Belun Ring BLR-100X

K211407 · Belun Technology Company Limited · DQA · Oct 21, 2021 · Cardiovascular

Device Facts

• Record ID: K211407
• Device Name: Belun Ring BLR-100X
• Applicant: Belun Technology Company Limited
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

Device Story

The Belun Ring BLR-100X is a wireless, wearable pulse oximeter worn on the base of the index finger. It uses spectrophotometric methodology, emitting red and infrared light to measure light absorption changes in oxygenated and deoxygenated blood. The device consists of a ring (for signal acquisition and parameter calculation), a cradle (for data storage, charging, and transfer), and a host program (for data export and visualization). It operates in hospital and home environments, used by patients for continuous monitoring up to 10 hours. Data is transferred via USB or Bluetooth to a host computer. The device provides SpO2 and pulse rate data to healthcare providers to assist in clinical assessment. It lacks alarms and is not intended for transport use.

Clinical Evidence

Clinical study conducted per ISO 80601-2-61:2017 evaluated SpO2 accuracy in steady-state/non-motion conditions across 70-100% SaO2 range. Accuracy was validated against arterial blood CO-Oximetry. The Accuracy Root Mean Square (ARMS) performance met specifications, supporting the claimed accuracy.

Technological Characteristics

Reflective pulse oximeter using red (658 nm) and infrared (886 nm) LEDs. Materials: TPE and PC. Connectivity: Bluetooth Low Energy and USB. Power: 3.7V lithium battery. Form factor: Ring worn on index finger. Software: Embedded firmware (Ring/Cradle) and host management program. Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-11, ISO 10993.

Indications for Use

Indicated for adult patients, including those well or poorly perfused, for continuous SpO2 and pulse rate monitoring in hospital and home settings for up to 10 hours. Not for single-use or out-of-hospital transport.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Belun Ring BLR-100C (K191417)

Reference Devices

• WatchPAT™ONE (WP1) (K183559)

Submission Summary (Full Text)

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October 21, 2021

Belun Technology Company Limited Leung Lap Wai Lydia CEO Unit 218, 2/F, Core Building 2, No. 1 Science Park West Avenue, Hong Kong Science Park Sha Tin, Hong Kong China

Re: K211407

Trade/Device Name: Belun Ring BLR-100X Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 17, 2021 Received: September 20, 2021

Dear Leung Lap Wai Lydia:

We have reviewed vour 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.

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

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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,

Todd Courtney Assistant Director DHT1C: Division of 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) K211407

Device Name Belun Ring BLR-100X

## Indications for Use (Describe)

Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="line-height: normal;"> <span style="orphans: 2;"> <span style="text-align: left;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="-webkit-text-stroke-width: 0px;"> <span style="display: inline !important;"> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D)</span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Vol 5 – 510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92. There is no prior submission for the device.

#### l. SUBMITTER

Belun TechnologyCompany Limited Unit 218, 2 Floor, Core Building 2, 1 Science Park West Avenue, Hong Kong Science Park, Shatin, Hong Kong Contact Person: Leung Lap WaiLydia Phone: [phone]

### II. PROPOSED DEVICE

Device Common Name: Pulse Oximeter Device Proprietary Name: Belun Ring BLR-100X Model: BLR-100X Classification Name and Reference: Oximeter (21 CFR 870.2700) Regulatory Class: II Product Code: DQA

### lll. PREDICATE DEVICE

The identified predicates: Belun Ring BLR-100C (manufactured by Belun Technology Company Limited and the subject of FDA 510(k) document no. K191417) The reference device: WatchPAT™ONE (WP1) (K183559, Itamar Medical, Inc.)

## IV. DEVICE DESCRIPTION

Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms. The proposed device consists of three parts: A Ring, a Cradle and a Host program.

The Ring, which is of a smooth and a light design and is easy to be worn and taken off, is intended to be worn on the base of the index finger. It provides comfortable and accurate measurements without the Cradle in the recording mode. To make the Optical module appropriately contact with the user's skin, the soft part of the Ring (hereinafter referred to as "the Ring arm") is designed to be changeable for fitting different sizes of fingers. The Cradle collects data from the Ring and charges up the Ring. It transfers the collected data to host via an attached USB cable or Bluetooth low power technology. The host program translates the data into text and graph which can be easily understood by the user. Using spectrophotometric methodology, the proposed device measures oxygen saturation by illuminating the skin and measuring changes in the light absorption of oxygenated (oxyhemoglobin) and deoxygenated blood (reduced hemoglobin) using light of two wavelengths: redand infrared. The

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ratio of absorbance at these wavelengths is calculated and calibrated against direct measurements of arterial oxygen saturation (SaO2) to establish the pulse oximeter's measurement of functional oxygen saturation of arterial hemoglobin (SpO2). The sensor of the Ring should be placed on the palmar side of the proximal phalanx of the index finger and along the radial artery.

