(184 days)
No
The summary describes the device's data acquisition and calculation of standard sleep parameters and indices based on acquired signals. There is no mention of AI, ML, or related concepts like training/test sets for algorithmic development. The performance studies focus on comparing calculated parameters to a gold standard and predicate devices, not on validating an AI/ML model's performance.
No
The device is described as a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging, and snoring level. Its intended use is to acquire, calculate, and report data to clinicians, and it is explicitly stated that the data is not intended to be used as the sole basis for diagnosing or prescribing treatment. Therapeutic devices are used for treating conditions, not solely for diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Somfit is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level." This indicates its role in aiding diagnosis.
No
The device description explicitly states that the Somfit is a "wearable, low voltage, battery operated device" which records signals from the patient's forehead. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Somfit system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Somfit's Function: The Somfit system is a non-invasive device that acquires physiological data directly from the patient's body (forehead electrodes, accelerometer, acoustic, and plethysmographic data). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "non-invasive prescription device for home use" and a "diagnostic aid for the detection of sleep-related breathing disorders, sleep staging... and snoring level." This involves monitoring and analyzing signals from the body, not testing samples.
Therefore, the Somfit system falls under the category of a non-invasive diagnostic device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Somfit system is a non-invasive prescription device for home use with patients suspected to have sleep-related breathing disorders. The Somfit is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. The Somfit system acquires electrical data from three frontal electrodes, tri-axial accelerometer data, acoustic and plethysmographic data. The Somfit calculates and reports to clinicians EEG/EOG channels, Sleep Stages, SpO2, Peripheral Arterial Tonometry (PAT) signal, pulse rate, and snoring level. The Somfit calculates and reports to clinicians derived parameters such as PAT-derived Apnea Hypopnea Index, Obstructive Desaturation Index; and hypnogram-derived indices such as time in each sleep stage. Somfit data is not intended to be used as the sole or primary basis for diagnosing any sleep-related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The Somfit is not intended for use as life support equipment, for example vital signs monitoring in intensive care unit. The Somfit is a prescription device indicated for adult patients aged 21 years and over.
Product codes (comma separated list FDA assigned to the subject device)
MNR, OMC
Device Description
The Somfit is a home-based sleep monitoring device which records signals from the patient's forehead and surrounding environment. Somfit is a wearable, low voltage, battery operated device which is attached to subject forehead via a self-adhesive and disposable skin electrode patch. The electrodes are placed on the anterior Prefrontal cortex (PFC) at the Fp1 and Fp2 positions according to the 10/20 EEG system. The device allows for recording of two frontal EEG signals, pulse rate, SPO2, Peripheral Arterial Tonometry (PAT), PPG, motion, and snore. Somfit uses a mobile phone application to acquire data wirelessly via Bluetooth LE technology, then transfer into a secure cloud, for management, storage and postprocessing. The software reports measured parameters in a format compatible with AASM guidelines, including sleep time, pAHI and conventional graphical displays such as a hypnogram.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
adult patients aged 21 years and over.
Intended User / Care Setting
clinicians / home use
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)
Non-Clinical Performance Data:
- Testing Activities:
- Electrical Safety Testing as per IEC 60601-1:2005 (Third Edition) + COR1:2006 + COR2:2007 + ● A1:2012
- Electromagnetic Compatibility Testing as per IEC 60601-1-2:2014, EN 60601-1-2:2015, and ● modification by the listed particular and collateral standards
- Home Healthcare Environmental testing as per IEC 60601-1-11:2015
- Electroencephalograph safety and performance testing as per IEC 60601-2-26:2012
- Pulse oximeter safety and performance testing as per ISO 80601-2-61:2011 including tests with ● functional simulator
- Hardware bench testing to verify electrical parameters and design specifications
- Software testing to verify functional requirements and system integration ●
- Results: All tests passed, demonstrated substantial equivalence, and did not raise additional concerns of safety and effectiveness.
