(268 days)
IntelliVue Patient Monitor
No
The summary describes signal processing and calculation of vital signs from sensor data, but does not mention AI or ML. The performance studies focus on traditional signal processing metrics and comparisons to a predicate device.
No.
The device is intended for continuous measurement of physiological parameters (heart rate, respiration rate) and alert notifications, not for treating any medical condition.
No
Explanation: The RHEA Vital Sign Vigilance System is used for continuous measurement of respiration rate and heart rate. While measuring vital signs is crucial for patient monitoring, the device description does not indicate that it diagnoses diseases or medical conditions based on these measurements. Its primary function is data acquisition and display, which supports clinical decision-making rather than performing a diagnosis itself.
No
The device description explicitly mentions hardware components: "Bedside unit, Sensor unit (including fiber cable)". The sensor detects movement vibrations and converts them into an optical signal, and the bedside unit receives this signal and performs calculations and displays. This indicates a physical hardware system, not a software-only device.
Based on the provided information, the RHEA Vital Sign Vigilance System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- RHEA System Function: The RHEA system measures vital signs (heart rate and respiration rate) directly from the patient's body in a contact-less manner. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "continuous measurement of respiration rate and heart rate for adults... in an automatic contact-less manner". This describes a physiological monitoring device, not an IVD.
- Device Description: The description details how the sensor detects movement vibrations from the patient's body, not how it analyzes biological samples.
Therefore, the RHEA Vital Sign Vigilance System falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 condition.
Product codes
BZO, DRT
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 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.
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
adults
Intended User / Care Setting
hospital or clinic setting
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
- Bench Testing:
- Parameter Performance Testing: This testing assessed the impact of: Ratio of heart rate amplitude to respiration rate amplitude, Patient position with respect to the sensor, Mattress thickness, Mattress materials, Patient weight on device performance. It also assessed the accuracy of heart rate and respiration rate measurements and on/off bed notifications using a simulator.
- 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 to 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.
- Clinical Data:
- Study Type: Accuracy confirmation study.
- Sample Size: Not explicitly stated, but subjects had heart rates between 51 and 115 bpm and respiratory rates between 9 and 32 br/min.
- Data Source: Comparison against the reference IntelliVue Patient Monitor.
- Key Results: The RHEA Vital Sign Vigilance System's accuracy for heart rate and respiration rate was confirmed. Performance did not degrade at the extremes of observed heart rate or respiratory rate ranges, nor did it vary with patient diagnosis/hospital location or body weight. Respiratory rate accuracy decreased when subjects were awake but remained below the specified performance standard. 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 or significant malfunctions were observed.
Key Metrics
- Heart Rate:
- Measurement Range: 30-170 bpm
- Accuracy: ±3 bpm or ±3%, whichever is greater
- Resolution: 1 bpm
- Baseline period: Less than 20s from the time patient start to stay still completely
- Respiratory Rate:
- Measurement Range: 0-45 rpm
- Accuracy: 7-45rpm ±2 rpm 0-6rpm None
- Baseline period: Less than 30s from the time patient start to stay still completely.
Predicate Device(s)
Reference Device(s)
IntelliVue Patient Monitor
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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)
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)
| ☑ 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 Technology
Mansion 2009 Shahe West Road
Shenzhen, China 518057 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tel: +86-86540386 |
| Contact: | Luo Li
Regulatory Affair Manager
Shenzhen Fiber Medical Technology Co. Ltd
+86 18576650186
li@darma.co |
| Submission Correspondent: | Donna-Bea Tillman, Ph.
Senior Consultant
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria, VA 22314
(410) 531-6542
dtillman@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 monitor
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 –
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 Frequency
Monitor/Monitor, Cardiac (incl.
Cardiotachometer and rate alarm)
monitor | Breathing Frequency Monitor, Cardiac
monitor (including Cardiotachometer
and rate alarm), Oximeter |
| Components | Bedside unit
Sensor unit | Bed Sensing Unit
Beside Unit
Optional OEM Oximetry Module |
| Energy Source and Input | AC Power | AC Power |
| | Input Voltage: 100240V AC (±10%);240V AC (±10%);
Input Current: 0.5A
Frequency: 50Hz/60Hz
Output Current: 1.5A Max | Input Voltage: 100
Input Current: 0.5A
Frequency: 50Hz/60Hz
Output Current: 0.9A Max |
| Battery | Lithium ion rechargeable battery used
to power the system if the system is
not connected to mains power, such as
during patient transfer or during
power failures.
Battery Capacity: 5000mAh
Rated Voltage: 3.7V DC | Lithium polymer rechargeable battery
used to power the system if the system
is not connected to mains power, such
as during patient transfer or during
power failures.
Battery Capacity: unknown
Rated Voltage: unknown |
| Sensor Technology | Optical Fiber | Piezoelectric |
| Heart Rate: | Measure heart rate in real-time when
patient lies down on the mattress.
Measurement Range: 30-170 bpm | Measure heart rate in real-time when
patient lies down on the mattress.
Measurement Range: 30-170bpm |
| | Accuracy: ±3 bpm or ±3%,
whichever is greater | Accuracy: ±4% or ±5 bpm, whichever
is greater |
| | Resolution: 1 bpm | Resolution: Unknown |
| | Baseline period: Less than 20s from
the time patient start to stay still
completely | 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 when
patient lays down on the mattress.
Measurement Range:0-45 rpm
Accuracy: 7-45rpm ±2 rpm 0-6rpm
None
Baseline period: Less than 30s from
the time patient start to stay still
completely. | Measure heart rate in real-time when
patient lays down on the mattress.
Measurement Range: 6-45 rpm
Accuracy: ±4% or ±1.5rpm, whichever
is greater
Resolution: Unknown |
| "Unexpected motion"
notification | "Unexpected motion" is shown on the
bedside unit display when the patient
is talking, moving or turning. This
information is used an indication that
there may be interference with the
current signal. | Not included |
| Motion Measurement | Not included | Measurement of the frequency of
patient movement |
| "Measurement out of
range" notification | Identifies when the heart rate or
respiratory rate is out of the
measurement range. | Not included |
| Bed Status | Identifies if the patient in in bed or out
of bed, and for how long the patient
has been in bed or out of bed. | Identifies if the patient in in bed or out
of bed, and for how long the patient has
been in bed or out of bed. |
| Data storage and export | Patient data can be recorded and
exported. | Patient data can be recorded and
exported |
| User Interface Display at
Bedside | Yes | No |
| Displayed Information | Information displayed at bedside unit:
Heart rate
Respiratory rate
Unexpected motion notification
Measurement out of range notification
Bed status | Information displayed at the beside
unit:
Heart Rate
Respiratory Rate
Bed Status
Motion Measurement |
| Weight | The sensor unit:
565g±10g
The bedside unit: 540g±10g | The sensor unit:
730g
The 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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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 -
8
- 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.