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 Description

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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Belun Ring BLR-100C, a pulse oximeter. It primarily focuses on demonstrating substantial equivalence to a predicate device (Belun Ring BLR-100) and a reference device (Nonin 3150 WristOx2).

Here's an analysis to extract the requested information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" in a pass/fail format alongside reported device performance for the BLR-100C. Instead, it relies heavily on comparing the BLR-100C's specifications to its predicate device (BLR-100) and a reference device (Nonin 3150 WristOx2). The implicit acceptance criterion is that the BLR-100C's performance specifications are substantially equivalent to or within acceptable limits of the predicate/reference devices, and it meets relevant international standards.

For SpO2 and PR accuracy, which are key physiological measurements for an oximeter, the document lists specifications that can be interpreted as de facto acceptance criteria based on its comparison with predicate devices.

Acceptance Criteria (Based on comparison with predicate/reference)	Reported Device Performance (Table 1, Proposed Device BLR-100C)
SpO2 Measurement Range: 70% ~ 100%	70% ~ 100%
SpO2 Accuracy: ± 2%	± 2%
PR Measurement Range: 30 bpm ~ 250 bpm	30 bpm ~ 250 bpm
PR Accuracy: ± 2 bpm or ± 2%, whichever is larger	± 2 bpm or ± 2%, whichever is larger
Data Average (Spot checking mode): Similar to predicate (8s)	8s
Data Average (Recording mode): Similar to reference (e.g., 1s for Recording mode)	1s
Data Update Period (Spot checking mode): Similar to predicate (≤20s)	≤20s
Data Update Period (Recording mode): Similar to reference (e.g., 1s)	1s
Compliance with: IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-1:2005 + a1:2012, ISO 80601-2-61:2011	Tested in accordance with these standards
Software Validation: Compliance with FDA guidance	In compliance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices from FDA
Biocompatibility: Demonstrated equivalence to predicate	BLR-100C used same materials as BLR-100, tests performed for K180174 (predicate) are applicable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on non-clinical (bench) testing and the clinical study data from its predicate device (Belun Ring BLR-100, K180174).

The text states: "BLR-100C is using the same PCB assembly (PCBA), materials for mechanical parts and bill-of-material as predicate device BLR-100 (K180174) except that the firmware, a resistor value on a PCB and an adhesive tape model have been changed such that "data collection and recording" function can be added in BLR-100C. Hence, the proposed device Belun Ring BLR-100C is verified in bench studies to meet the specifications fulfilled by the cleared predicate Belun Ring BLR-100 (K180174)."
And: "Hence, the clinical study of predicate BLR-100 remains valid for BLR-100C."

Therefore, the sample size and data provenance for the clinical validation of the BLR-100C are those of the predicate device, BLR-100. This specific 510(k) document (K191417) does not provide details about the sample size, country of origin, or whether the predicate's study was retrospective or prospective. It simply states the clinical data for the BLR-100 is considered valid for the BLR-100C.

For the non-clinical bench tests performed on the BLR-100C itself, sample sizes are not explicitly mentioned, but these would typically involve a smaller number of devices to verify specific functionalities and meet technical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As the clinical validation relies on the predicate device's study, details about ground truth establishment, including the number and qualifications of experts, would be found in the 510(k) submission for Belun Ring BLR-100 (K180174), not in K191417.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Similar to point 3, details about the adjudication method for clinical ground truth would be found in the K180174 submission.

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 MRMC study was done or reported as part of this 510(k). This device is a pulse oximeter, not an AI diagnostic imaging tool where MRMC studies are typically applicable. It provides direct physiological measurements (SpO2 and pulse rate) and does not involve "human readers" or "AI assistance" in the sense of image interpretation.

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

This device is a standalone oximeter in terms of its direct measurement capability. The "algorithm" for SpO2 and PR calculation is embedded within the device (Ring firmware). The performance assessment of the BLR-100C (and its predicate) against the reference method (e.g., co-oximetry, which would represent the "ground truth") intrinsically represents its standalone algorithmic performance. The document states it is for "spot-checking and/or data collection and recording."

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

For oximeters, the gold standard for measuring arterial oxygen saturation (SaO2) is typically laboratory co-oximetry performed on arterial blood samples. While not explicitly stated in this document, it is standard practice for pulse oximeter clinical studies to use co-oximetry as the ground truth. The document references ISO 80601-2-61:2011, which specifies requirements for pulse oximeters, and typically mandates such validation.

8. The sample size for the training set

This document describes a medical device, not a machine learning/AI algorithm that typically has a distinct "training set" and "test set." The "development" or "calibration" of such a device's algorithm would be part of its initial design and verification, which might involve a set of data, but it's not referred to as a "training set" in the machine learning sense here because this is a traditional, deterministic device. Details of any data used during the initial development/calibration of the BLR-100 or its core technology are not provided in this 510(k).

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

As per point 8, the concept of a "training set" in the context of an ML/AI model with ground truth establishment is not directly applicable to this traditional medical device. Any calibration or verification data used during the device's original development (for the predicate device BLR-100) would have likely used co-oximetry as a reference, but these details are not in this document.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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: +852 3706 5640

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 consists of two parts: A Ring and a Cradle.

