(207 days)
No
The description details a standard oscillometric blood pressure measurement method using a microprocessor to analyze pressure signals, which is a well-established technique and does not indicate the use of AI or ML. There are no mentions of AI, DNN, or ML in the provided text.
No
The device is described as a home-use digital monitor for measuring blood pressure, and it explicitly states, "The device is not intended to be a diagnostic device." While it provides health-related measurements, it doesn't state any therapeutic function.
No
The "Intended Use / Indications for Use" section explicitly states, "The device is not intended to be a diagnostic device."
No
The device description explicitly details hardware components such as an inflatable cuff, main unit (microprocessor, pressure sensor, pump, valve, battery), and an LCD. While software is mentioned as achieving the function, it is clearly integrated into and dependent on this physical hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The device is not intended to be a diagnostic device."
- Nature of Measurement: The device measures blood pressure using a non-invasive technique (cuff around the wrist) and an electronic sensor. This is a physical measurement of a physiological parameter, not an analysis of a sample taken from the body (which is characteristic of IVDs).
- Purpose: The device is intended for home use to measure blood pressure, not to diagnose a disease or condition based on the analysis of biological samples.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. This sphygmomanometer does not perform such analysis.
N/A
Intended Use / Indications for Use
Electronic Sphygmomanometer (Model JN-163EW) is a home use digital monitor intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm. The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Product codes
DXN
Device Description
Electronic Sphygmomanometer is designed to measure the systolic and diastolic blood pressure of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
Measurement method to define systolic and diastolic pressure is similar to the Oscillometric method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals and analyzes those signals to define the systolic and diastolic blood pressure and calculates heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".
The electronic sphygmomanometer achieves its function by a software. As the hardware includes an LCD, it can show the results of the blood pressure measurements and store 99 groups of data which can be checked and deleted.
The device is composed of a main unit and a cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by 2X AAA Lithium battery.
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
home use device
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:
ISO 80601-2-30, Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated noninvasive sphygmomanometers
IEC60601-1, Electrical safety
IEC60601-1-2, Electromagnetic compatibility
IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance
ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
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
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Electronic Sphygmomanometers were performed according to the standard ISO 81060-2:2019+A1:2020, 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.
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, 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.
March 3, 2023
Qingdao Yasee Medical Device Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K222394
Trade/Device Name: Electronic Sphygmomanometers Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 8, 2022 Received: August 8, 2022
Dear Prithul Bom:
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.
1
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) 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.
Robert T. Kazmierski -S
for
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) K222394
Device Name Electronic Sphygmomanometer
Indications for Use (Describe)
Electronic Sphygmomanometer (Model JN-163EW) is a home use digital monitor intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.5 cm. The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
| 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 summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
Submitter & Foreign Manufacture Identification
Qingdao Yasee Medical Device Co., Ltd. No.9 Xiuyuan Road, High-tech Industrial Development Zone, Oingdao City, 266112 Shandong Province, P.R. China Tel: +86 532 68012805 Submitter's FDA Registration Number: N/A
Contact Person
Name: Xiangqun Ye Company: JL Management and Consulting LLC Address: 755 Watershed Ct., Ann Arbor, MI 48105 Tel: +1.650.265.8159 Email: jlmcllc.info@gmail.com
Date of Summary: April 10, 2022
Device Name
| Trade name | Electronic Sphygmomanometer |
|---|---|
| Common Name | Electronic Sphygmomanometer |
| Classification Name | System, Measurement, Blood-Pressure, Non-Invasive |
| Device Classification | II |
| Regulation Number | 21 CFR 870.1130 |
| Panel | Cardiovascular |
| General Product Code | DXN |
Predicate Device Information:
- (1) K150908, "XM-01 Automatic Electronic Blood Pressure Monitor", manufactured by "Sky Innovation Technology (Shanghai) Limited."
| Trade/Device Name | XM-01 Electronic Automatic Blood Pressure Monitor |
|---|---|
| Regulation Number | 21 CFR 870.1130 |
| Regulation Name | Noninvasive Blood Pressure Measurement System |
| Regulatory Class | Class II |
| Product Code | DXN |
Device Description:
4
Electronic Sphygmomanometer is designed to measure the systolic and diastolic blood pressure of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
Measurement method to define systolic and diastolic pressure is similar to the Oscillometric method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals and analyzes those signals to define the systolic and diastolic blood pressure and calculates heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".
