(269 days)
No
The description focuses on standard oscillometric blood pressure measurement and does not mention any AI/ML components or related performance metrics/studies.
No.
The device is intended to measure blood pressure and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device is intended to measure diastolic, systolic blood pressure and pulse rate, which are physiological parameters used in the diagnosis and monitoring of medical conditions.
No
The device description clearly states it is a "battery driven automatic on-invasive blood pressure monitor" and mentions physical components like an inflatable cuff and variations with or without an LCD display and Bluetooth, indicating it is a hardware device with integrated 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 and pulse rate via a non-invasive technique using an inflatable cuff wrapped around the upper arm. This is a measurement taken directly from the living body (in vivo).
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples.
Therefore, based on the provided information, this device is a non-invasive blood pressure monitor, which is not classified as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to measure diastolic, systolic blood pressure and the pulse rate of an adult patient via non-invasive technique in which an inflatable cuff is wrapped around the upper arm. It is intended to be used at home. The intended arm circumference is 17cm22cm, 22cm32cm, 32cm~42cm.
Product codes
DXN
Device Description
The subjectdevice is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and the pulse rate of adult at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.
All the models included in this submission follow the same software, same measurement principle and same specifications. The WBP100 does not have LCD display but has Bluetooth; WBP201 does not have Bluetooth but has LCD display, and WBP202 has LCD display and Bluetooth. The difference will not affect the safety and effectiveness of the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult patient
Intended User / Care Setting
It is intended to be used 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
Not Found
Summary of Performance Studies
Non-clinical tests were conducted to verify that the subjectdevice met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subjectdevice complies with the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance, including the US National Differences; IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for basic safety, and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment; IEC 60601-1-2:2007, EN 60601-1-2:2007+AC:2010, IEC 60601-1-11:2010 Clause 12, EN 60601-1-11: 2010 Clause 12, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility; IEC 80601-2-30:2009+A1:2013, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
The clinical study was to evaluate the subjectElectronic Sphygmomanometer meets the accuracy requirements of the following standard: ISO 81060-2:2013, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles forming a bird-like shape, often referred to as the "Human Services Symbol."
November 3, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K160349
Trade/Device Name: Electronic Sphygmomanometer Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 25, 2016 Received: September 28, 2016
Dear Diana Hong:
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 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
1
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 yours.
Minda Jellison
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) K160349
Device Name Electronic Sphygmomanometer
Indications for Use (Describe)
The device is intended to measure diastolic, systolic blood pressure and the pulse rate of an adult patient via non-invasive technique in which an inflatable cuff is wrapped around the upper arm. It is intended to be used at home. The intended arm circumference is 17cm22cm, 22cm32cm, 32cm~42cm.
| 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 Drug 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
Tab #4 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K160349
-
- Date of Preparation: 10/31/2016
- Sponsor Identification 2.
Guangdong Biolight Meditech Co.,Ltd. Innovation First Road, Technical Innovation Coast, Zhuhai, 519085,China
Establishment Registration Number: 3007305624
Contact Person: Ms. Liang, jing Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang_j@blt.com.cn
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
-
- Identification of SubjectDevice
Trade Name: Electronic Sphygmomanometer Common Name: Electronic Blood Pressure Monitor; Model: WBP100, WBP201, WBP202
- Identification of SubjectDevice
Regulatory Information Classification Name: Noninvasive blood pressure measurement system Classification: 2 Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;
Indications for use:
The device is intended to measure diastolic, systolic blood pressure and the pulse rate of an adult patient via non-invasive technique in which an inflatable cuff is wrapped around the upper arm. It is intended to be used at home. The intended arm circumference is 17cm22cm, 22cm32cm, 32cm~42cm.
-
- Identification of Predicate Device
510k Number: K131558 Product Name: Electronic Blood Pressure Monitor, PG-800B Manufacturer: Shenzhen Pango Electronic Co., Ltd
- Identification of Predicate Device
-
Q. Reference Device Identification
510k Number: K131763 Product Name: Truscope Patient Monitor Manufacturer: Guangdong Biolight Meditech Co.,Ltd. -
- Device Description
The subjectdevice is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and the pulse rate of adult at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.
- Device Description
All the models included in this submission follow the same software, same measurement principle and same specifications. The WBP100 does not have LCD display but has Bluetooth; WBP201 does not have Bluetooth but has LCD display, and WBP202 has LCD display and Bluetooth. The difference will not affect the safety and effectiveness of the subject device.
