(391 days)
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).
The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The series will automatically starting to take measurements after the inflation of the cuff finished, the results will show the systolic pressure and diastolic pressure and pulse rate. The monitor will store the measurements automatically, which including the time, date, blood pressure and pulse. The record could be revisited. Total 74 sets of data could be stored for YE670A, 60 sets of data for YE670D, 60 sets of data for YE650A, 80 sets of data for YE650D and 74 sets of data for YE660B.
The provided text describes the 510(k) premarket notification for a series of Upper Arm Type Electronic Blood Pressure Monitors (YE650A, YE650D, YE660B, YE670A, and YE670D). The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through novel clinical study data.
Therefore, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML or diagnostic device that would typically involve a test set, ground truth, expert consensus, or MRMC studies. This is a blood pressure monitor, and its performance acceptance criteria are typically met through validation against recognized standards like ANSI/AAMI/ISO 81060-2 and IEC 80601-2-30.
Here's an analysis based on the provided text, focusing on what is stated or implied about performance validation for this type of device:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for blood pressure monitors are established by international standards. The document states that the Performance of the devices (YE650A, YE650D, YE670A, YE670D, and YE660B) meets:
- ANSI/AAMI/ISO 81060-2
- IEC 80601-2-30
These standards specify the accuracy requirements for non-invasive sphygmomanometers. While the document doesn't explicitly present a table of acceptance criteria and reported performance values from a clinical study for these specific devices, it does provide the following specifications and states they comply with the standards:
| Parameter | Acceptance Criteria (Implied by standard compliance and predicate comparison) | Reported Device Performance (for all listed models) | Predicate Device Performance |
|---|---|---|---|
| Measurement Pressure Range | Typically defined by the standard. | 0 ~ 280 mmHg (0 kPa ~ 37.3 kPa) | 0 mmHg ~ 299 mmHg (0 kPa ~ 39.9 kPa) |
| Pressure Range Accuracy | ±3 mmHg (±0.4 kPa) or higher (as per ISO 81060-2 for mean and standard deviation) | ±3 mmHg (±0.4 kPa) | ±3 mmHg (±0.4 kPa) or 2% of reading |
| Measurement Pulse Range | Typically defined by the standard. | 40 ~ 200 beats/min | 40 ~ 180 beats/min |
| Pulse Accuracy | ±5% of reading value (as per ISO 81060-2) | ±5% of reading value | Within ±5% of reading |
The core "proof" of meeting acceptance criteria for this device type, as documented here, is the declaration of compliance with these recognized international standards. These standards encompass the clinical validation of blood pressure measuring devices.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the clinical validation studies that would have been conducted to demonstrate compliance with ANSI/AAMI/ISO 81060-2. These details are typically found in the full test reports, which are not part of this summary document. For ISO 81060-2, a specific number of subjects (e.g., typically at least 85 subjects with a certain distribution of blood pressures) are required for the clinical validation test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the context of a blood pressure monitor's clinical validation. The "ground truth" for blood pressure measurements in validation studies (per ISO 81060-2) involves simultaneous auscultatory measurements performed by trained observers (often two observers for redundancy and comparison), against which the device's readings are compared. It's not about expert interpretation of an image or signal.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable in the sense of image interpretation adjudication. For blood pressure validation per ISO 81060-2, the method involves comparing the device's readings to those obtained by two trained auscultatory observers, often with a third observer or specific rules for resolving discrepancies if the initial two observers differ beyond a defined threshold. The standard specifies statistical analysis methods (e.g., Bland-Altman plots, mean difference, standard deviation) to assess agreement.
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 is a standalone diagnostic device for blood pressure measurement, not an AI-assisted diagnostic tool that aids human readers in interpreting complex medical images or signals.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. Blood pressure monitors operate largely as "standalone" automated devices. The performance evaluation (compliance with ISO 81060-2) assesses the device's accuracy in measuring blood pressure values independently, which are then displayed to the user. There isn't an "algorithm only" vs. "human-in-the-loop" distinction in the same way as for, say, an AI diagnostic aid. The device itself is the "algorithm" providing the measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for non-invasive blood pressure monitors, as defined by ISO 81060-2, is typically simultaneous auscultatory measurements performed by trained and certified observers using a calibrated sphygmomanometer and stethoscope. This is considered the clinical gold standard for non-invasive blood pressure.
