(163 days)
No
The summary describes signal processing of radar data to extract physiological parameters (RR, HR, motion, presence). There is no mention of AI, ML, or related concepts like training/test sets for algorithmic learning. The performance studies focus on agreement with reference devices, not on evaluating an AI/ML model's performance.
No
The device is described as being for "measurement of respiratory rate and heart rate" and "does not provide alarms for timely response in acute life-threatening situations." It monitors, but does not provide therapy.
No
The device measures respiratory rate and heart rate, motion, and presence/absence, and the data is intended to inform patient care. However, it explicitly states that it is "not indicated for active patient monitoring, and does not provide alarms for timely response in acute life-threatening situations" and "not intended to monitor heart rate in patients with arrhythmias," nor does it analyze or interpret the data to provide a diagnosis.
No
The device description explicitly states the system consists of a "Circadia Contactless Cardiorespiratory Monitor (the 'Monitor')", which is a hardware component using radar technology.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Circadia C200 System Function: The Circadia C200 System uses radar to monitor respiratory rate and heart rate contactlessly from the patient's body. It does not involve the collection or analysis of any biological specimens.
The device is a vital sign monitor that operates externally to the patient's body.
N/A
Intended Use / Indications for Use
The Circadia C200 System is intended for the measurement of respiratory rate and heart rate, including spot measurement.
The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities.
The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute life-threatening situations. The system is not intended to monitor heart rate in patients with arrhythmias.
The system is intended to be used by healthcare professionals (HCPs) and data are intended by HCPs to inform patient care.
The system also monitors patient motion, and patient presence or absence near the device (exits).
Product codes (comma separated list FDA assigned to the subject device)
DRT, BZQ
Device Description
The Circadia C200 System is a contactless system that uses radar to monitor respiratory rate (RR), heart rate (HR), motion, and presence of a patient in its detection range. The System is designed to monitor a patient automatically, without the need for the patient to wear or do anything, or for a healthcare professional (HCP) to interact with the device. The System is thus suitable for long-term and unsupervised monitoring.
The System may also be used to obtain on-demand spot measurements of heart rate and respiratory rate. This allows HCPs to control the frequency and timing of these measurements using the C200 System.
The System consists of the Circadia Contactless Cardiorespiratory Monitor (the "Monitor"), the Circadia Cloud Service (the "Cloud Service"), and the Circadia Pro App (the "App").
The Monitor may be installed next to a patient's bedside. It uses a radar-based motion sensor to detect micromotions caused by ventilation and heartbeat, to measure a patient's RR and HR while the patient is in its detection range at rest. Data is processed continuously on the Monitor, and streamed to the Cloud Service over a Wi-Fi network.
The Cloud Service offers a set of Application Programming Interfaces (APIs) that allows the Monitor to connect to the server and send data over a secure channel. In addition, it allows for patient data to be retrieved from the App.
The App allows a healthcare professional to retrospectively review RR and HR data from multiple connected Monitors. Motion and presence/exit data are available in real time. The App operates from an Android tablet (not supplied, not included in the System). The App includes a functionality to notify a user if no HR has been obtained within the most recent 8 hours.
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
Adult
Intended User / Care Setting
Healthcare professionals (HCPs) and data are intended to be reviewed by HCPs to inform patient care.
Healthcare facilities, including skilled nursing and long-term care facilities.
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)
Clinical testing was performed to evaluate RR monitoring performance, using the Circadia C100 System (reference device, K200445), which has identical hardware and RR monitoring functionality as the subject device. Clinical testing demonstrated that RR monitoring performance of the subject device was equivalent to the reference device.
Clinical testing was performed to evaluate HR monitoring performance, in two separate studies, by comparing subject device HR to gold standard reference HR (obtained using reference device K182030). Performance was assessed in clinical populations (n=49 and n=41 patients, for studies 1 and 2. respectively) and use cases representative of the subject device indications for use. Agreement with the gold standard was found to meet the pre-specified acceptance criteria of +/- 5 BPM. Clinical testing demonstrated that HR monitoring performance of the subject device was equivalent to the predicate device. Subject demographics and baseline characteristics for both studies can be found in Table 8-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement with the gold standard was found to meet the pre-specified acceptance criteria of +/- 5 BPM.
