenvironment	Home or clinical environment	Equivalent
Indication for Use	The Zmachine Synergyis an EEG andrespiratory signalrecorder. The device isintended for use byadult patients in thehome or clinicalenvironment, under thedirection of a qualified	The Nox T3 device isintended forambulatory recordingof physiological signalsduring sleep. Therecorded signals arethen downloaded to aPC where the signalscan be viewed andanalyzed by use of theNox T3 application	The Cadwell ApneaTrak deviceis intended for home sleeptesting, including theacquisition of physiological andenvironmental data. Therecorded signals are thentransmitted to a PC so that theycan be viewed. ApneaTrak is	The indications for usebetween the proposeddevice and the predicatehave no substantivedifferences.
	healthcare practitioner,to aid in the diagnosisof sleep disorders.	(Nocturnal). The NoxT3 system is indicatedfor use in patientsgreater than 2 years ofage.The Nox T3 system isNOT intended for anypatient monitoring orautomatic diagnosis.The intendedenvironments arehospitals, institutions,sleep centers, sleepclinics, or other testenvironments,including patient'shome.	intended for use on patientsolder than 2 years of age.ApneaTrak is intended for usein hospitals, sleep centers andother sleep testingenvironments, including thepatient's home. ApneaTrak isintended to be used whenprescribed by a qualifiedhealthcare provider for use onpatients suspected of sleepdisorders, specifically SleepDisordered Breathing (SDB)and requires review byqualified medical personnel.ApneaTrak is NOT intended toperform automatic diagnosis.
	Physical
Case Material	ABS Plastic	ABS Plastic	ABS Plastic	Equivalent
Dimension	61mm (2.40") W120mm (4.72) H24mm (0.94") D	80mm (2.5") W111mm (4.9") H18.5mm (0.8") D	73mm (2.87") W115mm (4.52") H25mm (0.98") D	Differences in physicaldimension do not raiseconcerns of safety oreffectiveness.
Weight	86g	280g	143.5g	Differences in physicaldimension do not raiseconcerns of safety oreffectiveness.
Functional
Acquisition Units	One unit	One unit	One unit	Equivalent
Number of ChannelInputs	6	7	8	The proposed device has2 additional EXG channelinputs. These additionalEXG channels arecomposed of the samehardware and arecontrolled in the samemanner as the other EXGchannels. As such,whether the overallnumber of EXG channelsis 2 or 3, the risk profileof the device does notchange. Therefore, thisdifference does not raiseconcerns of safety oreffectiveness.
Recording Time	Up to 30 hours	Up to 24 hours	Up to 24 hours	Differences in recordingtime do not raise concernsof safety or effectiveness.
Data Storage	On-board storage	On-board storage	On-board storage	Equivalent
Data Interface (PC)	USB	USB	USB	Equivalent
Connections toPatient	RIP belt for respiratoryeffort	RIP belt for respiratoryeffort	RIP or PVDF belts forrespiratory effort	All accessories arepreviously cleared,widely available medicaldevices.Differences do not raisequestions of safety andeffectiveness.
	Probes or Flexi wrap foroximetry	Probes or Flexi wrapfor oximetry	Probes for oximetry
	Plastic tubing and cannulafor pressure sensing	Plastic tubing andcannula for pressuresensing	Plastic cannula for pressuresensingPlastic snore microphone
Display Type	LEDs on device for signalcheck and device status	LCD on device forsignal check and devicestatus	LEDs on device for signalcheck and device status	Equivalent
Signals and Sensors
Signals Recorded	Respiratory EffortBody positionActivityOxygen SaturationPulseAirflowSnoreEEG	Respiratory Effort(Abdomen and Thorax)Body positionActivityOxygen SaturationPulseNasal/mask pressureAirflowSnoreEEG, EOG, EMG,ECGRespiratory sound	Respiratory Effort (Abdomenand Thorax)Body positionActivityOxygen SaturationPulseNasal/mask pressureAirflow (Pressure and Thermal)SnoreEEG, EOG, EMG, ECG	The addition of anindependent snore sensor(both sensors derive snorefrom the cannula as well)and additional ExG inputs(3 vs 1) do not raisequestions of safety oreffectiveness as thechannels are justmultiplied to meet clinicaluser's needs.Nasal/mask pressure isthe same as pressure-based airflow and wouldbe equivalent in thepredicate despite notbeing listed.
Sensor Technology	Solid state pressuresensorSolid stateposition/activity sensorRespiratory effort sensors(RIP Technology)OximetryZmachine EEGTechnology	Solid state pressuresensorSolid stateposition/activity sensorRespiratory effortsensors (RIPtechnology)OximetryMicrophoneGold cup electrodesAg/AgCL electrodes	Solid state pressure sensorSolid state position/activitysensorRespiratory effort sensors (RIPor PVDF technology)OximetrySnore MicrophoneGold cup electrodesAg/AgCL electrodes	EquivalentApneaTrak uses commonExG technology usinggold or Ag/AgCL cupelectrodes.The predicate device usesa snap style connector.Electrode connectionstyles do not raisequestions of safety oreffectiveness as they are
				both used commonly inthe industry.
Power and Isolation
Power Source	Internally powered usingli-ion rechargeable battery	Internally poweredusing AA disposablebattery	Internally powered using li-ionrechargeable battery	Equivalent
Patient Isolation	Device has no galvanicconnections to mainsduring operation as it is abattery-operated deviceNot possible to connectauxiliary devices to thedevice	Device has no galvanicconnections to mainsduring operation as it isa battery-operateddeviceNot possible to connectauxiliary devices to thedevice	Device has no galvanicconnections to mains duringoperation as it is a battery-operated deviceNot possible to connectauxiliary devices to the device	Equivalent
		Transmitter
RF Data transfer	None	Bluetooth wirelesstechnology	Bluetooth TransmitterEquipped, but disabled	Bluetooth transmitter hasbeen included as part ofthe ApneaTrak Hardwarebut is disabled byfirmware/software at thistime and is not availableto the user. Bluetoothfunctionality is subject tofuture 510(k) clearance.Equivalent currently.
Recorded Data
Access to recordeddata	Recorded data is stored inthe device. When thedevice is connected to aPC via USB cable thedevice provides access toits internal memory.	Recorded data is storedin the device. When thedevice is connected to aPC via USB cable thedevice provides accessto its internal memory.	Recorded data is stored in thedevice. When the device isconnected to a PC via USBcable the device providesaccess to its internal memory.	Equivalent
Recorded dataformat	Each channel of recordeddata is stored in anindividual file of theGCS2 data format.	All channels ofrecorded data arestored in proprietarydata format.	All channels of recorded dataare stored in EDF data format.	GCS2 appears to be thepredicate device'sproprietary data format.EDF is non-proprietary.Data format does notraise new concerns ofsafety or effectiveness.
Device Initialization	Yes	Yes	Yes	Equivalent
Data Download	Yes	Yes	Yes	Equivalent

