(73 days)
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.
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.
Here's an analysis of the acceptance criteria and study relevant to the Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series, based on the provided text:
Device: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (Models MD2200 and MD2210)
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for accuracy are based on ISO 81060-2. The document mentions blood pressure measurement accuracy of ± 3 mmHg and pulse rate measurement accuracy of ± 5% of the reading.
| Acceptance Criteria (According to ISO 81060-2 implied) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy: Mean difference ≤ 5 mmHg and Standard deviation ≤ 8 mmHg (AAMI/ISO 81060-2) | ± 3 mmHg |
| Pulse Rate Measurement Accuracy | ± 5 % of the reading |
Note: While the document explicitly states "± 3 mmHg" for BP accuracy and "± 5% of the reading" for pulse rate accuracy under the "Blood Pressure Measurement Accuracy" and "Pulse Rate Measurement Accuracy" rows respectively (Page 6, and in the table of comparison with predicate device at page 5), for blood pressure, the ISO 81060-2 standard (which is cited as the basis for the clinical test) typically uses criteria of mean difference ≤ 5 mmHg with a standard deviation ≤ 8 mmHg when assessing accuracy against a reference measurement.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 100 patients (49 males and 51 females)
- Data Provenance: Not explicitly stated regarding country of origin, but the study was described as a "Clinical Test Summary" to insure clinical accuracy, suggesting a prospective study designed for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated, though it mentions "Standard auscultation method was used as the reference blood pressure monitor," which implies trained medical professionals (e.g., physicians, nurses) performed the auscultation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document mentions "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in [a likely document reference: 209008 051 which is cut off]." This suggests a direct comparison method rather than an adjudication process between multiple experts for ground truth. The "standard auscultation method" itself serves as the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not done/Applicable: This type of study (MRMC) is generally not applicable to a device like a blood pressure monitor, which provides a direct measurement rather than an interpretation requiring human readers.
6. Standalone (Algorithm Only) Performance Study
- Yes: The clinical accuracy study, where the device's readings were compared against the standard auscultation method, is a standalone performance study of the algorithm (device) without human-in-the-loop performance improvement.
7. Type of Ground Truth Used
- Expert Consensus / Reference Standard: The ground truth was established using the "standard auscultation method" by a medical professional, which serves as a reference standard for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
- Not Applicable / Not Mentioned: This device uses an oscillometric methodology and is likely based on established physiological principles and algorithms rather than a machine learning model requiring a separate "training set" in the conventional sense of AI/ML. The clinical study mentioned is for validating performance, not for training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Mentioned: As noted above, the concept of a "training set" and associated ground truth establishment is not typically relevant for this type of device.
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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
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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
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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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
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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 | BPMeasurement | Pulse RateMeasurement | WHOClassification | IHB | LCD Type | LCD Size(mm) | User xMemory |
|---|---|---|---|---|---|---|---|
| MD2200 | ✓ | ✓ | ✓ | ✓ | Positive reflective | 42 x 48 | 2 x 120 |
| MD2210 | ✓ | ✓ | ✓ | ✓ | Positive reflective | 62 x 59 | 2 x 120 |
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| 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 forUse | This device is for use by medicalprofessional or home users. It isintended to measure the systolic anddiastolic blood pressure on an adultindividual by using a non-invasivetechnique, in which an inflatable cuffis wrapped around the wrist. | This device is for use by medicalprofessional or home users. It isintended to measure the systolic anddiastolic blood pressure on an adultindividual by using a non-invasivetechnique, in which an inflatable cuffis wrapped around the wrist. | Identical |
| MeasurementMethod | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| PatientPopulation | Adult | Adult | Identical |
| BPMeasurementRange | 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 × 120 memory space | 2 users × 120 memory space | Identical |
| Resolution ofMeasurement | Blood Pressure: 1 mmHg or 0.1kPaPulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg or 0.1kPaPulse Rate: 1 beat/ min | Identical |
| Blood PressureMeasurementAccuracy | ± 3 mmHg | ± 3 mmHg | Identical |
| Pulse RateMeasurementRange | 30 - 180 beats/min | 40 - 180 beats/min | Similar |
| Pulse RateMeasurementAccuracy | ± 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 |
| PressurizationMode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| OperatingCondition | Temperature: +5 to +40 °CHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700-1060 hPa | Temperature: +5 to +40 °CHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700-1060 hPa | Identical |
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GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
| Item | Predicate Device | New device | Comment |
|---|---|---|---|
| Storage andTransportationCondition | Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700-1060 hPa | Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric 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 |
| CompatibilitywithEnvironmentand OtherDevices | No influence with environment andother device | No influence with environment andother device | Identical |
| ApplicableStandard | - 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
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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.
§ 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).