DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES

• K Number: K133619
• Device Name: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
• Manufacturer: GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
• Date Cleared: 2014-03-05 ( 100 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended 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.

Device Description

Digital Automatic Blood Pressure Monitor BPM18 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.

Predicate Devices

K120675

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The testing described is for clinical accuracy against a standard method, not for validating an AI/ML algorithm.

Therapeutic

No.
A therapeutic device is used for treatment. This device is for measurement and monitoring of blood pressure, not for treatment.

Diagnostic

Yes

Explanation: The device measures vital signs (blood pressure and pulse rate), which are used by medical professionals or home users to assess a health condition or to monitor a disease. Therefore, it serves a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "non-invasive blood pressure measurement system" that "utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm". This indicates the device includes hardware components (cuff, pressure sensor, display panel) beyond just software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
• Device Function: The Digital Automatic Blood Pressure Monitor BPM18 Series measures blood pressure and pulse rate by applying a cuff to the upper arm and using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a specimen.

The description clearly states it's a "non-invasive blood pressure measurement system" and that it "detects your blood's movement through your brachial artery and converts the movement into a digital reading." This is a direct physiological measurement, not an in vitro test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes

DXN

Device Description

Digital Automatic Blood Pressure Monitor BPM18 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.

The device's key components are: a pressure sensor, an electric valve and an electronic control module together with an electric pump. The electric pump inflates (and deflates) the inflatable cuff automatically.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper arm

Indicated Patient Age Range

Age 16 or above

Intended User / Care Setting

medical professional or home user

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

One hundred patients (49 males and 51 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 81060-2:2009.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Test Summary: Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2009 as documented in Clinical Test report. One hundred patients (49 males and 51 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 81060-2:2009.

Non-Clinical Test Summary: Digital Automatic Blood Pressure Monitor BPM18 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:

• 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

As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM18 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM18 Series is equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Blood Pressure Measurement Accuracy: ± 3 mmHg or 2% of reading
Pulse Rate Measurement Accuracy: ± 5 % of the reading

Predicate Device(s)

K120675

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

510(k) Summary

MAR 0 5 2014

Submitter Identification 1.

510(k) Submitter	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Address	Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang
District, Shenzhen, Guang Dong, People's Republic of China
Phone Number	[phone]
Fax Number	[phone]
Contact Person	Mr. Patrick Chow
Date of Submission	19th November, 2013

Device Identification 2.

| Trade Name | Digital Automatic Blood Pressure Monitor BPM18 Series
[Model No.: MD18xy]

x --- The first character (0, 1, 2, 3, 4, 5, 6 & 7) 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 EN 60601-1-2.

y --- The second character (0 & 1) is for the identification
of cabinet (housing) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 BPM11 Series
Manufacturer	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Number	K120675

1

4. Device Description

Digital Automatic Blood Pressure Monitor BPM18 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.

The table below illustrate the feature presence in Digital Automatic Blood Pressure Monitor BPM18 Series.

| Model | Blood Pressure
Measurement | Pulse Rate
Measurement | WHO
Classification | Irregular
Heartbeat | LCD Type | Backlight
Illumination | DC
Jack | Memory |
|--------|-------------------------------|---------------------------|-----------------------|------------------------|--------------------------|---------------------------|------------|--------|
| MD1800 | ✓ | ✓ | ✓ | ✓ | Positive
Reflective | x | ✓ | 2120 |
| MD1810 | ✓ | ✓ | ✓ | ✓ | Positive
Transmissive | Blue | ✓ | 2120 |
| MD1820 | ✓ | ✓ | ✓ | ✓ | Positive
Transmissive | Orange | ✓ | 2120 |
| MD1830 | ✓ | ✓ | ✓ | ✓ | Negative
Transmissive | White | ✓ | 2120 |
| MD1840 | ✓ | ✓ | ✓ | ✓ | Positive
Reflective | x | x | 2120 |
| MD1850 | ✓ | ✓ | ✓ | ✓ | Positive
Transmissive | Blue | x | 2120 |
| MD1860 | ✓ | ✓ | ✓ | ✓ | Positive
Transmissive | Orange | x | 2120 |
| MD1870 | ✓ | ✓ | ✓ | ✓ | Negative
Transmissive | White | x | 2120 |
| MD1801 | ✓ | ✓ | ✓ | ✓ | Positive
Reflective | x | ✓ | 2120 |
| MD1811 | ✓ | ✓ | ✓ | ✓ | Positive
Transmissive | Blue | ✓ | 2120 |
| MD1821 | ✓ | ✓ | ✓ | ✓ | Positive
Transmissive | Orange | ✓ | 2120 |
| MD1831 | ✓ | ✓ | ✓ | ✓ | Negative
Transmissive | White | ✓ | 2120 |
| MD1841 | ✓ | ✓ | ✓ | ✓ | Positive
Reflective | x | x | 2120 |
| MD1851 | ✓ | ✓ | ✓ | ✓ | Positive
Transmissive | Blue | x | 2120 |
| MD1861 | ✓ | ✓ | ✓ | ✓ | Positive
Transmissive | Orange | x | 2120 |
| MD1871 | ✓ | ✓ | ✓ | ✓ | Negative
Transmissive | White | x | 2120 |

2

Indication for Use ഗ്

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.

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

Digital Automatic Blood Pressure Monitor BPM18 Series is compared to the predicate device, BPM11 Series (K120675) in the device comparison table below.

