The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).

Device Description

The subject device, Automatic Digital Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven by 4 AA batteries or AC adapter (optional). 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 at household, not for neonate or pregnancy.

This blood pressure monitor has the memory function of 60 reading of measuring data of two groups, 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.

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 Automatic Digital Blood Pressure Monitor is M5402(small adult)/M5403(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 provided text describes the 510(k) summary for the AVICHE Automatic Digital Blood Pressure Monitor (K210152). Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Standard or Predicate)	Reported Device Performance (K210152)
BP Accuracy: $\pm$ 3 mmHg (ISO 81060-2:2018)	$\pm$ 3 mmHg
BP Range: Comparable to predicate (0-300 mmHg)	0-280 mmHg
PR Range: Comparable to predicate (40-200 beats/min)	40-199 beats/min
Pulse Accuracy: $\pm$ 5% of reading value	$\pm$ 5% of reading value
Electrical Safety: Complies with IEC 60601-1	Complies with IEC 60601-1
Home Use Compliance: Complies with IEC 60601-1-11	Complies with IEC 60601-1-11
EMC Compliance: Complies with IEC 60601-1-2	Complies with IEC 60601-1-2
Biocompatibility: Complies with ISO 10993-1, FDA Guidance	Complies with ISO 10993-1, FDA Guidance
Software Level of Concern: Moderate	Moderate
Labels & Labeling: Conforms to FDA Regulatory Requirements	Conforms to FDA Regulatory Requirements
Memory Size: Comparable to predicate (Up to 60x2 sets of data or Up to 99x2 sets)	2x60 set of data
Operation Condition: Comparable to predicate (Temp +5~+40°C, Humidity 15%-90%RH, Air pressure 80.0kPa-105.0kPa)	Temperature +5~+40°C, Humidity $\leq$ 80%RH, Air pressure 80.0kPa-105.0kPa
Storage Condition: Comparable to predicate (Temp -20-+55 °C, Humidity 15%-90%RH, Air pressure Not publicly available)	Temperature -20-55 °C, Humidity 10%~90% RH, Air pressure 80.0kPa-105.0kPa
Power Supply: Comparable to predicate (4 AA batteries or 6V/600mA AC adapter)	4 AA batteries or 5V/1.0A AC adapter

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

Sample Size: 150 subjects.
Data Provenance: The text states "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement." This indicates a prospective study. The country of origin is not explicitly stated, but the submission is from a Chinese company, so it is likely derived from China.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. It only mentions that "Auscultation was applied as gold standard" and "qualified calibrated mercurial sphygmomanometer used as control group." This implies a clinical setting where trained professionals would perform the auscultatory measurements, but specifics are missing.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It simply states that auscultation was used as the "gold standard."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance

This is an automated blood pressure monitor, not an AI-assisted diagnostic device that involves human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not conducted.

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

Yes, a standalone performance study was done. The device itself (the "Automatic Digital Blood Pressure Monitor") is the algorithm-only component in terms of its measurement capability. The clinical trial directly assessed the accuracy of the device's measurements against a gold standard (auscultation), without intervention or interpretation by "human readers" in the typical sense of AI-assisted image analysis.

7. The Type of Ground Truth Used

The ground truth used was auscultation with a qualified calibrated mercurial sphygmomanometer. This is considered a direct physiological measurement by a trained operator, serving as the clinical gold standard for blood pressure measurement.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The clinical trial described (150 subjects) is presented as the performance validation for the device's accuracy. For non-adaptive devices like this, there isn't typically a "training set" in the machine learning sense. The device's underlying measurement algorithm would have been developed and refined through engineering and calibration, not necessarily "trained" on a specific dataset in the way an AI model is.

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

As mentioned above, information on a specific "training set" and its ground truth establishment is not provided, as it's not directly applicable to the type of device described. The device's measurement principle (oscillometric method) and its calibration would be based on established physiological principles and engineering standards.

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

September 23, 2020

AVICHE Shandong Medical Technology Co, Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210152

Trade/Device Name: Automatic Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 18, 2021 Received: August 25, 2021

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

{1}------------------------------------------------

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,

Stephen C. Browning -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210152

Device Name Automatic Digital Blood Pressure Monitor

Indications for Use (Describe)

The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).