Clinical Performance:
- Controlled Desaturation Study:
- Study Type: Comparison between Somfit SpO2 data and gold standard SaO2 data over an invasively controlled SaO2 range of 70%-100%.
- Sample Size: Not explicitly stated for this particular study, but data mentions 12 healthy patients for pulse rate analysis.
- Key Results: The Somfit root mean square error (ARMS) was 1.46%, out-performing Nonin and Masimo reference devices (2.15% and 1.94% respectively). The Watch-PAT300 user guide reports an ARMS of 1.88%. Somfit's ARMS of 1.46% supports substantial equivalence and satisfies ISO 80601-2-61.
- Pulse Rate Data Study:
- Study Type: Comparison of pulse rate data obtained from Somfit, Nonin, and Masimo reference oximeters during a controlled desaturation study.
- Sample Size: Two hundred and thirty-seven pulse rate samples were obtained from 12 healthy patients.
- Key Results: The root-mean square error between Somfit and Masimo oximeters was 1.91 BPM with a mean difference of 0.017 BPM. The root-mean square error between Somfit and Nellcor oximeters was 1.81 BPM with a mean difference of 0.00 BPM.
- Clinical Study for Comparing Somfit and Watch-PAT300:
- Study Type: Overnight recording of Somfit and Watch-PAT300 data concurrently with attended polysomnography (PSG) using the Grael device (gold standard).
- Sample Size: 92 subjects recorded across 3 site locations in Australia.
- Key Results:
- PAT-derived AHI (pAHI): Mean difference between Somfit and Watch-PAT300 pAHI was 0.294 (95% CI: -2.661, 2.074), supporting non-inferiority.
- Obstructive Desaturation Index (ODI): Mean difference of Somfit and PSG ODI was 0.658 (CI: -1.012, 2.326), which was less than Watch-PAT300 and PSG ODI (2.499, CI: 0.732, 4.265), indicating Somfit achieved higher accuracy.
- Sleep Stage Agreement (with PSG):
- N1/N2 merged sleep stages: Somfit 80.92% agreement (95% CI: 79.96, 81.89) vs. Watch-PAT300 61.77% (95% CI: 60.99, 62.55).
- NREM/REM/Wake stage differential: Somfit 86.79% agreement (95% CI: 85.76, 87.81) vs. Watch-PAT300 74.42% (95% CI: 73.51, 75.32).
- Sleep/Wake determination: Somfit 89.45% agreement (95% CI: 88.53, 90.38) vs. Watch-PAT300 82.09% (95% CI: 81.37, 82.82).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Controlled Desaturation Study:
- Somfit root mean square error (ARMS) for SpO2: 1.46%
- Nonin ARMS for SpO2: 2.15%
- Masimo ARMS for SpO2: 1.94%
- Watch-PAT300 ARMS for SpO2 (from user guide): 1.88%
Pulse Rate Data Study:
- Somfit vs. Masimo: root-mean square error 1.91 BPM, mean difference 0.017 BPM
- Somfit vs. Nellcor: root-mean square error 1.81 BPM, mean difference 0.00 BPM
Clinical Study for Comparing Somfit and Watch-PAT300:
- pAHI:
- Mean difference between Somfit and Watch-PAT300 PAT-derived AHI: 0.294 (95 percent confidence interval of -2.661, 2.074)
- ODI:
- Mean difference of Somfit and PSG ODI: 0.658 (confidence interval of -1.012, 2.326)
- Mean difference of Watch-PAT300 and PSG ODI: 2.499 (confidence interval of 0.732, 4.265)
- Sleep Stage Agreement with PSG:
- Somfit N1/N2 merged sleep stages agreement: 80.92% (95 percent CI: 79.96, 81.89)
- Watch-PAT300 N1/N2 merged sleep stages agreement: 61.77% (95 percent CI: 60.99, 62.55)
- Somfit NREM/REM/Wake stage differential agreement: 86.79% (95 percent CI: 85.76, 87.81)
- Watch-PAT300 NREM/REM/Wake stage differential agreement: 74.42% (95 percent CI: 73.51, 75.32)
- Somfit Sleep/Wake determination agreement: 89.45% (95 percent CI: 88.53, 90.38)
- Watch-PAT300 Sleep/Wake determination agreement: 82.09% (95 percent CI: 81.37, 82.82)
- Somfit Sleep Stage Sensitivities (compared to PSG):
- Pr(Wake | PSG Wake): 0.8004
- Pr(N1 | PSG N1): 0.1967
- Pr(N2 | PSG N2): 0.8540
- Pr(N3 | PSG N3): 0.6509
- Pr(REM | PSG REM): 0.8873
- Pr(N1+N2 | PSG N1+N2): 0.8388
- Pr(NREM | PSG NREM): 0.8897
- Pr(Sleep | PSG Sleep): 0.9244
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
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
November 30, 2023
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 consists of the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Compumedics Limited Michael Frischman Electronics Engineer 30-40 Flockhart St Abbotsford, Victoria 3067 Australia
Re: K231546
Trade/Device Name: Somfit Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR, OMC Dated: October 30, 2023 Received: October 30, 2023
Dear Michael Frischman:
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" (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).
