Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.

Device Description

Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended for measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm~~33cm and cuff of size 33cm~~47cm.

AI/ML Overview

The provided text describes a 510(k) submission for an Arm Blood Pressure Monitor (model: BPM-A7VL). This is a non-invasive blood pressure measurement system. The acceptance criteria and the study proving the device meets these criteria are primarily focused on its clinical accuracy, electrical safety, electromagnetic compatibility (EMC), biocompatibility, and software performance.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for blood pressure monitors are typically defined by recognized standards such as ISO 81060-2 and IEC 80601-2-30. The text explicitly states that the device's performance complies with these standards.

Table of Acceptance Criteria and Reported Device Performance:

Criteria Category	Standard/Parameter	Acceptance Criteria (from standard)	Reported Device Performance/Compliance
Clinical Accuracy	ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01 (Clinical Investigation)	Clinical Accuracy Requirements: (The document does not explicitly state the numerical acceptance criteria of ISO 81060-2, but it implies adherence to its statistical requirements for device vs. reference measurements.) Generally, for a device to be compliant, the mean difference between the device and reference measurements should be within ±5 mmHg with a standard deviation of 8 mmHg or less, for both systolic and diastolic pressure, when compared to the reference standard across a range of subjects. More stringent criteria often apply, such as the AAMI criteria which demands at least 85 subjects, specific distributions of age, arm circumference, and blood pressure ranges to ensure robust validation.	"The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01."
Blood Pressure Measurement Accuracy	Inherent Specification (often derived from standards)	±3 mmHg	±3 mmHg (Stated as "Same" as predicate device)
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, FDA Guidance	Negative for Cytotoxicity, Sensitization, and Irritation for patient-contacting components.	"The Material of Patient contact components of subject device has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization though testing against ISO 10993-10 and ISO 10993-23 tested and all test results are positive, the difference of subject device with predicate device A02-SE4 (K241129) do not raise new questions of safety and effectiveness." (Note: "all test results are positive" here means positive for the test procedure results indicating that the material passed the biocompatibility requirements, not that it tested positive for toxicity/sensitization/irritation).
Electrical Safety	ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1-11:2015/2020 (Home Healthcare Environment)	Device must meet general requirements for basic safety and essential performance, especially for devices used in home healthcare.	"The system complies with the AAMI ANSI ES60601-1, IEC 60601-1-11 for electrical safety..."
Electromagnetic Compatibility (EMC)	IEC 60601-1-2: 2014+AMD1:2020	Device must perform as intended in its electromagnetic environment without introducing unacceptable electromagnetic disturbances to other devices or being unduly affected by such disturbances.	"...the IEC 60601-1-2 standard for EMC..." (system complies).
Software Performance	IEC 62304 Edition 1.1 2015-06, FDA Guidance for software in medical devices (May 2005)	Software must be verified and validated to ensure it performs as intended and does not pose unacceptable risks (especially given its "moderate" level of concern).	"Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005. The software for this device was considered as a "moderate" level of concern... The system complies with IEC 62304 Edition 1.1 2015-06 for software verification."

