This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

Device Description

Digital Automatic Blood Pressure Monitor BPM25 & BPM26 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 of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

AI/ML Overview

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study proving compliance.

Disclaimer: This document is a 510(k) summary for a blood pressure monitor. It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical trial report. Therefore, some of your requested information, particularly regarding advanced aspects like MRMC studies, may not be explicitly detailed or even applicable to this type of device submission.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the blood pressure monitor are primarily based on the accuracy standards outlined in ISO 81060-2:2013 and the inherent accuracy specifications of the device itself.

Acceptance Criteria (from ISO 81060-2:2013 & Device Spec)	Reported Device Performance (from Clinical Test Summary)
Blood Pressure Measurement Accuracy
Mean difference and standard deviation of differences of test device versus reference standard (auscultation) for Systolic BP (SBP) and Diastolic BP (DBP) measurements within acceptable limits defined by ISO 81060-2:2013.	The document states "Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2013 as documented in Clinical Test report." and "no differences in the technological characteristics and questioning on safety or effectiveness to be raised." This implies the device met the ISO 81060-2:2013 statistical accuracy requirements, though specific mean differences or standard deviations are not explicitly stated in this summary. The device's stated accuracy from the comparison table is ± 3 mmHg for Blood Pressure and Pulse Rate: ± 5 % of the reading.
Pulse Rate Measurement Accuracy
Mean difference and standard deviation of differences of test device versus reference standard (auscultation) for pulse rate measurements within acceptable limits defined by ISO 81060-2:2013 (or equivalent).	As above, implied compliance with ISO 81060-2:2013. The device's stated accuracy from the comparison table is ± 5 % of the reading.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a Clinical Test conducted in accordance with ISO 81060-2:2013.

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

Sample Size for Test Set: One hundred (100) patients (54 males and 46 females).
Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be prospective as it involved inviting patients for the study.

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

The ground truth was established using the Standard Auscultation method. The document does not specify the number of expert clinicians (e.g., physicians, nurses) who performed the auscultation measurements. It also does not provide their specific qualifications or years of experience. It simply refers to the "Standard Auscultation method" as the reference.

4. Adjudication Method for the Test Set

The document states: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This suggests a direct comparison method rather than a separate adjudication process. No specific adjudication method like 2+1 or 3+1 for resolving discrepancies is mentioned, likely because the reference standard (auscultation) is considered the definitive ground truth for each measurement.

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 more common for diagnostic imaging devices where human interpretation plays a significant role in assessing diagnostic accuracy. For a blood pressure monitor, the performance is assessed against a physical reference measurement (auscultation), not typically against multiple human readers interpreting data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the described clinical test essentially represents a standalone performance evaluation of the algorithm built into the device. The device takes readings automatically and displays them, and these readings are directly compared to the auscultation reference. There is no human intervention in "interpreting" the device's output to make a diagnosis; the device itself provides the measurement.

7. The Type of Ground Truth Used

The type of ground truth used was expert reference standard (Standard Auscultation method). For blood pressure measurement devices, direct auscultation by a trained professional is the established gold standard for determining actual blood pressure values in a clinical setting.

8. The Sample Size for the Training Set

The document does not specify a separate training set sample size. For medical devices like this blood pressure monitor, particularly those using oscillometric methodology, the core internal algorithms are often developed and validated through extensive engineering, mathematical modeling, and internal testing during the design phase, rather than a "training set" in the machine learning sense. The clinical test described is a validation or test set activity.

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

As no separate training set is explicitly mentioned or detailed in the document, information on how its ground truth was established is not provided. If an internal "training" or development process involved ground truth measurements, these details are not part of this 510(k) summary, which focuses on the final validation study against the predicate device and relevant standards.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three human profiles incorporated into its design.

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

June 11, 2015

Grandway Technology (Shenzhen) Limited Mr. Patrick Chow. General Manager Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, Shenzhen, Guang Dong People's Republic of China

Re: K150373

Trade/Device Name: Digital Automatic Blood Pressure Monitor Bpm25 & Bpm26 Series [model No.: Md25x0/ Md26x0] Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: May 7, 2015 Received: May 11, 2015

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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.

Arnold Stein

for 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 6 Indication for Use Statement (Form FDA 3881)

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name	Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series
Indications for Use (Describe)	This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
Type of Use (Select one or both, as applicable)
	☐ Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)	Page 1 of 1
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Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series

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510(k) Summary

Submitter Identification 1.