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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 3150WristOx2)
Comparison Elements	Proposed Device (BLR-100C)	Predicate Device (BLR-100)	Reference Device (Model 3150WristOx2)
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-invasiveand stand-alone pulse oximeter,intended to be used for spot-checkingand/or data collection and recording ofoxygen saturation of arterialhemoglobin (SpO2) and the pulse rateof adult patients through index fingerin hospital and home environment. It isnot intended for single-use and out-of-hospital transport 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 is not intended for single-use andout-of-hospital transport use.	Nonin's Model 3150 WristOx2 PulseOximeter is a small wrist-worn deviceindicated for use in measuring,displaying, and storing functional oxygensaturation of arterial hemoglobin (SpO2)and pulse rate of adult and pediatricpatients. It is intended for spot-checkingand / or data collection and recording ofpatients who are well or poorlyperfused. The intended useenvironments are sleep and pulmonaryrehab labs, surgical recovery, criticalcare, emergency room, longterm care,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 3150WristOx2)
Comparison Elements	Proposed Device (BLR-100C)	Predicate Device (BLR-100)	Reference Device (Model 3150WristOx2)
Comparison Statement	The proposed device and the predicate device have the similar intended use and classification. The proposed deviceincludes data collection and recording that are similar to the reference device. The additional risk of safety andeffectiveness of the proposed device is evaluated.
Components	Pulse Oximeter Ring, CPU, displayscreen, signal processing unit, powerunit, built-in battery	Pulse Oximeter Ring, CPU, displayscreen, signal processing unit, powerunit, built-in battery	Sensor block, analog block,controller, LCD display and battery
MeasurementWavelength	Red658 nm ± 2 nm	658 nm ± 2 nm	660 nm
Wavelength	Infrared886 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 SupplyRequirement	3.1 V~ 4.2V DC	3.1 V~ 4.2V DC	3.0V DC
	Rated Current	500mA	1A	N/A
	Spo2 MeasurementRange	70% ~ 100%	70% ~ 100%	70% ~ 100%
	Spo2 Accuracy	± 2%	±2%	± 2 digits (8000J/Q/R series, no motion)
	PR MeasurementRange	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 3150WristOx2)
	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: 8sRecording mode: 1s	Spot checking mode: 8s	8-beat SpO2/pulse rate extendedaverage;4-beat SpO2/pulse rate average
	Data Update Period	Spot checking mode: ≤20sRecording mode: 1s	Spot checking mode: ≤20s	Recording mode: 1/3 secondSpot check mode: 1.5 second
	Waveform Display	No	No	No
	Pulse IntensityIndication	Yes	Yes	Yes
	Low-VoltageIndication	Yes	Yes	Yes
	Data Storage	Yes	No	Yes
	Can Be Connectedwith An ExternalOximeter Probe	Can only be connected to the specialdesigned oximeter ring	Can only be connected to the specialdesigned 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 3150WristOx2)
OperatingTemperature		10 ~ 40°C	10 ~ 40°C	-5 ~ 40 °C
Relative Humidity		≤75%	≤75%	10 % to 95 % relative humidity, non-condensing
Storage Environment		a) Temperature: -10 ~ +60 °Cb) Relative humidity: 10~~95%c) Atmospheric pressure:500hPa~~1060hPa	a) Temperature: -10 ~ +60 °Cb) Relative humidity: 10~~95%c) Atmospheric pressure:500hPa~~1060hPa	a) Temperature: -40 ~ +70 °Cb) Relative humidity: 10 % to 95 %relative humidity, non-condensing
Dimensions		Ring: 45 x 60 x 20mmCradle: 60 x 140 x 60mm	Ring: 45 x 60 x 20mmCradle: 60 x 140 x 60mm	51 x 73 x 19 mm (without sensor orwristband)
Weight		About 200g (with the lithium battery)	About 200g (with the lithium battery)	70g (with batteries and wristband)
IP Classification		IP22	IP22	IP33
Normal Service Life		3 years	3 years	5 years
Comparison Statement		Comparing with the predicate device, the additional specifications of the proposed device are Rated Current, DataAverage, Data Update Period, Data Storage and Data Export. Those differences of the performance specification are likethe reference device.
Contacting Material		TPU, PC	TPU, PC	Not indicated
Comparison Statement		The proposed device uses the same contacting material as the predicate device.

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VII. PERFORMANCE DATA

Non-clinical Test

The proposed device Belun Ring BLR-100C 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
. ISO 80601-2-61:2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

BLR-100C is using the same PCB assembly (PCBA), materials for mechanical parts and bill-of-material as predicate device BLR-100 (K180174) except that the firmware, a resistor value on a PCB and an adhesive tape model have been changed such that "data collection and recording" function can be added in BLR-100C. Hence, the proposed device Belun Ring BLR-100C is verified in bench studies to meet the specifications fulfilled by the cleared predicate Belun Ring BLR-100 (K180174).

The Software Validation is in compliance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices from FDA.

There is no change in batteries of the proposed device Belun Ring BLR-100C and the cleared predicate Belun Ring BLR-100 (K180174). Therefore, the tests performed and submitted for K180174 with respect to the IEC 62133 and UN38.3 are applicable to the proposed device.

BLR-100C in its final finished form is identical to predicate BLR-100 (K180174) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). Therefore, the tests performed and submitted with K180174 with respect to ISO 10993-1, ISO 10993-5 and ISO 10993-10 support the biocompatibility equivalence of the proposed device BLR-100C.

Clinical Study

BLR-100C is using the same PCB assembly (PCBA), materials for mechanical parts and bill-of-material as predicate device BLR-100 (K180174) except that the firmware, a resistor value on a PCB and an adhesive tape model have been changed such that "data collection and recording" function can be added in BLR-100C. Hence, the clinical study of predicate BLR-100 remains valid for BLR-100C.

VIII. CONCLUSIONS

In conclusion, the proposed device of Belun Ring BLR-100C has the same classification information, same intended use, similar design principle, similar product design and specification as the predicated device. The differences in technological characteristics do not raise different questions of safety and

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effectiveness. According to the results of non-clinical test, 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).