The RHEA Vital Sign Vigilance System is intended for continuous measurement of respiration rate and heart rate for adults (≤150kg), in an automatic contact-less manner, in hospital or clinic setting condition.

Device Description

The RHEA Vital Sign Vigilance System is designed for continuous and contact-less measurement of a patient's heart rate and respiratory rate. The system can also notify the user when the patient exits the bed. The system incorporates three main components: Bedside unit, Sensor unit (including fiber cable), and Data Export Software. The sensor detects movement vibrations from the patient's body and converts them into an optical signal. The bedside unit receives the optical signal from the sensor, calculates the heart rate and respiratory rate, displays the vital signs on the screen in real-time, and records and stores the patient data.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RHEA Vital Sign Vigilance System, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (from predicate or inferred)	Reported Device Performance (RHEA Vital Sign Vigilance System)
Heart Rate Measurement	Measurement Range: 30-170 bpm	Measurement Range: 30-170 bpm
	Accuracy: ±4% or ±5 bpm, whichever is greater (Predicate)	Accuracy: ±3 bpm or ±3%, whichever is greater (Superior to predicate)
	Resolution: Unknown (Predicate)	Resolution: 1 bpm
	Baseline period: Unknown (Predicate)	Baseline period: Less than 20s from the time patient starts to stay still completely
Respiratory Rate Measurement	Measurement Range: 6-45 rpm (Predicate)	Measurement Range: 0-45 rpm
	Accuracy: ±4% or ±1.5rpm, whichever is greater (Predicate)	Accuracy: 7-45rpm ±2 rpm. 0-6rpm: None. (This appears to be a different specification compared to the predicate, with a specific accuracy for a higher range and no accuracy for the very low end. The clinical data later clarifies that even with some degradation, it remained below the performance standard established in the study protocol.)
	Resolution: Unknown (Predicate)	Resolution: Unknown (Not explicitly stated for RHEA, but not a difference that raises new questions of safety/effectiveness given the accuracy performance.)
	Baseline period: Unknown (Predicate)	Baseline period: Less than 30s from the time patient starts to stay still completely

General Performance:

Parameter Performance Testing: The device's performance (heart rate, respiration rate accuracy, on/off bed notifications) was assessed under variations in heart rate amplitude to respiration rate amplitude, patient position, mattress thickness, mattress materials, and patient weight. The results "demonstrate that the performance of the RHEA device should not be significantly affected by variations in these factors within expected limits and that the device performs in accordance with specifications."
Denoising Performance Testing: The RHEA device was able to identify potential sources of motion artifact more frequently than the predicate device. The time required for the RHEA device to recover from motion artifacts was within specifications and comparable to the predicate device.
Clinical Data: The accuracy of the RHEA Vital Sign Vigilance System was confirmed for both heart rate and respiration rate when compared against the reference IntelliVue Patient Monitor. "The RHEA Vital Sign Vigilance System did not degrade toward the extremes of the observed range of heart rates (51 to 115 bpm) or respiratory rates (9 to 32 br/min) and did not vary with the patient diagnosis/hospital location or body weight."

Study Information

Sample sizes used for the test set and the data provenance:
- Clinical Data: The text does not explicitly state the specific sample size for the clinical test set. It mentions the observed range of heart rates (51 to 115 bpm) and respiratory rates (9 to 32 br/min) and discusses variations among different sites, implying a multi-site clinical study.
- Data provenance: Not explicitly stated, but the mention of "different sites" suggests a prospective, multi-site clinical study. The clinical data section describes the comparison of the RHEA device against a reference device, indicating a prospective clinical study with real patient data. It is not specified if the data is from a single country or multiple.
- Denoising Performance Testing: Twenty normal volunteers were used. Provenance is not specified (e.g., country of origin, retrospective/prospective). This appears to be a prospective bench study with human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth.
- For the clinical study, the ground truth was established by a reference device, the IntelliVue Patient Monitor, rather than expert consensus on images or interpretations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- "None" for establishing ground truth, as the ground truth was based on a reference device.
- The document does not describe any adjudication method for interpreting results or resolving discrepancies, as it was a direct comparison to a reference device.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device measures vital signs directly and automatically, not through interpretation by human readers. The clinical study compares the device's measurements to a reference medical device, not to human interpretation or human improvement with AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The clinical data section explicitly states, "The accuracy of the RHEA Vital Sign Vigilance System when compared against the reference IntelliVue Patient Monitor was confirmed for both heart rate and respiration rate." This is a direct comparison of the device's automated measurements (algorithm only) to a gold standard, without human intervention in the measurement process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the accuracy evaluation, the ground truth was data from a reference medical device: the IntelliVue Patient Monitor.
The sample size for the training set:
- The document describes performance testing and clinical evaluation of the final device. It does not provide information about the training set size used for developing the device's algorithms, as this is typically part of the development phase, not the regulatory submission's performance evaluation section.
How the ground truth for the training set was established:
- Similar to the training set size, the document does not detail how the ground truth for the training set was established. This information would be part of the device's development and internal validation, which is typically not disclosed in summary K-submissions unless specifically requested by FDA for complex AI/ML devices.