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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May 30, 2024
Circadia Technologies, Ltd. Erhan Ilhan Head of Quality and Regulatory 20 St Thomas Street London, Greater London SE1 9RS United Kingdom
Re: K234003
Trade/Device Name: The Circadia C200 System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: DRT, BZQ Dated: May 1, 2024 Received: May 1, 2024
Dear Erhan Ilhan:
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).
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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,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K234003
Device Name The Circadia C200 System
Indications for Use (Describe)
The Circadia C200 System is intended for the measurement of respiratory rate and heart rate, including spot measurement.
The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities.
The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute lifethreatening situations. The system is not intended to monitor heart rate in patients with arrhythmias.
The system is intended to be used by healthcare professionals (HCPs) and data are intended by HCPs to inform patient care.
The system also monitors patient motion, and patient presence or absence near the device (exits).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "CIRCADIA" in a sans-serif font. To the left of the word is a circular logo that is partially filled in with a dark blue color. The word "CIRCADIA" is also in a dark blue color. The background of the image is white.
510(k) Summary
1.0 Submitter Information Name: Circadia Technologies, Ltd. Address: Runway East Borough Market 20 St. Thomas Street. London SE1 9RS United Kingdom Contact Name: Erhan Ilhan Head of Quality and Regulatory Phone: (800) 985-5596 Date Prepared May 25, 2024
2.0 Subject Device
Trade Name: Common Name: Regulation Number: Class: Product Code: Premarket Review:
The Circadia C200 System Cardiac Monitor 21 CFR 870.2300 II DRT, BZQ OPEQ/OHT2A: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Cardiovascular
Review Panel:
3.0 Predicate Device
Trade Name: Common Name: Regulation Number: Class: Product Code: Premarket Review:
Vital Sign Monitoring Sensor (K202464) Cardiac Monitor 21 CFR 870.2300 II DRT, BZQ OPEQ/OHT2A: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Cardiovascular
4.0 Device Description
Review Panel:
The Circadia C200 System is a contactless system that uses radar to monitor respiratory rate (RR), heart rate (HR), motion, and presence of a patient in its detection range. The System is designed to monitor a patient automatically, without the need for the patient to wear or do anything, or for a healthcare professional (HCP) to interact with the device. The System is thus suitable for long-term and unsupervised monitoring.
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Image /page/4/Picture/0 description: The image contains the word "CIRCADIA" in a sans-serif font. To the left of the word is a circular logo. The logo is a dark blue color and appears to be a stylized representation of a circle with a crescent shape cut out of it.
The System may also be used to obtain on-demand spot measurements of heart rate and respiratory rate. This allows HCPs to control the frequency and timing of these measurements using the C200 System.
The System consists of the Circadia Contactless Cardiorespiratory Monitor (the "Monitor"), the Circadia Cloud Service (the "Cloud Service"), and the Circadia Pro App (the "App").
The Monitor may be installed next to a patient's bedside. It uses a radar-based motion sensor to detect micromotions caused by ventilation and heartbeat, to measure a patient's RR and HR while the patient is in its detection range at rest. Data is processed continuously on the Monitor, and streamed to the Cloud Service over a Wi-Fi network.
The Cloud Service offers a set of Application Programming Interfaces (APIs) that allows the Monitor to connect to the server and send data over a secure channel. In addition, it allows for patient data to be retrieved from the App.
The App allows a healthcare professional to retrospectively review RR and HR data from multiple connected Monitors. Motion and presence/exit data are available in real time. The App operates from an Android tablet (not supplied, not included in the System). The App includes a functionality to notify a user if no HR has been obtained within the most recent 8 hours.
5.0 Indications for Use
The Circadia C200 System is intended for the measurement of respiratory rate and heart rate, including spot measurement.
The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities.
The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute life-threatening situations. The system is not intended to monitor heart rate in patients with arrhythmias.
The system is intended to be used by healthcare professionals (HCPs) and data are intended to be reviewed by HCPs to inform patient care.
The system also monitors patient motion, and patient presence or absence near the device (exits).
6.0 Comparison to Predicate Device
The Circadia C200 System is substantially equivalent to the Vital Sign Monitoring Sensor (Model: XK300) predicate devices (K202464), based on similar intended use and
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Image /page/5/Picture/0 description: The image shows the logo for Circadia. The logo consists of a stylized circle on the left and the word "CIRCADIA" on the right. The circle is made up of two semi-circles, one filled in and one outlined. The word "CIRCADIA" is written in a sans-serif font.
technological characteristics.
