Arm Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm~36 cm.

Device Description

The Arm Blood Pressure Monitor is a battery powered automatic non-invasive pressure monitor, powered by 4 x1.5V AAA battery. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device has the data storage function for data reviewing. The proposed Arm Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The product is provided non-sterile, and not to be sterilized by the user prior to use.

AI/ML Overview

The provided text describes the 510(k) summary for an Arm Blood Pressure Monitor (models OB30, OB31, OB32, OB33). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The information primarily focuses on the device's technical specifications and how it meets the requirements for a non-invasive blood pressure measurement system.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Arm Blood Pressure Monitor are primarily defined by adherence to recognized international standards, particularly ISO 81060-2 for clinical performance, and other IEC standards for safety and electromagnetic compatibility.

Criterion Type	Acceptance Criteria (Standard Compliance)	Reported Device Performance
Clinical Performance	Meets Criterion 1 of ISO 81060-2: The mean difference between the device measurement and the reference standard should be within ±5 mmHg, with a standard deviation of no more than 8 mmHg. Meets Criterion 2 of ISO 81060-2: The percentage of absolute differences between the device measurement and the reference standard, within certain thresholds, (details not explicitly stated but implied by ISO 81060-2).	Clinical performance testing was conducted according to ISO 81060-2. "the results both meet criterion 1 and criterion 2 of ISO 81060-2." (This is a statement of compliance rather than explicit numbers, but it indicates the criteria were met).
Biocompatibility	Compliance with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), as per FDA Blue Book Memorandum #G95-1 and ISO 10993-1.	"According to the test results, the subject device is biocompatible for its intended use. And it is complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization)."
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-11, and IEC 80601-2-30.	"the device complies with the IEC 60601-1, IEC 60601-1-11, and IEC 80601-2-30 standards for safety."
EMC	Compliance with IEC 60601-1-2.	"and the IEC 60601-1-2 standard for EMC."
Usability	Compliance with IEC 62366-1 and IEC 60601-1-6.	"the device complies with IEC 62366-1 and IEC 60601-1-6."
Software V&V	Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for a "moderate" level of concern.	"Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." (Implies compliance based on submission).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The clinical performance testing included 85 subjects.
Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. Given the submitter's location in China (Yibin Junxin Electronics Technology Co., Ltd., SiChuan, China) and the application correspondent's location also in China (Share Info (Guangzhou) Medical Consultant Ltd., Guangzhou, China), it is highly probable that the study was conducted in China. The study was a prospective clinical performance test conducted to meet the ISO 81060-2 standard.
Subject Demographics: Aged from 22 to 81, with 52.9% male and 47.1% female participants. The limb size distribution complied with clause 5.1.4 of ISO 81060-2.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts or their qualifications. For blood pressure measurement device validation, the ground truth is typically established by trained clinical personnel using a reference standard device (e.g., a mercury sphygmomanometer) and following a strict protocol as outlined in ISO 81060-2.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method. In the context of blood pressure device validation (ISO 81060-2), ground truth derivation involves simultaneous or near-simultaneous measurements by trained observers using a reference method, against which the device's readings are compared. It's a direct comparison method rather than an "adjudication" in the sense of resolving disagreements between multiple independent expert interpretations, as would be common in imaging studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. For a blood pressure monitor, the study evaluates the device's accuracy against a clinical reference standard, not the improvement of human readers with AI assistance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Yes, a standalone performance study was done. The clinical performance testing described is precisely a standalone performance evaluation of the device. The device itself performs the measurement using an oscillometric technique, and its readings are directly compared to a reference standard to assess its accuracy. There is no "human-in-the-loop" in the generation of the device's measured blood pressure values.

7. Type of Ground Truth Used

The type of ground truth used was a clinical reference standard, as specified by ISO 81060-2. This typically involves simultaneous or sequential measurements by a trained observer using a validated reference method (e.g., a mercury sphygmomanometer with a Y-adapter or similar setup) against which the test device's readings are compared. It is a form of outcomes/measurement data validated against a gold standard in a clinical setting.