The system consists of three main platforms. Ring is responsible for signal acquisition, data processing, parameters calculation (SpO2/PRalgorithm), sensor interfacing and user interface. Cradle takes care of the data storage, data transfer and user interface. Host program is for data export and user interface.

The system includes two embedded software and one host program, namely the Ring firmware, the Cradle firmware and the Belun Ring Management. It is modularized and provideshigh stability. It is a highly robust and secure system with proper measure on the data integrity and security. The communication protocol is proprietary which provides a reliable and fast communication.

#### V. INDICATIONS FOR USE

Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

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## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE AND THE REFERENCE DEVICE VI.

| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100X) and Predicate Device (BLR-100C) and Reference Device<br>(WatchPAT™One – WP1) | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Comparison Elements | Proposed Device (BLR-100X) | Predicate Device (BLR-100C) | Reference Device (WatchPAT™One -<br>WP1) | |
| Product Name | Belun Ring BLR-100X | Belun Ring BLR-100C | WatchPAT™ONE (WP1) | |
| FDA 510(k) Document No. | K211407 | K191417 | K183559 | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 868.2375 | |
| Classification | II | II | II | |
| Classification Name | Oximeter | Oximeter | Ventilatory Effort Recorder | |
| Product Code | DQA | DQA | MNR | |
| Intended Use | Belun Ring BLR-100X is a wireless, non-<br>invasive and stand-alone pulse oximeter<br>intended to be used for continuous data<br>collection and recording of oxygen<br>saturation of arterial hemoglobin (SpO2)<br>and the pulse rate of adult patients<br>through indexfinger in hospital and<br>home environment for up to ten hours,<br>during no motion and motion<br>conditions, and for patients who are<br>well or poorly perfused. It is not<br>intended for single-use and out-of-<br>hospital transport use and does not<br>have alarms. | Belun Ring BLR-100C is a non-invasive<br>and stand-alone pulse oximeter,<br>intended to be used for spot-checking<br>and/or data collection and recording<br>of oxygen saturation of arterial<br>hemoglobin (SpO2) and the pulse<br>rate of adult patients through index<br>finger in hospital and home<br>environment. It is not intended for<br>single-use and out-of-hospital<br>transportuse. | The WatchPAT™ONE (WP1) device is a<br>non-invasive home care device for use<br>with patients suspected to have sleep<br>related breathing disorders. The WP1 is<br>a diagnostic aid for the detection of<br>sleep related breathing disorders, sleep<br>staging (Rapid Eye Movement (REM)<br>Sleep, Light Sleep, Deep Sleep and<br>Wake), snoringlevel and body position.<br>The WP1 generates a peripheral arterial<br>tonometry ("PAT") Respiratory<br>Disturbance Index ("PRDI"),<br>Apnea Hypopnea index ("PAHI"), Central<br>Apnea-Hypopnea index ("PAHIc"), PAT<br>sleep staging identification (PSTAGES)<br>and snoring level and body position | |
| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100X) and Predicate Device (BLR-100C) and Reference Device<br>(WatchPATTMOne – WP1) | | | | |
| Comparison Elements | Proposed Device (BLR-100X) | Predicate Device (BLR-100C) | Reference Device (WatchPATTMOne – WP1) | |
| | | | discrete states from an external<br>integrated snoring and body position<br>sensor. The WP1's PSTAGES and snoring<br>level and body position provide<br>supplemental information to its<br>PRDI/PAHI/PAHIc. The WP1's PSTAGES<br>and snoring level and body position are<br>not intended to be used as the sole or<br>primary basis for diagnosing any sleep<br>related breathing disorder, prescribing<br>treatment, or determining whether<br>additional diagnostic assessment is<br>warranted. PAHIc is indicated for use in<br>patients 17 years and older. All other<br>parameters are indicated for 12 years<br>and older. | |
| Comparison Statement | The proposed device and the predicate device have the similar intended use and classification. The proposed device<br>includes user Interface Display/Indicators that are similar to the reference device. The additional risk of safety and<br>effectiveness of the proposed device is evaluated. | | | |
| Components | Pulse Oximeter Ring, sensor unit, CPU,<br>accelerometer, LED indicator light, signal<br>processing unit, power unit, built-in<br>battery | Pulse Oximeter Ring, sensor unit,<br>CPU, accelerometer, display screen,<br>signal processing unit, power unit,<br>built-in battery | uPAT finger probe, actigraph, controller,<br>microphone, accelerometer, ZzzPAT<br>software, chest sensor | |
| | Red | $658 nm \pm 2 nm$ | $658 nm \pm 2 nm$ | - |

