(100 days)
Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series is for use by medical professional or home user. The WBPM22 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.
Digital Automatic Wrist Blood Pressure Monitor WBPM22 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 acceptance criteria and study proving adherence are detailed below for the Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series.
1. Table of Acceptance Criteria and Reported Device Performance
The clinical performance of the WBPM22 Series was assessed against the ISO 81060-2:2009 standard for non-invasive sphygmomanometers. The reported performance refers to the findings from the clinical test conducted.
| Metric (Criterion based on ISO 81060-2:2009) | Acceptance Criteria | Reported Device Performance (Summary from Clinical Test) |
|---|---|---|
| Blood Pressure Measurement Accuracy | Mean difference between device and reference measurement (mean of multiple readings) should be $\le \pm$ 5 mmHg for both systolic and diastolic pressure. Standard deviation of the difference between device and reference measurement should be $\le$ 8 mmHg for both systolic and diastolic pressure. | (Specific values for mean difference and standard deviation are not provided in the summary, but the report states "Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2009 as documented in Clinical Test report" implying compliance.) |
| Pulse Rate Measurement Accuracy | Not explicitly stated as an acceptance criterion in the provided text, but implied as a measurement capability. | The device measures and displays pulse rate. |
Note: The provided 510(k) summary only states that the testing was conducted "in accordance with ISO 81060-2:2009" and that no differences in technology raised safety or effectiveness concerns. It implies that the acceptance criteria from this standard were met, but does not provide specific numerical results for mean difference and standard deviation. The predicate device's accuracy is stated as "$\pm$ 3 mmHg or 2% of reading", and the new device maintains this specification. While this is a general accuracy claim, the clinical study specific criteria would be those of ISO 81060-2.
2. Sample Size and Data Provenance
- Sample Size for Test Set: 100 patients (49 males and 51 females).
- Data Provenance: The country of origin of the data is not explicitly stated, but the submission is from "GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED" in China, suggesting the study may have been conducted there. The study appears to be a prospective clinical accuracy study based on its design ("patients were invited for the study," "blood pressure measurements were repeated alternatively").
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated, but for a study following ISO 81060-2 standards, typically two trained observers (often physicians or nurses) are used for the auscultatory reference measurements. The text mentions "Standard auscultation method was used as the reference blood pressure monitor," which implies human operators obtaining these reference readings.
- Qualifications of Experts: Not explicitly stated. However, standard auscultation for blood pressure, especially in a clinical study for device validation, would typically be performed by trained healthcare professionals.
4. Adjudication Method
The adjudication method for establishing ground truth is not explicitly mentioned. However, ISO 81060-2 typically involves multiple auscultatory measurements and may include reconciliation or averaging between observers if more than one is used to minimize bias and establish a robust reference. The text states "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2009," which details a specific protocol for data collection, but not explicitly how discrepancies between human readings (if two observers were involved) would be handled.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This clinical study was designed to assess the standalone accuracy of the device against a reference standard (auscultation), not to evaluate the improvement of human readers with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The clinical test describes evaluating the "clinical accuracy of the device in accordance with ISO 81060-2:2009," where the device's measurements are compared directly to a "standard auscultation method" used as a reference. This is a direct measure of the algorithm's (and device's) accuracy without human interpretation or intervention in the measurement process after initiation.
7. Type of Ground Truth Used
The type of ground truth used was expert consensus / reference method. Specifically, the "standard auscultation method" was employed as the reference blood pressure measurement. This is considered the 'gold standard' for non-invasive blood pressure measurement in many clinical contexts and for validation studies.
8. Sample Size for Training Set
The document does not explicitly mention a training set or its sample size. This type of submission (510(k) for a blood pressure monitor) is for a medical device that relies on an established oscillometric methodology rather than a machine learning or AI algorithm that would typically require a separate training set for model development. The "device" in this context is a physical product with an embedded algorithm. The clinical test described is a validation or test set evaluation for the final device, not a training activity.
9. How Ground Truth for Training Set Was Established
As there is no mention of a distinct training set for an AI/ML model, the establishment of ground truth for a training set is not applicable based on the provided document. The device uses an "oscillometric methodology" which is a well-established principle for blood pressure measurement, not a novel AI requiring a separate data-driven training phase in the context of this 510(k) summary.
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510(k) Summary
ﺓ
Submitter Identification 1.
| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZ |
|---|---|
| Address | Block 6 and 7, Zhu Keng Industrial Zon |
| District, Shenzhen, Guang Dong, People's | |
| 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 Wrist Blood PSeries[Model No.: MD22xy]x --- The first character (2 & 3)cabinet (housing).y --- The second character (0, 1)change revision of device. Therefers to those device changesconformity test results of EMCperformance, i.e. IEC60601-1 and |
|---|---|
| Common Name | Non-invasive Blood Pressure Me |
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4. Device Description
Digital Automatic Wrist Blood Pressure Monitor WBPM22 Serie pressure measurement system for use by medical professional or measure the systolic and diastolic blood pressure, and pulse rate measurement and then display the readings on a digital panel.
The device utilizes the oscillometric methodology, in which an i around the Wrist of an individual, for blood pressure measuremen detects your blood's movement through your brachial artery and co a digital reading.