1
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.
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 medical devices and radiation-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).
Sincerely,
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices
2
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
510(k) Number (if known) K231546
Device Name Somfit
Indications for Use (Describe)
The Somfit system is a non-invasive prescription device for home use with patients suspected to have sleep-related breathing disorders. The Somfit is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. The Somfit system acquires electrical data from three frontal electrodes, triaxial accelerometer data, acoustic and plethysmographic data. The Somfit calculates and reports to clinicians EEG/EOG channels, Sleep Stages, SpO2, Peripheral Arterial Tonometry (PAT) signal, pulse rate, and snoring level. The Somfit calculates and reports to clinicians derived parameters such as PAT-derived Apnea Hypopnea Index, Obstructive Desaturation Index; and hypnogram-derived indices such as time in each sleep stage. Somfit data is not intended to be used as the sole or primary basis for diagnosing any sleep-related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The Somfit is not intended for use as life support equipment, for example vital signs monitoring in intensive care unit. The Somfit is a prescription device indicated for adult patients aged 21 years and over.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/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, sans-serif font. Below the company name is the tagline "Defining Life's Signals" also in blue.
510(k) Summary
Device Name: Somfit
The following 510(k) summary is being submitted in accordance with 21 CFR 807.92.
Submission Details
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: | Michael Frischman |
| Address: | 30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia |
| Phone number: | +61 (0) 3 8420 7362 |
| Fax number: | + 61 (0) 3 8420 7399 |
| Email: | michael.frischman@compumedics.com.au |
Submission Prepared: 30th May 2023
Subject Device Information:
| Trade name: | Somfit |
|---|---|
| Common name: | Somfit |
| Product code: | MNR, OMC |
| Classification Names: | Ventilatory Effort Recorder |
| Panel: | Anesthesiology |
| Device class: | II |
| Regulation number: | 21 CFR 868.2375 |
Predicate Device Information
| Trade Name: | Watch-PAT300 |
|---|---|
| Manufacturer: | Itamar Medical, Ltd. |
| 510(k) number: | K180775 |
| 510(k) Decision Date: | 17th August 2018 |
| Classification: | Ventilatory Effort Recorder |
| Product code: | MNR |
| Device class: | II |
| Regulation number: | 21 CFR 868.2375 |
5
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 capital letters. Below the company name is the tagline "Defining Life's Signals" also in blue.
