The RHEA Vital Sign Vigilance System

K190775 · Shenzhen Fiber Medical Technology Co. , Ltd. · BZQ · Dec 19, 2019 · Anesthesiology

Device Facts

• Record ID: K190775
• Device Name: The RHEA Vital Sign Vigilance System
• Applicant: Shenzhen Fiber Medical Technology Co. , Ltd.
• Product Code: BZQ · Anesthesiology
• Decision Date: Dec 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

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

Device Story

RHEA Vital Sign Vigilance System provides continuous, contact-less monitoring of heart rate and respiratory rate for adult patients in hospital or clinic settings. The system consists of a bedside unit and an optical fiber sensor placed under the mattress. The sensor detects patient movement vibrations, converting them into optical signals. The bedside unit processes these signals to calculate vital signs, which are displayed in real-time, stored, and exported. The system also detects bed status (in/out) and provides notifications for unexpected motion or measurements out of range. It is intended for use by healthcare providers to monitor patients during sleep or rest. The output allows clinicians to track patient status and detect potential issues, benefiting patient safety through non-invasive, continuous vigilance.

Clinical Evidence

Clinical study compared RHEA system accuracy against the IntelliVue Patient Monitor. Data showed RHEA performance did not degrade at heart rate extremes (51-115 bpm) or respiratory rate extremes (9-32 br/min). Respiration rate accuracy was 20% lower when subjects were awake but remained within protocol specifications. RHEA demonstrated better respiratory rate accuracy than the EarlySense predicate in all tested conditions. No device-related adverse events or significant malfunctions were reported.

Technological Characteristics

System uses optical fiber sensor technology to detect vibrations. Bedside unit includes a 5000mAh lithium-ion rechargeable battery (3.7V DC) and AC power input (100-240V). Complies with ANSI/AAMI ES 60601-1, IEC 60601-1-2 (EMC), and IEC 62133 (battery safety). Form factor includes a bedside unit and a separate sensor unit. Data export software is included. No patient-contacting materials.

Indications for Use

Indicated for continuous, contact-less measurement of heart rate and respiration rate in adult patients (≤150kg) in hospital or clinic settings during sleep or rest.

Regulatory Classification

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.

Predicate Devices

• EarlySense System 2.0 (K131379)

Reference Devices

• IntelliVue Patient Monitor

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

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| | 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.<br>Room 501, Sun Mate Science and Technology<br>Mansion 2009 Shahe West Road<br>Shenzhen, China 518057 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tel: [phone] |
| Contact: | Luo Li<br>Regulatory Affair Manager<br>Shenzhen Fiber Medical Technology Co. Ltd<br>[phone]<br>[e-mail] |
| Submission Correspondent: | Donna-Bea Tillman, Ph.<br>Senior Consultant<br>Biologics Consulting Group, Inc.<br>1555 King Street, Suite 300<br>Alexandria, VA 22314<br>[phone]<br>[e-mail] |
| Date Prepared: | December 18, 2019 |

