Belter Blood pressure meter is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Description

The Belter Blood pressure meter 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 with arm circumference ranging from 22 cm to 36cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa.

The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve and LCD. The subject device is powered by four AA alkaline batteries.

The device has a memory function that automatically stores up to 60 sets of the latest measurements. It can also display the latest measurement result.

The subject device embeds a Bluetooth that allows it to transport the measurement data to nearby receiving end.

The device also detects the appearance of irregular heartbeats during measurement. and gives a warning signal with readings.

AI/ML Overview

The "Belter Blood pressure meter, Model: ePA-46B" is intended to measure systolic and diastolic blood pressure and pulse rate in adults, for use in medical facilities or at home, and to detect irregular heartbeats. The study demonstrating its performance and meeting acceptance criteria is based on conformance to regulatory and performance standards.

Here's the breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Belter Blood pressure meter are defined by the conformance to various international standards, including ANSI/AAMI SP10 for automated sphygmomanometers. The reported device performance metrics are directly against the stated accuracy requirements within these standards.

Acceptance Criteria (from ANSI/AAMI SP10, and general accuracy for BP meters)	Reported Device Performance (Belter Blood pressure meter)
Pressure Accuracy: ±3 mmHg or 2% of reading (from predicate, similar to standard expectations)	Pressure Accuracy: ±3 mmHg (±0.4 kPa)
Pulse Rate Accuracy: ±5%	Pulse Rate Accuracy: ±5%
Measurement Range - Pressure: 0-299 mmHg (from predicate, similar to standard expectations)	Measurement Range - Pressure: 0-280 mmHg
Measurement Range - Pulse Rate: 40-180 bpm (from predicate, similar to standard expectations)	Measurement Range - Pulse Rate: 40-200 bpm
Cuff Size: (Predicate: 22-46cm)	Cuff Size: 22-36 cm
Conformance Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI SP10, ISO 10993-5, -10	Conforms to: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI SP10, ISO 10993-5, -10, IEC60601-1-11, ISO 10993-1, ISO 10993-10, EN1060-1, EN1060-3, EN1060-4

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

The document states that the ANSI/AAMI SP10 standard (Manual, electronic, or automated sphygmomanometers, 2002/A1:2003) was followed. The EN1060-4 standard (Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated Non-invasive sphygmomanometers, 2004) was also followed.

These standards typically specify subject recruitment criteria and sample sizes for clinical validation studies (e.g., minimum of 85 subjects with specific blood pressure ranges for AAMI SP10). However, the specific sample size used for the test set for the Belter device is not explicitly stated in the provided document. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated.

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

Since the study appears to be a clinical validation against established reference methods (auditory auscultation by trained observers often used in these standards), the "ground truth" would be established by these trained observers. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in this document. Standard practice for AAMI SP10 typically involves two or three trained observers whose measurements are averaged or adjudicated.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used. However, given the reliance on standards like ANSI/AAMI SP10 and EN1060-4, these standards typically outline methods for comparing automated device readings to reference measurements (e.g., using two or three trained observers whose readings are within a specified tolerance, and if not, a third observer or an adjudication process is used). The document does not specify a "2+1, 3+1, none" adjudication method, but the adherence to the standards implies a structured approach for ground truth determination.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging diagnostics or other AI-assisted detection tasks where human readers interpret data, and the AI's impact on their performance is measured. For a blood pressure monitor, the performance is assessed against a standard reference method, not by comparing human interpretation with and without AI assistance on complex cases.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The performance data presented and the conformance to standards like ANSI/AAMI SP10 and EN1060-4 refer to the device's accuracy in autonomously measuring blood pressure and pulse rate, without human intervention in the measurement process itself. The device is purely algorithmic in its core function of calculating BP from oscillometric data.

7. The Type of Ground Truth Used

The ground truth used for validating blood pressure monitors against standards like ANSI/AAMI SP10 and EN1060-4 is typically reference measurements obtained by trained observers using a calibrated auscultatory method (e.g., a mercury sphygmomanometer). This is considered the clinical 'gold standard' for non-invasive blood pressure measurement against which automated devices are compared. It's effectively an "expert consensus" or "expert reference" type of ground truth in a clinical setting.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" for the device. Automated blood pressure monitors like the Belter device are typically developed and calibrated based on established oscillometric algorithms and physical principles, rather than being "trained" on a dataset in the way a machine learning model would be. Calibration and internal testing would be part of the development process, but this is distinct from a machine learning training set.

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

As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth would have been established. The device operates based on a pre-defined algorithm derived from established physiological principles of oscillometry and is then validated clinically.

