(168 days)
WatchPAT™ONE (WP1) (K183559)
No
The summary describes standard pulse oximetry technology and algorithms for calculating SpO2 and pulse rate, with no mention of AI or ML.
No
The device is a pulse oximeter intended for data collection and recording of physiological parameters (SpO2 and pulse rate), not for providing treatment or therapy.
Yes
The device is a pulse oximeter that collects and records continuous data of oxygen saturation (SpO2) and pulse rate. These measurements are used in a clinical context to aid in the diagnosis and monitoring of various medical conditions.
No
The device description explicitly states that the device consists of three parts: a Ring, a Cradle, and a Host program. The Ring and Cradle are physical hardware components responsible for signal acquisition, data storage, and data transfer, in addition to the software components (firmware and host program).
Based on the provided information, the Belun Ring BLR-100X is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Belun Ring BLR-100X Function: The Belun Ring BLR-100X is a pulse oximeter that measures oxygen saturation and pulse rate non-invasively by illuminating the skin and measuring light absorption. It does not examine specimens derived from the human body in vitro.
Therefore, the Belun Ring BLR-100X falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
DQA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Index finger
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Hospital and home environment
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
Non-clinical Test:
The device was tested according to multiple standards including IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-1:2005 + a1:2012, IEC 62133:2012, ISO 80601-2-61:2017, BQB Bluetooth qualification, FCC Part 15B & FCC Part 18 certification.
The Belun Ring BLR-100X was validated for low perfusion saturation accuracy in bench testing against a functional tester with signal strength greater than 0.1% for saturation values ranging from 70% to 100%. Results showed the device returned the same saturation values within ± 3% compared to the functional tester.
The Belun Ring BLR-100X was validated for SpO2 and pulse rate accuracy in bench testing against a functional tester for SpO2 values from 70% to 100% and pulse rate from 30 bpm to 250 bpm under no motion and motion conditions. Results showed SpO2 values within ± 2.7% and pulse rate values within ± 2.5% or ± 2 bpm (whichever is larger) compared to the functional tester.
Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Management of Cybersecurity is in compliance with FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Biocompatibility testing met requirements in compliance with ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010.
Clinical Study:
Study type: Clinical Test following clause 201.12.1 of ISO 80601-2-61:2017.
Purpose: To evaluate SpO2 accuracy performance of the device placed on index fingers during steady state/non-motion conditions over the range of 70-100% SaO2, using arterial blood samples assessed by CO-Oximetry.
Key results: The Accuracy Root Mean Square (ARMS) performance of the oximetry system met the required specification in non-motion conditions for the range of 70 – 100% SaO2. The study provides supporting evidence that the device is compliant to the accuracy specification claimed by the manufacturer.
Key Metrics
SpO2 accuracy: ± 2.7%
PR accuracy: ± 2.5 bpm or ± 2%, whichever is larger
Predicate Device(s)
Belun Ring BLR-100C (K191417)
Reference Device(s)
WatchPAT™ONE (WP1) (K183559)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
1
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,
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 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: +852 37065640
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
4
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
| (WatchPAT™One – WP1) | ||||
|---|---|---|---|---|
| Comparison Elements | Proposed Device (BLR-100X) | Predicate Device (BLR-100C) | Reference Device (WatchPAT™One - | |
| 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- | |||
| 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 indexfinger 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. | 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 | ||||
| transportuse. | The WatchPAT™ONE (WP1) device is a | |||
| non-invasive home care device for use | ||||
| with patients suspected to have sleep | ||||
| related breathing disorders. The WP1 is | ||||
| a diagnostic aid for the detection of | ||||
| sleep related breathing disorders, sleep | ||||
| staging (Rapid Eye Movement (REM) | ||||
| Sleep, Light Sleep, Deep Sleep and | ||||
| Wake), snoringlevel and body position. | ||||
| The WP1 generates a peripheral arterial | ||||
| tonometry ("PAT") Respiratory | ||||
| Disturbance Index ("PRDI"), | ||||
| Apnea Hypopnea index ("PAHI"), Central | ||||
| Apnea-Hypopnea index ("PAHIc"), PAT | ||||
| sleep staging identification (PSTAGES) | ||||
| 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 | ||||
| (WatchPATTMOne – WP1) | ||||
| Comparison Elements | Proposed Device (BLR-100X) | Predicate Device (BLR-100C) | Reference Device (WatchPATTMOne – WP1) | |
| discrete states from an external | ||||
| integrated snoring and body position | ||||
| sensor. The WP1's PSTAGES and snoring | ||||
| level and body position provide | ||||
| supplemental information to its | ||||
| PRDI/PAHI/PAHIc. The WP1's PSTAGES | ||||
| and snoring level and body position are | ||||
| not intended to be used as the sole or | ||||
| primary basis for diagnosing any sleep | ||||
| related breathing disorder, prescribing | ||||
| treatment, or determining whether | ||||
| additional diagnostic assessment is | ||||
| warranted. PAHIc is indicated for use in | ||||
| patients 17 years and older. All other | ||||
| parameters are indicated for 12 years | ||||
| and older. | ||||
| Comparison Statement | The proposed device and the predicate device have the similar intended use and classification. The proposed device | |||
| includes user Interface Display/Indicators that are similar to the reference device. The additional risk of safety and | ||||
| effectiveness of the proposed device is evaluated. | ||||
| Components | Pulse Oximeter Ring, sensor unit, CPU, | |||
| accelerometer, LED indicator light, signal | ||||
| processing unit, power unit, built-in | ||||
