The Falcon HST 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 healthcare practitioner, to aid in the diagnosis of sleep disorders.

Device Description

The Falcon HST comprises hardware and software which provide separate parameters for recording, review, and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians.

The Falcon system consists of the main unit and the charging cradle. The main unit is a small device that is worn on the patient's chest over clothing. It is equipped with a touch-screen LCD and contains various channel inputs such as for the inductive plethysmography bands, and electrodes. The Falcon charging cradle is used to charge the device, as well as provide a USB interface for transferring study data to the PC.

AI/ML Overview

The manufacturer, Compumedics Limited, demonstrates the substantial equivalence of the Falcon HST to its predicate devices for aid in the diagnosis of sleep disorders. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Falcon HST are based on establishing substantial equivalence to its predicate devices, the Zmachine Synergy (K172986) and Zmachine DT-100 (K101830). The performance of the Falcon HST was deemed acceptable if its capabilities for recording EEG, respiratory effort, respiratory airflow, body position, and pulse oximetry, as well as its software's ability to produce AHI and sleep staging results, were found to be substantially equivalent to the predicate devices and gold standard polysomnography (PSG) data.

Acceptance Criteria / Performance Metric	Reported Device Performance
EEG Input Circuit Performance: Acquired EEG signals from Falcon HST are substantially equivalent to Zmachine Synergy with high agreement to design limits.	The EEG characteristics were found to be in high agreement with the design limits for all points of comparison. The EEG recording capabilities were found to be substantially equivalent.
Respiratory Effort Performance: Acquired respiratory effort signals from Falcon HST are substantially equivalent to Zmachine Synergy.	Both units (Falcon HST and Zmachine Synergy) produced similar readings during simulated inhalation and exhalation. The Respiratory Effort characteristics were found to be substantially equivalent.
Respiratory Airflow Performance: Acquired respiratory airflow signals from Falcon HST are substantially equivalent to Zmachine Synergy.	Both units produced similar readings when using nasal cannula with the same breathing rate. The Respiratory Airflow characteristics were found to be substantially equivalent.
Body Position Performance: Acquired body position signals from Falcon HST are substantially equivalent to Zmachine Synergy and Falcon HST reports angle with regard to gravity appropriately against an angular reference.	The acquired data from Falcon HST and Zmachine Synergy was analyzed, and the Body Position recording capabilities were found to be substantially equivalent after rotating devices through 360 degrees against an angular reference.
Pulse Oximetry Performance: Acquired pulse oximetry signals (heart rate and oxygen saturation) from Falcon HST are substantially equivalent to Zmachine Synergy.	The heart rate and oxygen saturation readings were found to be in high agreement when comparing the two systems. The Pulse Oximeter recording capabilities were found to be substantially equivalent.
Profusion PSG Software 5.1 Performance (AHI and Sleep Staging): Produces substantially equivalent results for calculating the apnea hypopnea index (AHI) and sleep staging (N1, N2, N3, REM and Wake) when compared to expert review of gold standard polysomnography data.	Clinical performance testing validated that the performance of the Profusion PSG software 5.1 produces substantially equivalent results for calculating the apnea hypopnea index (AHI) and sleep staging (N1, N2, N3, REM and Wake) when compared to expert review of gold standard polysomnography data. (Specific metrics for "substantially equivalent" were not detailed in the provided text but implied by the successful validation statement.)
Electrical Safety: Compliance with IEC 60601-1:2005 (Third Edition) + COR1:2006 + COR2:2007 + A1:2012 + A2:2020.	All tests passed.
EMC: Compliance with IEC 60601-1-2:2014 + A1:2020, EN 60601-1-2:2015+A1:2021.	All tests passed.
Mechanical and Environmental Requirements: Compliance with IEC 60601-1-11:2015+A1:2020.	All tests passed.
Electroencephalograph Safety and Performance: Compliance with IEC 80601-2-26:2019, including accuracy of amplitude and rate of variation signal reproduction, input dynamic range and differential offset voltage, input noise, frequency response, and common mode rejection ratio.	All tests passed.
Ambulatory Electrocardiography Systems Safety and Essential Performance: Compliance with IEC 60601-2-47:2012.	All tests passed.
Battery Safety: Compliance with IEC 62133-2:2017/AMD1:2021 for secondary cells and batteries containing alkaline or other non-acid electrolytes (Lithium systems).	All tests passed.
Functional Requirements: Performance meets hardware and software design specifications including functionality substantially equivalent to the Zmachine Synergy predicate device.	All tests passed with results equivalent to the Zmachine Synergy and Zmachine DT-100 and did not raise additional concerns of safety and effectiveness.