Type of Use (Select one or both, as applicable)	Day-to-Day Use (49 CFR 391 Subpart E) One-Time Contract Use (49 CFR 391 Subpart G)
-------------------------------------------------	-----------------------------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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}------------------------------------------------

510(k) Summary (K210152)

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

1.0 Submitter's Information

Name: AVICHE Shandong Medical Technology Co, Ltd. Address: Floor 26, Building A, A2-1 Jinan Pharm Valley, Gangxingsan Road,High-tech District, Jinan City, Shandong Province, China Tel: 86-15689734848 Contact: Zhike Song Date of Preparation: Aug.11,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Automatic Digital Blood Pressure Monitor Common name: Noninvasive Blood Pressure Measurement System Classification name: Noninvasive Blood Pressure Measurement System Model(s): HD10,HD20

3.0 Classification

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

4.0 Predicate Device Information

Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Device: Electronic Blood Pressure Monitor: YE620B, YE620D, YE660E, YE660F and YE680B

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

510(k) number: K200939

5.0 Indication for Use Statement

The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).

6.0 Device Description

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.

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 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

{5}------------------------------------------------

IEC 80601-2-30:2018, 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 intended use.

The clinical trials for the Automatic Digital Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive 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 subject device.

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

Table1-General Comparison
Item	Subject DeviceK210152	Predicate DeviceK200939	Remark
Product Code	DXN	DXN	SE
Regulation No.	21 CFR 870.1130	21 CFR 870.1130	SE
Class	II	II	SE
Intended Use	The Automatic Digital BloodPressure Monitor isintended to measure theblood pressure and pulserate of adult at household.(Not suitable for neonate,pregnancy orpre-eclampsia).	Electronic blood pressuremonitor is intended tomeasure the bloodpressure and pulse rate ofadult at household ormedical center. (Notsuitable for neonate,pregnancy orpre-eclampsia).	SE
Application Site	Upper Arm	Upper Arm	SE
CuffCircumference	22-36cm or 22-42cm(optional)	Type A (22cm~~32cm,22-45cm optional)Type B (22cm~~ 32cm,22-45cm optional)	SE
Patients	Arm Cuff - M5402(small	Patient contact materials of	SE

9.0 Technological Characteristic Comparison Table

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

ContactingMaterials	adult)/M5403(adult)provided by XuzhouMaikang Science andTechnology Ltd., andcleared by FDA(K151290).	the cuff have been testedin accordance withISO10993 and FDAguidance.
PatientPopulation	Adult	Adult	SE
MeasurementsItem	SYS, DIA,Pulse	SYS, DIA,Pulse	SE
Display	LCD Digital Display	LCD Digital Display	SE
Design Method	OscillometricMethod	OscillometricMethod	SE
MainComponent	LCD / Key / Cuff / MCU /Pump / Batteries	LCD / Key / Cuff / MCU /Pump / Batteries	SE

Table 2 Performance Comparison

Item	Subject DeviceK210152	Predicate DeviceK200939	Remark
BP Range	0-280 mmHg	0-300 mmHg	SE
BP Accuracy	$\pm$ 3 mmHg	$\pm$ 3 mmHg	SE
PR Range	40-199 beats/min	40 ~ 200 beats/min	SE
PulseAccuracy	$\pm$ 5% of reading value	$\pm$ 5% of reading value	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 60x2 sets of dataorUp to 99 sets of DataorUp to 99x2 sets of data	SE
OperationCondition	Temperature +5~+40°CHumidity $\leq$ 80%RHAir pressure80.0kPa-105.0kPa	Temperature +5°C ~ +40 °CHumidity 15%-90% RH(no condensation)Air pressure:Not publicly available	Analysis
StorageCondition	Temperature -20-55 °CHumidity 10%~90% RHAir pressure80.0kPa-105.0kPa	Temperature -20-+55 °CHumidity 15%-90% RH(no condensation)Air pressure: Not publiclyavailable	Analysis

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

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 AA batteries or 5V/1.0AAC adapter	4 AA batteries or 6V/600mAAC adapter	Analysis

Analysis:

The subject device is substantially equivalent to the predicate device. The differences in Operation Condition and Storage Condition between both devices are insignificant in terms of safety and effectiveness. Also, the little difference in power supply according to the Electrical Safety and EMC test result, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

Item	Proposed DeviceK210152	Predicate DeviceK200939	Remark
Electrical Safety	Comply with IEC 60601-1	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 IEC 60601-1-2	SE
Biocompatibility	Comply with ISO10993-1, FDA Guidance	Comply with ISO 10993-1,FDA Guidance, TestsincludedCytotoxicity, Sensitizationand IntracutaneousReactivity	SE
Label andLabeling	Conforms to FDARegulatoryRequirements	Conforms to FDARegulatory Requirements	SE
Level of Concernof the Software	Moderate	Moderate	SE

Table 3 Safety Comparison

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).