| battery | Pulse Oximeter Ring, sensor unit, | |||
| CPU, accelerometer, display screen, | ||||
| signal processing unit, power unit, | ||||
| built-in battery | uPAT finger probe, actigraph, controller, | |||
| microphone, accelerometer, ZzzPAT | ||||
| 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 | ||||
| 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 | ||||
| passed the clinical validation on the accuracy of the spo2 and pulse rate. Thus, it is proven to be effective. | |||||
| User Interface | |||||
| Display/ Indicators | Via host program interface | ||||
| Via Cradle (LED) | |||||
| Via Ring (LED) | Via Cradle display interface (OLED) | Via Smartphone User Interface | |||
| Via Main device (LED) | |||||
| Battery | 3.7V lithium battery | 3.7V lithium battery | One OTS 1.5V Alkaline AAA battery | ||
| Power Supply | |||||
| Requirement | 3.1 V~ 4.2V DC | 3.1 V~ 4.2V DC | 3.3V DC | ||
| Rated Current | 500mA | 500mA | N/A | ||
| Spo2 Measurement | |||||
| Range | 70%~ 100% | 70%~ 100% | - | ||
| Spo2 Accuracy | $\pm$ 2.7% | $\pm$ 2% | - | ||
| PR Measurement | |||||
| 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
| (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 | |||
| b) Relative humidity: 10~95% | ||||
| c) Atmospheric pressure: 500hPa~1060hPa | a) Temperature: -10~+60 °C | |||
| b) Relative humidity: 10~95% | ||||
| c) Atmospheric pressure: 500hPa~1060hPa | - | |||
| Dimensions | Ring: 44 x 60 x 18 mm | |||
| Cradle: 32 x 100 x 59 mm | Ring: 45 x 60 x 20mm | |||
| Cradle: 60 x 140 x 60mm | - | |||
| Weight | About 110 g (with the lithium battery) | About 200g (with the lithium battery) | - | |
| IP Classification | IP22 | IP22 | - | |
| Normal Service Life | 3 years | 3 years | - | |
| Comparison Statement | The technological characteristics and principles of operation of the subject device are similar to the predicate device. The subject BLR-100X, like its predicate, is a pulse oximeter that utilizes reflective red/IR wavelength for oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate measurement. Both Rings where are of a smooth and a light design and are easy to be worn and taken off, are intended to be worn on the base of the index finger. Both devices provide comfortable and accurate measurements without the Cradle in the recording mode. The Cradle collects data from the Ring and transfers to the host program for data display, which can be easily understood by the user. Comparing with the predicate device, the proposed device different from BLR-100C by exporting the collected data via Bluetooth or USB instead of USB only to a host such as computer equipment for recording data transfer and review. A computer program also replaced the predicate BLR-100C's user interface and communication similar to the reference device. In addition, the user interface of the computer program was designed to provide similar display and input as the BLR-100C. The differences in technological characteristics and principle of operation do not raise different questions of safety or effectiveness. | |||
| Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100X) and Predicate Device (BLR-100C) and Reference Device | ||||
| (WatchPAT™One – WP1) | ||||
| Comparison Elements | Proposed Device (BLR-100X) | Predicate Device (BLR-100C) | Reference Device (WatchPAT™One – | |
| WP1) | ||||
| Contacting Material | TPE, PC | TPU, PC | Not indicated | |
| Comparison Statement | The difference of material used in proposed device is TPE in which passed the bio-compatibility test, so that the contacting | |||
| material was proven to be safe to be used. |
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VII. PERFORMANCE DATA
Non-clinical Test
The proposed device Belun Ring BLR-100X is tested in accordance with both mandatory and voluntary standards, including:
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-1:2005 + a1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- . ISO 80601-2-61:2017 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- BQB Bluetooth qualification
- . FCC Part 15B & FCC Part 18 certification
The Belun Ring BLR-100X has been validated for low perfusion saturation accuracy in bench testing against functional tester with signal strength of greater than 0.1% for saturation values ranging from 70 to 100%. The results of the bench testing showed that the Belun Ring BLR-100X returned the same saturation values within ± 3 % when comparedto the functional tester used.
The Belun Ring BLR-100X has been validated for SpO2 and pulse rate accuracy in bench testing against functional tester for SpO2 values rangingfrom 70% to 100% and pulse ranging from 30 bpm to 250 bpm under no motion and motion conditions. The results of the bench testingshowed that the Belun Ring BLR-100X returned the same SpO2 values within ± 2.7% and pulse rate values within ± 2.5% or ± 2 bpm (which is larger) when compared to the functional tester used.
The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The Management of Cybersecurity is in compliance with FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards, including:
- . ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1 : Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- . ISO 10993-10:2010 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
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Clinical Study
The Clinical Test was conducted following the testing described in clause 201.12.1 of ISO 80601-2-61:2017, Medical electrical equipment- Part 2-61 Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
The purpose of this study was to evaluate the SpO2 accuracy performance of the Belun Ring BLR-100X placed on the index fingers during steady state / non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry.
The Accuracy Root Mean Square (ARMS) performance of the oximetry system met the required specification in non-motion conditions for the range of 70 – 100% SaO2. The results of the study provide supporting evidence that the Belun Ring BLR-100X is compliant to the accuracy specification claimed by the manufacturer.
VIII. CONCLUSIONS
In conclusion, the proposed device of BelunRing BLR-100X has the same classification information, similar intended use, similar design principle, similar product designand specification as the predicated device. According to the results of non-clinical test and clinical study, the proposed device is Substantially Equivalent (SE) to the predicate device.