The Circadia C100 System is indicated for both contactless spot checking and continuous measurement of respiratory rate data as part of a vital signs assessment. The system records, transmits, and displays respiratory rate from multiple connected devices for retrospective analysis only. The system is intended to be used under the care of clinicians and medically qualified personnel.

The system is indicated for use in adult patients during no-motion conditions, for patients in health care facilities. It is available for sale only upon the order of a physician or licensed health care provider.

The Circadia C100 System is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not intended to monitor vital signs. This system is not an apnea monitor.

Device Description

The Circadia C100 System consists of three components:

"The Monitor" - Circadia Contactless Breathing Monitor: The Monitor is a contact-less breathing monitor placed at a bedside table. The Monitor records respiratory rate of adult patients in hospitals and clinical settings (e.g. post-acute care settings such as General Care Floors (GCF), Inpatient Rehabilitation Facilities (IRF), and Skilled Nursing Facilities (SNF)). The Monitor utilizes a UWB-based (Ultra-Wideband based) motion sensor to detect the movement of the abdomen and the chest to derive respiratory data.
"The App" - Circadia Pro Android App: The App allows Technical Support Staff to setup and configure monitors and allows Clinical Staff to review data collected by the monitors. The App is operated from the central "hub" of a ward or nursing station to monitor data collected by multiple monitors for retrospective analysis only, not for active patient monitoring. The App operates from an Android tablet and uses a USB-C connection for initial configuration. The App is designed to communicate with The Monitor and allow it to connect to a Wi-Fi network and subsequently, The Cloud Service.
"The Cloud Service" - Circadia Cloud Service: The Cloud Service offers a set of APIs that allows the monitor to connect to server, send respiratory data over a secure channel, and allows the monitor to track Clinical Staff's personal data and the patient's respiratory data.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) summary for the Circadia C100 System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Circadia C100 System, specifically for its respiratory rate (RR) accuracy, are derived from the clinical testing results that demonstrated its substantial equivalence to a predicate device.

Acceptance Criterion (from testing demonstrating substantial equivalence)	Reported Device Performance
Accuracy of Respiration rate: +/- 2 breaths/min	Achieved 88.2% accuracy
95% limits of agreement: Within an acceptable range relative to predicate/gold standard	-3.2 to +0.7 breaths/min

Note: The document states that the performance met 'acceptance' but does not explicitly list the target acceptance criteria in the format of a table with specific thresholds. Instead, it presents the results of a comparison study intended to demonstrate substantial equivalence to a predicate device and a gold standard. The +/- 2 breaths/min accuracy and the -3.2 to +0.7 breaths/min 95% Limits of Agreements (LoA) are the results that satisfied the FDA's requirements for substantial equivalence for this device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Comparison to end-tidal CO2 capnography (gold standard): 12 patients
- Comparison to chest and abdomen worn band (predicate/reference device): 26 patients
- Total unique patients: While not explicitly stated, it seems these are two distinct sub-studies, leading to a total of 38 unique subjects (12 + 26).
Data Provenance: Not specified (e.g., country of origin, specific healthcare facilities). The document mentions "patients in health care facilities" (page 2) and "adult patients in hospitals and clinical settings" (page 4), but no specific location.
Retrospective or Prospective: Not explicitly stated. However, clinical testing for 510(k) submissions typically involves prospective data collection to evaluate real-time performance. Given the details about monitoring various conditions and subject postures, it suggests prospective data collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth for the capnography data is implicitly established by the device producing that data ("manually scored end-tidal CO2 capnography data"). For the chest/abdomen worn band, it serves as a comparative reference rather than a direct ground truth source that required expert interpretation for its output.

4. Adjudication Method for the Test Set

Not applicable/Not specified. The ground truth was established by readings from established medical devices (end-tidal CO2 capnography and a chest/abdomen worn band), not through expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
The study design focused on comparing the device's measurements against established methods (gold standard capnography and a predicate band), rather than evaluating how AI (or the device's) assistance improves human reader performance. This device is a measurement device, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The "accuracy of Respiration rate" and "95% limits of agreements" reported are for the Circadia C100 system itself, directly measuring the respiratory rate. The clinical testing specifically describes comparing the device's performance against the gold standard and the predicate device.

7. Type of Ground Truth Used

Clinical/Physiological Reference Data: The primary ground truth was "manually scored end-tidal CO2 capnography data" (from devices cleared in K040875 and K120888), which is considered a gold standard for respiratory rate measurement.
Comparative Reference: Performance was also compared against data from a "chest and abdomen worn band" (device cleared in K122516), which serves as a predicate/reference device rather than a ground truth in itself.

8. Sample Size for the Training Set

Not specified. This document is a 510(k) summary for a medical device that uses UWB-based motion sensing, not a machine learning or AI algorithm in the contemporary sense that typically relies on large training datasets for feature learning. While the device certainly processes signals, the document doesn't indicate a machine learning training phase with a distinct training set. The device likely uses signal processing algorithms tuned during development rather than trained on a large dataset in the way a deep learning model would be.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a distinct training set with established ground truth as for a machine learning model is not mentioned or implied by the description of the device's technology. The device utilizes physical principles (UWB radar to detect chest/abdomen movement) and signal processing, not a data-driven "training" process in the AI/ML context.