8. The sample size for the training set
Not applicable in the traditional sense of AI/ML training sets. Blood pressure monitors use established algorithms based on oscillometric principles, not machine learning algorithms trained on large datasets. The device's underlying algorithm is developed and refined by the manufacturer, but there isn't a "training set" like there would be for an AI model.
9. How the ground truth for the training set was established
Not applicable for the same reasons as point 8. The "ground truth" for the development of the oscillometric algorithm itself would be based on fundamental physiological principles and extensive engineering validation, likely drawing from datasets of pressure waveforms, but not a "training set" in the context of expert-labeled data for an AI model.
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March 27, 2018
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Rong Zhong Quality Assurance Yunyang Industrial Park Danyang, Jiangsu, China 212300
Re: K170605
Trade/Device Name: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 11, 2018 Received: February 26, 2018
Dear Rong Zhong:
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
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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.A. Willhelmme
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) K170605
Device Name
Upper Arm Type Electronic Blood Pressure Monitor Series Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D
Indications for Use (Describe)
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).
| Type of Use (Select one or both, as applicable) | Over-The-Counter Use (21 CFR 201.66) |
|---|---|
| ------------------------------------------------- | -------------------------------------- |
_ | 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 OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
-
- Date Prepared [21 CFR 807.92(a)(1)] 01/11/2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | Jiangsu Yuyue Medical Equipment& Supply Co., Ltd |
|---|---|
| Company Address: | Yunyang Industrial Park, Danyang, Jiangsu, China |
| Contact Person: | Rui, Li |
| Phone: | 0511-86900827 |
| Fax: | 0511-86900991 |
| Email: | Lirui@yuyue.com.cn |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic BloodPressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D |
|---|---|
| Common Name: | Electronic Blood Pressure Monitor Series |
| Product Code: | DXN |
| Regulation Number: | 870.1130 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of predicates within this submission is as follow:
| Predicate I | OMRON Healthcare (China) Co., Ltd. |
|---|---|
| Manufacturer: | |
| Trade Name: | Model HEM-7320 |
| Common Name: | Noninvasive Blood PressureMeasurement System |
| Product Code: | DXN |
| Classification Name: | Noninvasive blood pressure measurement |
| Regulation Number: | 21CFR 870.1130 |
| Classification: | Class II |
| FDA 510 (k) #: | K133383 |
-
- Description of the Device [21 CFR 807.92(a)(4)]
SECTION 7 - 2 of 5
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Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Image /page/4/Picture/2 description: The image shows the word "yuwell" in red font. The font is sans-serif and appears to be bolded. The word is slightly blurred, suggesting the image may be a close-up or a lower-resolution file.
The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The series will automatically starting to take measurements after the inflation of the cuff finished, the results will show the systolic pressure and diastolic pressure and pulse rate. The monitor will store the measurements automatically, which including the time, date, blood pressure and pulse. The record could be revisited. Total 74 sets of data could be stored for YE670A, 60 sets of data for YE670D, 60 sets of data for YE650A, 80 sets of data for YE650D and 74 sets of data for YE660B.
6. Intended Use [21 CFR 807.92(a)(5)]
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).
7. Technological Characteristic [21 CFR 807.92(a)(6)]
YE670series, YE650series and YE660B utilize modular design method, It consists of nine main modules: power-on self-test module, system initialization module, sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue.
The blood pressure monitor controls the pneumatic flow control module through single-chipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filter signal being read by single-chipped microcomputer for pressure and pulse signal, through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation/deflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.