510(k) Submitter	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Address	Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long GangDistrict, Shenzhen, Guang Dong, People's Republic of China
Phone Number	(00852)-2851-6789
Fax Number	(00852)-2851-6278
Contact Person	Mr. Patrick Chow
Date of Submission	12th February, 2015

2. Device Identification

Trade Name	Digital Automatic Blood Pressure Monitor BPM25 &
	BPM26 Series [Model No.: MD25x0/ MD26x0]

	x --- The first character (0, 1, 2, 3, 4, 5, 6, 7, 8, 9, A & B) is
	for the minor change revision of device. The mentioned
	"minor change" refers to those device changes not to be
	affecting the conformity test results of EMC & safety as well
	as device performance, i.e. IEC 60601-1 and IEC 60601-1-
	2.
Common Name	Non-invasive Blood Pressure Measurement System
Classification Name	Non-invasive Blood Pressure Measurement System
	(CFR 870.1130, Class II, Product Code DXN)

3. Predicate Device

Predicate Device	Digital Automatic Blood Pressure Monitor BPM18 Series
Manufacturer	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Number	K133619

Device Description 4.

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510(k) PREMARKET NOTIFICATION

measurement and then display the readings on a digital panel.

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

The table below illustrate the feature presence in Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series.

Model	BPMeasurement	Pulse RateMeasurement	WHO	IHB	LCD Type	Backlight	DCJack	VoiceFunction	Memory
MD2500	✓	✓	✓	✓	+ve Reflective	X	X	Buzzer	2 × 120
MD2510	✓	✓	✓	✓	+ve Reflective	X	✓	Voice	2 × 120
MD2520	✓	✓	✓	✓	+ve Reflective	X	✓	Buzzer	2 × 120
MD2530	✓	✓	✓	✓	+ve Reflective	X	X	Voice	2 × 120
MD2540	✓	✓	✓	✓	-ve Transmissive	✓	✓	Buzzer	2 × 120
MD2550	✓	✓	✓	✓	+ve Transmissive	✓	X	Buzzer	2 × 120
MD2560	✓	✓	✓	✓	-ve Transmissive	✓	✓	Voice	2 × 120
MD2570	✓	✓	✓	✓	-ve Transmissive	✓	X	Voice	2 × 120
MD2580	✓	✓	✓	✓	+ve Transmissive	✓	✓	Buzzer	2 × 120
MD2590	✓	✓	✓	✓	+ve Transmissive	✓	X	Buzzer	2 × 120
MD25A0	✓	✓	✓	✓	+ve Transmissive	✓	✓	Voice	2 × 120
MD25B0	✓	✓	✓	✓	+ve Transmissive	✓	X	Voice	2 × 120
MD2600	✓	✓	✓	✓	+ve Reflective	X	X	Buzzer	2 × 120
MD2610	✓	✓	✓	✓	+ve Reflective	X	✓	Voice	2 × 120
MD2620	✓	✓	✓	✓	+ve Reflective	X	✓	Buzzer	2 × 120
MD2630	✓	✓	✓	✓	+ve Reflective	X	X	Voice	2 × 120
MD2640	✓	✓	✓	✓	-ve Transmissive	✓	✓	Buzzer	2 × 120
MD2650	✓	✓	✓	✓	+ve Transmissive	✓	X	Buzzer	2 × 120
MD2660	✓	✓	✓	✓	-ve Transmissive	✓	✓	Voice	2 × 120
MD2670	✓	✓	✓	✓	-ve Transmissive	✓	X	Voice	2 × 120
MD2680	✓	✓	✓	✓	+ve Transmissive	✓	✓	Buzzer	2 × 120
MD2690	✓	✓	✓	✓	+ve Transmissive	✓	X	Buzzer	2 × 120
MD26A0	✓	✓	✓	✓	+ve Transmissive	✓	✓	Voice	2 × 120
MD26B0	✓	✓	✓	✓	+ve Transmissive	✓	X	Voice	2 × 120

5. Indication for Use

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Comparison of Technological Characteristics between New Device and 6. Predicate Devices

Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is compared to the predicate device, BPM18 Series (K133619) in the device comparison table below.

