(163 days)
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).
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.
Here's an analysis of the acceptance criteria and the studies that demonstrate the Circadia C200 System meets them, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on Heart Rate (HR) and Respiratory Rate (RR) monitoring performance. The specific acceptance criteria are stated for HR. For RR, it states equivalence to a reference device.
| Metric (for Heart Rate) | Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Agreement with gold standard (HR) | ± 5 BPM | Met the pre-specified acceptance criteria of ± 5 BPM | Clinical Testing (Studies 1 & 2) |
Note: For Respiratory Rate (RR), the document states that clinical testing demonstrated "RR monitoring performance of the subject device was equivalent to the reference device (Circadia C100 System, K200445)". The specific numerical acceptance criteria for RR are not explicitly detailed in this summary for the subject device, but rather implied by equivalence to the C100.
2. Sample Sizes and Data Provenance for Test Set:
-
Heart Rate (HR) Studies:
- Study 1: N = 49 patients
- Study 2: N = 41 patients
- Total: N = 90 patients across both studies.
- Data Provenance: The document does not explicitly state the country of origin. It describes the subjects as being from "clinical populations" and use cases "representative of the subject device indications for use," which are "clinical settings, such as skilled nursing and long-term care facilities." This suggests prospective clinical data collection.
-
Respiratory Rate (RR) Study:
- The sample size for the RR study is not explicitly stated in the summary, but it refers to "clinical testing" using the Circadia C100 System (reference device).
3. Number of Experts and Qualifications for Ground Truth:
The document does not explicitly state the "number of experts used to establish the ground truth" for the test set or their qualifications.
4. Adjudication Method for the Test Set:
The adjudication method is not explicitly stated in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this summary. The studies described are focused on the standalone performance of the device against a gold standard, not on how human readers' performance improves with or without AI assistance from this device.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone performance study was done. The clinical testing described for both Heart Rate and Respiratory Rate directly evaluates the performance of the Circadia C200 System's algorithm against a "gold standard reference HR" and a "reference device" for RR measurement.
7. Type of Ground Truth Used:
- Heart Rate (HR): The ground truth was established using a "gold standard reference HR (obtained using reference device K182030)." This implies a validated medical device known for accurate HR measurement.
- Respiratory Rate (RR): The ground truth was established by comparing the subject device's performance to the "Circadia C100 System (reference device, K200445)," which has identical hardware and RR monitoring functionality. This suggests the C100 itself served as the ground truth reference for RR measurement in its own clinical validation.
8. Sample Size for the Training Set:
The document does not provide any information about the sample size used for the training set of the device's algorithms. The summary focuses solely on pre-market clinical validation studies.
9. How Ground Truth for Training Set Was Established:
The document does not provide any information on how the ground truth for the training set was established. This information is typically not included in the 510(k) summary unless the device relies heavily on historical data for training in a way that directly impacts the clinical validation strategy.
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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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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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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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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 C200System | Predicate Device:Vital SignMonitoringSensor (ModelXK300) | Reference Device:Circadia C100System | Comments |
|---|---|---|---|---|
| 510(k) | K234003 | K202464 | K200445 | N/A |
| Decision date | N/A | 26-APR-2021 | 24-JUN-2020 | N/A |
| Product Name | Cardiac Monitor(IncludingCardiotachometer AndRate Alarm) | Cardiac Monitor(IncludingCardiotachometerAnd Rate Alarm) | BreathingFrequency Monitor | Identical to Predicate |
| Product Code | DRT, BZQ | DRT, BZQ | BZQ | Identical to Predicate |
| Intended Use | The intended use is tocontactlessly measureheart rate andrespiration rate anddetect patient motion. | The intended useis to contactlesslymeasure heart rateand respirationrate and detectpatient motion. | The intended use isto contactlesslymeasure respiratoryrate. | Identical to Predicate |
| Indicationsfor Use | The Circadia C200System is intended forthe measurement ofrespiratory rate andheart rate, includingspot measurement.The system isindicated for adultpatients in clinicalsettings, such asskilled nursing andlong-term carefacilities.The system is notindicated for activepatient monitoring,and does not providealarms for timelyresponse in acutelife-threateningsituations. The systemis not intended tomonitor heart rate inpatients witharrhythmias.The system is intendedto be used byhealthcareprofessionals (HCPs)and data are intendedto be reviewed byHCPs to inform patientcare.The system alsomonitors patientmotion, and patientpresence or absencenear the device (exits). | The Vital SignMonitoring Sensor(Model XK300) isintended tomeasure heart rateand respirationrate in adultpatients in ageneral carehospitalenvironmentincluding nursinghomes. The VitalSign MonitoringSensor can beused for homehealthcare for datacollection toinform patientcare but not toacutely treat apatient. XK300monitors thepresence orabsence of apatient in adetection area ofwithin 7 meters.The XK300 alsomonitors thelength ofcontinuous patientmotion or absenceof patient motion. | The Circadia C100System is indicatedfor both contactlessspot checking andcontinuousmeasurement ofrespiratory rate dataas part of a vitalsigns assessment.The system records,transmits, anddisplays respiratoryrate from multipleconnected devicesfor retrospectiveanalysis only. Thesystem is intendedto be used under thecare of cliniciansand medicallyqualified personnel.The system isindicated for use inadult patients duringno-motionconditions, forpatients in healthcare facilities. It isavailable for saleonly upon the orderof a physician orlicensed health careprovider.The Circadia C100System is notindicated for activepatient monitoring,as it does notprovide alarms fortimely response inlife-threateningsituations. It is notintended to monitorvital signs. Thissystem is not an | Similar to PredicateThe Subject device isnot intended for use inthe home environment. |
| apnea monitor. | ||||
| Patient Type | Adult | Adult | Adult | Identical to Predicate |
| UserPopulation | Healthcare Providers | HealthcareProviders | HealthcareProviders | Identical to Predicate |
| Environment | Healthcare facilities,including skillednursing andlong-term carefacilities. | General CareHospitalEnvironmentincluding NursingHomes | Healthcare facilities | Similar to Predicate |
| Technology | Contactless,radar-basedmeasurement ofmicro-motions | Contactless,radar-basedmeasurement ofmicro-motions | Contactless,radar-basedmeasurement ofmicro-motions | Identical to Predicate |
| Physiologicalphenomenonmeasured | Micro-motions of theskin, caused byventilation andheartbeat | Micro-motions ofthe skin, causedby ventilation andheartbeat | Micro-motions ofthe skin, caused byventilation andheartbeat | Identical to Predicate |
| Radar sensor | 6.4 - 7.8 GHz UWB | 6.4 - 7.8 GHzUWB | 6.4 - 7.8 GHz UWB | Identical to Predicate |
| ContactlessMonitoring | Yes | Yes | Yes | Identical to Predicate |
| Heart RangeMeasurementRange | 40 - 140 beats perminute | 60 - 120 beats perminute | N/A | Similar to Predicate |
| RespiratoryRateMeasurementRange | 7 - 38 breaths perminute | 6 - 55 breaths perminute | 7 – 38 breaths perminute | Similar to Predicateand Identical to C100Reference |
| DetectsPatientMotion, andPresence/Absence | Yes | Yes | No | Identical to Predicate |
Table 6-1: Comparison to the Predicate Device
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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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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 AlaskaNative | - | 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.
§ 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).