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.

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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from predicate device SONOSAT-W01T)	Reported Device Performance (Belun Ring BLR-100)
SpO2 Measurement Range	70% ~ 100%	70% ~ 100%
SpO2 Accuracy	± 2%	± 2% (from bench testing)
PR Measurement Range	25 bpm ~ 250 bpm	30 bpm ~ 250 bpm
PR Accuracy	± 3 bpm	± 2 bpm or ± 2%, whichever is larger

Note: The provided text primarily compares the proposed device to a predicate device and a reference device, rather than explicitly stating acceptance criteria for the proposed device itself. The "Acceptance Criteria" column above is derived from the performance specifications of the predicate device (SONOSAT-W01T) which the proposed device aims to be substantially equivalent to. The "Reported Device Performance" for SpO2 and PR accuracy directly reflect the findings from the non-clinical bench testing.

2. Sample size used for the test set and the data provenance

Clinical Study: The document states that the clinical test was conducted following ISO80601-2-61:2011, clause 201.12.1. This standard requires at least 10 healthy adult volunteers (male and female). However, the exact number of subjects used in the clinical study for the Belun Ring BLR-100 is not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though a clinical test following a standard like ISO80601-2-61 implies a prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for the clinical study was established using CO-Oximetry by analyzing arterial blood samples. This method is considered a direct and objective measure of arterial oxygen saturation (SaO2), serving as the "gold standard." Therefore, the ground truth was not established by a panel of human experts in this context.

4. Adjudication method for the test set

Not applicable, as the ground truth was based on objective laboratory measurements (CO-Oximetry) rather than subjective expert assessment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Belun Ring BLR-100 is a pulse oximeter that directly measures physiological parameters (SpO2 and pulse rate) and does not involve human readers interpreting images or data via an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done. Both non-clinical (bench testing) and clinical studies (against CO-Oximetry) evaluated the device's performance in measuring SpO2 and pulse rate without active human intervention in the interpretive process. The device provides direct measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical study, the ground truth for SpO2 accuracy was established using CO-Oximetry analysis of arterial blood samples.
For pulse rate accuracy, the non-clinical bench testing used a functional tester as the ground truth.

8. The sample size for the training set

The document describes a medical device for measuring SpO2 and pulse rate, not an AI or machine learning algorithm in the typical sense that would require an extensive "training set" of data for learning and model development. The algorithm for calculating SpO2 and pulse rate from light absorption is based on established spectrophotometric principles and is likely pre-programmed and calibrated, rather than "trained" on a large dataset. Therefore, a specific training set sample size is not mentioned as it's not applicable in the context of this device's underlying technology as described.

9. How the ground truth for the training set was established

As explained in point 8, the concept of a "training set" in the context of an AI/ML algorithm is not directly applicable here. The device uses spectrophotometric methodology, which is based on known physical principles and calibrated against direct measurements (like SaO2 from CO-Oximetry) during its development and manufacturing, rather than a data-driven training process in the AI sense.

Summary

{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)

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)

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 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.

{4}------------------------------------------------

calculation and sensor interfacing, while the Cradle takes care of the user interface including display output and button user input.

