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.

AI/ML Overview

The provided text describes the acceptance criteria and a clinical study conducted to demonstrate the substantial equivalence of the "Digital Automatic Blood Pressure Monitor BPM06 Series" to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Predicate Device Performance	BPM06 Series Performance	Result (Compared to Predicate)
Intended Use	Same	Same	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: 0-300 mmHg, Sys: 50-250 mmHg, Dia: 30-200 mmHg	Cuff: 0-300 mmHg, Sys: 50-250 mmHg, Dia: 30-200 mmHg	Identical
Number of Users	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	4x 1.5V AA-batteries; and/or AC adaptor (6V/600mA)	4x 1.5V AA-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	Temp: 10-40 °C, Hum: 30-85% R.H. max, Atm: 700-1060 kPa	Temp: 10-40 °C, Hum: 15-85% R.H. max, Atm: 700-1060 kPa	Equivalent (improved specification)
Storage and Transportation Condition	Temp: -20-60 °C, Hum: 10-95% R.H. max, Atm: 700-1060 kPa	Temp: -20-60 °C, Hum: 10-95% R.H. max, Atm: 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	No influence	Identical
Applicable Standard	Various (EN 1060-1, EN 1060-3, IEC 60601-1, etc.)	Various (ISO 10993-5, ISO 10993-10, EN 1060-1, etc.)	Equivalent (change of FDA recognized standard)

Note: The acceptance criteria for accuracy are implicitly defined by claiming "Identical" performance to the predicate device, which itself states "± 3 mmHg or 2% of reading" for blood pressure and "± 5 % of the reading" for pulse rate.

Study Proving Device Meets Acceptance Criteria

The document describes a clinical test summary to ensure clinical accuracy.

2. Sample Size and Data Provenance for Test Set

Sample Size: One hundred patients (45 males and 55 females).
Data Provenance: The document does not explicitly state the country of origin, but the applicant's address is listed in Shenzhen, Guangdong, People's Republic of China. The study appears to be prospective as patients were "recruited for the study."

3. Number of Experts and Qualifications for Ground Truth

The study used the standard auscultation method as the reference blood pressure monitor. While it's a technical method for establishing ground truth, the document does not specify the number of human experts (e.g., clinicians) or their qualifications involved in performing the auscultation measurements. It only mentions "medical professional" in the intended use.

4. Adjudication Method for Test Set

The document states that 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." This implies a direct comparison method rather than an adjudication method involving multiple experts to reconcile discrepancies. There is no explicit mention of an adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The comparison is between the device and a gold-standard measurement method (auscultation), not between human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire clinical test described is essentially a standalone performance study for the device (algorithm only, as there is no human-in-the-loop directly interpreting the device's output to make a diagnosis beyond reading the displayed numbers). The device's measurements were directly compared against the auscultation method.

7. Type of Ground Truth Used

The ground truth used was established by the standard auscultation method, which is a widely accepted clinical reference standard for blood pressure measurement. It's a form of expert-performed reference measurement.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This is expected as the BPM06 Series appears to be based on an established oscillometric methodology, similar to its predicate. The focus of the 510(k) submission is typically on validating the performance of the final device, not on the details of its internal algorithm development or training, unless it involves novel machine learning components.

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

Since no training set is explicitly mentioned, the method for establishing its ground truth is also not specified. The device likely uses algorithms and parameters that have been developed and validated over time for oscillometric blood pressure measurement.

Summary

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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 SeriesModel No.: MD06x0
	x --- The first character (0, 1, 3, 5 & 6) is for the minor change revisionof device. The mentioned "minor change" refers to those device changesnot 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

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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 forUse	Digital Automatic Blood Pressure MonitorBPM11 Series is for use by medicalprofessional or at home. The BPM11Series is intended to measure the systolicand diastolic blood pressure, and pulserate (heartbeat rate) of an individual byusing a non-invasive technique, in whichan inflatable cuff is wrapped around theupper arm of an individual. The inflatablecuff circumference is limited to 17cm -44cm via 3 different size of cuff. 3different cuff sizes are 17-22cm, 22-32cmand 32-44cm.	Digital Automatic Blood Pressure MonitorBPM06 Series is for use by medicalprofessional or at home. The BPM06Series is intended to measure the systolicand diastolic blood pressure, and pulserate (heartbeat rate) of an individual byusing a non-invasive technique, in whichan inflatable cuff is wrapped around theupper arm of an individual.	Equivalent
MeasurementMethod	Non-invasive, Oscillometric	Non-invasive, Oscillometric	Identical
IrregularHeartbeatDetection(IHB)	Yes	Yes	Identical
PatientPopulation	Age 16 or above	Age 16 or above	Identical
Blood PressureMeasurementRange	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 ofUser	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 TypeUser selection button: Sensor Type	Equivalent,same function
Blood PressureMeasurementAccuracy	± 3 mmHg or 2% of reading	± 3 mmHg or 2% of reading	Identical
Pulse RateMeasurementRange	30 - 180 beats/min	30 - 180 beats/min	Identical
Pulse RateMeasurementAccuracy	± 5 % of the reading	± 5 % of the reading	Identical
Display Type	LCD	LCD	Identical
Power Source	4 × 1.5 V AA-batteries; and/orAC adaptor (6V/600mA)	4 × 1.5 V AA-batteries; and/orAC adaptor (6V/600mA)	Identical
Comparison between BPM06 Series and predicate device
Item	Predicate Device	BPM06 Series	Comment
PressurizationMode	Automatic Inflation	Automatic Inflation	Identical
Deflation Mode	Automatic Exhaust/ Deflation	Automatic Exhaust/ Deflation	Identical
OperatingCondition	Temperature: 10 - 40 °CHumidity: 30 - 85 % R.H. maxAtmospheric Pressure: 700 - 1060 kPa	Temperature: 10 - 40 °CHumidity: 15 - 85 % R.H. maxAtmospheric Pressure: 700 - 1060 kPa	Equivalent,improvedspecification
Storage andTransportationCondition	Temperature: -20 - 60 °CHumidity: 10 - 95 % R.H. maxAtmospheric Pressure: 700 - 1060 kPa	Temperature: -20 - 60 °CHumidity: 10 - 95 % R.H. maxAtmospheric Pressure: 700 - 1060 kPa	Identical
AnatomicalSites	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, batteriesand packaging	Resistances, capacitance, transistors,amplifiers, pressure sensor, CPU, PCB,cuff ABS button, ABS cabinet, batteriesand packaging	Identical
CompatibilitywithEnvironmentand OtherDevices	No influence with environment and otherdevice	No influence with environment and otherdevice	Identical
ApplicableStandard	◇ 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 ofFDArecognizedstandard

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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

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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).

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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.

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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

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Additional Information - K ! 32240

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: December 31, 2013See PRA Statement on last page.
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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'
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FORM FDA 3881 (9/13)	Page 1 of 2
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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).