Reference Device(s) Information
| Trade Name: | NightOwl |
|---|---|
| Manufacturer: | Ectosense |
| 510(k) number: | K191031 |
| 510(k) Decision Date: | 6th March 2020 |
| Classification: | Ventilatory Effort Recorder |
| Product code: | MNR |
| Device class: | II |
| Regulation numbers: | 21 CFR 868.2375 |
| Trade Name: | X4 System |
| Manufacturer: | Advanced Brain Monitoring |
| 510(k) number: | K130013 |
| 510(k) Decision Date: | 31st January 2013 |
| Classification: | Reduced-Montage Standard Electroencephalograph |
| Product code: | OMC |
| Device class: | II |
| Regulation numbers: | 21 CFR 882.1400 |
| Trade Name: | SomnaPatch |
| Manufacturer: | Respironics Inc |
| 510(k) number: | K183625 |
| 510(k) Decision Date: | 18th October 2019 |
| Classification: | Ventilatory Effort Recorder |
| Product code: | MNR |
| Device class: | II |
| Regulation numbers: | 21 CFR 868.2375 |
Device Description
The Somfit is a home-based sleep monitoring device which records signals from the patient's forehead and surrounding environment. Somfit is a wearable, low voltage, battery operated device which is attached to subject forehead via a self-adhesive and disposable skin electrode patch. The electrodes are placed on the anterior Prefrontal cortex (PFC) at the Fp1 and Fp2 positions according to the 10/20 EEG system. The device allows for recording of two frontal EEG signals, pulse rate, SPO2, Peripheral Arterial Tonometry (PAT), PPG, motion, and snore. Somfit uses a mobile phone application to acquire data wirelessly via Bluetooth LE technology, then transfer into a secure cloud, for management, storage and postprocessing. The software reports measured parameters in a format compatible with AASM guidelines, including sleep time, pAHI and conventional graphical displays such as a hypnogram.
6
Image /page/6/Picture/0 description: The image shows the logo for Compumedics, a medical device company. The logo features a stylized letter "C" with a smaller letter "m" inside it, followed by the company name "COMPUMEDICS" in a bold, sans-serif font. Below the company name is the tagline "Defining Life's Signals" in a smaller, italicized font. The logo is simple, clean, and professional, and it effectively communicates the company's focus on medical technology and life sciences.
Intended Use / Indications For Use
The Somfit system is a non-invasive prescription device for home use with patients suspected to have sleep-related breathing disorders. The Somfit is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. The Somfit system acquires electrical data from three frontal electrodes, tri-axial accelerometer data, acoustic and plethysmographic data. The Somfit calculates and reports to clinicians EEG/EOG channels, Sleep Stages, Sp02, Peripheral Arterial Tonometry (PAT) signal, pulse rate, and snoring level. The Somfit calculates and reports to clinicians derived parameters such as PAT-derived Apnea Hypopnea Index, Obstructive Desaturation Index; and hypnogram-derived indices such as time in each sleep stage. Somfit data is not intended to be used as the sole or primary basis for diagnosing any sleep-related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The Somfit is not intended for use as life support equipment, for example vital signs monitoring in intensive care unit. The Somfit is a prescription device indicated for adult patients aged 21 years and over.
Comparison of Intended Use
The Somfit has the same intended use as the Watch-PAT300 as a Home Sleep Apnea Test device. The Somfit is intended only for adults, which narrows the indications for use. Somfit does not make clinical claims of distinguishing obstructive and central apnea, which conventionally is performed through direct measurement of airflow (such as nasal cannula) and respiratory effort (such as abdominal inductive belt),
Comparison of Technological Characteristics
The Somfit uses the same fundamental technology and principles of operation as the Watch-PAT300. Both devices are low power battery-operated ventilatory effort recorders utilizing oximeters, tri-axial accelerometers, microphone, and PAT-based technology. The Somfit is notably worn on forehead as opposed to the wrist, and uses an EEG sensor to directly measure brain activity and determine sleep stage. The Somfit data is acquired using a mobile application which uploads data to the Nexus360 Web Server for automatic and review by physician. This workflow is slightly different to the Watch-PAT300 which uses a push button interface, and stores study data in flash memory until a USB connection to a PC running zzzPAT software is made, and upload to the CloudPAT server is manually initiated. Further analysis of technological characteristics is available in the Substantial Equivalence discussion. The Somfit uses the same underlying principles of operation as the Watch-PAT300, and design differences do not raise questions of safety or effectiveness.
