Belun Ring

K191417 · Belun Technology Company Limited · DQA · Oct 10, 2019 · Cardiovascular

Device Facts

• Record ID: K191417
• Device Name: Belun Ring
• Applicant: Belun Technology Company Limited
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Belun Ring BLR-100C is a non-invasive and stand-alone pulse oximeter, intended to be used for spot-checking and/or 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. It is not intended for single-use and out-of-hospital transport use.

Device Story

Non-invasive pulse oximeter; consists of ring sensor and cradle. Ring worn on index finger; uses spectrophotometric methodology (red/infrared light) to measure SpO2 and pulse rate. Cradle provides user interface, display, and USB data export to external computers/mobile equipment. Operates in spot-checking mode (with cradle) or recording mode (standalone ring). Used in hospital and home environments by patients or clinicians. Dual CPU design: ring handles signal pre-conditioning, SpO2/PR algorithm, and sensor interfacing; cradle handles UI and data management. Provides objective SpO2 and pulse rate data to assist healthcare providers in monitoring patient oxygenation status.

Clinical Evidence

No new clinical data provided. Clinical study of predicate device (K180174) deemed valid for subject device due to identical PCB assembly, materials, and measurement principle, with only minor firmware and component changes for data recording functionality.

Technological Characteristics

Reflective pulse oximetry; red (658nm) and infrared (886nm) LEDs. Materials: TPU, PC. Dual CPU architecture. Connectivity: USB data export (no wireless). Power: 3.7V lithium battery. IP22 rating. Software: Embedded firmware in ring and cradle; proprietary communication protocol.

Indications for Use

Indicated for adult patients requiring spot-checking or data collection/recording of SpO2 and pulse rate via index finger in hospital or home settings.

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-100 (K180174)

Reference Devices

• Nonin 3150 WristOx2 (K102350)

Submission Summary (Full Text)

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October 10, 2019

Belun Technology Company Limited Lydia Leung CEO Unit 531B, Floor 5, Core Building 2 1 Science Park West Avenue, Hong Kong Science Park Sha Tin HONG KONG

Re: K191417

Trade/Device Name: Belun Ring BLR-100C Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: September 2, 2019 Received: September 4, 2019

Dear Lydia Leung:

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.

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

Sincerely,

for Todd Courtney Assistant 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191417

Device Name Belun Ring BLR-100C

### Indications for Use (Describe)

Belun Ring BLR-100C is a non-invasive and stand-alone pulse oximeter, intended to be used for spot-checking and/or 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. It is not intended for single-use and out-of-hospital transport use.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary

# K191417

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 Technology Company Limited Unit 531B, 5 Floor, Core Building 2, 1 Science Park West Avenue, Hong Kong Science Park, Shatin, Hong Kong Contact Person: Lydia Leung Phone: [phone]

#### II. PROPOSED DEVICE

Device Common Name: Pulse Oximeter Device Proprietary Name: Belun Ring BLR-100C Model: BLR-100C Classification Name and Reference: Oximeter (21 CFR 870.2700) Regulatory Class: II Product Code: DQA 510(k) Number: K191417

#### lll. PREDICATE DEVICE

The identified predicates: Belun Ring BLR-100 (manufactured by Belun Technology Company Limited and the subject of FDA 510(k) document no. K180174) The reference device: Nonin 3150 WristOx2 (K102350, Nonin Medical, Inc.)

#### DEVICE DESCRIPTION IV.

The proposed device Belun Ring BLR-100C is a non-invasive and stand-alone pulse oximeter, which can detect, display and transfer the measured oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate in hospital and home environment.

The proposed device consists of two parts: A Ring and a Cradle.

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 with the Cradle in the spot-checking mode or without the Cradle in the recording mode. The Cradle collects data from the Ring and translates the data into text and graph which can be easily understood by the user. It also exports the collected data via USB port to a host such as computer or mobile equipment for recording data transfer and review. They usually outside of patient environment, which is remote from the patient. There is no wireless function in this device.

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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: red and infrared. The 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 is using a customized dual CPU design to realize the functions. It consists of two main platforms: The Ring is responsible for signal pre-conditioning, data post-processing (SPO2/PR algorithm), parameters calculation and sensor interfacing, while the Cradle takes care of the user interface including a display for output and a button for input.

The system includes two embedded software, namely the Ring firmware and the Cradle firmware. It is modularized and provides high stability. The software systems work in conjunction with the Ring and the Cradle. The two platforms (Ring and Cradle) are connected via "Connectivity software module". The communication protocol is proprietary which provides a reliable and fast communication.

#### V. INDICATIONS FOR USE

Belun Ring BLR-100C is a non-invasive and stand-alone pulse oximeter, intended to be used for spotchecking and/or 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. It is not intended for single-use and out-of-hospital transport use.