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: 85 subjects were used for the clinical accuracy test.
- Data Provenance: The document does not explicitly state the country of origin. It indicates a "clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2," implying a formal clinical study. The submission is from Shenzhen IMDK Medical Technology Co., Ltd. (China), so it's highly probable the study was conducted retrospectively or prospectively in China, but this is not definitively stated. The study type is prospective clinical accuracy testing, as it involves a concurrent comparison with a reference standard.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The clinical accuracy testing for blood pressure monitors, as per ISO 81060-2, typically involves a comparison against a reference method (usually auscultatory measurements using a mercury or aneroid sphygmomanometer by trained observers). The document mentions "Aneroid sphygmomanometer" and "Measuring Method: Aneroid/auscultation method" as the reference equipment.
- ISO 81060-2 requires at least two trained observers (experts) to simultaneously and independently measure blood pressure using the reference method, usually blinded to each other's readings and the device's readings. The document does not explicitly state the number or qualifications of these observers, but their involvement is a fundamental requirement for ISO 81060-2 compliance. They would be healthcare professionals (e.g., physicians, nurses, technicians) specially trained and certified for accurate auscultatory blood pressure measurement.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For ISO 81060-2, the standard adjudication method typically involves the simultaneous independent measurements by two trained observers. If their readings differ by a certain threshold (e.g., > 4 mmHg), a third observer or a consensus reading might be involved for specific cases, or those readings might be discarded. The document does not detail the exact adjudication criteria but implies adherence to the ISO standard.
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:
- No, an MRMC comparative effectiveness study was not done. This document is for a non-invasive blood pressure monitor, which is a physical measurement device, not an AI-assisted diagnostic imaging tool where MRMC studies are typically performed. The "AI" component mentioned refers to the automated measurement algorithm within the device, not a separate AI for interpretation assistance to human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone performance was evaluated. The clinical accuracy study evaluates the device's (algorithm's) ability to accurately measure blood pressure independently of direct human interpretation, comparing its output directly against a highly accurate reference standard. The device itself is "standalone" in its measurement function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical accuracy study was established using expert auscultatory measurements (performed by trained observers) from a validated reference device (Aneroid sphygmomanometer, Model: CM-BPM-D, K211084), following the methodology prescribed by ISO 81060-2.
The sample size for the training set:
- Not applicable / Not specified. This submission is for a medical device that uses an oscillometric measurement principle and internal algorithms. It is not an AI/ML device that typically undergoes explicit "training" on a separate dataset in the same way as, for example, an image classification model. The software component mentioned underwent "verification and validation," which implies testing against requirements and design specifications, not training on a dataset. The algorithms are likely fixed based on established oscillometric principles.
How the ground truth for the training set was established:
- Not applicable. As explained above, there isn't a "training set" in the context of an AI/ML model for this type of device. The ground truth for the performance verification (clinical accuracy testing) was established via expert auscultatory measurements against a reference device, as detailed above.

Summary

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November 26, 2024

Shenzhen IMDK Medical Technology Co., Ltd. % Yiiie You Manager Oimmig Medical Consulting Service Co., Ltd RM.406, Building C, Run Science Park No.18 Shenzhou Road, Huangpu Guangzhou, Guangdong 510663 China

Re: K243118

Trade/Device Name: Arm Blood Pressure Monitor (model: BPM-A7VL) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 30, 2024 Received: September 30, 2024

Dear Yijie You:

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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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)

K243118

Device Name

Arm Blood Pressure Monitor (model: BPM-A7VL)

Indications for Use (Describe)

Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.

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

[As required by section 807.92(c)]

1. 510(k) owner (Applicant)

EstablishmentRegistrationnumber:		3015007456
Name:		Shenzhen IMDK Medical Technology Co., Ltd.
Address:		904, 9F, Guangming Tianan Cloud Park Building, 255Zhenmei Road, Zhenmei Community, Xinhu Street,Guangming District, Shenzhen, 518107, PEOPLE'SREPUBLIC OF CHINA
ContactPerson	Name:	Xia yuan
	Address:	904, 9F, Guangming Tianan Cloud Park Building, 255Zhenmei Road, Zhenmei Community, Xinhu Street,Guangming District, Shenzhen, 518107, PEOPLE'SREPUBLIC OF CHINA
	TEL:	+86-13662694320
	Email:	vicky-xia@imdker.com

2. Submission Correspondent (Authorized representative)

Name:	You Yijie
Company Name	Qimmiq Medical Consulting Service Co., Ltd
Address:	RM.406, Building C, Run Science Park, No.18Shenzhou Road, Huangpu, Guangzhou, Guangdong510663 P.R. China
TEL:	(+86)020-82245821
FAX:	(+86)020-82245821
Email:	jet.you@qimmiq-med.com

3. Device Information

Purpose of the application:	510(K) submission
Submission Type:	Traditional 510(K)
The reason for the 510(k):	It is a new device
Trade Name:	Arm Blood Pressure Monitor
Model:	BPM-A7VL
Common name of the device:	Arm Blood Pressure Monitor
Classification name:	System, Measurement, Blood-Pressure, Non-Inva

