Belun Ring

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 29, 2018 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: K180174 Trade/Device Name: Belun Ring BLR-100 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: February 23, 2018 Received: February 28, 2018 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. 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 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); good {1}------------------------------------------------ manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180174 Device Name Belun Ring BLR-100 ### Indications for Use (Describe) Belun Ring BLR-100 is a non-invasive and stand-alone pulse oximeter, intending for spot-checking 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) | | |----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:10pt"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Ch. 5 – 510(k) Summary This summary of 510(k) is being submitted in accordance with the requirements of 21 CRF 872.92. 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: +852 3706 5640 Date Prepared: May 03, 2018 #### II. PROPOSED DEVICE Device Common Name: Pulse Oximeter Device Proprietary Name: Belun Ring BLR-100 Model: BLR-100 Classification Name and Reference: Oximeter (21 CFR 870.2700) Regulatory Class: II Product Code: DQA #### III. PREDICATE DEVICE The identified predicates: SONOSAT-W01T Wrist Pulse Oximeter (K070371, Jiangsu Konsung Bio-Medical Science and Technology Co.,Ltd.) The reference device: PulseOx SPO7500 Pulse Oximeter (K040178, SPO Medical Equipment Ltd.) #### IV. DEVICE DESCRIPTION The proposed device Belun Ring BLR-100 is a non-invasive and stand-alone pulse oximeter, which can detect and display the measured oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate in hospital and home environment. The proposed device consists of two parts: Ring and Cradle. The Ring is intended to be worn on the bottom of index finger. The Cradle collects data from the ring and translates it into text and graph for the user. Using spectrophotometric methodology, the proposed device measures oxygen saturation by illuminating the skin and measuring changes in light absorption of oxygenated (oxyhemoglobin) and deoxygenated blood (reduced hemoglobin) using two-wavelengths light: 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 palmar side of the proximal phalanx of the index finger and the sensor is being place along the radial artery. The system uses a customized dual CPU design. It consists of two main platforms: the Ring is responsible for signal pre-conditioning, data post-processing (SPO2/PR algorithm), parameters {4}------------------------------------------------ calculation and sensor interfacing, while the Cradle takes care of the user interface including display output and button user input. The system includes two embedded software, namely Ring firmware and Cradle firmware. The software systems work in conjunction with Ring and 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-100 is a non-invasive and stand-alone pulse oximeter, intending for spot-checking 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. {5}------------------------------------------------ - #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE AND THE REFERENCE DEVICE VI. | Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100) and Predicate Device (SONOSAT-W01T) and Reference Device (PulseOx SPO 7500) | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison Elements | Proposed Device (BLR-100) | Predicate Device (SONOSAT-W01T) | Reference Device (PulseOx SPO7500) | | | Product Name | Pulse Oximeter | Wrist Pulse Oximeter | Pulse Oximeter | | | Model | BLR-100 | SONOSAT-W01T | PulseOx SPO7500 | | | FDA 510(k) Document No. | - | K152089 | K040178 | | | Manufacturer | Belun Technology Company Limited | Jiangsu Konsung Bio-Medical Science<br>and Technology Co.,Ltd | SPO Medical Equipment Ltd. | | | Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 870.2700 | | | Classification | II | II | II | | | Classification Name | Oximeter | Oximeter | Oximeter | | | Product Code | DQA | DQA | DQA | | | Intended 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. It is<br>not intended for single-use and out-of-<br>hospital transport use. | The Wrist Pulse Oximeter is intended<br>for spot checking in measuring and<br>displaying oxygen saturation of<br>functional arterial hemoglobin (SpO2)<br>and pulse rate of adult and pediatric<br>patients in hospitals, hospital facilities<br>and home healthcare environments. | The SPO PulseOx 7500 Pulse Oximeter,<br>a small, wrist-worn device, is indicated<br>for use is measuring, displaying and<br>storing functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse<br>rate. It may be used for spot checking<br>and/or data collection and recording of<br>adult and pediatric patients in<br>hospitals, medical facilities,<br>ambulatory, subacute and sleep study<br>environments. | | | Comparison Statement | The proposed device and the predicate device have the similar intended use and classification. There are only two<br>differences. First, the proposed device is intended to be used with the index finger. This difference limits the applicable<br>body part to the index finger which is also an applicable sensor site of the predicate device. Second, the proposed device<br>is not intended to be used for pediatric patients. This difference only limits the use of the proposed device to adults only | | | | | Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100) and Predicate Device (SONOSAT-W01T) and Reference Device (PulseOx SPO 7500) | | | | | | Comparison Elements | Proposed Device (BLR-100) | Predicate Device (SONOSAT-W01T) | Reference Device (PulseOx SPO7500) | | | | which is also an intended population of the predicate device. So, these two differences do not change the intended use of the proposed device. | | | | | Components | Pulse Oximeter Ring, CPU, display screen, signal processing unit, power unit, built-in battery | motherboard, SpO2 transducer and built-in battery | sensor block, analog block, controller, LCD display and battery | | | Measurement<br>Wavelength | Red | 658 nm ± 2 nm | 662 ± 3nm | Not indicated | | | Infrared | 886 nm ± 6 nm | 890 ± 5 nm | Not indicated | | Technology Type | reflective light | transmissive light | reflective light | | | Comparison Statement | The proposed device and the predicate device have the similar design principle and similar measurement wavelength.<br>There are two differences between the proposed and predicate device. First difference is that the proposed device uses reflective sensors while the predicate device uses transmission sensor. Second one is that the proposed device measures from the proximal phalanx of the finger while the predicate device measures from the fingertip. However, it's well-known that both the transmissive and reflective methods are very mature technologies and the pulse oximeter can work on any location of tissue bed containing pulsating arteriolar vessels, such as fingertip, earlobe, toe, forehead and proximal phalanx of fingers. | | | | | Performance specification | Display Type | OLED | OLED | LCD | | | Battery | 3.7V lithium battery | 4.2V Li-battery | 3.6V Lithium Battery, 1/2 AA Size | | | Power Supply<br>Requirement | 3.1 V~ 4.2V DC | 4.2V DC | 3.6V DC | | | Spo2 Measurement<br>Range | 70% ~ 100% | 70% ~ 100% | 40% ~ 99% | | | Spo2 Accuracy | ± 2% | ±2% | ± 2% or ± 2 digits, Less than 70%, unspecified | | Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100) and Predicate Device (SONOSAT-W01T) and Reference Device (PulseOx SPO 7500) | | | | | | Comparison Elements | Proposed Device (BLR-100) | Predicate Device (SONOSAT-W01T) | Reference Device (PulseOx SPO7500) | | | PR Measurement Range | 30 bpm ~ 250 bpm | 25bpm ~ 250bpm | 40 bpm ~ 250 bpm | | | PR Accuracy | ±2 bpm or ± 2%, which is larger | ±3 bpm | ± 3% or ± 3 digits | | | Data Update Period | ≤ 8s, which is changeable to individual pulse rate | Not indicated | <20s | | | Waveform Display | No | Yes | No | | | Pulse Intensity Indication | Yes | Yes | Yes | | | Low-Voltage Indication | Yes | Yes | Yes | | | Can Be Connected with An External Oximeter Probe | Can only be connected to the special designed oximeter ring | Yes | No | | | Data Can Be Transmitted to Computers | No | No | No | | | Atmosphere Pressure | 700hPa~1060hPa | Not indicated | Not indicated | | | Alarm Type…