Study Details:

Sample sizes used for the test set and the data provenance:
- Bench Testing (Side-by-Side Comparison): The text does not specify the exact number of devices or data points used for the side-by-side bench comparison tests between the Falcon HST and Zmachine Synergy for EEG input, respiratory effort, respiratory airflow, body position, and pulse oximetry. The description implies at least one of each device was used, subject to repeated measurements or simulated inputs.
- Clinical Performance Testing (Profusion PSG Software): The text does not provide a specific sample size for the clinical performance testing used to validate the software's ability to calculate AHI and sleep staging.
- Data Provenance: The document does not explicitly state the country of origin or whether the data for the mentioned tests was retrospective or prospective. For bench testing, it involved simulated inputs or direct comparison against predicate devices. For clinical performance testing of the software, it's compared against "gold standard polysomnography data," implying real patient data.
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):
- For the clinical performance testing of the Profusion PSG software, the ground truth for AHI and sleep staging was established through "expert review of gold standard polysomnography data." The number of experts and their specific qualifications (e.g., years of experience, specific certifications) are not specified in the provided text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method for establishing ground truth, particularly for the clinical performance testing where expert review was used.
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:
- The provided text does not mention an MRMC comparative effectiveness study involving human readers or any AI assistance. The study focuses on the device's equivalence to existing technology and the accuracy of its software against expert-reviewed data, not on human reader performance with or without AI assistance. The Falcon HST is an EEG and respiratory signal recorder, and its software is used to aid in the diagnosis by processing these signals, not primarily as an AI assistance tool for human interpretation in the context of what would typically be considered an MRMC study for AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- For the hardware components (EEG, respiratory effort, airflow, body position, pulse oximetry), standalone performance testing was conducted by comparing the Falcon HST's output directly against that of the predicate devices or against angular references/simulated inputs.
- For the Profusion PSG software 5.1, its ability to calculate AHI and sleep staging was validated by comparing its outputs directly against "expert review of gold standard polysomnography data." This indicates a standalone performance evaluation of the algorithm's output against established ground truth, effectively without human-in-the-loop for the algorithm's calculation step itself. The device is intended "to aid in the diagnosis," implying that its output will be reviewed by a human practitioner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For testing the accuracy of AHI and sleep staging calculations by the Profusion PSG software, the ground truth used was expert review of gold standard polysomnography data.
- For the bench testing of individual physiological parameters (EEG, respiratory effort, airflow, body position, pulse oximetry), the ground truth was established by comparison to the predicate device (Zmachine Synergy) or by using controlled simulated inputs and angular references.
The sample size for the training set:
- The document does not provide any information regarding a training set size. This might be because the device's algorithms or software features (like sleep staging) may have been developed and validated previously, or the submission focuses on demonstrating equivalence to established technologies rather than novel algorithm training. The software, Profusion PSG software 5.1, is mentioned to be identical to versions previously cleared (K072201 and K093223), suggesting its core functionality and training (if any) happened prior to this submission.
How the ground truth for the training set was established:
- As no information about a training set is provided, how its ground truth was established is not detailed in the document.

Summary

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February 20, 2025

Image /page/0/Picture/1 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Compumedics Limited % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Boulevard Warren, New Jersey 07059

Re: K242447

Trade/Device Name: Falcon HST Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV, OMC, MNR Dated: December 20, 2024 Received: December 20, 2024

Dear Dave Yungvirt:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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).

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Sincerely,

Jay R. Gupta -S

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

Submission Number (if known)

Device Name

Falcon HST

Indications for Use (Describe)
--------------------------------

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image is a logo for Compumedics. The logo features a blue circle with a stylized "m" inside of it. To the right of the circle is the word "COMPUMEDICS" in blue, and below that is the tagline "Defining Life's Signals" also in blue.

AJ231 Falcon HST 510(k) Summary

Device Name: Falcon HST

The following 510(k) summary is being submitted in accordance with 21 CFR 807.92.

Submission Details

Applicant Information:

Applicant Information:
Submitter:	Compumedics Limited
Address:	30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia
Phone number:	+61 (0) 3 8420 7300
Fax number:	+61 (0) 3 8420 7399
Contact person:	John Joseph
Address:	30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia
Phone number:	+61 (0) 3 8420 7362
Fax number:	+ 61 (0) 3 8420 7399
Email:	jjoseph@compumedics.com.au

Submission Prepared: November 25, 2024

Subject Device Information:

Trade name:	Falcon HST
Common name:	Falcon HST
Primary Product code:	OLV, OMC, MNR
Classification Names:	Electroencephalograph
Panel:	Neurological Devices
Device class:	II
Regulation numbers:	21 CFR 882.1400

Predicate Device Information

Primary Predicate Device:

Trade Name:	Zmachine Synergy
Manufacturer:	Consolidated Research of Richmond, Inc.
510(k) number:	K172986
510(k) Decision Date:	19th Dec 2017
Classification:	Electroencephalograph
Product code:	OLV, OMC, MNR
Device class:	II
Regulation numbers:	21 CFR 882.1400

Secondary Predicate Device:

Trade Name:	Zmachine DT-100
Manufacturer:	Consolidated Research of Richmond, Inc
510(k) number:	K101830
510(k) Decision Date:	31st Mar 2011
Classification:	Electroencephalograph
Product code:	OLV, OMC
Device class:	II
Regulation numbers:	21 CFR 882.1400

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Image /page/5/Picture/0 description: The image shows the logo for Compumedics. The logo consists of a blue circle with a stylized "m" inside, followed by the word "COMPUMEDICS" in blue, all caps. Below the company name is the tagline "Defining Life's Signals" also in blue.

Intended Use / Indications For Use

Device Description

Technology overview

Electroencephalograph (EEG)

Both Falcon HST and Zmachine Synergy use the same EEG hardware to acquire an EEG channel characteristic.

Respiratory effort

Respiratory Effort is sensed by the Falcon HST using a thoracic and abdominal effort belt, however Zmachine Synergy uses only a thoracic effort belt to record chest expansion and contraction during inhalation and exhalation (i.e. respiratory effort).

Respiratory nasal airflow

Both Falcon HST and Zmachine Synergy use the similar pressure transducer to acquire the respiratory nasal airflow signals.

Body position

Both the Falcon HST and Zmachine Synergy use solid-state accelerometer to acquire the body position signal.

Blood oxygen saturation and pulse

Both the Falcon HST and Zmachine Synergy use the similar pulse oximeter hardware and data output modes to acquire the blood oxygen saturation and pulse signals.

PC Software

The Falcon HST device is compatible with Profusion Sleep software v5.1 or greater, while the predicate device Zmachine DT-100 (K101830) is compatible with their analysis software. The main differences involve the addition of Falcon HST file format support and data retrieval.

Profusion PSG software 5.1 is identical to the Profusion PSG software which was separately cleared as a part of K072201 and K093223, and as a result, required software documentation is provided regarding this software.

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Image /page/6/Picture/0 description: The image is a logo for Compumedics. The logo consists of a blue circle with a cursive "m" inside of it, followed by the word "COMPUMEDICS" in blue. Below the word "COMPUMEDICS" is the phrase "Defining Life's Signals" in a smaller font.

The differences in software versions do not constitute a substantial change as they are not changes to underlying software specifications and are instead driver-level changes necessary for data conversion from the Falcon HST device. The system has been subject to functional testing with full coverage of data flow paths including USB communication which represents the predominant change between versions. Additionally, the Profusion Sleep interface has been used as part of the system setup for IEC 60601-1-2 and IEC 80601-2-26 tests as these include tests relating to signal display and accuracy of signal reproduction, especially in a noisy environment.

Substantial Equivalence

This document represents the discussion of the substantial equivalence of the Falcon HST with respect to its primary predicate device the Zmachine Synergy (K172986). To discuss the substantial equivalence of Profusion Sleep 5.1 software feature support to Falcon HST, another predicate device Zmachine DT-100 (K101830) is included as Zmachine Synergy (K172986) only focuses on hardware device application. Additionally, this document provides a comparison of intended use, as well as a comprehensive evaluation of technological characteristics. Available performance data is summarised to further support safety and effectiveness and substantial equivalence with respect to its predicate devices.

The Zmachine Synergy device was launched in 2017 by Consolidated Research of Richmond, Inc. It has been sold in respective markets since then. The intended use of the Falcon HST is the same as the Zmachine Synergy, as is the channels recorded and the basic use and technology.

The main differences are that the Falcon HST is a single unit with colour touch screen rather than a single button configuration in the Zmachine Synergy. The Falcon HST has a charging cradle unlike Zmachine Synergy which has a USB charging cable.

Based on the Indications for Use, results of technological, performance & safety testing and a comparison to the predicate devices, it is concluded that the Falcon HST system with Profusion Sleep 5.1 feature support is substantially equivalent to the Zmachine Synergy and Zmachine DT-100, and there are no new issues identified in terms of safety or effectiveness with respect to its intended use.

The below table contains a multi-parameter comparison between Falcon HST system with Profusion Sleep 5.1 support feature, the primary predicate device the Zmachine Synergy and the predicate device Zmachine DT-100. This table is included in AJ056 Falcon Substantial Equivalence Discussion with further analysis of differences where applicable.

Characteristic	Falcon HST	Zmachine Synergy (Primarypredicate device)	Zmachine DT-100(Predicate device)
Usage Information
Manufacturer	Compumedics Ltd.	Consolidated Research ofRichmond, Inc.	Consolidated Research ofRichmond, Inc.
510(k) Number		K172986	K101830
Classificationregulation	21 CFR 882.1400	21 CFR 882.1400	21 CFR 882.1400
Product Code	OLV, OMC, MNR	OLV, OMC, MNR	OLV and OMC
Indications foruse	The Falcon HST is an EEG andrespiratory signal recorder.The device is intended for useby adult patients in the homeor clinical environment,under the direction of aqualified healthcarepractitioner, to aid in thediagnosis of sleep disorders.	The Zmachine Synergy is an EEGand respiratory signal recorder.The device is intended for use byadult patients in the home orclinical environment, under thedirection of a qualified healthcarepractitioner, to aid in thediagnosis of sleep disorders.	The CRI Zmachine is a single-channel, EEG acquisition andanalysis system, designed foruse in the home or clinicalenvironments. This device isintended to be used by qualifiedhealthcare practitioners tomonitor the wake and sleepstates of adult patients and asan adjunct to their diagnosis ofsleep disorders.
Type of Use	Prescription-Use Only	Prescription-Use Only	Prescription-Use Only
IntendedEnvironment	Home or clinical environment	Home or clinical environment	Home or clinical environment
PatientPopulation	Adults	Adults	Adults
AcquiredChannels	AirflowPulse OximeterRespiratory EffortBody PositionEEG	AirflowPulse OximeterRespiratory EffortBody PositionEEG	EEG
Sensortechnology	Airflow: Solid state pressuretransducer (±6 mbar range)Pulse Oximetry: Nonin 3150Wrist-Ox2, BLE module.Respiratory Effort: Thoraciceffort belt based onrespiratory inductanceplethysmography (RIP).Body position: Solid stateaccelerometer, multipledifferential EXG channels.	Airflow: Solid state pressuretransducer (±6 mbar range)Pulse Oximetry: Nonin XPOD LPmodule.Respiratory Effort: Thoracic effortbelt based on respiratoryinductance plethysmography(RIP).Body position: Solid stateaccelerometer, multiple EEGchannels.	Zmachine DT-100 EEGtechnology
Sensortechnology	LED indicators. A singlecolour LED is provided toindicate unit status. This LEDis turned on or off (eithercontinuously or flashing)under control of thefirmware. The displayablecolour is blue.	LED indicators. A full-color LEDindicator is located beside eachconnector (airflow, effort,oximeter,and EEG) to indicate correct orincorrect hookup/operation.Anotherfull-color LED is located under themain power button to indicatesystem status.	LCD display. A full color,320×240 pixel, LCD displaywith an LED backlight is used topresent all system information.
Power Source	Internally powered using li-ion rechargeable battery	Internally powered using li-ionrechargeable battery	Internally powered using li-ionrechargeable battery
Internalmemory/ dataStorage	Storage on Falcon HSTonboard memory	Fixed microSD card	Removeable microSD card
CommunicationInterface	USB-C	USB	USB card reader
Access torecorded data	Recorded data is stored in thedevice. When the device isconnected to PC via USB cablethe device provides access toits internal memory.	Recorded data is stored in thedevice. When the device isconnected to PC via USB cable thedevice provides access to itsinternal memory.	Recorded data is stored in thedevice. The microSD card isremoved and connected to PCvia USB card reader to accessinternal memory.
Recorded dataformat	Each channel of recorded datais stored in an individual fileof the proprietary dataformat.	Each channel of recorded data isstored in an individual file of theGSC2 data format.	Each channel of recorded datais stored in an individual file ofthe binary data format.
Devicedimensions	92 x 78 x 11 mm	120 x 61 x 24 mm	116 x 68 x 21 mm
Type of Device	EEG-based sleep monitor	EEG-based sleep monitor	EEG-based sleep monitor
No. of EEGChannels	4	1	1
ElectrodePlacement	Mastoid	Mastoid	Mastoid
Analyze EEGData in Realtime	Yes	n/a	Yes
SleepClassification	Wake and Sleep	Wake and Sleep	Wake and Sleep
EEG AnalysisMethodology
Proprietary adaptivealgorithm using time andfrequency domain features	n/a	Proprietary adaptive algorithmusing time and frequencydomain features
Can ProvideInformation toAssist thePhysician inDiagnosis ofSleepDisorders?	n/a	Yes
Can ProvideInformation toAssist thePhysician in theApplication ofTreatment	n/a	Yes
ProvideInformation toAssist Physicianin theEvaluation ofTreatmentEfficacy?	n/a	Yes
CalculatesSummary SleepStatistics?	n/a	Yes
BatteryPowered?	Yes	Yes

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Image /page/7/Picture/0 description: The image shows the logo for Compumedics. The logo features a blue circle with a stylized "m" inside, followed by the word "COMPUMEDICS" in blue, sans-serif font. Below the company name is the tagline "Defining Life's Signals" also in blue.

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Image /page/8/Picture/0 description: The image shows the logo for Compumedics. The logo consists of a blue circle with a stylized "m" inside, followed by the word "COMPUMEDICS" in blue, and the tagline "Defining Life's Signals" below. The logo is simple and professional, and the blue color gives it a sense of trust and reliability.

The table above shows that there are no significant differences between Zmachine Synergy and the predicate devices that adversely affect product safety and effectiveness.

Testing Summary

Design and verification activities have been performed on the Falcon HST as a result of the risk analysis and product requirements. External tests have been completed for electrical safety (IEC 60601-1:2005 (Third Edition) + COR1:2006 + COR2:2007 + A1:2012 + A2:2020), EMC (IEC 60601-1-2:2014 + A1:2020, EN 60601-1-2:2015+A1:2021), and mechanical and environmental requirements (IEC 60601-1-11:2015+A1:2020). In addition, side-by-side bench comparison testing summarized in the table below, was performed in which a Falcon HST was compared against a Zmachine Synergy (K172986).

Test	Test Method Summary	Results
EEG InputCircuit	EEG is sensed by the Falcon HST andZmachine Synergy using the identical EEGamplifier and analog-to-digital conversionhardware. As such, the acquired signalsfrom both systems are expected to besubstantially equivalent.	The EEG characteristics were found to bein high agreement with the design limitsfor all points of comparison. As such, theEEG recording capabilities were found tobe substantially equivalent.
	To test, an arbitrary waveform generatorwas connected to the EEG input of a FalconHST and Zmachine Synergy device.
	Signals were generated by connecting thisarbitrary waveform generator to thesystems electrodes. Tests were not
	performed simultaneously, as waveforms
	were able to be replicated for each test using the same waveform generator.
RespiratoryEffort	Respiratory Effort is sensed by the Falcon HST using a thoracic and abdominal effort belt, however Zmachine Synergy uses only a thoracic effort belt to record chest expansion and contraction during inhalation and exhalation (i.e. respiratory effort).To test, the Falcon HST and Zmachine Synergy were subject to simulated inhalation and exhalation. As such, the acquired signals from both systems are expected to be substantially equivalent.	The acquired data from each system was analyzed in order to compare the Respiratory Effort readings.Both units produced similar readings. As such, the Respiratory Effort characteristics were found to be substantially equivalent.
RespiratoryAirflow	Respiratory Airflow is sensed by the Falcon HST and Zmachine Synergy using the similar pressure transducer hardware. As such, the acquired signals from both systems are expected to be substantially equivalent.Testing required use of nasal cannula in the same setting with the same breathing rate for both products.The acquired signals from both systems are expected to be substantially equivalent.	The acquired data from each system was analyzed in order to compare the Respiratory Airflow readings.Both units produced similar readings. As such, the Respiratory Airflow characteristics were found to be substantially equivalent.
BodyPosition	Body Position is sensed by the Falcon HST and Zmachine Synergy using an accelerometer module.As both systems are measuring the angle of the system with respect to gravity, and both systems are worn by the patient in the same configuration, the acquired signal from both systems are expected to be substantially equivalent if it can be demonstrated that the Falcon HST reports angle with regard to gravity appropriately against an angular reference. To test, the Falcon HST and Zmachine Synergy devices are rotated through 360 degrees against an angular reference.	The acquired data from the Falcon HST and Zmachine Synergy was analyzed in order to compare the appropriate body position readings.As such, the Body Position recording capabilities were found to be substantially equivalent.
PulseOximetry	Pulse Oximetry is sensed by the Falcon HST and Zmachine Synergy using identical pulse oximeter hardware and similar data output modes. The device used was a NOnin Medical 3150 WristOx, being FDA approved as per FDA 510K Nonin Medical 3150 WristOx – K102350 As such, the acquired signals from both are expected to be substantially equivalent. Testing was performed by attaching the pulse oximeter	The acquired data from each system was analysed in order to compare the Pulse Oximeter readings.The heart rate and oxygen saturation readings were found to be in high agreement when comparing the two systems together. As such, the Pulse Oximeter recording capabilities were found to be substantially equivalent.
to the index finger and obtaining a readingfrom the device one at a time, under thesame conditions.	Both units produced similar readings. Assuch, the Pulse Oximeter recordingcapabilities were found to besubstantially equivalent.
As such, the acquired signals from bothsystems are expected to be substantiallyequivalent.

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Image /page/9/Picture/0 description: The image shows the logo for Compumedics. The logo consists of a blue circle with a stylized "m" inside, followed by the word "COMPUMEDICS" in blue. Below the word "COMPUMEDICS" is the tagline "Defining Life's Signals" also in blue.

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Image /page/10/Picture/0 description: The image shows the logo for Compumedics. The logo consists of a blue circle with a stylized "m" inside, followed by the word "COMPUMEDICS" in blue, and the tagline "Defining Life's Signals" below. The logo is simple and professional, and the blue color gives it a sense of trust and reliability.

Additionally, following performance test was performed:

Electroencephalograph safety and performance testing as per IEC 80601-2-26:2019, Testing against the particular standard for electroencephalograph includes validation against multiple essential performance requirements such as accuracy of amplitude and rate of variation signal reproduction, input dynamic range and differential offset voltage, input noise, frequency response, and common mode rejection ratio.
. Ambulatory Electrocardiography systems safety and essential performance testing as per IEC 60601-2-47:2012.
. Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems IEC 62133-2:2017/AMD1:2021
. Bench testing against Falcon functional requirements to ensure that performance meets hardware and software design specifications including functionality substantially equivalent to the Zmachine Synergy predicate device.

All tests passed with results equivalent to the Zmachine Synergy and Zmachine DT-100 and did not raise additional concerns of safety and effectiveness. Clinical performance testing was provided to validate that the performance of the Profusion PSG software 5.1 produces substantially equivalent results for calculating the apnea hypopnea index (AHI) and sleep staging (N1, N2, N3, REM and Wake) when compared to expert review of gold standard polysomnography data.

Conclusion

Compumedics Ltd. considers the Falcon HST to be substantially equivalent to its primary predicate device the Zmachine Synergy and predicate device the Zmachine DT-100. The indications for use, technological characteristics, and underlying principles of operation are the same. There are no questions of safety and effectiveness, and substantial equivalence is supported by extensive performance testing data.

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).