Upper Arm Electronic Blood Pressure Monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.

Device Description

The Upper Arm Electronic Blood Pressure Monitor uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a " zero pressure" equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsation , which is used to determine the systolic and diastolic pressure, and also pulse rate.

AI/ML Overview

This document is a 510(k) summary for an Upper Arm Electronic Blood Pressure Monitor, aiming to demonstrate its substantial equivalence to a legally marketed predicate device. The information provided outlines the device's technical characteristics and the performance data submitted to support its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Key Acceptance Criteria and Reported Device Performance:

The primary performance criterion for a blood pressure monitor is its accuracy. The document states:

Acceptance Criteria	Reported Device Performance
BP Accuracy: ± 3mmHg	Meets criterion
PR Range: 40-199 bpm	Meets criterion

Study Details:

The clinical validation was conducted according to ISO 81060-2:2018+A1:2020 Non-invasive sphygmomanometers - Part 2: Clinical validation of intermittent automated measurement type.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Two clinical studies were performed. One study had 87 qualified subjects, and the other had 86 qualified subjects. The total combined sample size for the clinical test set is 173 (87 + 86).
- Data Provenance: The document does not explicitly state the country of origin for the data. It also does not specify if the studies were retrospective or prospective, but clinical validation studies for device clearance are typically prospective.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- The document describes "Clinical validation," which for blood pressure monitors typically involves comparison against a reference standard (e.g., auscultatory measurements by trained observers using a mercury sphygmomanometer). However, the document does not explicitly state the number of experts or their qualifications (e.g., physicians, nurses, or specific training) used for establishing the ground truth. It states "all data's mean error and standard deviation of differences in systolic, diastolic pressure is not beyond the limits set as per ISO 81060-2:2020," implying the ground truth was established following the standard's methodology.
Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method for the test set, such as 2+1 or 3+1. For blood pressure clinical validation, the ISO standard typically outlines a procedure for simultaneous measurements by multiple observers which inherently acts as a form of "adjudication" by seeking agreement or averaging.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with AI vs. without AI assistance) is relevant for diagnostic imaging devices where AI assists human interpretation. For a standalone measurement device like a blood pressure monitor, the performance is evaluated against a clinical standard, not human-AI collaboration.
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, a standalone performance evaluation was done. The entire clinical study described is a standalone evaluation of the device's accuracy in measuring blood pressure and pulse rate, independent of human interpretation assistance during the measurement process. The device's output (SYS, DYS, Pulse Rate) is the direct result of its algorithm and sensors.
Type of Ground Truth Used:
- The ground truth type is directly tied to the ISO 81060-2:2018+A1:2020 standard. This standard typically defines the ground truth as reference blood pressure measurements obtained by trained independent observers using a validated reference method (e.g., auscultation with a manometer), against which the automated device's readings are compared. It's a type of "expert consensus/reference measurement" ground truth.
Sample Size for the Training Set:
- The document does not provide information on the sample size used for the training set. For blood pressure monitors, the "training" (algorithm development) often happens with internal datasets or generalized physiological models, and the "test set" from clinical trials is for validation.
How the Ground Truth for the Training Set Was Established:
- As with the training set size, the document does not provide details on how the ground truth for an internal training set (if any specific to the algorithm's learning) was established. Assuming the device relies on established oscillometric principles and calibration, the "training" may refer more to engineering and calibration rather than a machine learning training dataset with labeled ground truth in the same sense as an AI diagnostic device.

Additional Performance Data:

Beyond clinical accuracy, the document lists several other performance data types provided:

Biocompatibility testing: Cytotoxicity, Sensitization, Irritation.
Electrical Safety, EMC, Performance testing: Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 62366-1, IEC 60601-1-2, IEC 80601-2-30, and IEC 80369-5.
Wireless testing: Compliance with ANSI C63.27-2021, AAMI TIR69:2020, FDA guidance, and FCC Part 15 Subpart C for its wireless module (Bluetooth and 4G for A01/A02 series respectively).
Cybersecurity: Addressed according to relevant FDA guidance.
Shelf-life: Evaluated for 5 years.
Reprocessing: Information provided per ISO 17664.

In summary, the provided document focuses primarily on the clinical validation of blood pressure accuracy and other critical engineering aspects against recognized international standards. It clearly indicates that the device met the accuracy requirements set by ISO 81060-2:2020. However, specific details often found in AI/imaging device submissions regarding expert adjudication, multi-reader studies, and detailed training data provenance are not as prominent, as they are less relevant for this type of medical device.

Summary

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K241129

ShenZhen GoodlyMed Technology Co., Ltd. % Kyra Kang, Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road Jingan District, Shanghai China

Re: K241129

Trade/Device Name: Upper Arm Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 23, 2024 Received: April 24, 2024

Dear Kyra Kang:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

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

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Indications for Use

Submission Number (if known)

K241129

Device Name

Upper Arm Electronic Blood Pressure Monitor

Indications for Use (Describe)

Upper Arm Electronic Blood Pressure Monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.

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

l. Submitter

ShenZhen GoodlyMed Technology Co.,Ltd.

