The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.

Device Description

The arm blood pressure monitor model AES-U171, AES-U181, AES-U131 are sphygmomanometers with electronic manometer intended to be used for the indirect (noninvasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults who over the age of 12 (not for neonatal) . The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LCD panel.

The monitors AES-U171, AES-U181 and AES-U131 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance, and AES-U171 have print function.

AI/ML Overview

The provided text describes the 510(k) summary for the Alicn Medical (Shenzhen), Inc. Arm Blood Pressure Monitor. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a detailed study report of a new, complex AI/ML device. Therefore, it does not fully align with all the requested subsections, especially those related to AI/ML specific criteria like MRMC studies, training set details, or complex ground truth establishment requiring multiple experts.

However, I can extract the relevant information regarding acceptance criteria and performance as presented for this type of medical device (a non-invasive blood pressure monitor) based on the principles of substantial equivalence and relevant standards.

Here's a breakdown of the information and how it relates to your request:

Acceptance Criteria and Study Details for the Arm Blood Pressure Monitor:

The primary acceptance criteria for this device, being a non-invasive blood pressure monitor, are defined by adherence to recognized international standards for accuracy and safety. The study proves the device meets these criteria by showing compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard / Parameter)	Reported Device Performance (Reference)
Accuracy (Blood Pressure)	±3mmHg (±0.4kPa)
(Based on ISO 81060-2)	"The performance test demonstrates the monitors meet the IEC 80601-2-30 and clinical test meets the ISO 81060-2."
Accuracy (Pulse Rate)	±5% of reading
(Based on IEC 80601-2-30)	"The performance test demonstrates the monitors meet the IEC 80601-2-30 and clinical test meets the ISO 81060-2."
Electrical Safety	Compliant with IEC 60601-1:2005+Am1:2012
Electromagnetic Compatibility (EMC)	Compliant with IEC 60601-1-2:2007 (and apparently a later standard, though only 2007 is explicitly listed against the predicate)
Home Healthcare Environment	Compliant with IEC 60601-1-11:2015
Specific Requirements for Blood Pressure Measurement	Compliant with IEC 80601-2-30:2009
Waterproof (Ingress Protection)	IP21 (meets IEC 60601-1-11 requirement of at least IP21 for portable medical equipment in non-transit-operable use)

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

Sample Size: Eighty-six patients (43 males and 43 females) for the clinical test.
Data Provenance: The document does not explicitly state the country of origin for the clinical test data, but the company is based in Shenzhen, China. The study is prospective, as it describes inviting patients for the study and conducting measurements.

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

For non-invasive blood pressure monitors, the "ground truth" for accuracy is typically established by comparative measurements against a reference standard method, not by multiple human experts forming a consensus.
In this case, the standard is the auscultation method, which is performed by healthcare professionals trained in its use. The document states: "Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm." The number and qualifications of the individuals performing the auscultation are not specified but are presumed to be appropriately trained medical personnel as per the ISO 81060-2 standard.

4. Adjudication Method for the Test Set:

No "adjudication method" in the sense of multiple experts independently reviewing and then resolving discrepancies (common in imaging studies for AI/ML) is mentioned or relevant here. The ground truth is directly measured using a standard, established method (auscultation). The ISO 81060-2 standard itself outlines the comparison methodology.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI often used in diagnostic imaging, where multiple human readers review cases to assess diagnostic performance with and without AI assistance. This device is a direct measurement medical device (blood pressure monitor), not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence, the primary performance evaluation of the device's accuracy is a standalone assessment. The device's measurements (systolic and diastolic BP, pulse rate) are compared directly against the reference standard (auscultation). While a human applies the cuff and initiates the measurement, the core measurement and algorithm for determining BP are intrinsic to the device, and its accuracy is evaluated independently of human interpretation of its output beyond simple reading.

7. The Type of Ground Truth Used:

Reference Standard Measurement: The ground truth for blood pressure and pulse rate accuracy was established using the standard auscultation method, as mandated by ISO 81060-2. This is a direct comparative measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

This document describes a 510(k) submission for a non-AI/ML device. Therefore, there is no specific "training set" in the machine learning sense. The device's underlying algorithm for oscillometric blood pressure measurement is based on established principles and calibrated to meet the accuracy requirements of the relevant standards (ISO 81060-2, IEC 80601-2-30).