The subject device has the same intended use as the predicate device cleared in K202464 which is to contactlessly measure heart rate and respiration rate in adult patients in a clinical setting, such as skilled nursing and long-term care facilities. Additionally, the subject and predicate devices are intended to monitor motion in the detection range, and to monitor the presence or absence of a patient in the detection range. The subject device has similar technological characteristics to the device cleared in K202464. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates. Table 6-1 compares the indications for use and characteristics of the Circadia C200 system to the predicate.
| Feature | Subject Device:
Circadia C200
System | Predicate Device:
Vital Sign
Monitoring
Sensor (Model
XK300) | Reference Device:
Circadia C100
System | Comments |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) | K234003 | K202464 | K200445 | N/A |
| Decision date | N/A | 26-APR-2021 | 24-JUN-2020 | N/A |
| Product Name | Cardiac Monitor
(Including
Cardiotachometer And
Rate Alarm) | Cardiac Monitor
(Including
Cardiotachometer
And Rate Alarm) | Breathing
Frequency Monitor | Identical to Predicate |
| Product Code | DRT, BZQ | DRT, BZQ | BZQ | Identical to Predicate |
| Intended Use | The intended use is to
contactlessly measure
heart rate and
respiration rate and
detect patient motion. | The intended use
is to contactlessly
measure heart rate
and respiration
rate and detect
patient motion. | The intended use is
to contactlessly
measure respiratory
rate. | Identical to Predicate |
| Indications
for Use | The Circadia C200
System is intended for
the measurement of
respiratory rate and
heart rate, including
spot measurement.
The system is
indicated for adult
patients in clinical
settings, such as
skilled nursing and
long-term care
facilities.
The system is not
indicated for active
patient monitoring,
and does not provide
alarms for timely
response in acute
life-threatening
situations. The system
is not intended to
monitor heart rate in
patients with
arrhythmias.
The system is intended
to be used by
healthcare
professionals (HCPs)
and data are intended
to be reviewed by
HCPs to inform patient
care.
The system also
monitors patient
motion, and patient
presence or absence
near the device (exits). | The Vital Sign
Monitoring Sensor
(Model XK300) is
intended to
measure heart rate
and respiration
rate in adult
patients in a
general care
hospital
environment
including nursing
homes. The Vital
Sign Monitoring
Sensor can be
used for home
healthcare for data
collection to
inform patient
care but not to
acutely treat a
patient. XK300
monitors the
presence or
absence of a
patient in a
detection area of
within 7 meters.
The XK300 also
monitors the
length of
continuous patient
motion or absence
of patient motion. | 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 | Similar to Predicate
The Subject device is
not intended for use in
the home environment. |
| | | | apnea monitor. | |
| Patient Type | Adult | Adult | Adult | Identical to Predicate |
| User
Population | Healthcare Providers | Healthcare
Providers | Healthcare
Providers | Identical to Predicate |
| Environment | Healthcare facilities,
including skilled
nursing and
long-term care
facilities. | General Care
Hospital
Environment
including Nursing
Homes | Healthcare facilities | Similar to Predicate |
| Technology | Contactless,
radar-based
measurement of
micro-motions | Contactless,
radar-based
measurement of
micro-motions | Contactless,
radar-based
measurement of
micro-motions | Identical to Predicate |
| Physiological
phenomenon
measured | Micro-motions of the
skin, caused by
ventilation and
heartbeat | Micro-motions of
the skin, caused
by ventilation and
heartbeat | Micro-motions of
the skin, caused by
ventilation and
heartbeat | Identical to Predicate |
| Radar sensor | 6.4 - 7.8 GHz UWB | 6.4 - 7.8 GHz
UWB | 6.4 - 7.8 GHz UWB | Identical to Predicate |
| Contactless
Monitoring | Yes | Yes | Yes | Identical to Predicate |
| Heart Range
Measurement
Range | 40 - 140 beats per
minute | 60 - 120 beats per
minute | N/A | Similar to Predicate |
| Respiratory
Rate
Measurement
Range | 7 - 38 breaths per
minute | 6 - 55 breaths per
minute | 7 – 38 breaths per
minute | Similar to Predicate
and Identical to C100
Reference |
| Detects
Patient
Motion, and
Presence/
Absence | Yes | Yes | No | Identical to Predicate |
Table 6-1: Comparison to the Predicate Device
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Image /page/6/Picture/0 description: The image shows the logo for Circadia. The logo consists of a circular symbol on the left and the word "CIRCADIA" on the right. The circular symbol is made up of two crescent shapes, one inside the other. The text is in a sans-serif font and is a dark blue color.