8. Sample Size for the Training Set

The document does not specify the sample size for a training set. This device is a hardware product with embedded software and an algorithm for oscillometric blood pressure measurement. While the algorithm was developed, the document focuses on the validation test set (85 subjects) and compliance with standards. It does not provide details on the data used for the development or training of the oscillometric algorithm itself. This information is typically proprietary and not included in a 510(k) summary unless specific software modifications or AI components require it.

9. How the Ground Truth for the Training Set Was Established

As the document does not specify a training set or its size, it also does not provide information on how the ground truth for a training set (if applicable for algorithm development) was established. For blood pressure monitoring, algorithms are usually developed and refined using large datasets of oscillometric waveforms and corresponding reference blood pressure values, established through similar rigorous clinical measurement protocols used for validation.

Summary

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January 19, 2022

Yibin Junxin Electronics Technology Co., Ltd. % Cassie Lee, Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3. Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China

Re: K211532

Trade/Device Name: Arm Blood Pressure Monitor, model OB30, OB31, OB33, OB33 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 3, 2021 Received: December 22, 2021

Dear Cassie Lee:

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.

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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) 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.

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular 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) K211532

Device Name Arm Blood Pressure Monitor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Submitter's Information 1.

Name: Yibin Junxin Electronics Technology Co., Ltd. Establishment Registration Number: Applying Address: No. 136, Xinggang Road, Lingang Zone, Yibin City, SiChuan, China Postal Code: 644000 Tel: +86 0831-3602202 Contact Person (including title): Guan Chaoze E-mail: peter@tablet-china.com

Application Correspondent:

Contact Person: Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@share-info.com

2. Date of the summary prepared: December 3, 2021

3. Subject Device Information

Type of 510(k): Traditional Common Name: Systems, measurement, blood pressure, Non-invasive Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Trade Name: Arm Blood Pressure Monitor Model Name: OB30, OB31, OB32, OB33 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 870.1130 Regulatory Class: II

4. Predicate Device Information

Sponsor: Shenzhen BSX Technology Electronics Co., Ltd. Trade Name: Arm-type Electronic Blood Pressure Monitor Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Common Name: Noninvasive Blood Pressure Measurement System 510(K) Number: K183058 Product Code: DXN Regulation Number: 870.1130 Requlation Class: II

Device Description 5.

The Arm Blood Pressure Monitor is a battery powered automatic non-invasive pressure monitor, powered by 4 x1.5V AAA battery.

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It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device has the data storage function for data reviewing. The proposed Arm Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm.

The product is provided non-sterile, and not to be sterilized by the user prior to use.

6. Intended Use / Indications for Use

7. Comparison to predicate device

The technological characteristics, features, specifications, mode of operation, and intended use of Arm Blood Pressure Monitor is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device 1	Remark
Company	Yibin Junxin Electronic TechnologyCo., Ltd.	Shenzhen BSX TechnologyElectronics Co., Ltd.	--
Product Name	Arm Blood Pressure Monitor	Arm-type Electronic BloodPressure Monitor	--
Model Name	OB30, OB31, OB32, OB33	BSX516, BSX523,BSX525, BSX583, BSX593 andBSX595	--
ClassificationName	Systems,Measurement,BloodPressure,Non-invasive	Systems,Measurement,BloodPressure,Non-invasive	Same
510(k) Number	Applying	K183058	--
Product Code	DXN	DXN	Same
Intended Use and Indications for Use
Intended Use /Indications forUse	Arm Blood Pressure Monitor is anon-invasive blood pressuremeasurement system intended tomeasure the diastolic and systolicblood pressures and pulse rate ofan adult individual by using a non-invasive oscillometric technique inwhich an inflatable cuff is wrappedaround the arm of which thecircumference includes 22 cm~36cm.	The blood pressure monitor is anon-invasive blood pressuremeasurement system intendedto measure the diastolic andsystolic blood pressures andpulse rate of an adult individualby using a non-invasiveoscillometric technique in whichan inflatable CUFF is wrappedaround the arm of which thecircumference includes 22cm~32 cm. It is intended to beused in hospital environment orat home.	Same
Electrical requirement