Item	Predicate Device	BPM18 Series	Comment
Indication for Use	Digital Automatic Blood Pressure Monitor
BPM11 Series is for use by medical professional or at home. The BPM11 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.	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.	Equivalent
Measurement Method	Non-invasive, Oscillometric	Non-invasive, Oscillometric	Identical
Irregular Heartbeat Detection (IHB)	Yes	Yes	Identical
Patient Population	Age 16 or above	Age 16 or above	Identical
Blood Pressure Measurement Range	Cuff Pressure: 0 - 300 mmHg
Systolic Pressure: 50 - 250 mmHg
Diastolic Pressure: 30 - 200 mmHg	Cuff Pressure: 0 - 300 mmHg
Systolic Pressure: 50 - 250 mmHg
Diastolic Pressure: 30 - 200 mmHg	Identical
Number of User	2 independent users	2 independent users	Identical
Memory Space	2 users x 120 memory space	2 users x 120 memory space	Identical
Blood Pressure Measurement Accuracy	$\pm$ 3 mmHg or 2% of reading	$\pm$ 3 mmHg or 2% of reading	Identical
Pulse Rate Measurement Range	30 - 180 beats/min	30 - 180 beats/min	Identical
Pulse Rate Measurement Accuracy	$\pm$ 5 % of the reading	$\pm$ 5 % of the reading	Identical

3

K133619

510(k) PREMARKET NOTIFICATION

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

Item	Predicate Device	BPM18 Series	Comment
Power Source	4 x 1.5 V AA-batteries; and/or
AC adaptor (6V/600mA)	4 x 1.5 V AAA-batteries; and/or
AC adaptor (6V/600mA)	Identical
Pressurization Mode	Automatic Inflation	Automatic Inflation	Identical
Deflation Mode	Automatic Exhaust/ Deflation	Automatic Exhaust/ Deflation	Identical
Operating
Condition	Temperature: 10 - 40 °C
Humidity: 30 - 85 % R.H. max
Atmospheric Pressure: 700 - 1060 kPa	Temperature: 10 - 40 °C
Humidity: 15 - 85 % R.H. max
Atmospheric Pressure: 700 - 1060 kPa	Equivalent,
improved
specification
Storage and
Transportation
Condition	Temperature: -20 - 60 °C
Humidity: 10 - 95 % R.H. max
Atmospheric Pressure: 700 - 1060 kPa	Temperature: -20 - 60 °C
Humidity: 10 - 95 % R.H. max
Atmospheric Pressure: 700 - 1060 kPa	Identical
Cuff Size (Arm
circumference)	17.0 - 22.0 cm
22.0 - 32.0 cm
32.0 - 44.0 cm	17.0 - 22.0 cm
22.0 - 32.0 cm
32.0 - 44.0 cm	Identical
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
Compatibility
with
Environment
and Other
Devices	No influence with environment and other
device	No influence with environment and other
device	Identical
Applicable
Standard	◇ EN 1060-1:1995/A2:2009
◇ EN 1060-3:1997/A2:2009
◇ IEC 60601-1:2005+
CORR.1(2006)+CORR. 2 (2007)
◇ EN 60601-1-2:2007
◇ FCC Part 15
◇ ISO 10993-5:2009
◇ ISO 10993-10:2002 + A1:2006
◇ EN 60601-1-4:2007
◇ ANSI/AAMI SP-10:2002	◇ 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	Equivalent

Digital Automatic Blood Pressure Monitor BPM18 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, a electric valve and an electronic control module together with 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.

Clinical and Non-clinical Tests 7.

Clinical Test Summary

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2009 as documented in Clinical Test report.

4

5 10(k) PREMARKET NOTIFICATION

One hundred patients (49 males and 51 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 81060-2:2009.

Non-Clinical Test Summary

Digital Automatic Blood Pressure Monitor BPM18 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:

• EN 1060-1:1995+A2:2009 や
• � EN 1060-3:1997+A2:2009
• � IEC 60601-1:2012
• や EN 60601-1-2:2007
• や FCC Part 15 Subpart B
• � ISO 10993-5:2009
• ゃ ISO 10993-10:2010
• ゃ IEC 62304:2006

As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM18 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM18 Series is equivalent to the predicate device.

8. Conclusion

Digital Automatic Blood Pressure Monitor BPM18 Series has the same intended use and similar technological characteristics as the predicate device, Digital Automatic Blood Pressure Monitor BPM11 Series (K120675). 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 BPM18 Series is substantially equivalent to the predicate device.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES. USA

Public Health Service

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

March 5, 2014

Grandway Technology (Shenzhen) Limited Patrick Chow Zhu Keng Industrial Zone Ping Shan, Long Gang District Shenshen, Guang Dong, 518118 CH

Re: KI33619

Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM18 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 12, 2014 Received: November 25, 2013

Dear Patrick 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

6

Page 2 - Patrick Chow

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely your

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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5 10(k) PREMARKET NOTIFICATION

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

Section 5 Indication for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Dato: Dacember 31, 2013 Son PRA Statement on last page.

510(k) Number (if known)

Device Name

Digital Automatic Blood Pressure Monitor BPM18 Series

Indications for Use (Describe)
Digital Autonatic Blood Pressure Meatin IS Series is for use by medical professional or home user. The BPM18 Scries is intended to messure the systelle bloud presure, and pulse rate of an addit individual by ming a non-invasive technique,
in which and is warged annund 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)
Date:	2014.03.05
	16:19:16 -05'00'
	for Bram Zuckerman

FORM FDA 3681 (9/13) Page 1 of 2

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5 10(k) PREMARKET NOTIFICATION

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

This section applies only to roquirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of Information is estimated to average 70 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and revise the collection of information. Send comments regarding this burden estimate or sny other aspect of this Information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff [e-mail]

"An egency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

Form FDA 3881 (8/13)

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Digital Automatic Blood Pressure Monitor BPM18 Series

Section 5-2