Summary

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June 24, 2020

Circadia Technologies Ltd. % Andrew Wu Software Consultant Rook Quality Systems, LLC. 1155 Mount Vernon Highway, Suite 800 Dunwoody, Georgia 30338

Re: K200445

Trade/Device Name: The Circadia C100 System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZO Dated: May 4, 2020 Received: May 7, 2020

Dear Andrew Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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,

for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200445

Device Name The Circadia C 100 System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CER 801 Subpart C)

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The Circadia C100 System 510(K) Summary

Date Prepared June 19, 2020

Manufacturer and 510(k) Owner

Circadia Technologies Ltd.

6 Delmey Close, Croydon, CR0 5QD, United Kingdom

Official Contact:	Fares Siddiqui, CEO
Telephone	+44-742-686-7304
Email:	fares@circadiatech.com

Representative/Consultant

Andrew Wu Rook Quality Systems, LLC 1155 Mount Vernon Hwy, Suite 800, Dunwoody, GA 30338

Telephone: +1-770-833-0116

Email: andrew.wu@rookqs.com

Device Information

Use

Proprietary Name:	The Circadia C100 System
Trade Name:	The Circadia C100 System
Classification Name:	Monitor, Breathing Frequency
Regulation Number:	21 CFR 868.2375
Product Code(s):	BZQ
Classification:
Review Panel:	Anesthesiology

Prescription

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Indications for Use

Device Description

The Circadia C100 System consists of three components:

"The Monitor" - Circadia Contactless Breathing Monitor: The Monitor is a contact-less breathing monitor placed at a bedside table. The Monitor records respiratory rate of adult patients in hospitals and clinical settings (e.g. post-acute care settings such as General Care Floors (GCF), Inpatient Rehabilitation Facilities (IRF), and Skilled Nursing Facilities (SNF)). The Monitor utilizes a UWB-based (Ultra-Wideband based) motion sensor to detect the movement of the abdomen and the chest to derive respiratory data.
"The App" - Circadia Pro Android App: The App allows Technical Support Staff to setup and configure monitors and allows Clinical Staff to review data collected by the monitors. The App is operated from the central "hub" of a ward or nursing station to monitor data collected by multiple monitors for retrospective analysis only, not for active patient monitoring. The App operates from an Android tablet and uses a USB-C connection for initial configuration. The App is designed to communicate with The Monitor and allow it to connect to a Wi-Fi network and subsequently, The Cloud Service.
"The Cloud Service" - Circadia Cloud Service: The Cloud Service offers a set of APIs that allows the monitor to connect to server, send respiratory data over a secure channel, and allows the monitor to track Clinical Staff's personal data and the patient's respiratory data.

Predicate Device Identification

The Circadia C100 System is substantially equivalent to the SleepMinder Breathing Frequency Indicator (model BM07) from BiancaMed Ltd (K103631).

The Circadia C100 System has the same intended use and similar indications, technological characteristics, and principles of operation to the device cleared in K103631. Therefore, K103631 is listed as the primary predicate device for The Circadia C100 System. EMBLETTA MPR from EMBLA SYSTEMS (K122516) is listed as a reference device.

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Equivalence to Predicate Device

The subject device has the same intended use and similar technological characteristics (e.g. pulsed radar as its sensor technology to monitor respiratory rate) to the device cleared in K103631.

Technological Characteristics: The Circadia C100 System utilizes a 6.394 to 7.844GHz pulsed radar as its sensor technology, in comparison to 5.8GHz pulsed radar in the device cleared in K103631. Leveraging the similar rationale in K103631, both frequencies are in common use as radiolocation frequencies and are in license-free portions of the electromagnetic spectrum. The choice of center frequency and pulsed are merely decisions. Both the subject device and predicate device are contactless respiratory monitors intended to be placed on desk top adjacent to a patient being measured. Both the subject device and predicate device utilize attenuation of the reflected radio signal to measure the chest movement of a patient for respiratory monitoring. Non-clinical testing was carried out to verify that the safety and effectiveness of the subject device is substantially equivalent to the predicate device based on the aforementioned technological characteristics of the subject device. Hence, there are no significant differences in the technological characteristics between the subject device and primary predicate device.