SECTION 7 - 3 of 5
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Image /page/5/Picture/1 description: The image shows the text "K170605" in the upper left corner. Below this text is the word "yuwell" in a stylized, red font. The word is slightly blurred, giving it a sense of motion or depth. A black line is at the bottom of the image.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
| Table 1 | YE650A | YE650D | YE670A | YE670D | YE660B | Predicate Device |
|---|---|---|---|---|---|---|
| Product Code | DXN | DXN | DXN | DXN | DXN | DXN |
| Regulation No. | 870.1130 | 870.1130 | 870.1130 | 870.1130 | 870.1130 | 870.1130 |
| Classification | II | II | II | II | II | II |
| Intended Use | 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) | 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) | 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) | 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) | 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) | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. |
| 510 (k) Number | N/A | N/A | N/A | N/A | N/A | K133383 |
| Design Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method |
SECTION 7 - 1 of 5
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| IIIIIe | |
|---|---|
| PatientPopulation | Adult | Adult | Adult | Adult | Adult | Adult |
|---|---|---|---|---|---|---|
| MeasurementSite | Upper Arm | Upper Arm | Upper Arm | Upper Arm | Upper Arm | Upper Arm |
| CuffCircumference | 220mm ~ 320mm | 220mm ~ 320mm | 220mm ~ 320mm | 220mm ~ 320mm | 220mm ~ 320mm | 220mm ~420mm |
| InflationMethod | Automatic byelectronic pump | Automatic byelectronic pump | Automatic byelectronic pump | Automatic byelectronic pump | Automatic byelectronic pump | Automatic byelectronic pump |
| DeflationMethod | Automatic PressureRelease Valve | Automatic PressureRelease Valve | Automatic PressureRelease Valve | Automatic PressureRelease Valve | Automatic PressureRelease Valve | Automatic PressureRelease Valve |
| Display | LCD Digital Display | Backlight LCDDigital Display | LCD Digital Display | LCD Digital Display | LCD Digital Display | LCD Display |
| PatientsContactingMaterials | Patient contactmaterials of the cuffhave been tested inaccordance with ISO10993 and FDAguidance. | Patient contactmaterials of the cuffhave been tested inaccordance with ISO10993 and FDAguidance. | Patient contactmaterials of the cuffhave been tested inaccordance with ISO10993 and FDAguidance. | Patient contactmaterials of the cuffhave been tested inaccordance with ISO10993 and FDAguidance. | Patient contactmaterials of the cuffhave been tested inaccordance with ISO10993 and FDAguidance. | Patient contactmaterial of the cuffhave been tested inaccordance with ISO10993 and FDAguidance. |
| Memory Size | Up to 60sets of data | Up to 80 sets of data | Up to 74 sets of data | Up to 60 sets of data | Up to 74 sets of data | Up to 100 sets ofdata |
| MeasurementPressure Range | 0 ~ 280 mmHg (0kPa ~ 37.3 kPa) | 0~280 mmHg (0kPa ~ 37.3 kPa) | 0 ~ 280 mmHg (0kPa ~ 37.3 kPa) | 0 ~ 280 mmHg (0kPa ~ 37.3 kPa) | 0~280mmHg (0-37.3kPa) | 0 mmHg ~ 299mmHg(0 kPa~ 39.9kPa) |
| Range Accuracy | 士3 mmHg(±0.4kPa) | 士3 mmHg(±0.4kPa) | ±3 mmHg(±0.4kPa) | 士3 mmHg(±0.4kPa) | 士3mmHg(±0.4kPa) | 土3mmHg(±0.4kPa)or 2% ofreading |
| MeasurementPulse Range | 40 ~ 200 beats/min | 40 ~ 200 beats/min | 40 ~ 200 beats/min | 40 ~ 200 beats/min | 40 ~ 200 beats/min | 40 ~ 180 beats/min |
| Pulse Accuracy | ±5% of readingvalue | 土5% of readingvalue | ±5% of readingvalue | ±5% of readingvalue | 土5% of readingvalue | Within ±5%ofreading |
| PressurizationSource | AutomaticPressurize | AutomaticPressurize | AutomaticPressurize | AutomaticPressurize | AutomaticPressurize | Automatic InternalPump |
| Pressure Sensor | SemiconductorPressure Sensor | SemiconductorPressure Sensor | SemiconductorPressure Sensor | SemiconductorPressure Sensor | SemiconductorPressure Sensor | SemiconductorPressure Sensor |