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Review panel:	Cardiovascular
Product code:	DXN
Regulation Class:	II
Regulation Number:	21 CFR 870.1130

4. Predicate Device Information

510(k) submitter/holder:	ShenZhen GoodlyMed Technology Co., Ltd.
510(K) Number:	K241129
Trade name:	Upper Arm Electronic Blood Pressure Monitor
Model:	A02-SE4
Review Panel:	Cardiovascular
Product Code:	DXN
Regulation Class:	II
Regulation Number:	21 CFR 870.1130

5. Device description

Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.

lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm~~33cm and cuff of size 33cm~~47cm.

Principle of operation:

This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate.

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6. Indications for Use

Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.

7. Summary of technological characteristics of device compared to the

SEComparisons	Subject device(Arm Blood Pressure Monitor,model: BPM-A7VL)	Predicate device(Upper Arm Electronic Blood PressureMonitor, Model: A02-SE4)	Discussion ofdifference
510K Number	/	K241129	/
Model	BPM-A7VL	A02-SE4	/
Classification	21CFR 870.1130	21CFR 870.1130	Same
Product Code	DXN	DXN	Same
FDA Class	II	II	Same
Indications forUse	Arm Blood Pressure Monitor is intended tomeasure the blood pressure and pulse rate ofperson older than twelve (12) years in householdor medical facilities.	Upper Arm Electronic Blood PressureMonitor is intended for used by aperson older than twelve (12) years tomeasure the systolic and diastolicblood pressure and pulse rate.	Same
PatientPopulation	person older than twelve (12) years	person older than twelve (12) years	Same
Design	table type	table type	Same
Design Method	Oscillometric	Oscillometric	Same
MeasurementSite	Upper Arm	Upper Arm	Same
CuffCircumference	23cm~~33cm;33cm~~47cm.	22cm~~42cm;32cm~~52cm.	Different(Discussion isindicated inD1)
Deflation Method	Automatic Pressure Release Valve	Automatic Pressure Release Valve	Same
Display	Backlight LCDDigital Display	Backlight LCDDigital Display	Same
Memory Size	99 groups	Not public	Different(Discussion isindicated inD2)
Blood PressureMeasurementRange	Measurement blood pressure range:SYS:60mmHg~~230mmHgDIA: 40mmHg~~130mmHg	BP Range: 0 ~ 299 mmHg	Different(Discussion isindicated inD3)
Blood PressureMeasurementAccuracy	±3 mmHg	±3 mmHg	Same
PulseMeasurementRange	40~200 beats/min	40 ~ 199 beats/min	Different(Discussion isindicated inD4)
PressurizationSource	Automatic Internal Pump	Automatic Internal Pump	Same
OperatingEnvironment	Ambient temperature: +5°C~ +40°CRelative humidity (RH): 15%~~85%Atmospheric pressure: 80 kPa~~106kPa	Not public	Different(Discussion isindicated inD5)
StorageEnvironment	Ambient temperature: -20 °C ~+50 °CRelative humidity (RH): 15%~~85%Atmospheric pressure: 80 kPa~~106kPa	Not public	Different(Discussion isindicated inD6)
Energy Source	Internal power supply DC 6V (4X1.5V (AA)batteries;External power supply: USB interface DC 5V 1A	4 X AA batteries or AC adapter	Different(Discussion isindicated inD7)
MeasurementItem	SYS, DYS, Pulse Rate	SYS, DYS, Pulse Rate	Same
Software LevelConcern	Moderate	Moderate	Same
Wireless	NA	4G	Different(Discussion isindicated inD8)
Performance	ISO 81060-2 Third edition 2018-11 Amendment 12020-01	ISO 81060-2:2020	Same
Performance	IEC 80601-2-30: Edition 2.0 2018-03	IEC 80601-2-30	Same
Biocompatibility	ISO 10993-1, FDA Guidance, Tests includedCytotoxicity, Sensitization and IntracutaneousReactivity	ISO 10993-1, FDA Guidance, Testsincluded Cytotoxicity, Sensitization andIntracutaneous Reactivity	Same
ElectricalSafety	ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012C1:2009/(R)2012 & A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021]	IEC60601-1	Same
EMC	IEC 60601-1-2: 2014+AMD1:2020	IEC 60601-1-2	Same
Home Use	IEC 60601-1-11:2015/2020	IEC 60601-1-11	Same
Material ofPatient contactcomponents	Shell: ABS757Display cover: PMMAM button and ON/Off button: ABS757	Not public	Different(Discussion isindicated inD9)
Dimensions	110mm x 103mm x 103 (mm)(Length $\times$ Width $\times$ Height)	Not public	Different(Discussion isindicated inD10)
Weight	Approximate 280g. (Without battery)	Not public	Different(Discussion isindicated inD11)
Principle ofoperation	Oscillometric Measuring method	Oscillometric Measuring method	Same
User Interface	Cuff, button	Cuff, button	Same
Software	Embedded	Embedded	Same