	Subject Device	Primary Predicate	Reference Device
Product Name	The Circadia C100System from CircadiaTechnologies Ltd(K200445)	SleepMinder BreathingFrequency Indicator(model BM07) fromBiancaMed Ltd(K103631)	EMBLETTA MPR fromEMBLA SYSTEMS(K122516)
Product Code	BZQ	BZQ	MNR
Primary Output	Displays respiratoryrate.	Displays respiratoryrate	Respiratory rate andheart rate.
Intended Use	The Circadia C100System is indicated forboth contactless spotchecking andcontinuousmeasurement ofrespiratory rate data aspart of a vital signsassessment. Thesystem records,transmits, and displaysrespiratory rate from	The device is intendedto be used for the spotmeasurement ofrespiration rate of anadult patient in ahospital and clinicalsetting. It is not a vitalsigns monitor or anapnea monitor.The device is indicatedfor use as suitable for	The Embletta MPR is adigital recording devicedesigned to be usedunder the direction of aphysician or trainedtechnician but may beapplied by a layperson.The EmblettaMPR records multiplephysiologicalparameters from a

	multiple connecteddevices forretrospective analysisonly. The system isintended to be usedunder the care ofclinicians and medicallyqualified personnel.The system is indicatedfor use in adult patientsduring no-motionconditions, for patientsin health care facilities.It is available for saleonly upon the order ofa physician or licensedhealth care provider.The Circadia C100System is not indicatedfor active patientmonitoring, as it doesnot provide alarms fortimely response in life-threatening situations.It is not intended tomonitor vital signs. Thissystem is not an apneamonitor.	use on adult patients. Itshould not be used onpatients that exhibituncontrolled limbmovement.	sleeping patient for thepurpose ofsimultaneous orsubsequent display ofthe parameters. Thedisplayed data assists inthe identification ofsleep-related medicaldisorders by trainedpersonnel.The Embletta MPR isintended to be used foradult and pediatric(excluding neonataland infant) studies. Thedevice is not equippedwith alarms and is notintended to be used asa monitor.The intendedenvironments includeany clean, dry, dustfree environmentsuitable for a patient'srelative comfort.The device does notmonitor or diagnosethe patient and doesnot issue any alarms.
Intended UseEnvironment	Hospital post-acutecare settings such asGeneral Care Floors(GCF), InpatientRehabilitation Facilities(IRF), and SkilledNursing Facilities (SNF).	Hospital and clinicalsetting.	The general intendedenvironments arehospitals, institutions,sleep centers, thehome and sleep clinicsor the patient's home.
Duration of Monitoring	Spot Check andContinuousMeasurement	Spot Check	Sleep
Patient Interface	Non patient contacting,	Non patient contacting,	Respiratory effort
	works from distancethrough clothing andduvet.	works from distancethrough clothing.	bands (chest andabdomen) in directcontact with thesubject. Nasal cannula,measures nasalpressure.
Measurementpositions	Subject can be Seatedor Lying down	Seated	Lying down
Parameters displayed	Respiratory Rate	Respiratory Rate	Respiratory rate andheart rate.
Technology Platform	Pulsed radar as itssensor technology.	Pulsed radar as itssensor technology.	Digital recorderconnected tocommercially availableelectrodes, cannulas,and thermistors.
RR MeasurementRange	7 - 38 breaths perminute	Not available.	Not available.
Sampling rate of RRdata	0.333 Hz	Not available.	Not available.
Update/TransmissionRate	0.333 Hz	Not available.	No real-time data,offline analysis only.

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Summary of Non-Clinical Testing

The following tests were performed to demonstrate safety and effectiveness of The Circadia C100 System based on current industry standards:

Cleaning: General cleaning procedure for monitor enclosure is recommended in the Instructions for Use.
Biocompatibility: Not applicable as there is no direct/indirect patient contacting components.
Software Verification: The software development and testing were executed with consideration to IEC 62304 Medical device software – Software life cycle processes.
· Electromagnetic Compatibility, Electrical Safety, Wireless Coexistence and Battery Safety: The subject device is tested in compliance with:
- o IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint) Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

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o IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence o
Performance Testing - Bench: A number of bench testing were executed using internal test protocols to demonstrate The C100 Circadia System performance met acceptance:
- O Circadia Monitor Drop Test
- Circadia Monitor Power Cord/Button Fatigue Test o

Circadia believes that the aforementioned non-clinical testing demonstrate that the subject device is designed and manufactured in such a way that, when used under the conditions and for the purposes intended, the safety and effectiveness, as well as the performance characteristic of the subject device is substantial equivalent to the predicate device.

Summary of Clinical Testing

To evaluate the performance of the Circadia C100 System, the subject device was compared to gold standard manually scored end-tidal CO2 capnography data (device cleared in K040875 and K120888) in 12 patients. Performance of the subject device was also compared to a chest and abdomen worn band (device cleared in K122516) in 26 patients. The accuracy of Respiration rate was found to be +/- 2 breaths/min (accuracy rate 88.2%) and the 95% limits of agreements was -3.2 to +0.7 breaths/min. Thus the aforementioned clinical testing demonstrate that the overall performance of the subject device on a total of 38 subjects with a wide range of age, body- mass index, and gender, as well as various health conditions, subject postures, aspect angle, monitoring distance, presence of duvet, etc. to reflect intended user profile and conditions, for spot and continuous measurement, supports substantial equivalence to the predicate.

Conclusion

Based on the testing performed, it can be concluded that the subject device does not raise new/different questions of safety or effectiveness compared to the predicate device. The indications for use, technological characteristics, and performance characteristics for The Circadia C100 System are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).