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TELL 510(k) Summary

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VELL 510(k) Summary S

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VELL 510(k) Summary S

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VELL 510(k) Summary S

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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 thesubject device is validated bycomplying with essentialperformance requirements fromthe following standards: IEC60601-2-26 and IEC 60601-2-40.	All tests results demonstratecompliance with thestandards.
Pulse Oximetry	The pulse oximetryfunctionality of the subjectdevice is validated bycomplying with ISO 80601-2-61 Particular requirements forpulse oximeters	All tests results demonstratecompliance with the standard.

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510(k) Summary

RespiratoryEffort	A known oscillating inputsignal was injected into therespiratory channel of thesubject device. The input andoutput data were plotted andquantitatively compared.	Passing result based on highmeasure of equivalencebetween input and outputsignals.
Airflow -Pressure	A known oscillating inputsignal was input to the airflowpressure channel of the subjectdevice. The input and outputdata were plotted andquantitatively compared.	Passing result based on highmeasure of equivalencebetween input and outputsignals.
Airflow -Thermal	A known oscillating inputsignal was input to the airflowthermal channel of the subjectdevice. The input and outputdata were plotted andquantitatively compared.	Passing result based on highmeasure of equivalencebetween input and outputsignals.
Snore	A known oscillating inputsignal was input to the snorechannel of the subject device.The input and output data wereplotted and quantitativelycompared	Passing result based on highmeasure of equivalencebetween input and outputsignals.

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.

Regulation Number and Section

§ 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).