701, Building C, Area C, Datianyang Industrial Zone, Shiwei Community, Matian Street, Guangming District, 518107 Shenzhen, PEOPLE'S REPUBLIC OF CHINA

Contact person: Ms. Maria Position: Regulatory manager Tel.: +86 -18002580887 E-mail: manager@goodlymed.com

Submission Correspondent

Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: kyra.kang@landlink-health.com

II. Proposed Device

Device Trade Name:	Upper Arm Electronic Blood Pressure Monitor
Common name:	Electronic Blood Pressure Monitor
Regulation Number:	21 CFR 870.1130
Regulatory Class:	Class II
Product code:	DXN
Review Panel:	Cardiovascular

III. Predicate Devices

510(k) Number:	K160019
Trade name:	U80 Series Electronic Blood Pressure Monitor
Common name:	Electronic Blood Pressure Monitor
Classification:	Class II
Product Code:	DXN
Manufacturer:	Shenzhen Urion Technology Co., Ltd.

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IV. Device description

Upper Arm Electronic Blood Pressure Monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.

There are two models of cuffs that can be used together: 22-42cm and 32-52cm

This device has two series: A01(including A01-SLB, A01-BL, A01-SL, A01) and A02 (including A02-SE4、A02-SEB、A02-BE、A02-SE、A02-E)

They have same Indications for use and similar technological characteristics, the electrical circuit design, critical components used and internal wiring are also similar.We chose model A02-SE4 with the most complex functions as the representative model.

V. Indication for use

Upper Arm Electronic Blood Pressure Monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.

Characteristics	Proposed device	Predicate device(K160019)	Discussionn
ProductCode	DXN	DXN	Same
IndicationsFor Use	Upper Arm Electronic BloodPressure Monitor is intendedfor used by a person olderthan twelve (12) years tomeasure the systolic anddiastolic blood pressure andpulse rate.	U80 Series Electronic BloodPressure Monitor is intendedto measure the systolic anddiastolic blood pressure aswell as the pulse rate of adultpersonvia non-invasive oscillometrictechnique in which aninflatable cuff is wrappedaround the upper arm. It canbe used at medical facilitiesor at home. The intended	Same
		upper arm circumference is22-36 cm.
MeasurementType	Upper arm	Upper arm	Same
PatientPopulation	people over 12 years old	AdultsPersonover12	Same
MeasurementItem	SYS, DYS, Pulse Rate	SYS, DYS, Pulse Rate	Same
Principle	Oscillometric	Oscillometric	Same
BP Range	0 ~ 299 mmHg	0 ~ 299 mmHg	Same
BPAccuracy	$\pm$ 3mmHg	$\pm$ 3 mmHg	Same
PR Range	40-199 bpm	40-199 bpm	Same
Cuff Size	Arm Circumference: 22-42cm, 32-52cm	Arm Circumference:22-36 cm	Similar
PowerSupply	A01 Series : Four AAAbatteries or AC adapterA02 Series : Four AA batteriesor AC adapter	Four AA batteries or ACadapter	Similar
SoftwareLevelConcern	Moderate	Moderate	Same

Table 1 General Comparison of Unner Arm Electronic Blood Pressure Monitor

VI. Comparison of technological characteristics with the predicate devices

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Wireless	A01: bluetooth	/	Different 1
	A02:4G

Analysis 1

The subject device has Wireless module while the predicate device does not. However, it is to transfer measurement results only. As for the wireless technology of the subject device, it has also been validated according to Relevant standards. As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effectiveness.

VII. Performance Data

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

Biocompatibility testing

The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

The biocompatibility testing includes the following tests:

Cytotoxicity
Sensitization
Irritation

Electrical Safety, EMC, Performance testing

● IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance

● IEC 60601-1-11: 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 60601-1-6: Medical Electrical Equipment - Part 1-6: General requirements ● for safety - Collateral Standard: Usability.

● IEC 62366-1: Medical devices – Application of usability engineering to medical devices.

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● IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

● IEC 80601-2-30: Medical electrical equipment - Particular requirements for basic safety and essential performance of automated non-invasive the sphygmomanometers.

● IEC 80369-5 Small-bore connectors for liguids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.

Wireless testing

● ANSI C63.27-2021 American National standard for evaluation of wireless coexistence

● AAMI TIR69:2017/(R2020) Risk management of radio-frequency wireless coexistence for medica devices and systems

● Radio frequency wireless technology in medical devices Guidance for industry and food and drug administration staff (August 14,2013)

● FCC Part 15 Subpart C 10-1-2022 Edition Part 15-Radio frequency devices Subpart C-Intentional Radiators

Cybersecurity

● Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Shelf-life

● 5-year shelf-life of the device has been evaluated by Shelf-life test.

Reprocessing

● ISO 17664 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices

VIII. Clinical Testing

The device was tested according to ISO 81060-2:2018+A1:2020 Non-invasive sphygmomanometers - Part 2: Clinical validation of intermittent automated measurement type. Two clinical studies were performed on the device matching with different models of cuff. The study population consisted of 87, and 86 qualified subjects

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respectively. all subjects were adults. All data's mean error and standard deviation of differences in systolic, diastolic pressure is not beyond the limits set as per ISO 81060-2:2020. No adverse effect and/or complications are found in this study.

IX. Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe and effective as the predicate device. Accordingly, the proposed device is substantially equivalent to the predicate device.

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).