Item	Predicate Device (K133619)	Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series	Comment
Indication for Use	Digital Automatic Blood Pressure Monitor BPM18 Series is for use by medical professional or home user. The BPM18 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.	This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.	Equivalent
Measurement Method	Non-invasive, Oscillometric	Non-invasive, Oscillometric	Identical
IHB Detection	Yes	Yes	Identical
Patient Population	Adult	Adult	Identical
BP Measurement Range	Cuff Pressure: 0 - 300 mmHgSystolic Pressure: 50 - 250 mmHgDiastolic Pressure: 30 - 200 mmHg	Cuff Pressure: 0 - 300 mmHgSystolic Pressure: 50 - 250 mmHgDiastolic Pressure: 30 - 200 mmHg	Identical
Number of User	2 independent users	2 independent users	Identical
Memory Space	2 users × 120 memory space	2 users × 120 memory space	Identical
Resolution of Measurement	Blood Pressure: 1 mmHg or 0.1kPaPulse Rate: 1 beat/ min	Blood Pressure: 1 mmHg or 0.1 kPaPulse Rate: 1 beat/ min	Identical
Blood Pressure Measurement Accuracy	± 3 mmHg or 2% of reading	± 3 mmHg	Equivalent
Pulse Rate Measurement Range	40 - 180 beats/min	40 - 180 beats/min	Identical
Pulse Rate Measurement Accuracy	± 5 % of the reading	± 5 % of the reading	Identical
Display Type	LCD	LCD	Identical
Power Source	4 × 1.5 V AAA-batteries; and/or AC adaptor (6V/600mA)	4 × 1.5V AA batteries and/or 6V AC adaptor	Equivalent
Pressurization Mode	Automatic Inflation	Automatic Inflation	Identical
Deflation Mode	Automatic Exhaust/ Deflation	Automatic Exhaust/ Deflation	Identical
Operating Condition	Temperature: 10 - 40 °CHumidity: 30 - 85 % R.H. maxAtmospheric Pressure: 700 – 1060hPa	Temperature: +5 to +40 °CHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700 – 1060hPa	Equivalent
Storage and Transportation Condition	Temperature: -20 - 60 °CHumidity: 10 - 95 % R.H. maxAtmospheric Pressure: 700 – 1060hPa	Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700 – 1060hPa	Equivalent
Comparison between Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series and Predicate device
Item	Predicate Device (K133619)	Digital Automatic Blood PressureMonitor BPM25 & BPM26 Series	Comment
Material	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging	Identical
CompatibilitywithEnvironmentand OtherDevices	No influence with environment and other device	No influence with environment and other device	Identical
ApplicableStandard	- EN 1060-1:1995+A2:2009- EN 1060-3:1997+A2:2009- IEC 60601-1:2012- EN 60601-1-2:2007- FCC Part 15 Subpart B- ISO 10993-5:2009- ISO 10993-10:2010- IEC 62304:2006- IEC 81060-2:2009	- EN 1060-1:1995+A2:2009- EN 1060-3:1997+A2:2009- IEC 60601-1:2012- EN 60601-1-2:2007- FCC Part 15 Subpart B- ISO 10993-5:2009- ISO 10993-10:2010- IEC 62304:2006- IEC 81060-2:2013	Equivalent

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Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is a non-invasive measuring device and utilizes the oscillometric methodology to measure the blood pressure reading. The key components of device are: a pressure sensor, an electric valve, an electronic control module, and an electric pump. The electric pump inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The predicate device adopts exactly same methodology and key components for measuring blood pressure.

7. Clinical and Non-clinical Tests

Clinical Test Summary

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2013 as documented in Clinical Test report.

One hundred patients (54 males and 46 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left upper arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013.

Non-Clinical Test Summary

Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met.

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The tests includes the follows:

510(k) PREMARKET NOTIFICATION

や EN 1060-3:1997+A2:2009
IEC 60601-1:2012 や
IEC 60601-1-2:2007 や
FCC Part 15 Subpart B <> ISO 10993-5:2009 >> ISO 10993-10:2010 <> IEC 62304:2006 <>
As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is equivalent to the predicate device.

8. Conclusion

Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series has the similar intended use and same technological characteristics as the predicate device, Digital Automatic Blood Pressure Monitor BPM18 Series (K133619). Moreover clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is substantially equivalent 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).