Summary

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510(K) Summary

JUL 2 5 2014 K134029

Date: December 12, 2013

Section 5

Submitter Information

Name: Shenzhen Belter Health Measurement and Analysis Technology Co.,ltd Address: 702,704, block C ,Tsinghua Unis science park,No.13 Langshan Rd,Hi-Tech Industrial park(north),Nanshan District,518057 shenzhen,People's Republic of China Tel: 0755-61869839 Fax: 0755-61869122 Contact person: pang ming E-mail: pangm@ebelter.com

Name of device

Trade name: Belter Blood pressure meter ,Model: ePA-46B Common name: Belter Blood pressure meter Classification name: System, Measurement, Blood Pressure, Noninvasive Production regulation: 21CFR 870.1130 Product code: DXN

Predicate Device

HEM-7200-Z (BP742)( Omron Healthcare Inc.,DXN,K121932)

Description

The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve and LCD. The subject device is powered by four AA alkaline batteries.

The device has a memory function that automatically stores up to 60 sets of the latest measurements. It can also display the latest measurement result.

The subject device embeds a Bluetooth that allows it to transport the measurement data to nearby receiving end.

The device also detects the appearance of irregular heartbeats during measurement. and gives a warning signal with readings.

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Intended use

Belter Blood pressure meter is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Substantially Equivalent

The Belter Blood pressure meter (ePA-46B) has the similar essential performance and the same Operation Principle as the predicated devices.

	Belter	Omron
Compared	ePA-46B	HEM-7200-Z (BP742)(K121932)
item
Indicationsfor Use	Belter Blood pressuremeter is intended tomeasure the systolic anddiastolic blood pressure aswell as the pulse rate ofadult person. It can beused at medical facilities orat home.The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal withreadings.	The device is a digitalmonitor intended for use inmeasuring blood pressureand pulse rate in adultpatient population.The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal withreadings.	Similar
Intendedpatient	Adult	Adult	Same
Environment of use	medical facilities or home	Home	Similar
OperationPrinciple	Oscillometric	Oscillometric	Same
Measurement Range	Pressure: 0-280mmHgPulse Rate: 40-200 bpm	Pressure: 0-299mmHgPulse Rate: 40 -180bpm	Similar
Accuracy	Pressure : ±3mmHg(±0.4kPa)Pulse Rate: ±5%	Pressure: ±3mmHg(±0.4kPa) or 2%of readingPulse Rate: ±5%	Similar
Displayscreen	LCD	LCD	Same
ScaleSelection	mmHg/Pka	mmHg/Pka	Same
Cuff	22-36 cm	22-46cm	Similar
Memory	60sets	30sets	Similar
Powersupply	4 AA batteries	4 AA batteries or ACAdaptor (AC 100-240 V)	Similar
OperatingEnvironment	Temperature : +10°C ~+40°C ; Humidity : 30 ~85%RH	Temperature : +10°C ~+40°C; Humidity : 30 to85%RH	Similar
StorageEnvironment	Temperature : -20 °C ~+50°C;Humidity: 20%~95%	Temperature : -25 °C ~+60°C;Humidity: 10%~95%	Similar
Weight	196g	340g(Not Includingbatteries)	Similar
Size	74mm×152mm×33mm	141mm×123mm×85mm	Similar
Conformance standard	IEC 60601-1, IEC60601-1-2, ANSI/AAMISP10, ISO 10993-5,-10	IEC 60601-1, IEC60601-1-2, ANSI/AAMISP10, ISO 10993-5,-10	Same

Table 1

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Performance Data

The following practices were followed and monitored for development of the Belter Blood pressure meter:

IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for . Safety, 1988+A1:1991+A2:1995
. IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests. 2007
ANSI/AAMISP10 Manual, electronic, or automated sphygmomanometers, . 2002/A1:2003
Medical electrical equipment --Part 1-11: . IEC60601-1-11 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,2010
. ISO 10993-1, Biological evaluation of medical devices-Part 1: Evaluation and testing, 2009
. ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
. ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
. EN1060-1:A1:1995+A2:2009 Non-invasive sphygmomanometers -Part 1: General requirements,2010
. EN1060-3 ,Non-invasive sphygmomanometers -Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems,2005
. EN1060-4 Non-invasive sphygmomanometers - Part 4:Test procedures to determine the overall system accuracy of automated Non-invasive

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sphygmomanometers,2004

Conclusion

The Belter Blood pressure meter (ePA-46B) is substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 25, 2014

ShenZhen Belter Health Measurement and Analysis Technology Co., Ltd Mr. Pang Ming, RA Manager 702,704, block C, Tsinghua Unis Science Park, No. 13 Langshan Rd, Hi-tech industrial park (north), Nanshan District, Shenzhen, Guangdong 518057 People's Republic of China

Re: K134029

Trade/Device Names: Belter Blood Pressure Meter, Model ePA-46B Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: June 17, 2014 Received: June 20, 2014

Dear Mr. Pang:

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. 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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Page 2 - Mr. Pang Ming

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Enclosure

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Section 4 Indications for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Belter Blood pressure meter

Model: ePA-46B

Indications for Use

Belter Blood pressure meter is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Sub part D)

Over-The-Counter Use __ X _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Page 1 of __ 1___

Bram Zuckerman

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).