Reference has been made to the X4 System in regards to the use of EEG as opposed to actigraphy for sleep staging. Reference has been made to the SomnaPatch for its use of reflectance oximetry at the forehead location. Reference has additionally been made to the NightOwl in regards to test methods used for the validation of PAT and PAT-derived AHI.
7
Image /page/7/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, sans-serif font. Below the company name is the tagline "Defining Life's Signals" also in blue.
Use of Reference Devices
In addition to the predicate Watch-PAT300, reference has been made to similar sleep assessment devices to assist in the determination of substantial equivalence, in accordance with FDA Guidance Documentation.
The use of a forehead-based reflectance oximeter by Somfit in comparison to a finger transmittance oximeter was noted as a technological difference by the FDA. The SomnaPatch (K183625) was leveraged as a reference device as it also uses forehead reflectance oximeter technology like Somfit. A tabular comparison and further technical discussion was provided to the FDA. Reference was additionally made to the SomnaPatch regarding the use of a functional simulator for verification and validation of the associated pulse rate channel.
The use of EEG technology for the determination of sleep stage as opposed to actigraphy used by Watch-PAT300 has been noted as a technological difference by the FDA. We believe that this does not raise questions of safety and effectiveness since direct measurement of brain activity through EEG is considered by the American Academy of Sleep Medicine to be preferable to actigraphy, and have provided discussion to that effect in document. However, regardless we leveraged the X4 System (K130013) as a reference device. The X4 System is one of several marketed devices which similarly records EEG/EOG at frontal locations for review by physicians with automatic analysis software (separately cleared as Sleep Profiler). This is fundamentally the same technology utilized by Somfit. Further technical discussion and comparison of devices was provided to the FDA.
The peripheral arterial tonometry (PAT) signal is derived directly from the PPG, where changes in morphology such as relative reduction in amplitude are indicative of sympathetic activity in response to respiratory events. There is no standardized methodology for calculation of PAT, and numerical values of the PAT signal are expected to differ based on electronic characteristics of the acquisition hardware, and other described factors. The primary methodology used by Somfit to validate the PAT channel is comparison of the PAT-derived apnea hypopnea index with that of the predicate device, and gold standard AHI as measured by Polysomnography. Reference was made to the NightOwl device (K191031) which reported the same methods for validation of their PAT channel. Further discussion of test methodology and comparison of devices was provided to the FDA.
Non-Clinical Performance Data
Testing activities were conducted as part of this submission to verify that the Somfit does not raise any issues of safety and effectiveness, and to verify implementation of risk controls. These included:
- Electrical Safety Testing as per IEC 60601-1:2005 (Third Edition) + COR1:2006 + COR2:2007 + ● A1:2012
- Electromagnetic Compatibility Testing as per IEC 60601-1-2:2014, EN 60601-1-2:2015, and ● modification by the listed particular and collateral standards
- Home Healthcare Environmental testing as per IEC 60601-1-11:2015
- Electroencephalograph safety and performance testing as per IEC 60601-2-26:2012
- Pulse oximeter safety and performance testing as per ISO 80601-2-61:2011 including tests with ● functional simulator
8
Image /page/8/Picture/0 description: The image shows the logo for Compumedics. The logo features a stylized "C" with a smaller, cursive "m" inside it, followed by the word "COMPUMEDICS" in capital letters. Below the company name is the tagline "Defining Life's Signals".
- Hardware bench testing to verify electrical parameters and design specifications
- Software testing to verify functional requirements and system integration ●
Further test details are available in this submission. All tests passed, demonstrated substantial equivalence, and did not raise additional concerns of safety and effectiveness. The test methods are in line with international standards where they exist, and other FDA-cleared devices where outputs have not vet been standardized.
Clinical Performance
Multiple clinical studies were conducted to provide clinical validation of Somfit performance. Detailed results and analysis are available in the substantial equivalence discussion, and clinical volume.
