(245 days)
No
The summary describes a standard automatic digital blood pressure monitor using an inflatable cuff and oscillometric method. There is no mention of AI or ML in the device description, intended use, or performance studies. The "blood pressure classification" function appears to be based on pre-defined ranges, not learned patterns.
No
The device is used to measure blood pressure and pulse rate for monitoring purposes, and does not provide therapy or treatment.
No
The device is an automatic blood pressure monitor, which measures blood pressure and pulse rate. While it includes a function for "blood pressure classification" to help users judge if their blood pressure is normal, its primary function is measurement, not diagnosing a medical condition. It provides data that could be used by a healthcare professional for diagnosis, but the device itself does not make a diagnosis.
No
The device description explicitly states it is an "automatic non-invasive Blood Pressure Monitor" that uses an "inflatable cuff" and can be powered by "4 AA batteries or AC adapter (optional)". These are all hardware components, indicating it is not a software-only device.
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 body (in vitro).
- Device Function: The Automatic Digital Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the upper arm and using a non-invasive method. This is a physical measurement taken on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate of adults at home. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, based on the definition of IVD and the description of the device and its intended use, the Automatic Digital Blood Pressure Monitor is not an In Vitro Diagnostic device. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).
Product codes
DXN
Device Description
The subject device, Automatic Digital Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven by 4 AA batteries or AC adapter (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
This blood pressure monitor has the memory function of 60 reading of measuring data of two groups, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.
Cuff supporting the use of Automatic Digital Blood Pressure Monitor is M5402(small adult)/M5403(adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).
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. (Not suitable for neonate, pregnancy or pre-eclampsia).
Intended User / Care Setting
household
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
The clinical trials for the Automatic Digital Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers -Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the subject device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Trial.
Sample Size: 150 subjects.
Key Results: The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the +-3mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
BP Accuracy: +- 3 mmHg
Pulse Accuracy: +- 5% of reading value
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
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September 23, 2020
AVICHE Shandong Medical Technology Co, Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K210152
Trade/Device Name: Automatic Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 18, 2021 Received: August 25, 2021
Dear Boyle Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210152
Device Name Automatic Digital Blood Pressure Monitor
Indications for Use (Describe)
The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).
| Type of Use (Select one or both, as applicable) | Day-to-Day Use (49 CFR 391 Subpart E) One-Time Contract Use (49 CFR 391 Subpart G) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------- |
__ 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 (K210152)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
Name: AVICHE Shandong Medical Technology Co, Ltd. Address: Floor 26, Building A, A2-1 Jinan Pharm Valley, Gangxingsan Road,High-tech District, Jinan City, Shandong Province, China Tel: 86-15689734848 Contact: Zhike Song Date of Preparation: Aug.11,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Automatic Digital Blood Pressure Monitor Common name: Noninvasive Blood Pressure Measurement System Classification name: Noninvasive Blood Pressure Measurement System Model(s): HD10,HD20
3.0 Classification
Production code: DXN Regulation number: 21 CFR 870.1130 Classification: Class II Panel: Cardiovascular
4.0 Predicate Device Information
- Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Device: Electronic Blood Pressure Monitor: YE620B, YE620D, YE660E, YE660F and YE680B
4
510(k) number: K200939
5.0 Indication for Use Statement
The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).
6.0 Device Description
The subject device, Automatic Digital Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven by 4 AA batteries or AC adapter (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
This blood pressure monitor has the memory function of 60 reading of measuring data of two groups, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.
Cuff supporting the use of Automatic Digital Blood Pressure Monitor is M5402(small adult)/M5403(adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).
7.0 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: IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-11:2015, 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
5
IEC 80601-2-30:2018, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
IEC 62304:2015 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.
8.0 Clinical Test Conclusion
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Automatic Digital Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers -Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the subject device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±3mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared.
