The proposed device, Arm Blood Pressure Monitor, is an automatic noninvasive Blood Pressure Monitor which can be driven by dry batteries. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.

The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.

This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.

This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not according to the World Health Organization/ International Society for hypertension(WHO/ISH) guidelines on the treatment of hypertension dated in 1999.

This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

Cuff supporting the use of Arm Blood Pressure Monitor is M5303(small adult)/M5304(adult)/ M5305(big adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).

AI/ML Overview

The information provided primarily describes a 510(k) submission for an Arm Blood Pressure Monitor (model RN-032A, RN-032C), indicating its substantial equivalence to a predicate device. The document mentions a clinical trial conducted to prove its performance.

Based on the provided text, here's what can be extracted regarding the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria for the device's accuracy are based on a specific standard: ISO 81060-2:2018.

Acceptance Criterion	Reported Device Performance
Blood Pressure Accuracy (Systolic & Diastolic)	Meets the requirements of ISO 81060-2:2018; achieved results within ±3mmHg of the gold standard.
Pulse Rate Accuracy	Not explicitly stated an acceptance criterion, but the general performance comparison table indicates ±5% of reading value for pulse accuracy. No specific clinical trial result for pulse rate accuracy is provided beyond meeting the standard.

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

Sample Size: 150 subjects.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical trial for device validation, it is generally assumed to be prospective.

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

The document states that "Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group". It does not specify the number or qualifications of the individuals performing the auscultation. For blood pressure measurement studies, the "experts" are typically trained operators using a standardized auscultation method.

4. Adjudication method for the test set

The document does not describe an adjudication method. For blood pressure studies using auscultation, there isn't typically an adjudication process in the same way there would be for image-based diagnostics. The auscultatory readings from the trained operators serve as the "gold standard" for comparison.

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

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is specifically relevant for AI-assisted diagnostic tools where human interpretation of images or data is a key component. This device is an automated blood pressure monitor, not an AI diagnostic tool.

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

Standalone Performance: Yes, in essence, the clinical trial described assesses the standalone performance of the automated blood pressure monitor. The device's measurements (algorithm's output) were compared directly against the gold standard (auscultation). The accuracy result of "within ±3mmHg" is the standalone performance.

7. The type of ground truth used

Type of Ground Truth: Expert consensus (specifically, auscultation by trained individuals or a qualified operator) using a qualified calibrated mercurial sphygmomanometer. This is the established clinical method for accurate blood pressure measurement.

8. The sample size for the training set

The document does not provide information on a training set sample size. This is a clinical validation study for a medical device's performance, not a study for a machine learning model that would typically have distinct training and test sets. The "clinical trial" described is the performance validation (test set).

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

Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this type of device validation study.

Summary

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Ningbo Ranor Medical Science & Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 CN

July 16, 2020

Re: K193456

Trade/Device Name: Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 25, 2019 Received: December 13, 2019

Dear Boyle Wang:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K193456

Device Name Arm Blood Pressure Monitor

Indications for Use (Describe)

The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.

Type of Use (Select one or both, as applicable)

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 requirements of SMDA 1990 and 21 CFR 807.92.

1.0 Submitter's Information

Name: Ningbo Ranor Medical Science & Technology Co., Ltd. Address: No. 127 Fenghui Road, Wangchun Industrial Park, Haishu District, Ningbo, China Tel: 86-574-89258788 Fax: 86- 574-88219485 Contact: Emma Hu Date of Preparation: Jul.14.2020

Designated Submission Correspondent

Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Arm Blood Pressure Monitor Common name: Noninvasive Blood Pressure Measurement System Classification name: Noninvasive Blood Pressure Measurement System Model(s): RN-032A,RN-032C

3.0 Classification

Production code: DXN Requlation number: 21 CFR 870.1130 Classification: Class II Panel: Cardiovascular

4.0 Predicate Device Information

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Manufacturer: Device: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D,

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YE660B, YE670A and YE670D 510(k) number: K170605

5.0 Indication for Use Statement

The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.

6.0 Device Description

The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.

This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

7.0 Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements

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for basic safety, and essential performance.

IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - 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 80601-2-30:2013, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.

IEC 62304:2015 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.

8.0 Clinical Test Conclusion

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use.

The clinical trials for the Arm Blood Pressure Monitor were performed the standard of of of lSO 81060-2:2018, Non-Invasive according a Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.

There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device.

The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±3mmHg.And the proposed device comply with the standard requirements and the accuracy the manufacture declared.

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9.0 Technological Characteristic Comparison Table

Table2-General Comparison
Item	Proposed deviceK193456	Predicated deviceK170605	Remark
Product Code	DXN	DXN	SE
Regulation No.	21 CFR 870.1130	21 CFR 870.1130	SE
Class	II	II	SE
Intended Use	The Arm blood pressuremonitor is for home usefor measuring bloodpressure and pulse rate.It is suitable for adult, notfor neonate orpregnancy.	Electronic blood pressuremonitor is intended tomeasure the bloodpressure and pulse rateof adult at household ormedical center. (Notsuitable for neonate,pregnancy orpre-eclampsia).	SE
ApplicationSite	Upper Arm	Upper Arm	SE
CuffCircumference	$220mm \sim 320mm$	$220mm \sim 320mm$	SE
PatientsContactingMaterials	Arm Cuff -M5303(smalladult)/M5304(adult)/M5305(big adult)provided by XuzhouMaikang Science andTechnology Ltd., andcleared by FDA(K151290).	Patient contact materialsof the cuff have beentested in accordance withISO10993 and FDAguidance.	SE
PatientPopulation	Adult	Adult	SE
MeasurementsItem	SYS,DYS,Pulse	SYS,DYS,Pulse	SE
Display	LCD Digital Display	LCD Digital Display	SE
DesignMethod	OscillometricMethod	OscillometricMethod	SE
MainComponent	LCD / Key / Cuff / MCU /Pump / Batteries	LCD / Key / Cuff / MCU /Pump / Batteries	SE

Table2-General Comparison

Table3 Performance Comparison

Item	Proposed Device	Predicate DeviceK170605	Remark
BP Range	0-299 mmHg	0-280 mmHg	Analysis

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BP Accuracy	±3 mmHg	±3 mmHg	SE
PR Range	40-180 beats/min	40 ~ 200 beats/min	Analysis
PulseAccuracy	±5% of readingvalue	±5% of readingvalue	SE
InflationMethod	Automatic byelectronic pump	Automatic byelectronic pump	SE
DeflationMethod	Automatic PressureRelease Valve	Automatic PressureRelease Valve	SE
Memory Size	2x60 set of data	Up to 60sets of data	Analysis
OperationCondition	5-40 °C15%-80% RH80kPa~106kPa	10-40 °C15%-90% RH (nocondensation)	Analysis
StorageCondition	-20-55 °C≤95% RH50kPa~105kPa	-20-55 °C15%-90% RH (nocondensation)	Analysis
Data Storage	SYS, DIA, PR,Measurement Time, No.	SYS, DIA, PR,Measurement Time, No.	SE
PerformanceStandard	Comply with IEC80601-2-30	Comply with IEC80601-2-30	SE
Power Supply	4 AAA batteries	4 AA batteries	Analysis

Analysis:

The proposed device is substantially equivalent to the predicate device. The differences between both devices are insignificant in terms of safety and effectiveness. Based on the nonclinical and clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

Table4 Safety Comparison

Item	Proposed Device	Predicate DeviceK170605	Remark
Electrical Safety	Comply with IEC60601-1	Comply with IEC 60601-1	SE
Home Use	Comply with IEC60601-1-11	Comply with IEC60601-1-11	SE
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SE
Biocompatibility	Comply with ISO10993-1, FDAGuidance	Comply with ISO10993-1, FDA Guidance,Tests includedCytotoxicity, Sensitizationand Intracutaneous	SE

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		Reactivity
Label andLabeling	Conforms to FDARegulatoryRequirements	Conforms to FDARegulatory Requirements	SE
Level ofConcern of theSoftware	Moderate	Moderate	SE

10.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.

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).