V. INDICATIONS FOR 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 Scienceand 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-invasiveand stand-alone pulse oximeter,intending for spot-checking of oxygensaturation of arterial hemoglobin(SpO2) and the pulse rate of adultpatients through index finger inhospital and home environment. It isnot intended for single-use and out-of-hospital transport use.	The Wrist Pulse Oximeter is intendedfor spot checking in measuring anddisplaying oxygen saturation offunctional arterial hemoglobin (SpO2)and pulse rate of adult and pediatricpatients in hospitals, hospital facilitiesand home healthcare environments.	The SPO PulseOx 7500 Pulse Oximeter,a small, wrist-worn device, is indicatedfor use is measuring, displaying andstoring functional oxygen saturation ofarterial hemoglobin (SpO2) and pulserate. It may be used for spot checkingand/or data collection and recording ofadult and pediatric patients inhospitals, medical facilities,ambulatory, subacute and sleep studyenvironments.
Comparison Statement	The proposed device and the predicate device have the similar intended use and classification. There are only twodifferences. First, the proposed device is intended to be used with the index finger. This difference limits the applicablebody part to the index finger which is also an applicable sensor site of the predicate device. Second, the proposed deviceis 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
MeasurementWavelength	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.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 SupplyRequirement	3.1 V~ 4.2V DC	4.2V DC	3.6V DC
	Spo2 MeasurementRange	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	Not available	Not indicated	Not available
Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100) and Predicate Device (SONOSAT-W01T) and Reference Device (PulseOxSPO 7500)
Comparison Elements	Proposed Device (BLR-100)	Predicate Device (SONOSAT-W01T)	Reference Device (PulseOx SPO7500)
Adjustable Alarm Range	Not available	Not indicated	Not available
Default Limit	Not available	Not indicated	Not available
OperatingTemperature	10~40°C	5~40°C	4~42 °C
Relative Humidity	≤75%	30%~80% Non-condensing	Not indicated
Cleaning andDisinfecting	Wipe the Ring and the Cradlerespectively with a soft clothmoistened with 70% Isopropyl alcohol,a low-level disinfectant.Do not let water drop or flow into thedevice.	Not indicated	Wipe the exposed surfaces with a softcloth or a moistened pad with a milddetergent solution or an isopropylalcohol solution (70%).Clean the two optical elements thatare in the sensor with a Q-tip.Clean your PulseOx 7500™ devicewhenever you see any kind of soil, dirtor obstruction in the unit..Check that there are no dirt or bloodon the optical elements inside thesensor fixator.
Storage Environment	a) Temperature: -10 ~ +60 °Cb) Relative humidity: ≤95%c) Atmospheric pressure:500hPa~1060hPa	a) Temperature: -20 ~ +60 °Cb) Relative humidity: 10%-95% Non-condensing	-20 ~ +70 °CUp to 95% Non-condensing
Dimensions	Ring: 45 x 60 x 20mmCradle: 60 x 140 x 60mm	Not indicated	64 x 42x 22mm
Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100) and Predicate Device (SONOSAT-W01T) and Reference Device (Pulse OxSPO 7500)
Comparison Elements		Proposed Device (BLR-100)	Predicate Device (SONOSAT-W01T)	Reference Device (PulseOx SPO7500)
Weight		About 200g (with the lithium battery)	56g	55g Including Battery
Normal Useful Life		3 years	3 years	1 years
Comparison Statement		The proposed device has similar product specification as the predicate device.
Contacting Material		TPU, PC	ABS, PC, PVC	Not indicated
Comparison Statement		The proposed device has similar contacting material as predicate device. The contacting material has passed thebiocompatibility test and does not affect the performance.
Performance Test	Pre-clinical Testing	Complied with ISO 80601-2-61:2011.	Compliance with ISO 80601-2-61	a meta-analysis was performed tocompare the performance of thePulseOx devices to blood samplingtesting results in accordance with FDADraft Guidance Document on Non-Invasive Pulse Oximeters. Analysisresults show a sufficient correlation tothe Gold Standard.
EMC and ElectricalSafety	Electrical Safety	complied with IEC60601-1:2005	Compliance with IEC60601-1	Complied with IEC 60601-1
Table 1 Performance Specification Comparison Table between the Proposed Device (BLR-100) and Predicate Device (SONOSAT-W01T) and Reference Device (Pulse Ox SPO 7500)
Comparison Elements		Proposed Device (BLR-100)	Predicate Device (SONOSAT-W01T)	Reference Device (PulseOx SPO7500)
	ElectromagneticCompatibility	complied with IEC60601-1-2:2014	Compliance with IEC60601-1-2	Complied with IEC60601-1-2
	Special requirement		compliance with IEC 60601-1-11	Compliance with IEC 60601-1-11
Bio-compatibility		complied withISO10993-1:2009/(R)2013 ISO10993-5:2009ISO10993-10:2010	Compliance with ISO10993-1Testing result: No toxicity to cells, Nodelayed contact sensitization, Noirritation to skin	Not indicated
Protection of electrical hazards of appliedparts		Type BF	Type BF	Type BF
IP Classification		IP22	Not indicated	Not waterproof

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

VII. PERFORMANCE DATA

Non-clinical Test

The Belun Ring BLR-100 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: General requirements 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.
. ST/SG/AC.10/11/Rev.5, amend.2, 38.3 Recommendations on the Transport of Dangerous Goods – Manual of Tests and Criteria
. ISO 80601-2-61:2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

The Belun Ring BLR-100 have been validated for low perfusion accuracy in bench testing against functional tester with signal strength of greater than 0.06% for saturation values ranging from 70 to 100%. The results of the bench testing showed that the Belun Ring BLR-100 returned the same saturation values within ± 2 digits when compared to the functional tester used.

The Belun Ring BLR-100 have been validated for pulse rate accuracy in bench testing against functional tester for pulse rate values ranging from 30bpm to 250bpm. The bench testing showed that the Belun Ring BLR-100 returned the same pulse rate values within ± 2% or ± 2bpm (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 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 10993-1:2009, 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

Clinical Study

The Clinical Test was conducted following the testing described in clause 201.12.1 of ISO80601-2-61:2011, Medical electrical equipment- Part 2-61 Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.

{12}------------------------------------------------

The purpose of this study was to evaluate the SpO2 accuracy performance of the Belun Ring BLR-100 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-100 is compliant to the accuracy specification claimed by the manufacturer.

VIII. CONCLUSIONS

In conclusion, the proposed device of Belun Ring BLR-100 has the same classification information, similar intended use, similar design principle, similar product design and 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.

Regulation Number and Section

§ 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).