(73 days)
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components.
No.
The device is intended to measure blood pressure, not to treat a condition or restore health.
No
Explanation: While the device measures blood pressure, which can be an indicator of health, its primary function as described is to measure and display physiological parameters (blood pressure and pulse rate), not to diagnose a disease or condition. It provides data for a medical professional to interpret, but it does not make a diagnosis itself.
No
The device description explicitly states it is a "Digital Automatic Wrist Blood Pressure Monitor" and utilizes an "inflatable cuff" and "digital panel" to display readings, indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The description clearly states that this device measures blood pressure using a non-invasive technique by wrapping a cuff around the wrist. It measures the movement of blood through the artery. This is a measurement taken directly from the living body (in vivo).
The device is a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.
Product codes
DXN
Device Description
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 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 wrist 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 Wrist Blood Pressure Monitor SWBPM22 Series.
Model: MD2200
BP Measurement: ✓
Pulse Rate Measurement: ✓
WHO Classification: ✓
IHB: ✓
LCD Type: Positive reflective
LCD Size (mm): 42 x 48
User x Memory: 2 x 120
Model: MD2210
BP Measurement: ✓
Pulse Rate Measurement: ✓
WHO Classification: ✓
IHB: ✓
LCD Type: Positive reflective
LCD Size (mm): 62 x 59
User x Memory: 2 x 120
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 home users
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
Not Found
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 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 arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in.
Non-Clinical Test Summary: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:
- ISO 81060-1:2007
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- IEC 60601-1-2:2014
- FCC Part 15 Subpart B
All of the clinical and non-clinical testing performed on Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle with three faces in profile.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Grandway Technology (Shenzhen) Limited Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone, Ping Shan District, Shenzhen, 518118 CHINA
Re: K163113
Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series, Models MD2200 and MD2210 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 16, 2016 Received: December 23, 2016
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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M. A. Hillemann
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series, models MD2200 and MD2210
Indications for Use (Describe)
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements 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 79 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 of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Re: K
CHECK ONLY ONE
ত্রি 510(k) Summary. Attached is a summary of safety and effectiveness information upon which an equivalence determination could be based.
510(k) Statement. I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent) of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
Oh ha-by
Patrick Chow, General Manager (00852)-2851-6789 02-Nov-2016
4
1. Submitter identification
| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Address | Block 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, 518118, |
| Shenzhen, People's Republic of China | |
| Phone Number | (00852)-2851-6789 |
| Fax Number | (00852)-2851-6278 |
| Contact Person | Mr. Patrick Chow |
| 01 | 02-Nov-2016 |
2. Device identification
| Trade Name | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
[Model No.: MD2200 and MD2210] |
|---------------------|-------------------------------------------------------------------------------------------------|
| 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 Wrist Blood Pressure Monitor SWBPM22 Series |
|---|---|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K142088 |
Device Description 4.
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 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 wrist 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 Wrist Blood Pressure Monitor SWBPM22 Series.
| Model | BP
Measurement | Pulse Rate
Measurement | WHO
Classification | IHB | LCD Type | LCD Size
(mm) | User x
Memory |
|--------|-------------------|---------------------------|-----------------------|-----|---------------------|------------------|------------------|
| MD2200 | ✓ | ✓ | ✓ | ✓ | Positive reflective | 42 x 48 | 2 x 120 |
| MD2210 | ✓ | ✓ | ✓ | ✓ | Positive reflective | 62 x 59 | 2 x 120 |
5
| GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED | 510(k) Summary | |
|---|---|---|
5. Indication for use
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.
6. Comparison of technological characteristics between new Device and predicate Devices
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is compared to the predicate device, Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (K142088) in the device comparison table below.
| Item | Predicate Device | New device | Comment |
|---|---|---|---|
| Indication for | |||
| Use | This device is for use by medical | ||
| professional or home users. It is | |||
| intended to measure the systolic and | |||
| diastolic blood pressure on an adult | |||
| individual by using a non-invasive | |||
| technique, in which an inflatable cuff | |||
| is wrapped around the wrist. | This device is for use by medical | ||
| professional or home users. It is | |||
| intended to measure the systolic and | |||
| diastolic blood pressure on an adult | |||
| individual by using a non-invasive | |||
| technique, in which an inflatable cuff | |||
| is wrapped around the wrist. | Identical | ||
| Measurement | |||
| Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Patient | |||
| Population | Adult | Adult | Identical |
| BP | |||
| 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 |
| Resolution of | |||
| Measurement | Blood Pressure: 1 mmHg or 0.1kPa | ||
| Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg or 0.1kPa | ||
| Pulse Rate: 1 beat/ min | Identical | ||
| Blood Pressure | |||
| Measurement | |||
| Accuracy | ± 3 mmHg | ± 3 mmHg | Identical |
| Pulse Rate | |||
| Measurement | |||
| Range | 30 - 180 beats/min | 40 - 180 beats/min | Similar |
| Pulse Rate | |||
| Measurement | |||
| Accuracy | ± 5 % of the reading | ± 5 % of the reading | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 2 × 1.5 V AAA-batteries | 2 × 1.5 V AAA-batteries | Identical |
| Pressurization | |||
| Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating | |||
| Condition | Temperature: +5 to +40 °C | ||
| Humidity: 15 to 93 % R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | Temperature: +5 to +40 °C | ||
| Humidity: 15 to 93 % R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | Identical |
6
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
| Item | Predicate Device | New device | Comment |
|---|---|---|---|
| Storage and | |||
| Transportation | |||
| Condition | Temperature: -25 to +70 °C | ||
| Humidity: up to 93% R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | Temperature: -25 to +70 °C | ||
| Humidity: up to 93% R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | 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 60601-1:2012
- IEC 60601-1-2:2007
- FCC Part 15 Subpart B
- IEC 81060-2:2009 | - ISO 81060-1:2007
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- IEC 60601-1-2:2014
- FCC Part 15 Subpart B
- IEC 81060-2:2013 | Equivalent |
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 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, an 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 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 arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in . 209008 051
Non-Clinical Test Summary
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:
- 4 ISO 81060-1:2007
- EN 1060-3:1997+A2:2009 や
- や IEC 60601-1:2012
- � IEC 60601-1-2:2014
7
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
◆ FCC Part 15 Subpart B
All of the clinical and non-clinical testing performed on Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is equivalent to the predicate device.
8. Conclusion
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series has the same intended use and same technological characteristics as the predicate device, Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (K142088). Moreover both clinical and non-clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is substantially equivalent to the predicate device.