### 2. DEVICE

| Device Trade Name: | The RHEA Vital Sign Vigilance System (models:<br>EL30, EL60, EL90) |
|----------------------|-----------------------------------------------------------------------------------|
| Device Common Name: | Breathing frequency monitor, Heart rate monitor |
| Classification Name: | 21 CFR 868.2375 Breathing frequency monitor<br>21 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 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 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 –<br>RHEA Vital Sign Vigilance System | Predicate device –<br>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 Frequency<br>Monitor/Monitor, Cardiac (incl.<br>Cardiotachometer and rate alarm)<br>monitor | Breathing Frequency Monitor, Cardiac<br>monitor (including Cardiotachometer<br>and rate alarm), Oximeter |
| Components | Bedside unit<br>Sensor unit | Bed Sensing Unit<br>Beside Unit<br>Optional OEM Oximetry Module |
| Energy Source and Input | AC Power | AC Power |
| | Input Voltage: 100~240V AC (±10%);<br>Input Current: 0.5A<br>Frequency: 50Hz/60Hz<br>Output Current: 1.5A Max | Input Voltage: 100~240V AC (±10%);<br>Input Current: 0.5A<br>Frequency: 50Hz/60Hz<br>Output Current: 0.9A Max |
| Battery | Lithium ion rechargeable battery used<br>to power the system if the system is<br>not connected to mains power, such as<br>during patient transfer or during<br>power failures.<br>Battery Capacity: 5000mAh<br>Rated Voltage: 3.7V DC | Lithium polymer rechargeable battery<br>used to power the system if the system<br>is not connected to mains power, such<br>as during patient transfer or during<br>power failures.<br>Battery Capacity: unknown<br>Rated Voltage: unknown |
| Sensor Technology | Optical Fiber | Piezoelectric |
| Heart Rate: | Measure heart rate in real-time when<br>patient lies down on the mattress.<br>Measurement Range: 30-170 bpm | Measure heart rate in real-time when<br>patient lies down on the mattress.<br>Measurement Range: 30-170bpm |
| | Accuracy: ±3 bpm or ±3%,<br>whichever is greater | Accuracy: ±4% or ±5 bpm, whichever<br>is greater |
| | Resolution: 1 bpm | Resolution: Unknown |
| | Baseline period: Less than 20s from<br>the time patient start to stay still<br>completely | Baseline period: Unknown |
| Feature | Subject device –<br>RHEA Vital Sign Vigilance System | Predicate device –<br>The EarlySense 2.0 System K131379 |
| Respiratory Rate: | Measure heart rate in real-time when<br>patient lays down on the mattress.<br>Measurement Range:0-45 rpm<br>Accuracy: 7-45rpm ±2 rpm 0-6rpm<br>None<br>Baseline period: Less than 30s from<br>the time patient start to stay still<br>completely. | Measure heart rate in real-time when<br>patient lays down on the mattress.<br>Measurement Range: 6-45 rpm<br>Accuracy: ±4% or ±1.5rpm, whichever<br>is greater<br>Resolution: Unknown |
| "Unexpected motion"<br>notification | "Unexpected motion" is shown on the<br>bedside unit display when the patient<br>is talking, moving or turning. This<br>information is used an indication that<br>there may be interference with the<br>current signal. | Not included |
| Motion Measurement | Not included | Measurement of the frequency of<br>patient movement |
| "Measurement out of<br>range" notification | Identifies when the heart rate or<br>respiratory rate is out of the<br>measurement range. | Not included |
| Bed Status | Identifies if the patient in in bed or out<br>of bed, and for how long the patient<br>has been in bed or out of bed. | Identifies if the patient in in bed or out<br>of bed, and for how long the patient has<br>been in bed or out of bed. |
| Data storage and export | Patient data can be recorded and<br>exported. | Patient data can be recorded and<br>exported |
| User Interface Display at<br>Bedside | Yes | No |
| Displayed Information | Information displayed at bedside unit:<br>Heart rate<br>Respiratory rate<br>Unexpected motion notification<br>Measurement out of range notification<br>Bed status | Information displayed at the beside<br>unit:<br>Heart Rate<br>Respiratory Rate<br>Bed Status<br>Motion Measurement |
| Weight | The sensor unit:<br>565g±10g<br>The bedside unit: 540g±10g | The sensor unit:<br>730g<br>The bedside unit: 235g±10g |
| Dimensions | The sensor unit:<br>35 (H) ×241 (W) × 600 (L)<br>The bedside unit:<br>30 (H) ×165 (W) × 261 (L) | The sensor unit:<br>6.45 (H) ×210 (W) × 300 (L)<br>The bedside unit:<br>65.07 (H) ×62 (W) × 145.6 (L) |
| Defibrillation Proof | No | No |

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The subject device has the same intended use and similar indications for use, fundamental technology, performance, functionality, and operation principle as the predicate device. The differences do not raise new questions of safety and effectiveness.

### 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.