predicate devices (K241129)

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The discussion of differences exist between the subject and predicate devices is listed in following:

D1: The difference of Cuff Circumference between subject device is that the intended Cuff Circumference range of subject device is 23-33 cm & 33-47cm and predicate device is 22~42cm&32-52cm, the Cuff Circumference range of subject device is in the range of predicate device, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, the results of clinical trial meet the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, therefore, the difference of subject device with predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.
D2: The Memory Size of subject device is different with predicate device predicate device A02-SE4 (K241129) which will not affect the safety and effectiveness.
D3: The difference of Blood Pressure Measurement Range between subject device and predicate device is that the Blood Pressure Indication Range of subject device is DIA: 40 mmHg~~130mmHg & SYS: 60 mmHg~~230mmHg and predicate device is BP Range: 0 ~ 299 mmHg, the Blood Pressure Indication Range of subject device is in the range of predicate device and meets the requirements of IEC 80601-2-30: Edition 2.0 2018-03, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, the results of clinical trial meet the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, therefore, the difference of subject device with predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.
D4: The Measurement Pulse Range of subject device is tiny different with predicate device, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01, therefore, the difference of subject device with predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.
D5: The operating Environment of subject device are different with predicate device A02-SE4 (K24129), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
D6: The Storage Environment of subject device is different with predicate device A02-SE4 (K241129), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI

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ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.

D7: The Energy Source of subject device are different with predicate devices, the difference introduces risks mitigated by the electromagnetic compatibility and electrical safety testing in accordance with IEC 60601-1-2 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
D8: The subject device does not have wireless function which will not affect the safety and effectiveness.
D9: The Material of Patient contact components of subject device has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization though testing against ISO 10993-10 and ISO 10993-23 tested and all test results are positive, the difference of subject device with predicate device A02-SE4 (K241129) do not raise new questions of safety and effectiveness.
D10: The Dimensions of subject device is different with predicate device predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.
D11: The Weight of subject device is tiny different with predicate device A02-SE4 (K241129) will not affect the safety and effectiveness.

8. Discussion of Non-Clinical Tests Performed for Safety and

effectiveness are as follows

The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1-11:2015/2020, IEC 60601-1-2: 2014+AMD1:2020 for electromagnetic compatibility, IEC 80601-2-30: Edition 2.0 2018-03, ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01 for performance, IEC 62304 Edition 1.1 2015-06 for software verification and ISO 10993-5:2009 for Cytotoxicity endpoints, ISO 10993-10:2021 and ISO 10993-23:2021 for Sensitization and Irritation endpoints are complied. See below table for details:

Standards	Standards Name
ANSI AAMI ES60601-1:2005/(R)2012 &A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012(Cons. Text) [Incl. AMD2:2021]	Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And Essential Performance
IEC 60601-1-2: 2014+AMD1:2020	Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance-- Collateral Standard: Electromagnetic Disturbances -Requirements And Tests
IEC 60601-1-11:2015/2020	Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance -Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in the homehealthcare environment
IEC 80601-2-30: Edition 2.0 2018-03	Medical electrical equipment - Part 2-30: Particularrequirements for the basic safety and essential performanceof automated non-invasive sphygmomanometers

