Digital Automatic Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm – 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.

Device Description

Digital Automatic Blood Pressure Monitor BPM03 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual in each measurement and then displays the readings on a digital panel.

The BPM03 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for the blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movements into a digital reading.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Digital Automatic Blood Pressure Monitor BPM03 Series, based on the provided text:

Acceptance Criteria and Device Performance Study

The submission states that the Digital Automatic Blood Pressure Monitor BPM03 Series meets the requirements of ANSI/AAMI SP-10-2002. This standard defines the performance, accuracy, and clinical validation requirements for automated sphygmomanometers. While the document doesn't explicitly list specific numerical acceptance criteria (e.g., mean difference and standard deviation for blood pressure readings), compliance with ANSI/AAMI SP-10-2002 implies adherence to its specified limits for accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ANSI/AAMI SP-10-2002)	Reported Device Performance
Blood Pressure Accuracy:
Mean difference (device vs. reference) <= +/- 5 mmHg	The device "meets the requirement of ANSI/AAMI SP-10-2002." This implies that the mean difference is within +/- 5 mmHg for both systolic and diastolic blood pressure.
Standard deviation of differences <= 8 mmHg	The device "meets the requirement of ANSI/AAMI SP-10-2002." This implies that the standard deviation of differences is within 8 mmHg for both systolic and diastolic blood pressure.
Pulse Rate Accuracy:
Not explicitly detailed in the provided document, but typically covered by the standard.	The device measures and displays pulse rate, and its compliance with ANSI/AAMI SP-10-2002 suggests its accuracy meets the standard's requirements for pulse rate.

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

Sample Size for Test Set: Not explicitly stated in the provided text.
Data Provenance: Not explicitly stated. The document mentions "A systematic & independent clinical test was conducted," but does not specify the country of origin or whether it was retrospective or prospective.

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

Number of Experts: Not explicitly stated in the provided text.
Qualifications of Experts: Not explicitly stated. For a clinical validation study adhering to ANSI/AAMI SP-10-2002, the ground truth (reference blood pressure measurements) would typically be established by two or more trained observers (experts) using a mercury sphygmomanometer or an equivalent reference device, following a standardized protocol. These observers would be trained and certified in blood pressure measurement techniques.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. In clinical validation studies for blood pressure monitors, if multiple observers are used, their readings are usually averaged or adjudicated if there are discrepancies beyond a certain threshold.

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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a standalone blood pressure monitor and does not involve AI assistance for human readers in interpreting results.

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

Standalone Performance Study: Yes, a standalone performance study was conducted. The "systematic & independent clinical test" was performed to validate the performance of the Digital Automatic Blood Pressure Monitor BPM03 Series, which operates as an algorithm-only device (oscillometric method) to determine blood pressure and pulse rate without human oversight or interpretation of results beyond reading the displayed values.

7. The Type of Ground Truth Used

Type of Ground Truth: Although not explicitly stated as "ground truth," the clinical test was conducted to validate the device's performance against the requirements of ANSI/AAMI SP-10-2002. This standard mandates validation against simultaneous auscultatory blood pressure measurements performed by trained observers using a reference device (e.g., mercury sphygmomanometer). Therefore, the ground truth would have been established by expert auscultatory measurements.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The document describes a "clinical test" for validation, not a study involving machine learning model training. The device uses an oscillometric methodology, which is a well-established algorithm for blood pressure measurement rather than a machine learning model that requires a training set.

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

Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning algorithm. The oscillometric algorithm itself is based on pneumatic and physiological principles.

Summary

{0}------------------------------------------------

K123073 Page 1 of 3

Section IV: 510k Summary

MAR 1 ,1 2013

Applicant's Identification
Applicant	Grandway Technology (Shenzhen) Limited
Phone Number	(00852)-2851-6789
Fax Number	(00852)-2851-6278
Contact Person	Mr. Patrick Chow
Date of Application	21st September 2012

Device's Identification

Device Proprietary Name

Digital Automatic Blood Pressure Monitor BPM03 Series

Model No.: MD03x0

x --- The first character (0, 1, 2, 3, 4, 5 or 6) is for the minor change revision of device. The mentioned "minor change" refers to those device changes not to be affected the conformity test results of EMC & safety as well as device performance, i.e. IEC 60601-1 and EN 60601-1-2.

Common Name Classification Name Non-invasive Blood Pressure Measurement System Non-invasive Blood Pressure Measurement System (Class Il per 21 CFR 870.1130)

Marketed Devices to which Equivalence is Claimed

DEVICE	MANUFACTURER	510(k) Number
AVITA BPM6 Series Blood Pressure Meter(or Monitor)	AViTA Corp	K033397

Device Description

-**

{1}------------------------------------------------

Intended Use (Indication for Use)

Digital Automatic Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm - 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.

Comparison of Technological Characteristics between New Device and Predicate Devices

The Digital Automatic Blood Pressure Monitor BPM03 Series is a non-invasive measuring device and utilizes the oscilliometric methodology to measure the blood pressure reading. The key components of device are a pressure sensor, electric valve and an electronic control module together with an electric pump, which inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The predicate device adopts exactly same methodology and key components for measuring the blood pressure reading.

Clinical & Non-clinical Tests

A systematic & independent clinical test was conducted to validate the performance of the Digital Automatic Blood Pressure Monitor BPM03 Series. The results demonstrated that BPM03 Series meets the requirement of ANSI/AAMI SP-10-2002.

Comprehensive safety and EMC tests were performed and compiled to demonstrate BPM03 Series is safe for use. Tests include

EN1060-1:1995/A1:2002 EN1060-3:1997/A1:2005 IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) EN60601-1-2:2007 FCC Part 15 ISO10993-5:2009 ISO10993-10:2010 EN60601-1-4:2007

Conclusion

Digital Automatic Blood Pressure Monitor BPM03 Series has the same intended use and similar technological characteristics as predicate device (K033397). Moreover, bench testing contained in this submission and clinical testing supplied demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness

ייר

{2}------------------------------------------------

and the control control of the control of the control of

to be raised. Thus, the Digital Automatic Blood Pressure Monitor BPM03 Series is substantially equivalent to the predicate device.

. .

a de la marka de la personal de la provinsi de la provinsi de la provinsi de la provinsi de la vista visi se se se se se se se se se se se se se se se se se se se se se se s : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

: :

్- గ్రా

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design. The symbol consists of a staff with a serpent entwined around it, representing healing and medicine.

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

March 11, 2013

Grandway Technology (Shenzhen) Limited c/o Mr. Patrick Chow Building 6 and 7, Zhu Keng Industrial Zone Ping Shan, Long Gang District, Shenzhen CHINA 518118

Re: K123073

Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM03 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 17, 2013 Received: February 8, 2013

Dear Mr. Chow:

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.

{4}------------------------------------------------

Page 2 - Mr. Patrick Chow,

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

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

Enclosure

{5}------------------------------------------------

Section V: Statement of Indications for Use

K123073 510(k) Number (if known):

Device Name:

Digital Automatic Blood Pressure Monitor BPM03 Series

Model No.: MD03x0

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR . .

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

Arab

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.03.11
11:03:52 -04'00'

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).