The Arm Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

Device Description

AOJ-33series arm blood pressure monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device. AOJ-33B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for AOJ-33A.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B, meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for blood pressure monitors are typically defined by international standards like ISO 81060-2. The document states that the device was tested to ISO 81060-2:2018.

Acceptance Criteria (from ISO 81060-2:2018; implicitly accepted by FDA clearance)	Reported Device Performance (from Clinical Study on AOJ-33A)
Mean error and standard deviation of differences for systolic pressure within specified limits of ISO 81060-2:2018	Met: "All data's mean error and standard deviation of differences for systolic... pressure is not over the limits of ISO 81060-2:2018."
Mean error and standard deviation of differences for diastolic pressure within specified limits of ISO 81060-2:2018	Met: "All data's mean error and standard deviation of differences for ...diastolic pressure is not over the limits of ISO 81060-2:2018."
Blood pressure measurement range: $\pm$ 3 mmHg	Met: "$\pm$ 3 mmHg" (This is listed under "Accuracy" in the comparison table, implying it's the expected accuracy).
Heart rate measurement accuracy: $\pm$ 5% of reading	Met: "$\pm$ 5% of reading" (This is listed under "Accuracy" in the comparison table).

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

Sample Size: 100 adult subjects (49 female, 51 male).
Data Provenance: The document does not explicitly state the country of origin. It indicates it was a clinical validation study performed on AOJ-33A, implying it was a prospective study conducted for regulatory submission.

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

The document refers to a "Same Arm Sequential Method" clinical validation study in accordance with ISO 81060-2:2018. This standard typically involves multiple trained observers (experts) taking sequential measurements using a reference sphygmomanometer. However, the document does not specify the exact number of experts or their qualifications.

4. Adjudication method for the test set

The document states "The Same Arm Sequential Method was chosen." This method, as described in ISO 81060-2, involves comparing the automated device measurements to those taken by trained observers using a reference manual sphygmomanometer on the same arm. While it implies a comparison against expert readings, the document does not explicitly detail an adjudication method (e.g., 2+1, 3+1). The standard outlines procedures for obtaining reference measurements, which inherently involve a form of expert consensus or highly standardized measurement to establish ground truth.

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

This question is not applicable as the device is an automated blood pressure monitor and not an AI-assisted diagnostic tool for human readers. It directly measures and displays blood pressure and pulse rate.

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

Yes, a standalone performance evaluation was done. The clinical validation study described is for the device (AOJ-33A) functioning independently to measure blood pressure and pulse rate, without human interpretation or assistance during the measurement process.

7. The type of ground truth used

The ground truth for the clinical study was established by comparison with established reference measurements, likely from a manual sphygmomanometer operated by trained observers, as per the ISO 81060-2:2018 standard for non-invasive sphygmomanometers. This effectively represents a validated, expert-derived measurement.

8. The sample size for the training set

The document does not specify a separate training set sample size. The clinical data mentioned (100 adult subjects) refers to the testing or validation set for the device's performance against the standard. For medical devices like blood pressure monitors, the "training" (i.e., calibration and algorithm development) often occurs internally during the device design phase, and explicit "training set" data for regulatory submission in the same way as an AI algorithm is typically not detailed.

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

As there is no explicit mention of a separate "training set" in the context of data for regulatory submission (beyond the device's inherent design and calibration), this information is not provided in the document. The general principle for developing such devices involves engineering and clinical testing to ensure accurate readings, which implicitly leverages previous data and established hemodynamic principles to calibrate the oscillometric algorithm.

Summary

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July 26, 2023

Shenzhen AOJ Medical Technology Co., Ltd. Jack Wang Deputy Chief Room 301 & 4F, Blk A, Building A, Jingfa IM Park, Xiaweiyuan Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China

Re: K222994

Trade/Device Name: Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 12, 2023 Received: June 13, 2023

Dear Jack 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.

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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.

Robert T. Kazmierski - S

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) K222994

Device Name

Arm Blood Pressure Monitor, models AOJ-33A, AOJ-33B

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

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Shenzhen AOJ Medical Technology Co., Ltd.Room 301&4F, Block A, Building A,Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, XixiangStreet, Bao'an District, 518126, Shenzhen, ChinaTEL: 86 755-27786026
Contact Person:	Jack Wang
Prepare date:	September 16, 2022
2. Device name andclassification:	Device Name: Arm Blood Pressure MonitorModels: AOJ-33A and AOJ-33BRegulation No .: 21 CFR 870.1130Review Panel: CardiovascularClassification Name: Cardiovascular Diagnostic DevicesProduct code: DXNRegulatory Class: Class II
3. Reason forSubmission:	New Application. No prior submission for this device before.
3. Class III devicestatement	Not applicable, the subject device is a Class II device.
4. Predicate Devices:	Reference predicate: Shenzhen AOJ Medical Technology Co., Ltd., AOJ-30BElectronic Blood Pressure Monitor cleared under K191180.
5. Device Description:	The predicates have not been subject to any recall before.AOJ-33series arm blood pressure monitor is designed as a battery driven automaticnon-invasive blood pressure monitor. It can automatically complete the inflation,deflation and measurement, which can measure systolic and diastolic bloodpressure as well as the pulse rate of adult person at upper arm within its claimedrange and accuracy via the oscillometric technique. The result will be displayed inthe international unit mmHg or Kpa.
	The device has the data storage function in order for data reviewing, including thesystolic pressure, diastolic pressure, pulse rate and measurement time. The devicealso has low voltage indication, which will be triggered when the battery is low.
	The proposed device is intended to be used in medical facilities or at home. And theeffectiveness of this sphygmomanometer has not been established in pregnant(including pre-eclamptic) patients.
	The product is provided non-sterile, and not to be sterilized by the user prior to use.
	All the models included in this submission follow the same software, samemeasurement principle and same specifications. The main differences are color ofthe face shell and keys, which will not affect the safety and effectiveness of thedevice.