A formal controlled desaturation study was conducted in accordance with ISO 80601-2-61 at Hypoxia Lab. This involved comparison between Somfit Sp0, data and gold standard Sa0, data over an invasively controlled Sall, range of 70%-100%. The Somfit root mean square error (Appe) was 1.46%, out-performing Nonin and Masimo reference devices used during the study, which reported 2.15% and 1.94% respectively. The Watch-PAT300 user guide reports an ARMS of 1.88% based on results from its own controlled desaturation study. The Somfit's ARMS of 1.46% for the same is less, supporting the claim of substantial equivalence, and satisfying performance requirements of ISO 80601-2-61.
Pulse rate data was obtained from Nonin and Masimo reference oximeters during a controlled desaturation study. Two hundred and thirty-seven pulse rate samples were obtained from 12 healthy patients, and analysed using the statistical methods mandated by ISO 80601-2-61. The root-mean square error was found to be 1.91 BPM with a mean difference of 0.017 BPM between the Somfit and Masimo oximeters. The rootmean square error was found to be 1.81 BPM with a mean difference of 0.00 BPM between the Somfit and Nellcor oximeters. Potential sources of error may include inadequate synchronization between devices, since oximeters provide a range of data update rates, and were placed at differing anatomical locations, as well as additional patient motion associated with the condition of profound hypoxemia during wake. In addition to testing against a pulse rate simulator, this clinical performance data supports the claim of substantial equivalence and satisfies validation requirements of ISO 80601-2-61.
A clinical study was conducted to obtain clinical data for the purpose of comparing Somfit and Watch-PAT300. A study protocol was reviewed and approved by an Independent Ethics Committee with predefined hypotheses, study population, endpoints, and analysis techniques. In total 92 subjects were recorded across 3 site locations in Australia. All subjects had Somfit and Watch-PAT300 recording overnight data while undergoing attended polysomnography using the Grael device, which is the gold standard technology to assist in the diagnosis of sleep disorders. Watch-PAT300 and Somfit measured parameters such as PAT-derived AHI (pAHI) and sleep stage concordance were evaluated, and directly compared to each other, and the established ground truth.
Somfit and Watch-PAT300 PAT-derived AHI had a mean difference of 0.294 with 95 percent confidence interval of -2.661, 2.074, which was within the predetermined margin supporting the non-inferiority hypothesis. The mean difference of Somfit and PSG ODI of 0.658 with confidence interval of -1.012, 2.326 was less than the mean difference of Watch-PAT300 and PSG ODI of 2.499 with confidence interval of 0.732,
9
Image /page/9/Picture/0 description: The image shows the logo for Compumedics. The logo features a stylized blue "C" with a smaller, cursive "m" inside it. To the right of the "C" is the company name, "COMPUMEDICS," in a bold, sans-serif font, also in blue. Below the company name is the tagline, "Defining Life's Signals," in a smaller, italicized font.
4.265, indicating Somfit achieved higher accuracy with respect to the gold standard. Somfit had an 80.92% agreement (95 percent Cl: 79.96, 81.89) for N1/N2 merged sleep stages compared to Watch-PAT300 61.77% ( 95 percent CI: 60.99, 62.55). Somfit had a 86.79% agreement (95 percent CI: 85.76, 87.81) for NREM/REM/Wake stage differential compared to Watch-PAT300 of 74.42% agreement (95 percent Cl: 73.51, 75.32). Somfit had an 89.45% agreement (95 percent CI: 88.53, 90.38) with PSG for sleep/wake determination compared to Watch-PAT300 of 82.09% (95 percent CI: 81.37, 82.82).
The sleep staging confusion matrix for agreement between Somfit and PSG is presented in table 1. The PSG epochs were classified based on the consensus of three scoring sleep technologists.
| Somfit | ||||||
|---|---|---|---|---|---|---|
| PSG | Wake | N1 | N2 | N3 | REM | |
| Wake | 16773 | 981 | 1579 | 142 | 1480 | |
| N1 | 2123 | 1335 | 2502 | 27 | 799 | |
| N2 | 2007 | 1337 | 29089 | 836 | 782 | |
| N3 | 166 | 34 | 4206 | 8224 | 11 | |
| REM | 700 | 89 | 611 | 17 | 11157 |
Table 1: Confusion Matrix between the Somfit and PSG sleep staging
The calculated sensitivities of sleep stages and combinations of sleep stages are presented in table 2, including the number of epochs used for each calculation.
