(100 days)
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.
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 provided documentation describes the Digital Automatic Blood Pressure Monitor BPM18 Series. This device is a non-invasive blood pressure measurement system intended for use by medical professionals or at home to measure systolic and diastolic blood pressure and pulse rate.
Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (BPM18 Series) |
|---|---|
| Blood Pressure Measurement Accuracy: ± 3 mmHg or 2% of reading | Meets Blood Pressure Measurement Accuracy: Confirmed via clinical test in accordance with ISO 81060-2:2009. |
| Pulse Rate Measurement Accuracy: ± 5 % of the reading | Meets Pulse Rate Measurement Accuracy: Confirmed via clinical test in accordance with ISO 81060-2:2009. |
| Blood Pressure Measurement Range: Cuff Pressure: 0 - 300 mmHg, | Identical: Cuff Pressure: 0 - 300 mmHg, |
| Systolic Pressure: 50 - 250 mmHg, Diastolic Pressure: 30 - 200 mmHg | Systolic Pressure: 50 - 250 mmHg, Diastolic Pressure: 30 - 200 mmHg |
| Pulse Rate Measurement Range: 30 - 180 beats/min | Identical: 30 - 180 beats/min |
| Operating Condition: Temperature: 10 - 40 °C, Humidity: 30 - 85 % R.H. max, Atmospheric Pressure: 700 - 1060 kPa | Equivalent, improved specification: Temperature: 10 - 40 °C, Humidity: 15 - 85 % R.H. max, Atmospheric Pressure: 700 - 1060 kPa |
| Applicable Standards (key ones mentioned): EN 1060-1, EN 1060-3, IEC 60601-1, IEC 60601-1-2, ISO 81060-2 | Complies with updated versions of relevant standards including IEC 60601-1:2012 and IEC 81060-2:2009. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 100 patients (49 males and 51 females) were enrolled in the clinical study.
- Data Provenance: Not explicitly stated, but the submission is from "GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED" in "People's Republic of China", suggesting the study likely took place in that region. The study is prospective in nature as patients were "invited for the study" with blood pressure measurements taken specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- The ground truth was established using the "Standard auscultation method." This method is typically performed by trained medical professionals (e.g., a physician or nurse) using a stethoscope and sphygmomanometer.
- The document does not specify the number of experts, nor their specific qualifications (e.g., number of years of experience).
4. Adjudication Method for the 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 ISO 81060-2:2009."
- This implies a direct comparison for individual measurements rather than an adjudication process between multiple readers for ground truth generation. The auscultation method likely served as the single reference (ground truth) against which the device's readings were compared. There is no mention of a 2+1 or 3+1 adjudication method.
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 explicitly mentioned or conducted. The study focused on the accuracy of the device against a reference standard (auscultation) rather than comparing human reader performance with and without AI assistance. The device is a standalone blood pressure monitor without AI-assisted interpretation capabilities mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Yes, a standalone performance study was done. The "Clinical Test Summary" describes the device's performance against the "standard auscultation method" without human intervention for the device's measurement and interpretation of blood pressure. The device itself uses an oscillometric methodology to produce digital readings.
7. The Type of Ground Truth Used
- The ground truth used was expert measurement/reference standard, specifically the "Standard auscultation method."
8. The Sample Size for the Training Set
- The document does not specify a training set sample size. This is typical for medical devices like blood pressure monitors that use established physical principles (oscillometric method) rather than complex machine learning algorithms that require extensive training data. The device's design and parameters would be developed and refined through engineering and calibration, not typically by training on a large dataset in the way a deep learning model would.
9. How the Ground Truth for the Training Set Was Established
- Since there's no mention of a training set in the context of machine learning, there's no ground truth established for a training set. The device relies on its internal algorithms and calibration based on known physiological principles of oscillometric blood pressure measurement.
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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 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 | 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 theminor change revision of device. The mentioned "minorchange" refers to those device changes not to be affectingthe conformity test results of EMC & safety as well asdevice performance, i.e. IEC 60601-1 and EN 60601-1-2.y --- The second character (0 & 1) is for the identificationof 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 |
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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 PressureMeasurement | Pulse RateMeasurement | WHOClassification | IrregularHeartbeat | LCD Type | BacklightIllumination | DCJack | Memory |
|---|---|---|---|---|---|---|---|---|
| MD1800 | ✓ | ✓ | ✓ | ✓ | PositiveReflective | x | ✓ | 2*120 |
| MD1810 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | Blue | ✓ | 2*120 |
| MD1820 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | Orange | ✓ | 2*120 |
| MD1830 | ✓ | ✓ | ✓ | ✓ | NegativeTransmissive | White | ✓ | 2*120 |
| MD1840 | ✓ | ✓ | ✓ | ✓ | PositiveReflective | x | x | 2*120 |
| MD1850 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | Blue | x | 2*120 |
| MD1860 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | Orange | x | 2*120 |
| MD1870 | ✓ | ✓ | ✓ | ✓ | NegativeTransmissive | White | x | 2*120 |
| MD1801 | ✓ | ✓ | ✓ | ✓ | PositiveReflective | x | ✓ | 2*120 |
| MD1811 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | Blue | ✓ | 2*120 |
| MD1821 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | Orange | ✓ | 2*120 |
| MD1831 | ✓ | ✓ | ✓ | ✓ | NegativeTransmissive | White | ✓ | 2*120 |
| MD1841 | ✓ | ✓ | ✓ | ✓ | PositiveReflective | x | x | 2*120 |
| MD1851 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | Blue | x | 2*120 |
| MD1861 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | Orange | x | 2*120 |
| MD1871 | ✓ | ✓ | ✓ | ✓ | NegativeTransmissive | White | x | 2*120 |
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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 MonitorBPM11 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 MonitorBPM18 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 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 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 |
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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/orAC adaptor (6V/600mA) | 4 x 1.5 V AAA-batteries; and/orAC adaptor (6V/600mA) | Identical |
| Pressurization Mode | 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 |
| Cuff Size (Armcircumference) | 17.0 - 22.0 cm22.0 - 32.0 cm32.0 - 44.0 cm | 17.0 - 22.0 cm22.0 - 32.0 cm32.0 - 44.0 cm | 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 | ◇ 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.
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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.
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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
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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 (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 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 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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GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Section 5 Indication for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood 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:
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Form FDA 3881 (8/13)
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Digital Automatic Blood Pressure Monitor BPM18 Series
Section 5-2
§ 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).