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K222994

AOJ-33B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for AOJ-33A.

Indications for The Arm Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive Use: oscillometric technique at medical facilities or at home.

7. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate devices.

Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

ITEM	Proposed DeviceAOJ-33 series	Predicate DeviceAOJ-30B/K191180	ComparisonResult
Manufacturer	Shenzhen AOJ Medical TechnologyCo., Ltd.	Shenzhen AOJ Medical TechnologyCo., Ltd.	Same
Intended Use/Indicationsfor Use	The Arm Blood Pressure Monitor isintended to measure the systolic anddiastolic blood pressure as well as thepulse rate of adult person vianon-invasive oscillometric techniquein which an inflatable CUFF iswrapped around the upper arm atmedical facilities or at home.	The Electronic Blood PressureMonitor is intended to measure thesystolic and diastolic blood pressureas well as the pulse rate of adultperson via non-invasive oscillometrictechnique in which an inflatableCUFF is wrapped around the upperarm at medical facilities or at home.	Same
Contraindications	Not Known	Not Known	Same
Application scenario	Medical Facilities and Home Use	Medical Facilities and Home Use	Same
Operational Specifications
Principle	Oscillometric	Oscillometric	Same
Measurement Item	SYS, DYS, Pulse Rate	SYS, DYS, Pulse Rate	Same
Patient population	Adult	Adult	Same
Measurement site	Upper arm	Upper arm	Same
Blood pressuremeasurement range	30-255 mmHg	30-255 mmHg	Same
Accuracy	$\pm$ 3 mmHg	$\pm$ 3 mmHg	Same
Heart rate measurementrange	40-199 bpm	40-199 bpm	Same
Accuracy	$\pm$ 5% of reading	$\pm$ 5% of reading	Same
Cuff size	22 - 42 cm	22 - 36 cm	Different
Display	Blood Pressure (Systolic andDiastolic), Pulse rate, Date, Time,WHO BP Classification	Blood Pressure (Systolic andDiastolic), Pulse rate, Date, Time,WHO BP Classification	Same

	Indicating Bar, Low Battery Icon, Heart Icon, Memory Record Number	Indicating Bar, Low Battery Icon, Heart Icon, Memory Record Number
Auto shutdown	YES	YES	Same
Operating environment	Temperature: 5°-40°C Humidity:15%-90% RH, Atmospheric pressure: 70 kPa -106 kPa	Temperature: 5°-40°C Humidity:15%-90% RH, Atmospheric pressure:70 kPa -106 kPa	Same
Storage environment	Ambient Temperature: -20°C to 55°CRelative Humidity: 10-93% RH,Atmospheric pressure:70 kPa -106 kPa	Ambient Temperature: -20°C to 55°CRelative Humidity: 10-93% RH,Atmospheric pressure:70 kPa -106 kPa
Battery type	Lithium-ion battery, D.C. 3.7V	6Vdc (4 * 1.5V AAA batteries)	Different
Weight	AOJ-33A: About 225gAOJ-33B: About 225g	Approx. 483.8 g without battery	Different
Dimensions	AOJ-33A:123 mm (Length) x 59 mm(Width) x 28mm (Height) (48.43inches x 23.23 inches x11.02inches )AOJ-33B: 125 mm (Length) x 48mm (Width) x 28 mm (Height)(49.21 inches x 18.9 inches x 11.02inches)	138 mm * 120 mm * 59 mm
Patient Contacting	Surface-contacting,Less than 24 h	Surface-contacting,Less than 24 h	Same
Biocompatibilityevaluation	Cytotoxicity, skin sensitization andirritation	Cytotoxicity, skin sensitization andirritation	Same
Electrical safety	IEC 60601-1IEC 60601-1-11ISO 80601-2-30	IEC 60601-1IEC 60601-1-11ISO 80601-2-30	Same
EMC	IEC 60601-1-2	IEC 60601-1-2	Same
Biocompatibility	ISO 10993-1ISO 10993-5ISO 10993-10	ISO 10993-1ISO 10993-5ISO 10993-10	Same
Data transmission	Has wireless function with Bluetoothand available for AOJ-33B only	Not available	Different

Table 1 Comparison between predicate AOJ-30B and the subject device

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As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The differences between the subject and predicate devices will not raise different questions of safety or effectiveness.

8. Performance Testing:

Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.

Non-Clinical Data:

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

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Biocompatibility testing

The biocompatibility evaluation for the device were conducted in accordance with the 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 worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:

Cytotoxicity
Skin Sensitization
Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 MEDICAL ELECTRICAL EQUIPMENT -Part 1-11: General requirements far basic safety and essential performance -Collateral Standard: Requirements for medical equipment and medical electrical systems used in the home healthcare environment^ and the IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.

Bench Testing

Bench testing was conducted on the device, consisting of all the accessories in the system. The system complies with the ISO 80601-2-30 Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers for performance effectiveness.

Software Verification and Validation Testing

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 fbr this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Clinical data:

AOI-33A was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. the clinical validation data on AOJ-33A can cover AOJ-33B. The Same Arm Sequential Method was chosen and performed on AOJ-33A. This study included 100 adult subjects (49 female, 51 male) with an age range of 12 to 60 years. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.

9. Conclusion:

Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the AOJ-33 series Arm Blood Pressure Monitor is substantially equivalent to the predicate devices.

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).