| Stage detection
Sensitivities | Somfit
(No. PSG epochs) | WatchPAT
(No. PSG epochs) |
|----------------------------------|----------------------------|------------------------------|
| Pr(Wake PSG Wake) | 0.8004, (20955) | 0.3497, (20909) |
| Pr(N1 PSG N1) | 0.1967, (6789) | N/A, (6770) |
| Pr(N2 PSG N2) | 0.8540, (34051) | N/A, (34006) |
| Pr(N3 PSG N3) | 0.6509,(12641) | 0.4799, (12641) |
| Pr(REM PSG REM) | 0.8873, (12574) | 0.7219, (12555) |
| Pr(N1+N2 PSG N1+N2) | 0.8388,(40840) | 0.7662, (40776) |
| Pr(NREM PSG NREM) | 0.8897, (53481) | 0.9042, (53417) |
| Pr(Sleep PSG Sleep) | 0.9244, (66055) | 0.9706, (65972) |
Table 2. Sensitivities for different sleep stages and combinations of sleep stages.
The estimates of differences in the percent agreement between Watch-PAT300 and PSG consensus versus the percent agreement between Somfit and PSG consensus for the three sets of sleep staging categories are presented in table 3.
| Point estimate, | 95% | 97.5% | |
|---|---|---|---|
| % | Confidence Interval | Confidence Interval | |
| N1, N2 merged | -19.23 | [-22.57; -15.89] | [-23.07; -15.39] |
| NREM/REM/Wake | -12.49 | [-15.97; -8.99] | [-16.49; -8.49] |
| Sleep/Wake | -7.45 | [-10.89; -4.03] | [-11.37; -3.53] |
Table 3: Estimates of the difference in sleep staging percent between Somfit and PSG consensus, and between Watch-PAT and PSG consensus using non-parametric bootstrap sampling.
10
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" in a smaller font below. The logo is simple and professional, and the blue color gives it a sense of trust and reliability.
A detailed comparison is provided through evaluation of design features such as energy source, principles of operation, materials, and user interface. Further comparison and analysis is available in VOL_012_Substantial Equivalence Discussion.
| | Predicate Device Watch-PAT300
(K180775) | New Device
Somfit |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Itamar Medical Ltd | Compumedics Limited |
| Device Classification | MNR | MNR, OMC |
| FDA Classification | Class II | Class II |
| Indications for Use | The Watch-PAT300 (WP300) device is a non-invasive
home care device for use with patients suspected to
have sleep related breathing disorders. The WP300 is
a diagnostic aid for the detection of sleep related
breathing disorders, sleep staging (Rapid Eye
Movement (REM) Sleep, Light Sleep, Deep Sleep and
Wake), snoring level and body position. The WP300
generates a peripheral arterial tonometry ("PAT")
Respiratory Disturbance Index ("PRDI"), Apnea-
Hypopnea index ("PAHI"), Central Apnea-Hypopnea
index ("PAHIc"), PAT sleep staging identification
(PSTAGES) and optional snoring level and body
position discrete states from an external integrated
snoring and body position sensor. The WP300's
PSTAGES and snoring level and body position provide
supplemental information to its PRDI/PAHI/PAHIc.
The WP300's PSTAGES and snoring level and body
position are not intended to be used as the sole or
primary basis for diagnosing any sleep related
breathing disorder, prescribing treatment, or
determining whether additional diagnostic assessment
is warranted. PAHIc is indicated for use in patients 17
years and older. All other parameters are indicated for
12 years and older | The Somfit system is a non-invasive prescription device for
home use with patients suspected to have sleep-related
breathing disorders. The Somfit is a diagnostic aid for the
detection of sleep-related breathing disorders, sleep staging
(REM, N1, N2, N3, Wake), and snoring level. The Somfit system
acquires electrical data from three frontal electrodes, tri-axial
accelerometer data, acoustical and plethysmographic data.