The table below illustrate the feature presence in Digital Autom Monitor WBPM22 Series.
| Model | Blood PressureMeasurement | Pulse RateMeasurement | WHOClassification | IrregularHeartbeat |
|---|---|---|---|---|
| MD2220 | ✓ | ✓ | ✓ | ✓ |
| MD2222 | ✓ | ✓ | ✓ | ✓ |
| MD2223 | ✓ | ✓ | ✓ | ✓ |
| MD2230 | ✓ | ✓ | ✓ | ✓ |
| MD2231 | ✓ | ✓ | ✓ | ✓ |
| MD2232 | ✓ | ✓ | ✓ | ✓ |
Indication for Use 5.
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Comparison of Technological Characteristics betwe 6. Predicate Devices
Digital Automatic Wrist Blood Pressure Monitor WBPM22 Se predicate device, WBPM15 Series (K120673) in the device compar
| Item | Predicate Device | WBPM22 Series | |
|---|---|---|---|
| Indication for Use | Digital Automatic Wrist Blood PressureMonitor WBPM15 Series is for use bymedical professional or at home. TheWBPM15 Series is intended to measurethe systolic and diastolic blood pressure,and pulse rate (heartbeat rate) of anindividual by using a non-invasivetechnique, in which an inflatable cuff iswrapped around the wrist of an individual.The inflatable cuff circumference islimited to 13.5cm - 19.5cm. | Digital Automatic WristMonitor WBPM22 Series is for use bymedical professional or at home. TheWBPM22 Series is intended to measurethe systolic and diastolic blood pressure,and pulse rate of an individual byusing a non-invasive technique, in whichan inflatable cuff is wrapped around thewrist. | |
| Measurement Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | |
| Irregular HeartbeatDetection(IHB) | Yes | Yes | |
| PatientPopulation | Age 16 or above | Age 16 or above | |
| 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 | |
| Number ofUser | 2 independent users | 2 independent users | |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space2 users × 120 memory space | |
| Blood PressureMeasurementAccuracy | $\pm$ 3 mmHg or 2% of reading | $\pm$ 3 mmHg or 2% of reading | |
| Pulse Rate | 30 - 180 beats/min | 30 - 180 beats/min | |
| Item | Predicate Device | WBPM22 Series | Comment |
| 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 |
| 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,change uponFDA'srecognizedstandard |
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K133618
510(k) PREMARKET NOTIFICATION
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Digital Automatic Wrist Blood Pressure Monitor WBPM22 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.
7. Clinical and Non-clinical Tests
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 wrist. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2009.
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Non-Clinical Test Summary
Digital Automatic Wrist Blood Pressure Monitor WBPM22 Serie non-clinical tests to show that all requirement specifications and met. The tests includes the follows:
- EN 1060-1:1995+A2:2009 �
- や 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 Digit Pressure Monitor WBPM22 Series are same as the predicate devic is conducted to show the performance of Digital Automatic Wris WBPM22 Series is equivalent to the predicate device.
8. Conclusion
Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series and same technological characteristics as the predicate device, Digi Pressure Monitor WBPM15 Series (K120673). Moreover both testing has demonstrated that no differences in the technolo questioning on safety or effectiveness to be raised. Thus, Digital Pressure Monitor WRPM22 Series is substantially equivalent to the
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
March 5, 2014
Grandway Technology (Shenzhen) Limited Patrick Chow Zhu Keng Industrial Zone Ping Shan, Long Gang District Shenshen, Guang Dong, 518118 CH
Re: K133618
Trade/Device Name: Digital Automatic Wrist Blood Pressure M Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement Sy 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 referenced above and have determined the device is substantially equival for use stated in the enclosure) to legally marketed predicate devices mar commerce prior to May 28, 1976 the engatment date of the Medical Develop
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Page 2 - Patrick Chow
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In ad publish further announcements concerning your device in the Federal Rep
Please be advised that FDA's issuance of a substantial equivalence detern that FDA has made a determination that your device complies with other or any Federal statutes and regulations administered by other Federal age with all the Act's requirements, including, but not limited to: registration Part 807); labeling (21 CFR Part 801); medical device reporting (reporting related adverse events) (21 CFR 803); good manufacturing practice require the quality systems (QS) regulation (21 CFR Part 820); and if applicable, radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
If you desire specific advice for your device on our labeling regulation (2 contact the Division of Small Manufacturers, International and Consume free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.h Also, please note the regulation entitled, "Misbranding by reference to pr (2) CFR Part 807.97). For questions regarding the reporting of adverse e regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postm
You may obtain other general information on your responsibilities under Division of Small Manufacturers, International and Consumer Assistance (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.l
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510(k) PREMARKET NOTIFICATION
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Section 5 Indication for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: December 31, 2013 |
| Indications for Use | See PRA Statement on last page. |
510(k) Number (if known)
(if known) ਤ ।ਐਮ.) ਅਨ
Device Name
Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series
Indications for Uso (Dosenbe)
Digital Automatic Wrist Blood Pressure Manitor WBPM22 Series is for use by medical professional or home user. The WBPM22 Scrics is intended to measure the systelle blood pressure. and puble rate of un allult intisitiativity using a not-invasit c technique, in which an inflatable cuff is wrapped around the wrist.
| 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 16:08:17 -05'00' for Bram Zuckerman |
|---|---|
| ------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------- |
| FORM FDA 3881 (9/13) | Page 1 of 2 |
|---|---|
| ---------------------- | ------------- |
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5 10(k) PREMARKET NOTIFICATION
K133618
p.2 of 2
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
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Form For 3881 (9/13)
Page 2 of 2
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).