The electronic sphygmomanometer achieves its function by a software. As the hardware includes an LCD, it can show the results of the blood pressure measurements and store 99 groups of data which can be checked and deleted.
The device is composed of a main unit and a cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by 2X AAA Lithium battery.
Indications for Use:
Electronic Sphygmomanometer (Model JN-163EW) is a home use digital monitor intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Testing Summary:
To prove the safety and effectiveness of Electronic Sphygmomanometer, the device was tested according to corresponding standards.
Non-Clinical Performance Testing
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:
ISO 80601-2-30, Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated noninvasive sphygmomanometers
IEC60601-1, Electrical safety
5
IEC60601-1-2, Electromagnetic compatibility
IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance
ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
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 Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Electronic Sphygmomanometers were performed according to the standard ISO 81060-2:2019+A1:2020, 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.
Comparison with Predicate Device
The following table shows similarities and differences between our device and the predicate devices.
| Description | Subject Device | Predicate Device (K150908) | Comparison |
|---|---|---|---|
| Indication | |||
| for Use | Electronic Sphygmomanometer | ||
| (Model JN-163EW) is a home use | |||
| digital monitor intended for use in | |||
| measuring blood pressure in adult | |||
| patient population with wrist | |||
| circumference ranging from 13.5 cm | |||
| to 19.5 cm. | |||
| The device is not intended to be a | |||
| diagnostic device. Contact your | |||
| physician if hypertensive values are | |||
| indicated. | XM-01 Automatic Electronic Blood | ||
| Pressure Monitor is a home use digital | |||
| monitor intended for use in measuring | |||
| blood pressure and pulse rate in adult | |||
| patient population with wrist | |||
| circumference ranging from 13.5 cm | |||
| to 19.5 cm. | |||
| The device is not intended to be a | |||
| diagnostic device. Contact your | |||
| physician if hypertensive values are | |||
| indicated. | Same | ||
| Component | Main Unit, Cuff, Battery | Main Unit, Cuff, Battery | Same |
| Measurement | |||
| Method | Oscillographic | Oscillographic | Same |
Table 1: Comparison of Intended Use, Mechanism, Labeling, and Design
6
| User Control | User can manually control
measurement | User controls measurement from
mobile devices through mobile
application software | Minor
difference |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Labelling | Company Name and Address,
Specifications, Product
Descriptions, Indications for Use,
Contraindication for Use,
Precautions, Warnings, Safety
Terms and Conditions, Safety Alert
Description, Safety and Performance
Standards, etc. | Company Name and Address,
Specifications, Product Descriptions,
Indications for Use, Contraindication
for Use, Precautions, Warnings, Safety
Terms and Conditions, Safety Alert
Description, Safety and Performance
Standards, etc. | Same |
| Power
Source | AAA Lithium Battery | Rechargeable Lithium Battery | Similar |
| Cuff | Wrist warp around | Wrist warp around | Same |
| Display | LCD Display | Remote display on mobile devices | See
discussion |
| Wireless
Mode | None | Bluetooth | See
discussion |
| Data Storage | Local | On mobile devices and on server | See
discussion |
Our device is essentially identical to the predicate device in terms of indications for use, design, mechanism, and labeling between subject device and the predicate device. The several minor differences do not affect the safety and effectiveness of the device.
Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that "Electronic Sphygmomanometers (Model JN-163EW)" and its predicate devices have identical indications for use, design, mechanism, labeling, and similar performance, clinical tests.
The difference between the "Electronic Sphygmomanometers (Model JN-163EW)"and its predicate device do not raise any question regarding its safety and effectiveness.
"Electronic Sphygmomanometers (Model JN-163EW)", as designed and manufactured, are as safe and effective as its predicate device, and therefore is substantially equivalent as its predicate device.
The summary includes the conclusions drawn from the nonclinical and clinical tests (discussed above) that demonstrate that the device is as effective, and performs as well as or better than the predicate device according to 807.92(b)(3).