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

As there is no distinct "training set" for an AI/ML algorithm, this question is not directly applicable. The device's design and calibration process would involve engineering and physiological principles to ensure accurate oscillometric measurements, rather than learning from a labeled dataset. The clinical testing described serves as validation that the developed device performs accurately against a gold standard.

Summary

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January 3, 2019

Alicn Medical (Shenzhen), Inc Meisong Fang Manager 4/F, B Building, Shenfubao Modern Optical Factory Kengzi Street, Pingshan District Shenzhen, 518122 CHINA

Re: K180435

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: November 26, 2018 Received: November 26, 2018

Dear Meisong Fang:

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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Stephen C. Browning -S5

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180435

Device Name Arm Blood Pressure Monitor

Indications for Use (Describe)

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 the requirements of SMDA and 21 CFR §807.92.

The assigned 510(k) number is: _K180435

1.0 Information of Submitter and Correspondent

Submitter's information:

Alicn Medical (Shenzhen), Inc. Address: 4/F, B Building, Shenfubao Modern Optical Factory, Kengzi Street, Pingshan District, Shenzhen, Guangdong, China, 518122 Phone:+86-755-26501548 Fax: +86-755-26504849 Contact Person: Meisong Fang E-mail: hans.fang@alicn.com.hk

Submission correspondent's information:

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd Address: Room 2012#, Gebu commercial building, Hongxing community, Songgang street, Baoan district, Shenzhen 518000, China Contact Person: Reanny Wang; E-mail: cefdacfda@163.com

2.0 Device Information

Type of 510(k) submission:	Traditional
Trade Name:	Arm blood pressure monitor
Model:	AES-U171, AES-U181 and AES-U131
Classification name:	System, Measurement, Blood-Pressure, Non-Invasive
Review Panel:	Cardiovascular
Product Code:	DXN
Device Class:	II
Regulation Number:	21 CFR 870.1130

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3.0 Predicate Device Information

Sponsor:	Shenzhen Urion Technology Co., Ltd.
Device:	Upper Arm Electronic Blood Pressure Monitor, U80AH
510(K) Number:	K160019

4.0 Device Description

5.0 Intended Use

The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.

6.0 Performance Summary

Clinical Test Summary

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report. Eighty-six patients (43 males and 43 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm. Blood pressure measurements were repeated

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alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2.

Non-Clinical Test Summary

The Subject Device has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows:

□ IEC 60601-1:2005+Am1:2012

□ IEC 60601-1-2:2007

□ IEC 60601-1-11:2015

□ IEC 80601-2-30:2009

7.0 Comparison to predicate device and conclusion

The subject device is substantially equivalent to predicate devices, K160019, U80AH. The substantial equivalence chart is provided as follows:

Elements ofComparison	Predicate Device(K160019)	Subject Device			Judgment
Models	U80AH	AES-U171	AES-U181	AES-U131	--
Company	Shenzhen Urion TechnologyCo., Ltd.	Alicn Medical (Shenzhen), Inc.			--
DeviceName	Upper Arm Electronic BloodPressure Monitor	Arm Blood Pressure Monitor			--
Product code	DXN	DXN			SE
Regulation #	21CFR870.1130	21CFR870.1130			SE
Intended use	The U80 Series Upper ArmElectronic Blood PressureMonitor is intended tomeasure the systolic anddiastolic blood pressure aswell as the pulse rate ofadult person via non-invasive oscillometrictechnique in which aninflatable cuff is wrappedaround the upper arm. It canbe used at medical facilitiesor at home. The intendedupper arm circumference is22-36cm.Suitable for adultswho over the age of 12.	The Arm Blood Pressure Monitor isintended to measure the systolic anddiastolic blood pressure as well as thepulse rate of adult person via non-invasive oscillometric technique inwhich an inflatable cuff is wrappedaround the upper arm. It can be usedat medical facilities or at home. Theintended upper arm circumference is22-32cm.Suitable for adults who overthe age of 12.			SE, onlyupper armcircumferenceis difference,refer toRemark 3
Elements ofComparison	Predicate Device(K160019)	Subject Device			Judgment
Models	U80AH	AES-U171	AES-U181	AES-U131	--
Measurement type	Upper arm	Upper arm			SE
Patientpopulation	Adults person over 12	Adults person over 12			SE
Measurement Item	SYS, DYS, Pulse rate	SYS, DYS, Pulse rate			SE
Principle	Oscillometric	Oscillometric			SE
BPmeasurement range	0-290mmHg	0-290mmHg (0-39kPa)			SE
BP accuracy	±3mmHg (±0.4kPa)	±3mmHg (±0.4kPa)			SE
PRmeasurement range	40-199 bpm	40-199 pulses/min			SE
PRmeasurement accuracy	±5% of reading	±5% of reading			SE
Powersupply	DC6.0V, 4×AA alkalinebatteries or AC adapter	DC7.4V/850mAhinternalpolymer li-ion battery	DC6.0V, 4×AAAbatteries		SE, refer toremark 1
Waterproof	IP22	IP21			SE, refer toremark 2
Degree ofprotectionagainstelectricshock	Type BF applied part	Type BF applied part			SE
Cuff sizesuitable forarm size	About 22cm between 36cm	cuff: 22cm~32cm			SE, refer toRemark 3
Automaticpower off	In 3 minutes	Automatically turn off after 60 seconds			Difference,Refer toRemark 4
Elements ofComparison	Predicate Device(K160019)	Subject Device			Judgment
Models	U80AH	AES-U171	AES-U181	AES-U131	--
Operationenvironment	5 °C -40°C, 15%-80%RH,70-106kPa	5°C-40°C, 15%-80%RH, 70-106kPa	5°C-40°C, 15%-80%RH, 70-106kPa	5°C-40°C, 15%-80%RH, 70-106kPa	SE
Storageenvironment	-20 °C -55 °C , 1 0% -85% RH,avoid crash, sun burn or rainduring transportation	-20°C-55℃, 15%-85% RH, 70-106kPa	-20°C-55℃, 15%-85% RH, 70-106kPa	-20°C-55℃, 15%-85% RH, 70-106kPa	SE, Refer toRemark 5

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Alicn Medical (Shenzhen), Inc.

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Alicn Medical (Shenzhen), Inc.

Remark 1 :

The power supply of subject device AES-U171 is DC7.4V /850mAh internal polymer li-ion battery, and the predicate device U80AH is DC6.0V, 4×AA alkaline batteries. The subject devices are compliance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11 standards. So the difference will not raise any safety or effectiveness issue.

Remark 2 :

The Arm blood pressure monitor is portable medical equipment in non-transit-operable use, according to IEC 60601-1-11 standard requirement, the enclosure ingress of water and particulate matter requirement should be IP21 at least. The subject devices are compliance with IEC 60601-1-11 standard requirement. So the difference will not raise any safety or effectiveness issue.

Remark 3:

The intended arm circumferences (22-32 cm) of the proposed and predicate device are different. This difference is very slight, and the cuff size is appropriate to the claimed intended arm circumference per IEC 80601-2-30.Therefore, this point is considered as substantially equivalent.

Remark 4:

The time of automatic power off is difference with predicate device, the time of subject devices is less than predicate device, but they are both compliance with the IEC 80601-2-30 standard, so the difference will not raise any safety or effectiveness issue.

Remark 5:

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The Relative Humidity of storage environment of subject devices is difference with predicate device, and they are both compliance with IEC60601-1-11 standard, it will not raise any safety or effectiveness issue.

8.0 Conclusions

Arm blood pressure monitor, Model AES-U171, AES-U181 and AES-U131 have the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates product safety by successful completion of testing to the IEC 60601-1 standard and electromagnetic standard IEC 60601-1-2. The performance test demonstrates the monitors meet the IEC 80601-2-30 and clinical test meets the ISO 81060-2. These conclude that any differences in their characteristics do not raise any safety and effectiveness issues.

Form the above information we conclude the subject device, AES-U171, AES-U181 and AES-U131are substantially equivalent to the predicate devices, U80AH.

9.0 Summary prepared date

February 7, 2018

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).