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Power Supply	4x1.5V AAA Alkaline Battery	4x1.5V AAA Alkaline Battery(BSX516, BSX525, BSX583,BSX593 and BSX595)3.7V 400mAh Li-ion Battery(BSX523)	Same
Performance specification
Measurement Site	Upper Arm	Upper Arm	Same
Measuring scope	Pressure: 0mmHg~~260 mmHg;Pulse: 40 bpm~~199 bpm	Pressure: 0mmHg~299 mmHgPulse: 40 bpm ~180 bpm	SimilarNote 1
Pressureresolution	1 mmHg or 0.1kPa	1 mmHg or 0.1kPa	Same
Measuringaccuracy	Pressure: ±3mmHg (±0.4kPa)Pulse: ±5%	Pressure: ± 3mmHgPulse: ±5%	Same
CuffCircumference	22~36cm	22~32cm	SimilarNote
Inflation andDeflation	Automatic	Automatic	Same
MeasuringMethod	Non-invasive Oscillometric	Non-invasive Oscillometric	Same
Patient Population	Adult	Adult	Same
Display	LCD	LCD	Same
Operationcondition	Temperature: +5 to +40 °C,Humidity: 15 to 80%Atmospheric Pressure: 80 kPa~105kPa	Temperature: +5 to +40 °C,Humidity: 15 to 85%Atmospheric Pressure: 80kPa~106 kPa	SimilarNote 1
Transport/storageenvironment	Temperature: -20°C ~ +50°C,Humidity: 15%~~93%Atmospheric Pressure: 80 kPa~~105kPa	Temperature: -20°C~+55 °C,Humidity: 10 to 93%Atmospheric Pressure: 70kPa~106 kPa	SimilarNote 1
Safety	IEC 60601-1IEC 60601-1-11IEC 80601-2-30	IEC 60601-1IEC 60601-1-11IEC 80601-2-30	Same
EMC	IEC 60601-1-2	IEC 60601-1-2	Same
Biocompatibility	ISO 10993	ISO 10993	Same

Note1:

Although "Power Supply", "Measuring scope", "Cuff circumference", "Operation condition and "Transport/storage environment" of the subject device are a little different from the predicate devices, but the difference of subject device is very similar to the K183058. So, these parameters' differences will not raise any safety or effectiveness issues.

8. Performance Data and Test Summary

The following performance data were provided in support of the substantial equivalence determination.

8.1 Nonclinical test performed

Biocompatibility testing 1)

The biocompatibility evaluation for the Arm Blood Pressure Monitor was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of

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Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The biocompatibility testing included the following tests:

. Cytotoxicity
. Sensitization
. Irritation

According to the test results, the subject device is biocompatible for its intended use. And it is complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).

Electrical safety and electromagnetic compatibility (EMC) 2)

Electrical safety and EMC testing were conducted on the Arm Blood Pressure Monitor (models: OB30, OB31, OB32, OB33), the device complies with the IEC 60601-1, IEC 60601-1-11, and IEC 80601-2-30 standards for safety and the IEC 60601-1-2 standard for EMC.

3) Usability Testing

Usability testing were conducted on the Arm Blood Pressure Monitor (models: OB30, OB31, OB32, OB33), the device complies with IEC 62366-1 and IEC 60601-1-6.

Software Verification and Validation Testing 4)

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction of, or a latent design flaw in, the Software Device lead s to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

8.2 Clinical performance testing performed

Clinical performance testing was conducted on the Arm Blood Pressure Monitor (models: OB30, OB31, OB32, OB33) according to the ISO 81060-2.

As this device is for adults only, the testing Included 85 subjects, aged from 22 to 81, 52.9% of participants are male and 47.1% are female, the limb size distribution of all subjects complied with clause 5.1.4 of ISO 81060-2.

The subject devices use the oscillometric method to measure blood pressure, the accuracy of determination depends on the sensor, race and ethnicity differences do not have an effect on the measuring result in the specified measuring scope.

During the testing, there were no adverse effects and complications occurred, and the results both meet criterion 1 and criterion 2 of ISO 81060-2.

9. Final Conclusion:

The conclusions drawn from the nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the leqally marketed device K183058.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).