K Number

Device Name

DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES

Manufacturer

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

Date Cleared

2013-12-16

(151 days)

Product Code

DXN

Regulation Number

870.1130

Intended Use

Digital Automatic Blood Pressure Monitor BPM06 Series is for use by medical professional or at home. The BPM06 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.

Device Description

Digital Automatic Blood Pressure Monitor BPM06 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 display the readings on a digital panel. The BPM06 Series 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 Digital Automatic Blood Pressure Monitor BPM06 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K120675

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components. The performance studies are based on clinical testing against a reference method, not on training or validating an AI/ML model.

Therapeutic

No.
This device is a diagnostic device that measures blood pressure and pulse rate, it does not provide therapy or treatment.

Diagnostic

Yes
The device is described as "intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate)" and "display the readings on a digital panel." While it doesn't offer a diagnosis itself, the act of measuring and displaying physiological parameters for medical professionals or home use is a function of a diagnostic device, as it provides data that can be used for diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a pressure sensor, electric valve, electronic control module, and electric pump, which are integral to its function.

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).
This device's function: The Digital Automatic Blood Pressure Monitor BPM06 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 performed on the body.

The description clearly states it's a "non-invasive blood pressure measurement system" and that it measures blood pressure by wrapping a cuff around the upper arm. This is a direct measurement on the individual, not an analysis of a sample taken from the individual.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DXN

Device Description

The BPM06 Series 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 Digital Automatic Blood Pressure Monitor BPM06 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

1 - 2 cm above joint

Indicated Patient Age Range

Age 16 or above

Intended User / Care Setting

medical professional or at home

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

Clinical Test Summary:
One hundred patients (45 males and 55 females) were recruited 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 ANSI/A AMI/IEC 81060-2.

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 ANSVAAMI/EC 81060-2 as documented in Clinical Test report.
One hundred patients (45 males and 55 females) were recruited 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 ANSI/A AMI/IEC 81060-2.

Non-Clinical Testing Summary:
Bench tests were performed and found that BPM06 Series met all requirement specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:

ISO10993-5:2009
ISO10993-10:2010
EN1060-1:1995/A1:2002
EN1060-3:1997+A2:2009
IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007)
EN60601-1-2:2007
FCC Part 15 Subpart B
EN60601-1-4:1996

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

K132240 Page 1 of 4

Section IV: 510k Summary

DEC 1 6 2013

Applicant	Grandway Technology (Shenzhen) Limited
Address	Block 6 & 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District,
	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 Application	16th July, 2013

Applicant's Identification

Device's Identification

| Trade Name | Digital Automatic Blood Pressure Monitor BPM06 Series
Model No.: MD06x0 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | x --- The first character (0, 1, 3, 5 & 6) 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 |
| Common Name | Non-invasive Blood Pressure Measurement System |
| Classification Name | Non-invasive Blood Pressure Measurement System
(Class II per 21 CFR 870.1130) |

Marketed Devices to which Equivalence is Claimed (Predicate Device)

Manufacturer	Grandway Technology (Shenzhen) Limited
Device	Digital Automatic Blood Pressure Monitor BPM11 Series
(Model No.: MD11xy)
510(k) Number	K120675

Device Description

Intended Use (Indication for Use)

Comparison of Technological Characteristics between New Device and Predicate Devices

Comparison between BPM06 Series and predicate device
Item	Predicate Device	BPM06 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
BPM06 Series is for use by medical
professional or at home. The BPM06
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.	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 × 120 memory space	2 users × 120 memory space	Identical
Button (Key)
Type	Button Type only	Clock button: Button Type
User selection button: Sensor Type	Equivalent,
same function
Blood Pressure
Measurement
Accuracy	± 3 mmHg or 2% of reading	± 3 mmHg or 2% of reading	Identical
Pulse Rate
Measurement
Range	30 - 180 beats/min	30 - 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 AA-batteries; and/or
AC adaptor (6V/600mA)	4 × 1.5 V AA-batteries; and/or
AC adaptor (6V/600mA)	Identical
Comparison between BPM06 Series and predicate device
Item	Predicate Device	BPM06 Series	Comment
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
Anatomical
Sites	1 - 2 cm above joint	1 - 2 cm above joint	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	◇ ISO 10993-5:2009
◇ ISO 10993-10:2010
◇ EN 1060-1:1997+A2:2009
◇ EN 1060-3:1997+A2:2009
◇ IEC 60601-1:2012
◇ EN 60601-1-2:2007
◇ EN 60601-1-4:1996
◇ IEC 62304:2006
◇ FCC Part 15 Subpart B
◇ ISO 81060-2:2009
◇ IEC 80601-2-30:2009	Equivalent,
change of
FDA
recognized
standard

Clinical and Non-Clinical Test Summary

Clinical Test Summary

Testing to insure clinical accuracy of the device in accordance with ANSVAAMI/EC 81060-2 as documented in Clinical Test report.

One hundred patients (45 males and 55 females) were recruited 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 ANSI/A AMI/IEC 81060-2.

Non-Clinical Testing Summary

We have performed bench tests and found that BPM06 Series met all requirement specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:

ISO10993-5:2009
A ISO10993-10:2010
ア EN1060-1:1995/A1:2002
V EN1060-3:1997+A2:2009
V IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007)
A EN60601-1-2:2007
ア FCC Part 15 Subpart B
V EN60601-1-4:1996

Conclusion

Digital Automatic Blood Pressure Monitor BPM06 Series has the same intended use and similar technological characteristics as the predicate device, BPM11 Series (K120675). Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, the Digital Automatic Blood Pressure Monitor BPM06 Series is substantially equivalent to the predicate device, BPM11 Series (K120675).

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, superimposed over three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.

Public Health Service

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

December 16, 2013

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

Re: K132240

Trade/Device Name: Digital automatic blood pressure monitor bpm06 series Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 8, 2013 Received: July 30, 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 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.

Page 2 - Patrick Chow

1998 - 1991 - 1991 - 1991

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollnumber (800) 638-2041 or (301) 796-7100 or or at its Internet address free 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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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

Additional Information - K ! 32240

് സംഭവങ്ങളുടെ പ

| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page. |

------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------

510(k) Number (if known)
K132240

text

Device Name

Digital Automatic Blood Pressure Monitor BPM06 Series

Indications for Use (Describe)

Digital Automatic Blood Pressure Manitor BPM06 Series is for wo by wedical professional or at hama. The BPM06 Series is intended to measure the systellic blood pressure, and pubersto (branthest rate) of an individual by uning a non-invasive technique, in which an inflatable ouff is wrapped around the upper arm of an individual.

Type of Use (Select one or both, as applicable)
	Over-The-Counter Use (21 CFR 601 Subpart C)
	Prescription Use (Part 21 CFR 601 Subpart D)

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)	Digitally signed by Owen P. Faris -S Date: 2013.12.16 16:12:50 -05'00'
------------------------------------------------------------------------------	------------------------------------------------------------------------

FORM FDA 3881 (9/13)	Page 1 of 2
----------------------	-------------