(157 days)
Not Found
No
The description details standard oscillometric blood pressure measurement and data storage, with no mention of AI or ML algorithms for measurement, analysis, or classification. The WHO classification is based on a fixed reference table.
No.
It measures physiological parameters (blood pressure and pulse rate) but does not treat, mitigate, or prevent a disease or condition. Its function is diagnostic/monitoring.
Yes
Explanation: 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. It also has a function to indicate the WHO Blood Pressure Classification, further suggesting its use in diagnostic assessment.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" and describes physical components like a wrist cuff and keys, indicating it is a hardware device with embedded software, not a software-only medical device.
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. They are used to examine these samples outside of the body (in vitro).
- Device Function: The Wrist Type Automatic Blood Pressure Monitor measures blood pressure and pulse rate directly from the patient's wrist using the oscillometric technique. This is a non-invasive measurement taken on the body, not a test performed on a sample from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm.
Product codes
DXN
Device Description
The proposed device, Wrist Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.
The proposed blood pressure monitor includes 5 models, which are BP165W, BP180W, BP186W and BP 188W. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
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 patient population
Intended User / Care Setting
medical facilities 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
- IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
- IEC 60601-1-11 Edition 2.0 2015-01, 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 80601-2-30 Edition 1.1 2013-07, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
- ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
The clinical accuracy of the proposed device was evaluated per the following standard. The test results demonstrated that the proposed device comply with the standard requirements.
ISO 81060-2 Second Edition 2013-05-01, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type.
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 2, 2018
Shenzhen Jiacom Technology Co., Ltd. % Diana Hong, General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K172972
Trade/Device Name: Wrist Type Automatic Blood Pressure Monitor, Models: BP165W. BP180W, BP186W and BP188W Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 30, 2018 Received: February 1, 2018
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 of medical device-related adverse events) (21 CFR 803); good
1
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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
M& Hillelement
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172972
Device Name
Wrist Type Automatic Blood Pressure Monitor, Models: BP165W, BP180W, BP186W and BP188W
Indications for Use (Describe)
Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm.
| 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)
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3
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: K172972
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- Date of Preparation: 01/16/2018
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- Sponsor Identification
Shenzhen Jiacom Technology Co., Ltd
No.A6 Building, silicon valley power, Qinghu park, Longhua street, Bao'an district, Shenzhen, Guangdong, 518109, China
Establishment Registration Number: Not yet registered.
Contact Person: Luo Tianfeng Position: Registration specialist Tel: +86-755-29015600 Fax: +86-755-29575792 Email: zhongjingming@szjiakang.com
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- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Wrist Type Automatic Blood Pressure Monitor Common Name: Wrist Blood Pressure Monitor Models: BP165W, BP168W, BP180W, BP186W and BP188W
Regulatory information:
Classification Name: Noninvasive blood pressure measurement system Classification: 2 Product Code: DXN Regulation Number: 21 CFR 870.1130 Review Panel: Cardiovascular
Intended Use Statement:
Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm.
Device Description
The proposed device, Wrist Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.
The proposed blood pressure monitor includes 5 models, which are BP165W, BP180W, BP186W and BP 188W. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
న. Identification of Predicate Device
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510(k) Number: K131569 Product Name: Electronic Blood Pressure Monitor, PG-800A Series
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Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
A AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
-
IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
-
A IEC 60601-1-11 Edition 2.0 2015-01, 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
-
A IEC 80601-2-30 Edition 1.1 2013-07, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
-
A ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
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- Clinical Test Conclusion
The clinical accuracy of the proposed device was evaluated per the following standard. The test results demonstrated that the proposed device comply with the standard requirements.
ISO 81060-2 Second Edition 2013-05-01, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type.
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- Substantially Equivalent (SE) Comparison
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| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | DXN | DXN |
| Regulation Number | 21 CFR 870.1130 | 21 CFR 870.1130 |
| Class | II | II |
| Intended Use | Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm. | PG-800A Series Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm. |
| Measurement Site | wrist | wrist |
| Patient Population | Adult | Adult |
| Measurement Item | Systolic Pressure, Diastolic Pressure, Pulse Rate | Systolic Pressure, Diastolic Pressure, Pulse Rate |
| Measurement Method | Oscillometric | Oscillometric |
| Component | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries |
| Blood Pressure Range | 30 ~ 280 mmHg | 30 ~ 280 mmHg |
| Pulse Rate Range | 40 ~ 200 bpm | 40 ~ 199 bpm |
| WHO BP Classification | Yes | |
| Per WHO Classification | Yes | |
| Per WHO Classification | ||
| Wrist circumference | 13.5-19.5 cm | 13.5-19.5 cm |
| Particular Performance | Comply with | |
| IEC 80601-2-30:2009 and | ||
| ISO 81060-2:2013 | Comply with ANSI/AAMI SP10 | |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Biocompatibility | No Cytotoxicity, sensitization, or irritation | Comply with ISO 10993 requirements |
| Software Level Concern | Moderate | Moderate |
Table 1 Comparison of Technology Characteristics
The proposed device and its predicate devices have the identical indented use, components, principle and
7
performance. The difference between the proposed device and the predicate device do not raise any question regarding its safety and effectiveness.
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- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion