(188 days)
No
The summary describes a device for recording and analyzing physiological signals for sleep disorder diagnosis. It mentions software for review and analysis but does not explicitly mention or imply the use of AI or ML algorithms for this analysis. The performance studies focus on hardware equivalence and software calculation of standard metrics (AHI, sleep staging) compared to expert review, not on the performance of an AI/ML model.
No.
The device is intended to aid in the diagnosis of sleep disorders by recording various physiological signals, not to treat them.
Yes
The device is described as aiding in the diagnosis of sleep disorders by recording and analyzing physiological parameters like EEG, EOG, ECG, and respiratory signals. This function directly supports the diagnostic process.
No
The device description explicitly states that the Falcon HST "comprises hardware and software" and details hardware components like the main unit, charging cradle, touch-screen LCD, channel inputs, and electrodes. Performance studies also include testing of hardware aspects like electrical safety, EMC, and mechanical requirements.
Based on the provided information, the Falcon HST is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Falcon HST Function: The Falcon HST records physiological signals directly from the patient's body (EEG, respiratory signals, EOG, ECG). It does not analyze samples taken from the body.
- Intended Use: The intended use is to aid in the diagnosis of sleep disorders by recording physiological signals, not by analyzing biological specimens.
Therefore, the Falcon HST falls under the category of a medical device that records physiological parameters in vivo (within the living body), rather than an IVD device which analyzes samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OLV, OMC, MNR
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.
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
Adults
Intended User / Care Setting
Qualified healthcare practitioner / home or clinical environment
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)
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).
Study Type: Bench Comparison Testing
Sample Size: Not Specified
Key Results:
- EEG Input Circuit: The EEG characteristics were found to be in high agreement with the design limits for all points of comparison. As such, the EEG recording capabilities were found to be substantially equivalent.
- Respiratory Effort: Both units produced similar readings. As such, the Respiratory Effort characteristics were found to be substantially equivalent.
- Respiratory Airflow: Both units produced similar readings. As such, the Respiratory Airflow characteristics were found to be substantially equivalent.
- Body Position: As such, the Body Position recording capabilities were found to be substantially equivalent.
- Pulse Oximetry: 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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"
1
(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).
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Falcon HST
| Indications for Use (Describe) |
|---|
| -------------------------------- |
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.
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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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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Intended Use / Indications For Use
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.
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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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 (Primary
predicate device) | Zmachine DT-100
(Predicate device) |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Usage Information | | | |
| Manufacturer | Compumedics Ltd. | Consolidated Research of
Richmond, Inc. | Consolidated Research of
Richmond, Inc. |
| 510(k) Number | | K172986 | K101830 |
| Classification
regulation | 21 CFR 882.1400 | 21 CFR 882.1400 | 21 CFR 882.1400 |
| Product Code | OLV, OMC, MNR | OLV, OMC, MNR | OLV and OMC |
| Indications for
use | 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. | 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 healthcare
practitioner, to aid in the
diagnosis of sleep disorders. | The CRI Zmachine is a single-
channel, EEG acquisition and
analysis system, designed for
use in the home or clinical
environments. This device is
intended to be used by qualified
healthcare practitioners to
monitor the wake and sleep
states of adult patients and as
an adjunct to their diagnosis of
sleep disorders. |
| Type of Use | Prescription-Use Only | Prescription-Use Only | Prescription-Use Only |
| Intended
Environment | Home or clinical environment | Home or clinical environment | Home or clinical environment |
| Patient
Population | Adults | Adults | Adults |
| Acquired
Channels | Airflow
Pulse Oximeter
Respiratory Effort
Body Position
EEG | Airflow
Pulse Oximeter
Respiratory Effort
Body Position
EEG | EEG |
| Sensor
technology | Airflow: Solid state pressure
transducer (±6 mbar range)
Pulse Oximetry: Nonin 3150
Wrist-Ox2, BLE module.
Respiratory Effort: Thoracic
effort belt based on
respiratory inductance
plethysmography (RIP).