Summary

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December 19, 2019

Shenzhen Fiber Medical Technology Co. Ltd. % Donna-Bea Tillman Senior Consultant Biologics Consulting Group 1555 King Street, Suite 300 Alexandria, Virginia 22314

Re: K190775

Trade/Device Name: The RHEA Vital Sign Vigilance System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZO, DRT Dated: November 18, 2019 Received: November 18, 2019

Dear Donna-Bea Tillman:

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.

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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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Michael Ryan Division 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) K190775

Device Name RHEA Vital Sign Vigilance System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Reproductive Use (Part 21 CFR 600 Subpart D)
☐ Source Tissue Use (21 CFR 1271)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the RHEA Vital Sign Vigilance System is provided below.

1. SUBMITTER

Applicant:	Shenzhen Fiber Medical Technology Co. Ltd.Room 501, Sun Mate Science and TechnologyMansion 2009 Shahe West RoadShenzhen, China 518057
	Tel: +86-86540386
Contact:	Luo LiRegulatory Affair ManagerShenzhen Fiber Medical Technology Co. Ltd+86 18576650186li@darma.co
Submission Correspondent:	Donna-Bea Tillman, Ph.Senior ConsultantBiologics Consulting Group, Inc.1555 King Street, Suite 300Alexandria, VA 22314(410) 531-6542dtillman@biologicsconsulting.com
Date Prepared:	December 18, 2019

2. DEVICE

Device Trade Name:	The RHEA Vital Sign Vigilance System (models:EL30, EL60, EL90)
Device Common Name:	Breathing frequency monitor, Heart rate monitor
Classification Name:	21 CFR 868.2375 Breathing frequency monitor21 CFR 870.2300 Heart rate monitor
Regulatory Class:	Class II
Product Code:	BZQ/DRT

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PREDICATE DEVICE 3.

Predicate Device: K131379 - EarlySense System 2.0

DEVICE DESCRIPTION 4.

The RHEA Vital Sign Vigilance System is available in three models. The only difference between the models is the color of the bedside unit.

Table 1: RHEA Vital Sign Vigilance System Models

Models	Colors
The RHEA Vital Sign Vigilance System EL30	Silver
The RHEA Vital Sign Vigilance System EL60	White
The RHEA Vital Sign Vigilance System EL90	Blue

The system incorporates three main components:

Bedside unit (also referred to "main unit")
Sensor unit (including fiber cable) (also referred to as "optical fiber sensor")
Data Export Software (referred to in internal project documentation as 'data export ● software', referred to as 'Fiber Data Management software' in the operator's manual). This software is not considered a medical device, as explained below.

The sensor detects movement vibrations from the patient's body and converts them into an optical signal. The bedside unit receives the optical signal from the sensor, calculates the heart rate and respiratory rate, displays the vital signs on the screen in real-time, and records and stores the patient data.

INTENDED USE/INDICATIONS FOR USE ട്.

The RHEA Vital Sign Vigilance System is intended for continuous measurement of respiration rate and heart rate for adults(≤150kg), in an automatic contact-less manner, in hospital or clinic setting during sleep or resting condition

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TECHNOLOGICAL COMPARISON 6.

Feature	Subject device –RHEA Vital Sign Vigilance System	Predicate device –The EarlySense 2.0 System K131379
Product Code	BZQ/DRT	BZQ/DRT/DQA
Regulation Number	21 CFR 868.2375/870.2300	21 CFR 868.2375/870.2300/870.2700
Classification Name	Breathing FrequencyMonitor/Monitor, Cardiac (incl.Cardiotachometer and rate alarm)monitor	Breathing Frequency Monitor, Cardiacmonitor (including Cardiotachometerand rate alarm), Oximeter
Components	Bedside unitSensor unit	Bed Sensing UnitBeside UnitOptional OEM Oximetry Module
Energy Source and Input	AC Power	AC Power
	Input Voltage: 100~240V AC (±10%);Input Current: 0.5AFrequency: 50Hz/60HzOutput Current: 1.5A Max	Input Voltage: 100~240V AC (±10%);Input Current: 0.5AFrequency: 50Hz/60HzOutput Current: 0.9A Max
Battery	Lithium ion rechargeable battery usedto power the system if the system isnot connected to mains power, such asduring patient transfer or duringpower failures.Battery Capacity: 5000mAhRated Voltage: 3.7V DC	Lithium polymer rechargeable batteryused to power the system if the systemis not connected to mains power, suchas during patient transfer or duringpower failures.Battery Capacity: unknownRated Voltage: unknown
Sensor Technology	Optical Fiber	Piezoelectric
Heart Rate:	Measure heart rate in real-time whenpatient lies down on the mattress.Measurement Range: 30-170 bpm	Measure heart rate in real-time whenpatient lies down on the mattress.Measurement Range: 30-170bpm
	Accuracy: ±3 bpm or ±3%,whichever is greater	Accuracy: ±4% or ±5 bpm, whicheveris greater
	Resolution: 1 bpm	Resolution: Unknown
	Baseline period: Less than 20s fromthe time patient start to stay stillcompletely	Baseline period: Unknown
Feature	Subject device –RHEA Vital Sign Vigilance System	Predicate device –The EarlySense 2.0 System K131379
Respiratory Rate:	Measure heart rate in real-time whenpatient lays down on the mattress.Measurement Range:0-45 rpmAccuracy: 7-45rpm ±2 rpm 0-6rpmNoneBaseline period: Less than 30s fromthe time patient start to stay stillcompletely.	Measure heart rate in real-time whenpatient lays down on the mattress.Measurement Range: 6-45 rpmAccuracy: ±4% or ±1.5rpm, whicheveris greaterResolution: Unknown
"Unexpected motion"notification	"Unexpected motion" is shown on thebedside unit display when the patientis talking, moving or turning. Thisinformation is used an indication thatthere may be interference with thecurrent signal.	Not included
Motion Measurement	Not included	Measurement of the frequency ofpatient movement
"Measurement out ofrange" notification	Identifies when the heart rate orrespiratory rate is out of themeasurement range.	Not included
Bed Status	Identifies if the patient in in bed or outof bed, and for how long the patienthas been in bed or out of bed.	Identifies if the patient in in bed or outof bed, and for how long the patient hasbeen in bed or out of bed.
Data storage and export	Patient data can be recorded andexported.	Patient data can be recorded andexported
User Interface Display atBedside	Yes	No
Displayed Information	Information displayed at bedside unit:Heart rateRespiratory rateUnexpected motion notificationMeasurement out of range notificationBed status	Information displayed at the besideunit:Heart RateRespiratory RateBed StatusMotion Measurement
Weight	The sensor unit:565g±10gThe bedside unit: 540g±10g	The sensor unit:730gThe bedside unit: 235g±10g
Dimensions	The sensor unit:35 (H) ×241 (W) × 600 (L)The bedside unit:30 (H) ×165 (W) × 261 (L)	The sensor unit:6.45 (H) ×210 (W) × 300 (L)The bedside unit:65.07 (H) ×62 (W) × 145.6 (L)
Defibrillation Proof	No	No

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PERFORMANCE DATA 7.

Biocompatibility Testing

There are no direct or indirect patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device.

Electrical safety and electromagnetic compatibility (EMC)

The RHEA Vital Sign Vigilance System was assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) ● 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
IEC 62133:2012 (Second Edition) Secondary cell and batteries containing alkaline or other non-acid electrolytes

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a Moderate Level of Concern.

Bench Testing

The following performance testing demonstrates that the device meets all performance requirements:

Parameter Performance Testing: .
This testing assessed the impact of the following factors on device performance:
Ratio of heart rate amplitude to respiration rate amplitude -
Patient position with respect to the sensor -
Mattress thickness -
Mattress materials -

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Patient weight -
The testing also assessed the accuracy of heart rate and respiration rate measurements and on/off bed notifications using a simulator.

The results of the testing demonstrate that the performance of the RHEA device should not be significantly affected by variations in these factors within expected limits and that the device performs in accordance with specifications.

Denoising Performance Testing ●
This testing evaluated the resistance of the RHEA device to common sources of motion artifact and system noise when compared to the predicate Early Sense device. Twenty normal volunteers were asked lay quietly on a bed and either the RHEA device or the predicate Early Sense device was placed under the mattress. Subjects were asked to perform a range of activities such as raising their hand or coughing, and the impact of these activities on the output of the monitoring device was noted. The results demonstrated that the RHEA device was able to identify potential sources of motion artifact more frequently than the predicate device, and that the time required for the RHEA device to recover from motion artifacts was within specifications and comparable to the predicate device.

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Data

The accuracy of the RHEA Vital Sign Vigilance System when compared against the reference IntelliVue Patient Monitor was confirmed for both heart rate and respiration rate.

The RHEA Vital Sign Vigilance System did not degrade toward the extremes of the observed range of heart rates (51 to 115 bpm) or respiratory rates (9 to 32 br/min) and did not vary with the patient diagnosis/hospital location or body weight. The respiration rate accuracy (but not the heart rate accuracy) decreased when subjects were awake (20% higher RMSD) but remained below the performance standard specified in the study protocol and varied among sites (the least accurate site's respiratory rate RMSD was 50% higher than the most accurate). EarlySense's respiratory rate accuracy was also worse with awake subjects and varied among sites and was in all cases worse than RHEA's.

No device-related adverse events nor significant malfunctions related to the investigational or reference device were observed.

These data demonstrate that the performance of the subject RHEA Vital Sign Vigilance System is substantially equivalent to that of the predicate EarlySense System 2.0 in regards to both safety and effectiveness.

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CONCLUSION 8.

The subject device has the same intended use and similar indications for use, fundamental technology, performance, functionality, and operation principle as the predicate device. Based on the detailed comparison between the predicate devices and the subject devices, the performance testing and conformance with applicable standards, the RHEA Vital Sign Vigilance System can be found 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).