(126 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and data storage. There is no mention of AI, ML, or any advanced algorithms beyond the basic NIBP algorithm and WHO classification referencing.
No.
This device is for measuring blood pressure, which is a diagnostic function, not a therapeutic one. It does not treat or prevent any disease.
Yes
A diagnostic device measures and provides information about physiological parameters to assess a patient's health status. This device measures blood pressure and pulse rate, which are physiological parameters used in diagnosing conditions.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" and includes components like an "inflatable cuff." This indicates it is a hardware device with integrated 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.
- Device Function: The description clearly states that this device is an "Arm Type Automatic Blood Pressure Monitor" that measures blood pressure and pulse rate using a non-invasive oscillometric technique with a cuff wrapped around the arm. This is a measurement taken on the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, this device falls under the category of a non-invasive medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Arm Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The proposed device, Arm 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 upper arm 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 9 models, which are BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, and BP-JC312. 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
Upper arm
Indicated Patient Age Range
Adult
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)
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.
The SP10 standard is no longer an FDA recognized consensus standard for evaluating the safety and performance of NIBP system, therefore the particular performance proposed device was conducted according to IEC 80601-2-30, the test results demonstrated that the proposed device meet the requirements of IEC 80601-2-30. In addition, the clinical investigation of the proposed device has been conducted according to ISO 81060-2:2013 to demonstrate the clinical accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2018
Shenzhen Jiacom Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K172896
Trade/Device Name: Arm Type Automatic Blood Pressure Monitor BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 25, 2017 Received: December 28, 2017
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. Iisting 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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
Page 2 - Diana Hong
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,
. A. Wilhelm
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172896
Device Name
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
Indications for Use (Describe)
Arm Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Tab #7 510(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: K172896
-
- Date of Preparation: 12/20/2017
-
- 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
-
- 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
4
4. Identification of Proposed Device
Trade Name: Arm Type Automatic Blood Pressure Monitor Common Name: Arm Blood Pressure Monitor Models: BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
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:
Arm Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.
Device Description
The proposed device, Arm 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 upper arm 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 9 models, which are BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, and BP-JC312. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
5
-
న. Identification of Predicate Device
510(k) Number: K131558 Product Name: Electronic Blood Pressure Monitor -
- Non-Clinical Test Conclusion
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:
- Non-Clinical Test Conclusion
-
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.
-
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.
-
- 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.
-
- Substantially Equivalent (SE) Comparison
6
| Item | Proposed Device | Predicate Device |
|---|---|---|
| K131558 | ||
| Product Code | DXN | DXN |
| Regulation Number | 21 CFR 870.1130 | 21 CFR 870.1130 |
| Class | II | II |
| Intended Use | Arm Type Automatic Blood Pressure | |
| Monitor is a digital monitor intended for | ||
| use in measuring blood pressure and pulse | ||
| rate in adult patient population via | ||
| non-invasive oscillometric technique in | ||
| which an inflatable cuff is wrapped around | ||
| the arm. It can be used at medical facilities | ||
| or at home. The intended arm | ||
| circumference is 22-32 cm. | 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 arm. It can be used at | ||
| medical facilities or at home. The | ||
| intended arm circumference is 22-32 | ||
| cm. | ||
| Measurement Site | Upper arm | Upper arm |
| 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 | ||
| Size | BP310A: | |
| L133.2mmW102.6mmH65mm | PG-800B6D: | |
| L138mmW121mmH83mm | ||
| BP313A: L137mmW121mmH90mm | ||
| BP351A: L136mmW95mmH65mm | ||
| BP362A: L133mmW103mmH63mm | ||
| BP366A: L145mmW105mmH53mm | ||
| BP369A: L130mmW108mmH53mm | ||
| BP380A: L125mmW71mmH61mm | ||
| BP389A: L141.7mmW96.5mmH53mm | ||
| BP-JC312: L137mmW121mmH90mm | ||
| Weight | BP310A: Approx. 390g(with batteries) | PG-800B6D: |
| About 430g excluding batteries | ||
| BP313A: Approx. 313g(with batteries) | ||
| BP351A: Approx.412g(with batteries) | ||
| BP362A: Approx.362(with batteries) | ||
| BP366A: Approx 405g(with batteries) |
| Table 1 Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| -------------------------------------------------- | -- | -- | -- | -- |
7
| | BP369A: Approx.415g(with batteries)
BP380A: Approx.368g(with batteries)
BP389A: Approx.368g(with batteries)
BP-JC312: Approx.417g(with batteries) | Systolic pressure, diastolic pressure,
unit of pressure, pulse rate, pulse
indicator, date, time, WHO BP
classification indicating bar, low
battery indicator, memory |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display | Systolic pressure, diastolic pressure, unit
of pressure, pulse rate, irregular heartbeat,
pulse indicator, date, time, WHO BP
classification indicating bar, low battery
indicator, memory | |
| Blood Pressure
Range | 30 ~ 280 mmHg | 30 ~ 280 mmHg |
| Blood Pressure
Accuracy | 3 mmHg | 3 mmHg |
| Pulse Rate Range | 40 ~ 200 bpm | 40 ~ 199 bpm |
| Pulse Rate
Accuracy | $\pm$ 5% | $\pm$ 5% |
| WHO BP
Classification | Yes
Per WHO Classification | Yes
Per WHO Classification |
| Arm circumference | 22-32mm | 22-32mm |
| Particular
Performance | Comply with
IEC 80601-2-30:2009 and ISO
81060-2:2013 | Comply with ANSI/AAMI SP10 |
| Power Supply | four AA batteries | four AA or LR6 batteries |
| Voltage | 6V | 6V |
| 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 |
| Patient-contact
component and
material | Cuff: Terylene
Tube: Polyvinyl chloride (PVC) | Cuff – Nylon
Enclosure - ABS
Key - ABS |
| Biocompatibility | No Cytotoxicity, sensitization, or irritation | Comply with ISO 10993
requirements |
| Software Level
Concern | Moderate | Moderate |
| Labeling | Conforms to 21CFR part 801 | Conforms to 21CFR part 801 |
The size, weight, and Pulse Rate Range of proposed device and predicate device are different. But the difference is very slight, and size, weight and Pulse Rate Range of proposed device is clearly indicated in user manual. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
The proposed device displays the irregular heartbeat, while the predicate device does not display. The
8
function of irregular heartbeat display has been validated per Software testing. Therefore, will not result in any safety and effectiveness issue of the proposed device.
The SP10 standard is no longer an FDA recognized consensus standard for evaluating the safety and performance of NIBP system, therefore the particular performance proposed device was conducted according to IEC 80601-2-30, the test results demonstrated that the proposed device meet the requirements of IEC 80601-2-30. In addition, the clinical investigation of the proposed device has been conducted according to ISO 81060-2:2013 to demonstrate the clinical accuracy. Therefore this difference on the particular performance will not affect the safety and effectiveness of the proposed device.
The patient contact components and materials of the proposed and predicate device are different. But both of them comply with ISO 10993 requirements. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.