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ISO 81060-2 Third edition 2018-11Amendment 1 2020-01	Non-invasive sphygmomanometers - Part 2: Clinicalinvestigation of intermittent automated measurement type
ISO 10993-5:2009	Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity
ISO 10993-10:2021	Biological evaluation of medical devices - Part 10: Tests forskin sensitization
ISO 10993-23:2021	Biological evaluation of medical devices - Part 23: Tests forirritation
IEC 62304 Edition 1.1 2015-06	Medical device software - Software life cycle processes

● Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device BPM-A7VL. The system complies with the AAMI ANSI ES60601-1, IEC 60601-1-11 for electrical safety, the IEC 60601-1-2 standard for EMC, IEC 80601-2-30 and ISO 81060-2 for performance.

● Software Verification and Validation Testing

Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.

Software Description:

The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in Minor Injury, either to a patient or to a user of the device. The software of the system, on the whole, is accountable for the system scheduler of the device, including Pressure and pulse signal acquisition, calculation and display, the button presses of end user, display the result of the measurement data storage and average calculation, memory data query, prompt of error message, low battery voltage detection and prompt, measurement Unit conversion.

9. Discussion of Clinical Accuracy Testing Performed

The clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01.

Subjects requirement	Number specified in ISO 81060-2Third edition 2018-11 Amendment 12020-01	Actual number
Total	A minimum of 85 people	85
Male	At least 26 people	39
Female	At least 26 people	46
Age > 12	100%	100%
Arm circumference range	23-33 cm;At least 18 people	44
	33-47 cm;At least 25 people	41

The clinical accuracy testing evaluated 85 of subjects, division of all subjects:

{11}------------------------------------------------

	23 ≤ x <29 cm	≥ 20%	28	32.94%
	29 ≤ x <35 cm	≥ 20%	20	23.53%
	35 ≤ x < 41 cm	≥ 20%	20	23.53%
	41 ≤ x ≤ 47 cm	≥ 20%	17	20.00%
	44 ≤ x ≤ 47 cm	≥10%	10	11.76%
	23 ≤ x ≤ 26 cm	≥10%	14	16.47%
Systolic BP	Systolic BP ≤ 100mmHg	≥5%	117	17.21%
	Systolic BP ≥ 160mmHg	≥5%	68	10.00%
	Systolic BP ≥140mmHg	≥20%	196	28.82%
Diastolic BP	Diastolic BP ≤ 60mmHg	≥5%	49	7.21%
	Diastolic BP ≥ 100mmHg	≥5%	134	19.71%
	Diastolic BP ≥ 85mmHg	≥20%	303	44.56%

The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01.

Reference equipment used for measurements:

Name	Aneroid sphygmomanometer
Model	CM-BPM-D
Manufacturer	Shanghai Caremate Medical Device Co. Ltd
Measuring Method	Aneroid/auscultation method
K number	K211084

10. Conclusions

The Arm Blood Pressure Monitor, model: BPM-A7VL, have the same intended use and similar characteristics as the cleared predicate device Arm Blood Pressure Monitor, Model: A02-SE4. Moreover, bench testing contained in this submission supplied demonstrate that the differences existed between BPM-A7VL and A02-SE4 do not raise any new questions of safety or effectiveness.

The non-clinical tests support the safety of the device and the hardware verification and validation demonstrate that the Arm Blood Pressure Monitor, model: BPM-A7VL performs as intended in the specified use conditions are same with predicate device. The clinical performance tests demonstrate that the Arm Blood Pressure Monitor, model: BPM-A7VL performs comparably to the predicate device that is currently marketed for the same intended use. Thus, the Arm Blood Pressure Monitor, model: BPM-A7VL is Substantially Equivalent (SE) 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).