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

| Table 1 Performance Specification Company he Proposed Device (BLR-100C) and Predicate Device (BLR-100) and Reference Device (Model 3150<br>WristOx2) | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Comparison Elements | Proposed Device (BLR-100C) | Predicate Device (BLR-100) | Reference Device (Model 3150<br>WristOx2) | |
| Product Name | Pulse Oximeter | Pulse Oximeter | Pulse Oximeter | |
| Model | BLR-100C | BLR-100 | Model 3150 WristOx2 | |
| FDA 510(k) Document No. | | K180174 | K102350 | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Classification | = | 11 | ll | |
| Classification Name | Oximeter | Oximeter | Oximeter | |
| Product Code | DQA | DQA | DQA | |
| Intended Use | 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 of<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and the pulse rate<br>of adult patients through index finger<br>in hospital and home environment. It is<br>not intended for single-use and out-of-<br>hospital transport use. | Belun Ring BLR-100 is a non-invasive<br>and stand-alone pulse oximeter,<br>intending for spot-checking of oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and the pulse rate of adult<br>patients through index finger in<br>hospital and home environment.<br>It is not intended for single-use and<br>out-of-hospital transport use. | Nonin's Model 3150 WristOx2 Pulse<br>Oximeter is a small wrist-worn device<br>indicated for use in measuring,<br>displaying, and storing functional oxygen<br>saturation of arterial hemoglobin (SpO2)<br>and pulse rate of adult and pediatric<br>patients. It is intended for spot-checking<br>and / or data collection and recording of<br>patients who are well or poorly<br>perfused. The intended use<br>environments are sleep and pulmonary<br>rehab labs, surgical recovery, critical<br>care, emergency room, longterm care,<br>home use and mobile units. | |
| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100C) and Predicate Device (BLR-100) and Reference Device (Model 3150<br>WristOx2) | | | | |
| Comparison Elements | Proposed Device (BLR-100C) | Predicate Device (BLR-100) | Reference Device (Model 3150<br>WristOx2) | |
| Comparison Statement | The proposed device and the predicate device have the similar intended use and classification. The proposed device<br>includes data collection and recording 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, CPU, display<br>screen, signal processing unit, power<br>unit, built-in battery | Pulse Oximeter Ring, CPU, display<br>screen, signal processing unit, power<br>unit, built-in battery | Sensor block, analog block,<br>controller, LCD display and battery | |
| Measurement<br>Wavelength | Red<br>658 nm ± 2 nm | 658 nm ± 2 nm | 660 nm | |
| Wavelength | Infrared<br>886 nm ± 6 nm | 886 nm ± 6 nm | 910 nm | |
| Technology Type | reflective light | reflective light | transmissive light | |
| Comparison Statement | The proposed device has same components, measurement wavelength and technology as the predicate device. | | | |
| Performance specification | Display Type | OLED | OLED | LCD |
| | Battery | 3.7V lithium battery | 3.7V lithium battery | Two 1.5-volt AAA alkaline batteries |
| | Power Supply<br>Requirement | 3.1 V~ 4.2V DC | 3.1 V~ 4.2V DC | 3.0V DC |
| | Rated Current | 500mA | 1A | N/A |
| | Spo2 Measurement<br>Range | 70% ~ 100% | 70% ~ 100% | 70% ~ 100% |
| | Spo2 Accuracy | ± 2% | ±2% | ± 2 digits (8000J/Q/R series, no motion) |
| | PR Measurement<br>Range | 30 bpm ~ 250 bpm | 30 bpm ~ 250 bpm | 18 bpm ~ 300 bpm |
| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100C) and Predicate Device (BLR-100) and Reference Device (Model 3150 WristOx2) | | | | |
| | Comparison Elements | Proposed Device (BLR-100C) | Predicate Device (BLR-100) | Reference Device (Model 3150<br>WristOx2) |
| | PR Accuracy | $\pm$ 2 bpm or $\pm$ 2%, which is larger | $\pm$ 2 bpm or $\pm$ 2%, which is larger | $\pm$ 3 digits |
| | Data Average | Spot checking mode: 8s<br>Recording mode: 1s | Spot checking mode: 8s | 8-beat SpO2/pulse rate extended<br>average;<br>4-beat SpO2/pulse rate average |
| | Data Update Period | Spot checking mode: ≤20s<br>Recording mode: 1s | Spot checking mode: ≤20s | Recording mode: 1/3 second<br>Spot check mode: 1.5 second |
| | Waveform Display | No | No | No |
| | Pulse Intensity<br>Indication | Yes | Yes | Yes |
| | Low-Voltage<br>Indication | Yes | Yes | Yes |
| | Data Storage | Yes | No | Yes |
| | Can Be Connected<br>with An External<br>Oximeter Probe | Can only be connected to the special<br>designed oximeter ring | Can only be connected to the special<br>designed oximeter ring | Yes |
| | Data Export | USB | No | USB and Bluetooth |
| | Atmosphere Pressure | 700hPa~1060hPa | 700hPa~1060hPa | Up to 4 atmospheres |
| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100C) and Predicate Device (BLR-100) and Reference Device (Model 3150 | | | | |
| WristOx2) | | | | |
| Comparison Elements | | Proposed Device (BLR-100C) | Predicate Device (BLR-100) | Reference Device (Model 3150<br>WristOx2) |
| Operating<br>Temperature | | 10 ~ 40°C | 10 ~ 40°C | -5 ~ 40 °C |
| Relative Humidity | | ≤75% | ≤75% | 10 % to 95 % relative humidity, non-<br>condensing |
| Storage Environment | | a) Temperature: -10 ~ +60 °C<br>b) Relative humidity: 10~95%<br>c) Atmospheric pressure:<br>500hPa~1060hPa | a) Temperature: -10 ~ +60 °C<br>b) Relative humidity: 10~95%<br>c) Atmospheric pressure:<br>500hPa~1060hPa | a) Temperature: -40 ~ +70 °C<br>b) Relative humidity: 10 % to 95 %<br>relative humidity, non-condensing |
| Dimensions |…