(207 days)
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.
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.
The provided document describes the 510(k) submission for the Electronic Sphygmomanometer (Model JN-163EW). This submission demonstrates the device's substantial equivalence to a predicate device and includes information about performance testing, including clinical trials.
However, the document does not provide the detailed acceptance criteria and a study that proves the device meets those criteria in the format requested. Specifically, it lacks:
- A table of specific quantitative acceptance criteria for blood pressure measurement accuracy (e.g., mean absolute difference, standard deviation) and the corresponding reported performance values for the subject device.
- Detailed information about the sample size, data provenance, ground truth establishment, expert qualifications, and adjudication methods for the clinical study.
- Information about MRMC studies or independent standalone algorithm performance.
The document states that clinical trials were performed according to ISO 81060-2:2019+A1:2020, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. This standard defines the methodology for clinically validating automated sphygmomanometers, including acceptance criteria. While the submission states that "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement," it does not present the results of this clinical trial against the acceptance criteria outlined in the standard.
Therefore, I cannot fully answer the request based on the provided text, as the specific performance data against defined acceptance criteria is missing. I can, however, extract what information is present regarding the clinical study and identify what is missing.
Based on the provided text, here is what can be inferred and what is explicitly missing regarding the acceptance criteria and study:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a table. However, the document mentions that "The clinical trials for the Electronic Sphygmomanometers were performed according to the standard ISO 81060-2:2019+A1:2020." This ISO standard defines specific accuracy requirements for automated sphygmomanometers. For example, ISO 81060-2 typically requires:
- Mean difference between the device and reference method to be within ±5 mmHg.
- Standard deviation of the difference to be within 8 mmHg.
- Specific percentages of measurements falling within ±5 mmHg, ±10 mmHg, and ±15 mmHg.
- These apply to both systolic and diastolic blood pressure.
- Reported Device Performance: NOT PROVIDED IN THE DOCUMENT. The document states that performance testing was carried out and that the device meets "performance specifications for its intended use" and that "clinical tests" demonstrate effectiveness, but it does not provide the numerical results (e.g., mean difference, standard deviation) from the clinical study that would demonstrate it met the ISO 81060-2 criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document only states "relevant volunteers were collected." The specific number required by ISO 81060-2 is typically at least 85 subjects with sufficient blood pressure distribution across different ranges (hypertensive, normotensive, hypotensive). The document does not specify the actual number of subjects used in this study.
- Data Provenance: Not explicitly stated. Likely collected prospectively as it refers to "actual clinical trial." The country of origin of the data is not specified, but given the manufacturer is in China, it's plausible the study was conducted there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Establishment: The ISO 81060-2 standard requires ground truth for blood pressure measurements to be established by two or more trained observers using a reference sphygmomanometer (e.g., mercury or an accepted equivalent).
- Number and Qualifications of Experts: The document does not specify the number of experts or their qualifications (e.g., trained clinicians, physicians) used for establishing the ground truth in this particular study.
4. Adjudication method for the test set:
- Adjudication Method: ISO 81060-2 typically involves multiple observers taking simultaneous measurements on the same subject. The standard specifies how the readings from these observers are to be handled (e.g., averaging of simultaneous readings from two independent observers, with a third observer if there's a significant discrepancy). The document does not explicitly state the adjudication method used, beyond the general reference to adherence to ISO 81060-2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is an Electronic Sphygmomanometer, which directly measures blood pressure. It is not an AI-based diagnostic imaging device that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a standalone automated device. Its "algorithm" is the oscillometric method embedded in the device to calculate blood pressure. The clinical validation per ISO 81060-2 is effectively a standalone performance test, comparing the device's readings to standard reference measurements performed by human observers.
7. The type of ground truth used:
- The ground truth for blood pressure measurement, as per ISO 81060-2, is typically established through simultaneous auscultatory measurements performed by trained human observers using a reference sphygmomanometer (e.g., mercury or appropriately calibrated aneroid/electronic device). This is a highly controlled clinical measurement.
8. The sample size for the training set:
- Not Applicable/Not Provided. Electronic sphygmomanometers using the oscillometric method are based on established biophysical principles and do not typically involve a "training set" in the machine learning sense. Their internal algorithms are generally fixed based on these principles and extensive engineering validation, rather than being "trained" on a large dataset of patient measurements to learn patterns. If any internal parameters were optimized, the document does not mention it or the size of such a dataset.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided, for the same reasons as point 8.
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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.
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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
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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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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:
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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
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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 |
|---|---|---|---|
| Indicationfor Use | Electronic Sphygmomanometer(Model JN-163EW) is a home usedigital monitor intended for use inmeasuring blood pressure in adultpatient population with wristcircumference ranging from 13.5 cmto 19.5 cm.The device is not intended to be adiagnostic device. Contact yourphysician if hypertensive values areindicated. | XM-01 Automatic Electronic BloodPressure Monitor is a home use digitalmonitor intended for use in measuringblood pressure and pulse rate in adultpatient population with wristcircumference ranging from 13.5 cmto 19.5 cm.The device is not intended to be adiagnostic device. Contact yourphysician if hypertensive values areindicated. | Same |
| Component | Main Unit, Cuff, Battery | Main Unit, Cuff, Battery | Same |
| MeasurementMethod | Oscillographic | Oscillographic | Same |
Table 1: Comparison of Intended Use, Mechanism, Labeling, and Design
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| User Control | User can manually controlmeasurement | User controls measurement frommobile devices through mobileapplication software | Minordifference |
|---|---|---|---|
| Labelling | Company Name and Address,Specifications, ProductDescriptions, Indications for Use,Contraindication for Use,Precautions, Warnings, SafetyTerms and Conditions, Safety AlertDescription, Safety and PerformanceStandards, etc. | Company Name and Address,Specifications, Product Descriptions,Indications for Use, Contraindicationfor Use, Precautions, Warnings, SafetyTerms and Conditions, Safety AlertDescription, Safety and PerformanceStandards, etc. | Same |
| PowerSource | AAA Lithium Battery | Rechargeable Lithium Battery | Similar |
| Cuff | Wrist warp around | Wrist warp around | Same |
| Display | LCD Display | Remote display on mobile devices | Seediscussion |
| WirelessMode | None | Bluetooth | Seediscussion |
| Data Storage | Local | On mobile devices and on server | Seediscussion |
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).
§ 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).