K Number

Device Name

Belun Ring

Manufacturer

Belun Technology Company Limited

Date Cleared

2018-05-29

(127 days)

Product Code

DQA

Regulation Number

870.2700

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K070371

Reference Devices

K040178

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard pulse oximetry technology using spectrophotometry and signal processing algorithms, with no mention of AI or ML.

Therapeutic

No
The device is a diagnostic tool designed for measuring physiological parameters (oxygen saturation and pulse rate) and does not provide therapy or treatment.

Diagnostic

Yes

Explanation: The device is a pulse oximeter intended for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate." Measuring these vital signs provides information that can be used to diagnose various medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of two hardware parts: a Ring and a Cradle, and describes their physical functions and components (sensors, CPUs, display).

IVD (In Vitro Diagnostic)

Based on the provided information, the Belun Ring BLR-100 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
Belun Ring BLR-100 Function: The Belun Ring BLR-100 is a pulse oximeter that measures oxygen saturation and pulse rate non-invasively by shining light through the finger. It does not analyze samples taken from the body.

Therefore, the Belun Ring BLR-100 falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DQA

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Index finger (proximal phalanx)

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 Belun Ring BLR-100 was tested in accordance with mandatory and voluntary standards including IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-1:2005 + a1:2012, IEC 62133:2012, ST/SG/AC.10/11/Rev.5, amend.2, 38.3, and ISO 80601-2-61:2011.
Low perfusion accuracy was validated in bench testing against a functional tester with signal strength greater than 0.06% for saturation values ranging from 70% to 100%. The device returned the same saturation values within ± 2 digits compared to the functional tester.
Pulse rate accuracy was validated in bench testing against a functional tester for pulse rate values ranging from 30 bpm to 250 bpm. The device returned the same pulse rate values within ± 2% 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.
Biocompatibility tests were in compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010.

Clinical Study:

Study Type: Clinical Test following clause 201.12.1 of ISO80601-2-61:2011.
Sample Size: Not specified.
Purpose: 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, 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 results provide supporting evidence that the device is compliant with the accuracy specification claimed by the manufacturer.

Key Metrics

SpO2 Accuracy: ± 2%
PR Accuracy: ±2 bpm or ± 2%, which is larger

Predicate Device(s)

K070371

Reference Device(s)

K040178

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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

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

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)

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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.

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

V. INDICATIONS FOR USE

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
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
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.	The Wrist Pulse Oximeter is intended
for spot checking in measuring and
displaying oxygen saturation of
functional arterial hemoglobin (SpO2)
and pulse rate of adult and pediatric
patients in hospitals, hospital facilities
and home healthcare environments.	The SPO PulseOx 7500 Pulse Oximeter,
a small, wrist-worn device, is indicated
for use is measuring, displaying and
storing functional oxygen saturation of
arterial hemoglobin (SpO2) and pulse
rate. It may be used for spot checking
and/or data collection and recording of
adult and pediatric patients in
hospitals, medical facilities,
ambulatory, subacute and sleep study
environments.
Comparison Statement	The proposed device and the predicate device have the similar intended use and classification. There are only two
differences. First, the proposed device is intended to be used with the index finger. This difference limits the applicable
body part to the index finger which is also an applicable sensor site of the predicate device. Second, the proposed device
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
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.
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
Requirement	3.1 V~ 4.2V DC	4.2V DC	3.6V DC
	Spo2 Measurement
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