Body position: Solid state
accelerometer, multiple
differential EXG channels. | Airflow: Solid state pressure
transducer (±6 mbar range)
Pulse Oximetry: Nonin XPOD LP
module.
Respiratory Effort: Thoracic effort
belt based on respiratory
inductance plethysmography
(RIP).
Body position: Solid state
accelerometer, multiple EEG
channels. | Zmachine DT-100 EEG
technology |
| Sensor
technology | LED indicators. A single
colour LED is provided to
indicate unit status. This LED
is turned on or off (either
continuously or flashing)
under control of the
firmware. The displayable
colour is blue. | LED indicators. A full-color LED
indicator is located beside each
connector (airflow, effort,
oximeter,
and EEG) to indicate correct or
incorrect hookup/operation.
Another
full-color LED is located under the
main power button to indicate
system status. | LCD display. A full color,
320×240 pixel, LCD display
with an LED backlight is used to
present all system information. |
| Power Source | Internally powered using li-
ion rechargeable battery | Internally powered using li-ion
rechargeable battery | Internally powered using li-ion
rechargeable battery |
| Internal
memory/ data
Storage | Storage on Falcon HST
onboard memory | Fixed microSD card | Removeable microSD card |
| Communication
Interface | USB-C | USB | USB card reader |
| Access to
recorded data | Recorded data is stored in the
device. When the device is
connected to 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 PC via USB cable the
device provides access to its
internal memory. | Recorded data is stored in the
device. The microSD card is
removed and connected to PC
via USB card reader to access
internal memory. |
| Recorded data
format | Each channel of recorded data
is stored in an individual file
of the proprietary data
format. | Each channel of recorded data is
stored in an individual file of the
GSC2 data format. | Each channel of recorded data
is stored in an individual file of
the binary data format. |
| Device
dimensions | 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 EEG
Channels | 4 | 1 | 1 |
| Electrode
Placement | Mastoid | Mastoid | Mastoid |
| Analyze EEG
Data in Real
time | Yes | n/a | Yes |
| Sleep
Classification | Wake and Sleep | Wake and Sleep | Wake and Sleep |
| EEG Analysis
Methodology | | | |
| Proprietary adaptive
algorithm using time and
frequency domain features | n/a | Proprietary adaptive algorithm
using time and frequency
domain features | |
| Can Provide
Information to
Assist the
Physician in
Diagnosis of
Sleep
Disorders? | n/a | Yes | |
| Can Provide
Information to
Assist the
Physician in the
Application of
Treatment | n/a | Yes | |
| Provide
Information to
Assist Physician
in the
Evaluation of
Treatment
Efficacy? | n/a | Yes | |
| Calculates
Summary Sleep
Statistics? | n/a | Yes | |
| Battery
Powered? | 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 Input | ||
| Circuit | EEG is sensed by the Falcon HST and | |
| Zmachine Synergy using the identical EEG | ||
| amplifier and analog-to-digital conversion | ||
| hardware. As such, the acquired signals | ||
| from both systems are expected to be | ||
| substantially equivalent. | The EEG characteristics were found to be | |
| in high agreement with the design limits | ||
| for all points of comparison. As such, the | ||
| EEG recording capabilities were found to | ||
| be substantially equivalent. | ||
| To test, an arbitrary waveform generator | ||
| was connected to the EEG input of a Falcon | ||
| HST and Zmachine Synergy device. | ||
| Signals were generated by connecting this | ||
| arbitrary waveform generator to the | ||
| systems electrodes. Tests were not | ||
| performed simultaneously, as waveforms | ||
| were able to be replicated for each test using the same waveform generator. | ||
| 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). |
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. |
| Respiratory
Airflow | 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. |
| Body
Position | 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. |
| Pulse
Oximetry | 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 reading
from the device one at a time, under the
same conditions. | Both units produced similar readings. As
such, the Pulse Oximeter recording
capabilities were found to be
substantially equivalent. | |
| As such, the acquired signals from both
systems are expected to be substantially
equivalent. | | |
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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.