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device | ||
| K210152 | Predicate Device | ||
| K200939 | Remark | ||
| Product Code | DXN | DXN | SE |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | SE |
| Class | II | II | SE |
| Intended Use | The Automatic Digital Blood | ||
| Pressure Monitor is | |||
| intended to measure the | |||
| blood pressure and pulse | |||
| rate of adult at household. | |||
| (Not suitable for neonate, | |||
| pregnancy or | |||
| pre-eclampsia). | Electronic blood pressure | ||
| monitor is intended to | |||
| measure the blood | |||
| pressure and pulse rate of | |||
| adult at household or | |||
| medical center. (Not | |||
| suitable for neonate, | |||
| pregnancy or | |||
| pre-eclampsia). | SE | ||
| Application Site | Upper Arm | Upper Arm | SE |
| Cuff | |||
| Circumference | 22-36cm or 22-42cm | ||
| (optional) | Type A (22cm~32cm, | ||
| 22-45cm optional) | |||
| Type B (22cm~ 32cm, | |||
| 22-45cm optional) | SE | ||
| Patients | Arm Cuff - M5402(small | Patient contact materials of | SE |
9.0 Technological Characteristic Comparison Table
6
| Contacting
Materials | adult)/M5403(adult)
provided by Xuzhou
Maikang Science and
Technology Ltd., and
cleared by FDA
(K151290). | the cuff have been tested
in accordance with
ISO10993 and FDA
guidance. | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----|
| Patient
Population | Adult | Adult | SE |
| Measurements
Item | SYS, DIA,Pulse | SYS, DIA,Pulse | SE |
| Display | LCD Digital Display | LCD Digital Display | SE |
| Design Method | Oscillometric
Method | Oscillometric
Method | SE |
| Main
Component | LCD / Key / Cuff / MCU /
Pump / Batteries | LCD / Key / Cuff / MCU /
Pump / Batteries | SE |
Table 2 Performance Comparison
| Item | Subject Device
K210152 | Predicate Device
K200939 | Remark |
|------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------|
| BP Range | 0-280 mmHg | 0-300 mmHg | SE |
| BP Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | SE |
| PR Range | 40-199 beats/min | 40 ~ 200 beats/min | SE |
| Pulse
Accuracy | $\pm$ 5% of reading value | $\pm$ 5% of reading value | SE |
| Inflation
Method | Automatic by
electronic pump | Automatic by
electronic pump | SE |
| Deflation
Method | Automatic Pressure
Release Valve | Automatic Pressure
Release Valve | SE |
| Memory Size | 2x60 set of data | Up to 60x2 sets of data
or
Up to 99 sets of Data
or
Up to 99x2 sets of data | SE |
| Operation
Condition | Temperature +5~+40°C
Humidity $\leq$ 80%RH
Air pressure
80.0kPa-105.0kPa | Temperature +5°C ~ +40 °C
Humidity 15%-90% RH
(no condensation)
Air pressure:
Not publicly available | Analysis |
| Storage
Condition | Temperature -20-55 °C
Humidity 10%~90% RH
Air pressure
80.0kPa-105.0kPa | Temperature -20-+55 °C
Humidity 15%-90% RH
(no condensation)
Air pressure: Not publicly
available | Analysis |
7
| Data Storage | SYS, DIA, PR,
Measurement Time, No. | SYS, DIA, PR,
Measurement Time, No. | SE |
|-------------------------|-----------------------------------------|------------------------------------------|----------|
| Performance
Standard | Comply with IEC
80601-2-30 | Comply with IEC
80601-2-30 | SE |
| Power Supply | 4 AA batteries or 5V/1.0A
AC adapter | 4 AA batteries or 6V/600mA
AC adapter | Analysis |
Analysis:
The subject device is substantially equivalent to the predicate device. The differences in Operation Condition and Storage Condition between both devices are insignificant in terms of safety and effectiveness. Also, the little difference in power supply according to the Electrical Safety and EMC test result, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
| Item | Proposed Device
K210152 | Predicate Device
K200939 | Remark |
|-------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------|
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE |
| Home Use | Comply with IEC
60601-1-11 | Comply with IEC
60601-1-11 | SE |
| EMC | Comply with IEC
60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Biocompatibility | Comply with ISO
10993-1, FDA Guidance | Comply with ISO 10993-1,
FDA Guidance, Tests
included
Cytotoxicity, Sensitization
and Intracutaneous
Reactivity | SE |
| Label and
Labeling | Conforms to FDA
Regulatory
Requirements | Conforms to FDA
Regulatory Requirements | SE |
| Level of Concern
of the Software | Moderate | Moderate | SE |
Table 3 Safety Comparison
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.