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7.0 Performance Data (Non-Clinical Testing)
The following tests were performed to demonstrate safety based on current industry standards:
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- . Software Verification and Validation (per IEC 62304:2006/A1:2015)
- . Electrical Safety (per IEC 60601-1:2005)
- . EMC Testing (per IEC 60601-1-2:2014)
- . Wireless Testing (per IEEE C63.27-2017)
- Motion Validation
- . Presence Validation
- . HR Detectable Range Verification
- . HR Acquisition Rate Verification
- Circadia Monitor Drop Test .
- Circadia Monitor Power Cord/Button Fatigue Test ●
The results of these tests indicate that the Circadia C200 System is substantially equivalent to the predicate device.
8.0 Performance Data (Clinical Testing)
To evaluate the performance of the Circadia C200 System, heart rate (HR) and respiratory rate (RR) clinical validation was performed.
Clinical testing was performed to evaluate RR monitoring performance, using the Circadia C100 System (reference device, K200445), which has identical hardware and RR monitoring functionality as the subject device. Clinical testing demonstrated that RR monitoring performance of the subject device was equivalent to the reference device.
Clinical testing was performed to evaluate HR monitoring performance, in two separate studies, by comparing subject device HR to gold standard reference HR (obtained using reference device K182030). Performance was assessed in clinical populations (n=49 and n=41 patients, for studies 1 and 2. respectively) and use cases representative of the subject device indications for use. Agreement with the gold standard was found to meet the pre-specified acceptance criteria of ± 5 BPM. Clinical testing demonstrated that HR monitoring performance of the subject device was equivalent to the predicate device. Subject demographics and baseline characteristics for both studies can be found in Table 8-1.
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Image /page/9/Picture/0 description: The image shows the logo for Circadia. The logo consists of a stylized circle on the left and the word "CIRCADIA" on the right. The circle is dark blue and has a crescent shape cut out of it. The text is also dark blue and in all caps.
Table 8-1: Subject baseline demographics
| Characteristic | Study 1, N=49 | Study 2, N=41 | Total, N=90 |
|---|---|---|---|
| Age [years] | |||
| Range | 33 - 92 | 27 - 88 | 27 - 92 |
| Median (interquartile range) | 75 (11) | 72 (12) | 73 (14) |
| Gender [N (%)] | |||
| Female | 27 (55%) | 21 (51%) | 48 (53%) |
| Male | 22 (45%) | 20 (49%) | 42 (47%) |
| Body-mass index [kg/m²] | |||
| Range | 17 - 73 | 15 - 56 | 15 - 73 |
| Median (interquartile range) | 32 (11) | 27 (8) | 28 (12) |
| Race [N (%)] | |||
| American Indian or Alaska | |||
| Native | - | 1 (2%) | 1 (1%) |
| Asian | 2 (4%) | 1 (2%) | 3 (3%) |
| Black or African American | 7 (14%) | 13 (32%) | 20 (22%) |
| White | 40 (82%) | 23 (56%) | 63 (70%) |
| More than one race | - | 3 (7%) | 3 (3%) |
| Ethnicity [N (%)] | |||
| Hispanic or Latino | 6 (12%) | 6 (15%) | 12 (13%) |
| Not Hispanic or Latino | 43 (88%) | 35 (85%) | 78 (87%) |
N, number; kg, kilogram; m, meter.
9.0 Warnings and Important Use Conditions
The C200 System is not intended to monitor heart rate in patients with arrhythmias, such as atrial fibrillation. Use within this patient population will likely result in reduced performance.
For optimal heart rate monitoring performance, the C200 System Monitor is intended to be used to the side of the patient, and should be positioned 1.0 meter (3.0 feet) or less from the patient.
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10.0 Conclusion
The Circadia C200 System is substantially equivalent to the predicate device based on the testing performed, the same intended use and similar indications, technological characteristics and principles of operation. The differences between the devices have been properly evaluated through the software verification and validation, bench test validation, and clinical validation, and do not present any new issues of safety or effectiveness. Thus, the Circadia C200 System was determined to be substantially equivalent to the predicate devices.