Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.

The arm automatic blood pressure monitor BF1112, BF1112, BF1113 and BF1115 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criterion	Reported Device Performance
Accuracy (Blood Pressure)	Pressure: ±3mmHg (±0.4kPa) or 2% of reading (from predicate)	Pressure: ±3mmHg (±0.4kPa)
Accuracy (Pulse Rate)	Pulse Rate: ±5%	Pulse Rate: ±5%
Measurement Range (Pressure)	0mmHg~299mmHg (from predicate)	0mmHg~~280mmHg (0kPa~~37.3kPa)
Measurement Range (Pulse Rate)	40bpm ~ 180bpm	40bpm ~ 180bpm

Study Details

1. Sample size used for the test set and the data provenance:
- Sample Size: The document states that the clinical study was "evaluated according to ANSI/AAMI SP10." However, the exact sample size for the test set is not explicitly mentioned in the provided text. ANSI/AAMI SP10 is a standard for blood pressure measuring devices, and it outlines requirements for clinical validation, including sample sizes (typically a minimum of 85 subjects for accuracy assessment). Without further information, we cannot confirm the precise number of subjects used in this specific study.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the applicant is from Shenzhen, China, and the predicate device manufacturer is Omron Healthcare, Inc.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. For blood pressure monitors, ground truth is typically established by trained observers taking manual auscultatory measurements using a mercury manometer or a validated oscillometric device, but the number and qualifications of such observers are not detailed here.
3. Adjudication method for the test set:
- This information is not provided in the text.
4. 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. This is a blood pressure monitor, not an AI-assisted diagnostic device typically evaluated with MRMC studies comparing human readers. The device is standalone.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The device is an "Arm automatic blood pressure monitor" and operates as a standalone device, providing blood pressure and pulse rate measurements directly. The clinical study evaluated the device's performance against a standard, implying a standalone assessment of its accuracy.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for blood pressure monitor validation, as per ANSI/AAMI SP10, typically involves manual auscultatory measurements performed by trained observers using a reference standard (like a mercury sphygmomanometer). While not explicitly stated as "expert consensus," this method relies on expert human measurement.
7. The sample size for the training set:
- This information is not provided in the text. For traditional medical devices like this, there isn't typically a distinct "training set" in the sense of machine learning algorithms. The device's underlying algorithm is developed and calibrated, and then its performance is validated against a separate test set. The document only mentions "Laboratory testing" for specification validation.
8. How the ground truth for the training set was established:
- As there isn't a "training set" described in the machine learning sense, the method for establishing ground truth for a training set is not applicable here. The device's design and calibration would have been based on established physiological principles and engineering practices, likely involving various test conditions and reference measurements during development, but this is distinct from a machine learning training set.

Summary

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K130325 DEC 2 4 2013

510(k) Summary

1. Applicant

Applicant Name:	SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
Address:	2/F West, M-7 Sinosteel Building, Maqueling Estate,
	Hi-Tech Industrial Park, Nanshan District,
	Shenzhen 518057. China

Contact person:

Name:	Xie Qiongyu
Phone numbers:	86-0755-26710795
Fax numbers:	86-0755-26012025
E-mail:	xieqy@bpump.com.cn
Date Prepared:	2013-1-30

2. Device information

. Trade name: Arm automatic blood pressure monitor
Model No .: BF1110, BF1112, BF1113 and BF1115
. Regulation Description: Noninvasive blood pressure measurement system.
Regulation Number: 21 CFR 870.1130
� Product Code: DXN
. Class: II
. Review Panel: Cardiovascular
Indications for Use: It is intended for measuring adult blood pressure and pulse rate � over-the-counter.

3. Predicate Devices

. Noninvasive blood pressure measurement system
. K-number: K121932
� Product Code: DXN
Intended User � Over the counter
� Patient Population This device is intended for use on adults
Indications for Use:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

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

Manufactured by: e Omron Healthcare, Inc.
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4. Description of the device

5. Testing data and Clinical study

Laboratory testing was conducted to validate and verify that Arm automatic blood pressure monitor met all requirements of related international standards, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of the bellow consensus standards.