5
8. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the subjectdevice met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subjectdevice complies with the following standards:
IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance, including the US National Differences
IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for basic safety, and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60601-1-2:2007, EN 60601-1-2:2007+AC:2010, IEC 60601-1-11:2010 Clause 12, EN 60601-1-11: 2010 Clause 12, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
IEC 80601-2-30:2009+A1:2013, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
-
- Clinical Test Conclusion
The clinical study was to evaluate the subjectElectronic Sphygmomanometer meets the accuracy requirements of the following standard:
- Clinical Test Conclusion
ISO 81060-2:2013, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type.
-
- Substantially Equivalent
| Subject Device | Predicate Device | |
|---|---|---|
| ITEM | WBP100, WBP201, WBP202 | |
| Electronic Sphygmomanometerr | PG-800B, K131558 | |
| Electronic Blood Pressure Monitor | ||
| Product Code | DXN | DXN |
| Class | II | II |
| Intended Use | The device is intended to measure diastolic, systolic | |
| blood pressure and the pulse rate of an adult patient | ||
| via non-invasive technique in which an inflatable | ||
| cuff is wrapped around the upper arm. It is intended | ||
| to be used at home. The intended arm circumference | Electronic Blood Pressure Monitor is | |
| intended to measure diastolic, systolic blood | ||
| pressure as well as the pulse rate of adult | ||
| person via non-invasive technique in which | ||
| an inflatable cuff is wrapped around the |
Table 1 Substantially Equivalent Comparison between the Subject Device and Predicate Device
6
| | is 17cm22cm, 22cm32cm, 32cm42cm. | upper arm. It can be used at medical facilities32cm. |
or at home. The intended arm circumference
is 22cm
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Measurement Type | Upper arm | Upper arm |
| Patient Population | Adult | Adult |
| Measurement Item | Systolic Pressure, Diastolic Pressure, Pulse Rate | Systolic Pressure, Diastolic Pressure, Pulse Rate |
| Principle | Oscillometric | Oscillometric |
| Component | Main unit, cuff, battery | Main unit, cuff, battery |
| Nominal (operating)
ranges for measured
parameteers | 0-300 mmHg for blood pressure | Unknown |
| Measurement ranges
for measured
parameteers | 10-255 mmHg for blood pressure
30 - 255 mmHg (SYS),
10 -220 mmHg (DIA))
40-240 bpm for pulse rate | 30-280 mmHg for blood pressure
40-199 bpm for pulse rate |
| Patient Contact
Material | Cuff - Polyester fabric, Raised fabric | Cuff – Nylon |
| Bicompatibility | Comply with ISO10993 series standards
No cytotoxicity;
No irritation to skin;
No significant evidence of sensitization | Comply with ISO10993 series standards
No cytotoxicity;
No irritation to skin;
No significant evidence of sensitization |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2:2007 | Comply with IEC 60601-1-2:2007 |
| Accuracy clinical
investigation | ISO 81060-2:2013 | SP 10 |
| Software Level
Concern | Moderate | Moderate |
The subject device and its predicate devices have the idented use, components, principle and similar performance. The difference between the subject device and the predicate device do not raise any question regarding its safety and effectiveness.
| ITEM | Subject device
Electronic Sphygmomanometer | Reference Device, K131763
Truscope Patient Monitor, |
|-----------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Models | WBP100, WBP210, WBP202 | Truscope Elite A8 |
| Manufacturer | Guangdong Biolight Meditech Co.,Ltd. | Guangdong Biolight Meditech Co.,Ltd. |
| Patient Contact
Material | Component: Shell of main unit
Material: Polycarbonate and
acrylonitrile-butadiene-styrene | Component: Shell of main unit
Material: Polycarbonate and
acrylonitrile-butadiene-styrene |
Table 2 Main Unit Material Comparison between the Subject Device and Reference Device
7
The device (K131763) was selected as the reference device is used to demonstrate the biocompatibility of the patient contact material of the subject device.
The subject device and reference device are all manufactured by Biolight Company. The materials of shell of main unit of the subject device, acrylonitrile-butadiene-styrene and Polycarbonate, are identical to the materials of shell of Biolight product, Truscope Patient Monitor, as it was approved in K131763, in formulation, processing and sterilization, and no other chemicals have been added.
Therefore the biocompatibility of the main unit of the subject device is acceptable.
The subject device, WBP series Electronic Sphygmomanometer, is determined to be Substantially Equivalent (SE) to the predicate device (K131558), and reference device (K131763) in respect of safety and effectiveness.