The blood pressure monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.

Device Description

The Arm-type Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor, of which BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, and BSX523 is powered by 3.7V 400mAh Li-ion Battery. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The difference between the six models include the battery type and the backlight indicator. BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, while BSX523 is powered by 3.7V 400mAh Li-ion Battery. Moreover, the subject device is equipped with backlight indicator except models BSX516 and BSX525. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed Arm-type Electronic Blood Pressure Monitor share the similar software, measurement principle and NIBP algorithm. 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for an Arm-type Electronic Blood Pressure Monitor (K183058) from Shenzhen BSX Technology Electronics Co., Ltd. Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document references compliance with several international standards which inherently contain acceptance criteria for the respective tests. However, it does not explicitly present a table detailing specific numerical acceptance criteria and the device's reported performance against each. Instead, it states that "all testing passed pre-specified criteria."

The most directly comparable performance criteria mentioned are related to accuracy, in comparison to the predicate device:

Performance Metric	Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance (as stated or implied)
Accuracy (Static Pressure)	±3 mmHg	±3 mmHg (stated as "Same" as predicate)
Accuracy (Pulse)	±5%	±5% (stated as "Same" as predicate)
Blood Pressure Measurement Range	30 ~ 280 mmHg (Predicate)	0 ~ 299 mmHg (Proposed Device)
Pulse Rate Measurement Range	40 - 199 bpm (Predicate)	40 - 180 bpm (Proposed Device)

Note: While the proposed device's measurement ranges differ, the document concludes that these are "minor differences, which do not raise different questions of safety or effectiveness," implying they still meet acceptable performance for the intended use. The critical accuracy metrics (static pressure and pulse) are identical to the predicate device.

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

Test Set Sample Size: The document states that "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard specifies requirements for the number of subjects (typically a minimum of 85 subjects with specific demographic distribution) for clinical validation of automated non-invasive sphygmomanometers. While the exact number of subjects tested for this specific submission is not explicitly stated, the reference to the standard implies adherence to its sample size requirements.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that this is a 510(k) submission for a medical device by a Chinese company (Shenzhen BSX Technology Electronics Co., Ltd.), it is highly probable that the data originated from studies conducted in China. Clinical validation studies according to ISO 81060-2 are typically prospective.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical test set. For a blood pressure monitor, ground truth is typically established by simultaneous auscultatory measurements performed by trained and certified observers according to specific protocols (e.g., those outlined in ISO 81060-2).

4. Adjudication method for the test set

The document does not explicitly mention the adjudication method. However, for a clinical validation study of an automated sphygmomanometer according to ISO 81060-2, the ground truth is established by simultaneous auscultatory measurements, typically by two independent observers blinded to each other's readings and ideally to the automated device's readings. If there's a discrepancy, a third observer might be involved, or a pre-defined adjudication process would be followed, but these specifics are not detailed in the provided text.

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 section is not applicable to the described device. The device is an "Arm-type Electronic Blood Pressure Monitor," which is an automated measurement system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this type of device.

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

This section is applicable and describes the primary performance evaluation. The device is a standalone automated blood pressure monitor. Its performance, as evaluated against the ISO 81060-2 standard, inherently assesses the algorithm's (and the device's overall system's) ability to accurately measure blood pressure without human intervention other than proper placement and initiation of the measurement. The clinical data section confirms this: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

7. The type of ground truth used

For the clinical validation, the ground truth for blood pressure measurements is established through simultaneous auscultatory measurements performed by trained observers, as specified by the ISO 81060-2 standard. This is the universally accepted reference method for validating automated blood pressure monitors.

8. The sample size for the training set

This information is not provided. The document focuses on regulatory submission requirements for safety and effectiveness, not on the developmental aspects of the device's algorithm, which would involve a training set. For an oscillometric blood pressure monitor, the "training set" would refer to the data used to develop and refine the proprietary oscillometric algorithm. This data is part of the manufacturer's internal development process and is typically not disclosed in a 510(k) summary, which focuses on validation.

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

This information is not provided. Similar to the training set sample size, the specifics of algorithm development and the establishment of ground truth for that process are proprietary and not typically included in a public 510(k) summary. It would involve a similar process of comparing oscillometric waveforms to simultaneously obtained auscultatory or invasive blood pressure readings in a large and diverse patient population to train and validate the algorithm.

Summary

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July 3, 2019

Shenzhen BSX Technology Electronics Co., Ltd. Zhijian Zhao Sales Director Rm301.3F&4F, 8th Building, LiHao Industrial Area No.78 AiNan Road, Longgang Shenzhen. 518116 CHINA

Re: K183058

Trade/Device Name: Arm-type Electronic Blood Pressure Monitor, Models BSX516, BSX523, BSX525, BSX583, BSX593 and BSX595 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 13, 2019 Received: May 29, 2019

Dear Zhijian Zhao:

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 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 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) K183058

Device Name

Arm-type Electronic Blood Pressure Monitor, Models BSX516, BSX525, BSX583, BSX593 and BSX595

Indications for Use (Describe)

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

❏ Research Use ( As 1 CFR 201 Subpart D )
☑ Some Other Use ( As 1 CFR 201 Subpart C )

__ 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. Applicant	Shenzhen BSX Technology Electronics Co., Ltd.
	Rm301.3F&4F, 8th Building, LiHao Industrial Area, No.78 AiNan Road,Longgang, Shenzhen 518116, Shenzhen, P.R. China
	Tel.: +86 -755- 2870 2440Fax: +86 -755- 2888 2567
Contact Person	Zhijian Zhao
Prepare date	2019-05-10
2. Device nameand classification	Device Name: Arm-type Electronic Blood Pressure MonitorModels: BSX516, BSX523, BSX525, BSX583, BSX593 and BSX595
	Classification Name:
	21 CFR 870.1130
	Noninvasive Blood Pressure Measurement System
	Product code: DXN
	Regulatory Class: Class II
3. PredicateDevice(s)	Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic Blood PressureMonitor / K170151
4. DeviceDescription	The Arm-type Electronic Blood Pressure Monitor is a battery powered automaticnon-invasive blood pressure monitor, of which BSX516, BSX525, BSX583,BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, and BSX523is powered by 3.7V 400mAh Li-ion Battery. It can automatically complete theinflation, deflation and measurement, which can measure systolic and diastolicblood pressure and pulse rate of the adult person at upper arm within its claimedrange and accuracy via the oscillometric technique. User can select the unit of themeasurement: mmHg or kPa.The difference between the six models include the battery type and the backlightindicator. BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by4x1.5V AAA Alkaline Battery, while BSX523 is powered by 3.7V 400mAh Li-ionBattery. Moreover, the subject device is equipped with backlight indicator exceptmodels BSX516 and BSX525.The device has the data storage function in order for data reviewing, including thesystolic pressure, diastolic pressure, pulse rate and measurement time. The proposedArm-type Electronic Blood Pressure Monitor share the similar software,measurement principle and NIBP algorithm.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.

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The blood pressure monitor is a non-invasive blood pressure measurement system 5. Indications for intended to measure the diastolic and systolic blood pressures and pulse rate of an Use adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.

6. 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 device.

Please refer to following table to find differences between the subject device and predicate device.

ITEM	Proposed DeviceBSX516, BSX523, BSX525,BSX583, BSX593 and BSX595	Predicate DevicePG-800B36/ K170151	ComparisonResult
Manufacture	Shenzhen BSX TechnologyElectronics Co., Ltd.	Shenzhen Pango Electronic Co., Ltd.	---
Indications forUse	The blood pressure monitor is anon-invasive blood pressuremeasurement system intended tomeasure the diastolic and systolicblood pressures and pulse rate of anadult individual by using anon-invasive oscillometric techniquein which an inflatable CUFF iswrapped around the arm of which thecircumference includes 22 cm~32cm. It is intended to be used inhospital environment 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 inflatable cuffis wrapped around the upper arm. Itcan be used at medical facilities or athome. The intended armcircumference includes 22 cm~~32 cmand 32 cm~~42 cm.	Different
Contraindications	Not Known	Not Known	Same
Clinical Use	Medical Facilities and Home Use	Medical Facilities and Home Use	Same
Patient Population	Adult	Adult	Same
MeasurementType	Upper arm	Upper arm	Same
MeasurementPrinciple	Oscillometric	Oscillometric	Same
Components	LCD / Key / Cuff / MCU / Pump /Batteries	LCD / Key / Cuff / MCU / Pump /Batteries	Same
Power Source	4x1.5V AAA Alkaline Battery(BSX516, BSX525, BSX583,BSX593 and BSX595)	4x1.5V AAA Alkaline Battery	Same
	3.7V 400mAh Li-ionBattery(BSX523)		Different
PhysicalDimensions(mm)(LengthWidthHeight)	Approx:516: 110 x130 x 58523: 106 x 145 x 68.5525: 110 x130 x 58583: 112 x 132 x 70.5593: 112 x 132 x 70.5595: 112 x 132 x 70.5	Approx: 140 x100 x50	Different
Weight	Approx: 370g, containing dry battery,CUFF	Approx: 420 g, excluding battery	Different

Table 1 Comparison between the predicate PG-800B36 and the subject device

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Measurement
Range	BloodPressure	0 ~ 299 mmHg	BloodPressure	30 ~ 280 mmHg	Different
	Pulse Rate	40 -180 bpm	Pulse Rate	40-199 bpm
Accuracy	StaticPressure	$\pm3$ mmHg	StaticPressure	$\pm3$ mmHg	Same
	Pulse	$\pm5%$	Pulse	$\pm5%$
ArmCircumference	22 cm~32 cm		22 cm~42 cm		Different
Patient ContactMaterial	Cuff - Polyester		Cuff -Nylon		Different
Applied Standards	IEC 60601-1IEC 60601-1-2IEC 60601-1-1180601-2-30:200981060-2:2013		IEC 60601-1IEC 60601-1-2IEC 60601-1-1180601-2-30:200981060-2:2013		Same
OperationEnvironments	+ 5℃~ + 40℃, 15%RH~~85%RHAtmospheric Pressure: 80 kPa~~106kPa		+ 5℃~ + 40℃, 15%RH~~93%RHAtmospheric Pressure: 50 kPa~~106kPa		Different
StorageEnvironments	- 20℃~ + 55℃, 10%RH~~93%RHAtmospheric Pressure: 70 kPa~~106kPa		- 20℃~ + 55℃, 0%RH~~93%RHAtmospheric Pressure: 50 kPa~~106kPa

As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the system.

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.

Biocompatibility testing

The biocompatibility evaluation for the Arm-type Electronic Blood Pressure Monitor and the NIBP CUFF 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 Arm-type Electronic Blood Pressure Monitor, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.

Bench Testing

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Bench testing was conducted on the Arm-type Electronic Blood Pressure Monitor, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2010 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. ISO 80601-2-30: 2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standards 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 for 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:

Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement tvpe.

Summary

Based on the non-clinical and clinical performance as documented in the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.

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 BSX Arm-type Electronic 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).