Clinical study has been evaluated according to ANSI/AAMI SP10.

Applied Standard:
Electrical Safety and performance requirements:IEC 60601-1
AAMI performance standard ANSI/AAMI SP10
Home-used medical equipment requirements and Environmental test:IEC 60601-1-11
Electromagnetic Compatibility Requirements:EN 60601-1-2
Biocompatibility Evaluation for NIBP CuffISO 10993-1, ISO 10993-5, ISO 10993-10
Clinical Evaluation:ANSI/AAMI SP10

6. Comparison to Predicate Devices

Items	Arm automatic blood pressure monitor	Noninvasive blood pressuremeasurement system
Manufacture	SHENZHEN PUMP MEDICAL: SYSTEM CO.,LTD.	Omron Healthcare, Inc.
ModelSpecification	BF1110 & BF1112	HEM-7200-Z (BP742)
	BF1113 & BF1115
Intended use	It is intended for measuring adult blood pressureand pulse rate.	The device is a digital monitorintended for use in measuringblood pressure and pulse ratein adult patient population.

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			The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal with readings.
Patientpopulation	Adult	Adult
Environmentof use	Home	Home
MeasuringPrinciple	Oscillometric Method	Oscillometric Method
Measurement Range	Pressure: 0mmHg~~280mmHg(0kPa~~37.3kPa)Pulse Rate: 40bpm ~ 180bpm	Pressure: 0mmHg~299mmHgPulse Rate: 40bpm ~180bpm
Accuracy	Pressure:±3mmHg (±0.4kPa)Pulse Rate: ±5%		Pressure: ±3mmHg (±0.4kPa)or 2% of readingPulse Rate:±5%
Display	TN-LCD DigitalDisplay	BF1113: VA-LCD DigitalDisplayBF1115:TN-LCDDigitalDisplay	LCD
Memory	90 sets memory ofmeasurement values	50 sets of measurementvalues (blood pressureand pulse rate) for eachuser (Memory1 andMemory 2)	30 sets of measurementvalues (blood pressure andpulse rate) for each user (Aand B)
PowerSource	4 AA Alkalinebattery or AC Adaptor(AC 100~240 V)	4 AAA Alkaline battery orAC Adaptor (AC 100~240 V )	4 AA batteries or AC Adaptor(AC 100~240 V)
OperatingEnvironment	Temperature: +5°C~+40°C;Humidity: ≤93%RH		Temperature: +10°C~+40°C:Humidity: 30 to 85%RH
Storage andTransportEnvironment	Temperature: -25°C~+70°C;Humidity: 10%~95%		Temperature: -25°C~+60°C:Humidity: 10%~95%
Weight	294g(Without batteries)	270g(Without batteries)	340g (Not Including batteries)
Size	140mm×110mm×70mm		141mm×123mm×85mm

The subject device is Substantially Equivalent (SE) to the predicate device which is US legally market device.

7. Conclusion

As stated above, the Arm automatic blood pressure monitors (Models: BF1110, BF1112, BF1113 and BF1115) are safe and effective, and comply with the appropriate medical device standards. And they are substantially equivalent to the earlier identified predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 24, 2013

Shenzhen Pumo Medical System Co., Ltd. c/o Ms. Ivy Chen, Shenzhen Huatongwei International Inspection Co., Ltd. Keji Nan No. 12 Road, Hi-tech Park Shenzhen. Guangdong CHINA 518057

Re: K130325

Trade/Device Names: Arm Automatic Blood Pressure Monitor, with models BF1110, BF1112, BF1113 and BF1115 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 3, 2013 Received: December 12, 2013

Dear Ms. Chen:

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 - Ms. Ivy Chen

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 (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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known): _K130325

Device Name: Arm automatic blood pressure monitor

Indications for Use:

It is intended for measuring adult blood pressure and pulse rate.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use V (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODIE)

Date:
2013.12.24
09:39:44 -05'00'

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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).