The Somfit calculates and reports to clinicians EEG/EOG
channels, Sleep Stages, SpO2, Peripheral Arterial Tonometry
(PAT) signal, pulse rate, and snoring level. The Somfit
calculates and reports to clinicians derived parameters such as
PAT-derived Apnea Hypopnea Index, Obstructive Desaturation
Index; and hypnogram-derived indices such as time in each
sleep stage. Somfit data is not intended to be used as the sole
or primary basis for diagnosing any sleep-related breathing
disorder, prescribing treatment, or determining whether
additional diagnostic assessment is warranted. The Somfit is
not intended for use as life support equipment, for example
vital signs monitoring in intensive care unit. The Somfit is a
prescription device indicated for adult patients aged 21 years
and over. |
| Type of Use | Prescription Use Only | Prescription Use Only |
| Patient population | 12 years and above, with some features 17 years and
above | Adults – 21 years and above |
| Usage Environment | Home | Home |
| Mass | 98g (excluding uPAT probe weight of 20g) | ≤ 15g (with battery) |
| Dimensions | 69mm x 59mm x 17mm | 43mm x 43 mm x 19.7 mm
(device + charging cradle) |
| Biocompatibility | Overnight use on intact skin | Overnight use on intact skin |
| Materials | Plastic Bracelet (unspecified) | Adhesive (wet) electrode
ABS Plastic |
| Sold Sterile or
Sterilization Required | No | No |
| Energy Source | One OTS 1.5V Alkaline AAA battery OR one
rechargeable AAA 1.2V Nickel-metal hydride (NiMH)
rechargeable battery
700mAh | 1 x 120mAh 3.7V Li-Ion battery |
| Battery Life | Approximately 10 hours | Hours of Use:
On standby/idle mode: 48 hours (2 days) |
| | | Recording: 16 hours continuous recording |
| Microprocessor | ARM (Nordic) | ARM (TI) |
| Electronic Sensors | Photodiode | Photodiode |
| | Oximeter front end (AFE4404) | Oximeter front end (AFE4404) |
| | Microphone | Microphone |
| | Accelerometer | Accelerometer |
| | | EEG Amplification |
| Channel | PAT | PAT |
| | Pulse Rate | Pulse Rate |
| | Oximetry | Oximetry |
| | Actigraphy | EEG |
| | Snoring (Optional) | Snoring |
| | Body Position (Optional) | Motion |
| | Chest Movement (Optional) | |
| Analysis Output | pRDI | pAHI |
| | pAHI | Sleep stages |
| | pAHIc | Snoring Level |
| | ODI | ODI |
| | Sleep stages | |
| | Snoring level (optional) | |
| | Body Position discrete states (Optional) | |
| Application Site | Main device on wrist with finger probe. | Forehead |
| Device Visual Indicator | OLED screen | Green and blue LEDs on device, mobile application |
| User Control | Device push buttons | Start/stop button on mobile application |
| Data Collection | Study data is saved on device flash memory then | Study data is wirelessly transferred through Bluetooth from |
| | transferred to PC via USB cable. Data can be accessed | the device to a mobile application. Data is then uploaded to |
| | by zzzPAT software and uploaded to CloudPAT web | Nexus360 web server for storage and analysis. |
| | server. | |
11
Image /page/11/Picture/0 description: The image shows the logo for Compumedics. The logo features a stylized "C" with a smaller "m" inside it, followed by the word "COMPUMEDICS" in blue, sans-serif font. Below the company name is the tagline "Defining Life's Signals".
Table 4: Comparison of Technological Characteristics
Conclusion
Compumedics Ltd. considers the Somfit to be substantially equivalent to its predicate device the Watch-PAT300. The intended use as an HSAT device are identical. The fundamental principles of operation are the same, and where differences exist they have been discussed. There are no questions of safety and effectiveness, and substantial equivalence is supported by extensive performance testing and clinical data.