(100 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities.
No
The device is described as a "Digital Automatic Wrist Blood Pressure Monitor" intended to "measure" blood pressure and pulse rate, which are diagnostic functions, not therapeutic ones.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly lists hardware components such as a pressure sensor, electric valve, electronic control module, and electric pump, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series measures blood pressure and pulse rate using a non-invasive technique (a cuff wrapped around the wrist). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate directly from the individual's wrist.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Digital Automatic Wrist Blood Pressure Monitor 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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 Pressure
Measurement | Pulse Rate
Measurement | WHO
Classification | Irregular
Heartbeat |
|---|---|---|---|---|
| MD2220 | ✓ | ✓ | ✓ | ✓ |
| MD2222 | ✓ | ✓ | ✓ | ✓ |
| MD2223 | ✓ | ✓ | ✓ | ✓ |
| MD2230 | ✓ | ✓ | ✓ | ✓ |
| MD2231 | ✓ | ✓ | ✓ | ✓ |
| MD2232 | ✓ | ✓ | ✓ | ✓ |
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
Adult
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
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.
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Blood Pressure
Measurement
Accuracy: ± 3 mmHg or 2% of reading
Pulse Rate: 30 - 180 beats/min
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 P
Series
[Model No.: MD22xy]
x --- The first character (2 & 3)
cabinet (housing).
y --- The second character (0, 1)
change revision of device. The
refers to those device changes
conformity test results of EMC
performance, i.e. IEC60601-1 and |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Non-invasive Blood Pressure Me |
1
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 Pressure
Measurement | Pulse Rate
Measurement | WHO
Classification | Irregular
Heartbeat |
|--------|-------------------------------|---------------------------|-----------------------|------------------------|
| MD2220 | ✓ | ✓ | ✓ | ✓ |
| MD2222 | ✓ | ✓ | ✓ | ✓ |
| MD2223 | ✓ | ✓ | ✓ | ✓ |
| MD2230 | ✓ | ✓ | ✓ | ✓ |
| MD2231 | ✓ | ✓ | ✓ | ✓ |
| MD2232 | ✓ | ✓ | ✓ | ✓ |
Indication for Use 5.
2
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 Pressure | ||
| Monitor WBPM15 Series is for use by | |||
| medical professional or at home. The | |||
| WBPM15 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 wrist of an individual. | |||
| The inflatable cuff circumference is | |||
| limited to 13.5cm - 19.5cm. | Digital Automatic Wrist | ||
| Monitor WBPM22 Series is for use by | |||
| medical professional or at home. 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. | |||
| Measurement Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | |
| Irregular Heartbeat | |||
| Detection | |||
| (IHB) | Yes | Yes | |
| Patient | |||
| Population | Age 16 or above | Age 16 or above | |
| 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 | |||
| Number of | |||
| User | 2 independent users | 2 independent users | |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space | |
| 2 users × 120 memory space | |||
| Blood Pressure | |||
| Measurement | |||
| Accuracy | $\pm$ 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 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 | ||
| 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, | ||
| change upon | |||
| FDA's | |||
| recognized | |||
| standard |
3
Page 4 of 5
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.
4
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
5
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
6
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
Image /page/6/Picture/5 description: The image shows the text "Sincerely yours,". The text is in a serif font and is black. There is a signature below the text, but it is illegible.
7
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 |
|---|---|
| ---------------------- | ------------- |
8
5 10(k) PREMARKET NOTIFICATION
K133618
p.2 of 2
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
This section applies only to requirements of the Paperwark Reduction Act of 1995. *Do NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burtion 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 review the collection, including suggestions for reducing this burden estimate or any other supect
of this internation, including suggestions for reducing this burden, to
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paparwork Reduction Act (PRA) Staff PRAStationia.hha.gov
"An agency may not conduct or spensor, and a person is not required to respond to, a collection af information unless it displays a currently valid OMB number.
Form For 3881 (9/13)
Page 2 of 2
Digital Automatic Blood Pressure Monitor BPM18 Series
Section 5-2