| OperatingEnvironment | Temperature: +10 °C~ +40 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: +10 °C~ +40 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: +10 °C~ +40 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: +10 °C~ +40 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: +10 °C~ +40 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: +10 °C (50-104 °F)Humidity: 30% RH~ 85% RH(nocondensation) |
| StorageEnvironment | Temperature: -20 °C~ +55 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: -20 °C~ +55 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: -20 °C~ +55 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: -20 °C~ +55 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: -20 °C~ +55 °CHumidity: 15% RH~ 90% RH(nocondensation) | Temperature: -20 °C~ +60 °CHumidity: 10% RH~ 95% RH(nocondensation) |
| Energy Source | 4 AA batteries | 4 AA batteries | 4 AA batteries | 4 AA batteries | 4 AA batteries | 4 AA batteries orAC Adapter |
| Display Content | Cuff Pressure, Pulse,Date,Time,Systolic/DiastolicPressure, errormessage,measurementsresults in memory,Irregular Heart BeatFeature, Bodymovement detectionCuff WrappingDetection | Cuff Pressure, Pulse,Date,Time,Systolic/DiastolicPressure, errormessage,measurementsresults in memory,Irregular Heart BeatFeature, Bodymovement detectionCuff WrappingDetection | Cuff Pressure, Pulse,Date,Time,Systolic/DiastolicPressure, errormessage,measurementsresults in memory,Irregular Heart BeatFeature, Bodymovement detectionCuff WrappingDetection | Cuff Pressure, Pulse,Date,Time,Systolic/DiastolicPressure, errormessage,measurementsresults in memory,Irregular Heart BeatFeature, Bodymovement detectionCuff WrappingDetection | Cuff Pressure, pulse,Systolic/Diastolic,error message,measurement resultsin the memory, Date,Time. | Cuff Pressure,Systolic/DiastolicPressure, pulse rate,error message,measurement resultsin the memory |
| Controls | SET Button,Plus/Minus Button,START/PULSEButton | SET Button,Plus/Minus Button,START/PULSEButton | SET Button,Memory Button,START/PULSEButton | SET Button,Memory Button,START/PULSEButton | Memory Button,Start Button | START/STOPbutton, Date/TimSetting Button,UP/DOWN Button,USER ID SelectionsButton |
| Performance | ANSI/AAMI/ISO81060-2IEC80601-2-30 | ANSI/AAMI/ISO81060-2IEC80601-2-30 | ANSI/AAMI/ISO81060-2IEC80601-2-30 | ANSI/AAMI/ISO81060-2IEC80601-2-30 | ANSI/AAMI/ISO81060-2IEC80601-2-30 | ANSI/AAMI/ISO81060-2IEC80601-2-30 |
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SECTION 7 - 3 of 5
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| Biocompatibility | ISO 10993-1, FDAGuidance, TestsincludedCytotoxicity,Sensitization andIntracutaneousReactivity | ISO 10993-1, FDAGuidance, TestsincludedCytotoxicity,Sensitization andIntracutaneousReactivity | ISO 10993-1, FDAGuidance, TestsincludedCytotoxicity,Sensitization andIntracutaneousReactivity | ISO 10993-1, FDAGuidance, TestsincludedCytotoxicity,Sensitization andIntracutaneousReactivity | ISO 10993-1, FDAGuidance, TestsincludedCytotoxicity,Sensitization andIntracutaneousReactivity | ISO 10993-1, FDAGuidance, TestsincludedCytotoxicity,Sensitization andIntracutaneousReactivity |
|---|---|---|---|---|---|---|
| Electrical Safety | IEC60601-1 | IEC60601-1 | IEC60601-1 | IEC60601-1 | IEC60601-1 | IEC60601-1 |
| EMC | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 |
| Home Use | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 |
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Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
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9. Conclusion [21 CFR 807.92(b)(3)]
The Upper Arm Type Electronic Blood Pressure Monitor650A, 650D, 670A, 670D and 660B are substantially equivalent to predicate device because both devices use identical technology and same intended use, also testing standards are identical with the predicates. The differences between both devices are insignificant in terms of safety and effectiveness.
SECTION 7 - 5 of 5
§ 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).