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| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100X) and Predicate Device (BLR-100C) and Reference Device | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------|
| (WatchPATTMOne - WP1) | | | | | |
| Comparison Elements | | Proposed Device (BLR-100X) | Predicate Device (BLR-100C) | Reference Device (WatchPATTMOne – WP1) | |
| Performance specifications | Measurement<br>Wavelength | Infrared | $886 nm \pm 6 nm$ | $886 nm \pm 6 nm$ | - |
| | Technology Type | | reflective light | reflective light | transmissive light |
| | Comparison Statement | | The proposed device has same measurement wavelength and technology as the predicate device. The proposed device had<br>passed the clinical validation on the accuracy of the spo2 and pulse rate. Thus, it is proven to be effective. | | |
| | | User Interface<br>Display/ Indicators | Via host program interface<br>Via Cradle (LED)<br>Via Ring (LED) | Via Cradle display interface (OLED) | Via Smartphone User Interface<br>Via Main device (LED) |
| | | Battery | 3.7V lithium battery | 3.7V lithium battery | One OTS 1.5V Alkaline AAA battery |
| | | Power Supply<br>Requirement | 3.1 V~ 4.2V DC | 3.1 V~ 4.2V DC | 3.3V DC |
| | | Rated Current | 500mA | 500mA | N/A |
| | | Spo2 Measurement<br>Range | 70%~ 100% | 70%~ 100% | - |
| | | Spo2 Accuracy | $\pm$ 2.7% | $\pm$ 2% | - |
| | | PR Measurement<br>Range | 30 bpm ~ 250 bpm | 30 bpm~ 250 bpm | - |
| | | PR Accuracy | $\pm$ 2.5 bpm or $\pm$ 2%, which is larger | $\pm$ 2 bpm or $\pm$ 2%, which is larger | - |
| | | Data Average | Recording mode: 8s | Spot checking mode: 8s | - |
| | | Data Update Period | Recording mode: 8s | Spot checking mode: ≤20s | - |

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| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100X) and Predicate Device (BLR-100C) and Reference Device<br>(WatchPAT™One - WP1) | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Comparison Elements | Proposed Device (BLR-100X) | Predicate Device (BLR-100C) | Reference Device (WatchPAT™One – WP1) | |
| Waveform Display | No | No | No | |
| Pulse Intensity Indication | No | Yes | No | |
| Low-Voltage Indication | Yes | Yes | - | |
| Data Storage | Yes | Yes | - | |
| Can Be Connected with An External Oximeter Probe | Can only be connected to the special designed oximeter | Can only be connected to the special designed oximeter | Yes | |
| Data Collection | Sensors connect direct to cradle Study data is transferred from cradle to host through USB or wirelessly through Bluetooth | Sensors connect direct to cradle Study data is transferred from cradle to host through USB | Sensors connect direct to main device Study data is wirelessly transferred (Bluetooth) from main device to mobile phone and from the mobile phone to a storage on a web server over the Internet | |
| Atmosphere Pressure | 700hPa~1060hPa | 700hPa~1060hPa | - | |
| Operating Temperature | 10 ~ 38°C | 10 ~ 40°C | - | |
| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100X) and Predicate Device (BLR-100C) and Reference Device | | | | |
| (WatchPATTMOne - WP1) | | | | |
| Comparison Elements | | Proposed Device (BLR-100X) | Predicate Device (BLR-100C) | Reference Device (WatchPATTMOne - WP1) |
| Relative Humidity | | ≤75% | ≤75% | - |
| Storage Environment | | a) Temperature: -10~+60 °C<br>b) Relative humidity: 10~95%<br>c) Atmospheric pressure: 500hPa~1060hPa…