(97 days)
The Arm blood pressure monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.
The proposed device, Arm Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven both battery and AC power supply. 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, not for neonate or pregnancy. The measuring method for the Arm Blood Pressure Monitor is oscillation mensuration. And all values can be read out in one LCD panel. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data.The blood pressure storing 2x99 set memory value, each measurement it will automatically stored. When it stored 2x99 set memory value, the old value will be covered by the new one. It can show the latest 3 times average value. User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result: User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure, diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power.
This document is a 510(k) Premarket Notification from Xuzhou Yongkang Electronic Science Technology Co., Ltd. for their Arm Blood Pressure Monitor (Model YK-BPA1). It aims to demonstrate substantial equivalence to a legally marketed predicate device.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Arm Blood Pressure Monitor are primarily derived from the ISO 81060-2:2013 standard for clinical validation of automated non-invasive sphygmomanometers.
| Criteria Category | Acceptance Criteria (Standard) | Reported Device Performance (YK-BPA1) |
|---|---|---|
| Blood Pressure Accuracy | Mean difference within +/- 5 mmHg compared to standard reference. | Meets ISO 81060-2:2013 requirements (within +/- 5mmHg) |
| Pulse Rate Accuracy | +/- 5% of reading value | +/- 5% of reading value |
| Measurement Range (BP) | Not explicitly stated as acceptance, but device range. | 20-280 mmHg |
| Measurement Range (PR) | Not explicitly stated as acceptance, but device range. | 40-199 beats/min |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 150 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. It is implied to be a prospective study ("relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement").
3. Number of Experts and Qualifications for Ground Truth
- The document does not explicitly state the number of experts or their specific qualifications. It mentions that "Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device." This implies trained personnel were involved in taking the reference measurements, but their number and specific qualifications (beyond being "qualified") are not detailed.
4. Adjudication Method for Test Set
- The document does not specify a formal adjudication method (like 2+1 or 3+1). The ground truth was established through Auscultation using a qualified calibrated mercurial sphygmomanometer, which is a direct measurement method rather than a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the accuracy of an automated blood pressure monitor against a gold standard, not on how it assists human readers.
6. Standalone (Algorithm Only) Performance
- Yes, the performance study effectively evaluates the standalone performance of the Arm Blood Pressure Monitor. The study validates the accuracy of the device's automated measurements against a clinical gold standard (auscultation).
7. Type of Ground Truth Used
- Clinical Measurements / Expert Consensus (Implicit): The ground truth was established through auscultation using a qualified, calibrated mercurial sphygmomanometer. This involves direct physiological measurement, performed by what are assumed to be trained and qualified personnel (implicitly, experts in taking blood pressure measurements via auscultation).
8. Sample Size for Training Set
- The document does not provide information on the sample size for a training set. This is a medical device validation, and the provided clinical data is for performance testing, not for training an AI/ML algorithm. The device described appears to be a traditional automated blood pressure monitor, not an AI-driven one.
9. How Ground Truth for Training Set was Established
- Not applicable. The document describes the validation of a standard automated blood pressure monitor, not an AI/ML-driven device that requires a training set with established ground truth.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
March 24, 2019
Xuzhou Yongkang Electronic Science Technology Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608. No. 738. Shangcheng Rd., Pudong Shanghai, 200120 Cn
Re: K183491
Trade/Device Name: Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 17, 2018 Received: December 17, 2018
Dear Boyle Wang:
We have reviewed vour 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
Shawn W. Forrest -S 2019.03.24 22:04:34 -04'00'
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) K183491
Device Name Arm Blood Pressure Monitor
Indications for Use (Describe)
The Arm blood pressure monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Tab #06 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 submitter's information
Name: Xuzhou Yongkang Electronic Science Technology Co., Ltd Address: 4F Building C8, 40 Jingshan Road, Economic and Technological Development Zone, Xuzhou, Jiangsu,221000,China Tel: 86-516- 87892766-601 Fax: 86- 516-87892766 -606 Contact: Kai Li Date of Preparation: Mar.24.2019
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Arm Blood Pressure Monitor Common name: Noninvasive Blood Pressure Measurement System Classification name: Noninvasive Blood Pressure Measurement System Model(s): YK-BPA1
3.0 Classification
Production code: DXN Regulation number: 21 CFR 870.1130 Class II Classification: Panel: Cardiovascular
4.0 Predicate device information
Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Device: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D
{4}------------------------------------------------
510(k) number: K170605
5.0 Indication for Use Statement
The Arm Blood Pressure Monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.
6.0 Device description
The proposed device, Arm Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven both battery and AC power supply. 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, not for neonate or pregnancy.
The measuring method for the Arm Blood Pressure Monitor is oscillation mensuration. And all values can be read out in one LCD panel.
User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data.The blood pressure storing 2x99 set memory value, each measurement it will automatically stored. When it stored 2x99 set memory value, the old value will be covered by the new one. It can show the latest 3 times average value.
User can set the time as year, month, day, hour and minute;
User can enable or disable the function of voice broadcast about measurement result:
User can select the unit of the measurement: mmHg or KPa;
The device has the data storage function for data reviewing, including the data of systolic pressure, diastolic pressure, pulse rate and measurement time.
The device has low power indicator to indicate the states of low batteries power.
Cuff supporting the use of Xuzhou Yongkang electronic sphygmomanometer:
M5303(small adult)/M5304(adult)/ M5305(big 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 60601-1-2:2007, Medical electrical equipment - Part 1-2: General
{5}------------------------------------------------
requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 80601-2-30:2013, 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 intend use.
The clinical trials for YK-BPA1 were performed according the standard of ISO 81060-2:2013, 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 proposed device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2013 within the ±5mmHg.And the proposed device comply with the standard requirements and the accuracy the manufacture declared.
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Proposed device | Predicated deviceK170605 | Remark |
| Product Code | DXN | DXN | SE |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | SE |
| Class | II | II | SE |
| Intended Use | The Arm blood pressuremonitor is used formeasuring bloodpressure and pulse rate.The monitor can be usedin hospitals, families,schools and medicalcenters. It is suitable foradult, not for neonate orpregnancy. | Electronic blood pressuremonitor is intended tomeasure the bloodpressure and pulse rateof adult at household ormedical center. (Notsuitable for neonate,pregnancy orpre-eclampsia). | SE |
| Application | Upper Arm | Upper Arm | SE |
Table1-General Comparison
9.0 Technological Characteristic Comparison Table
{6}------------------------------------------------
| Site | |||
|---|---|---|---|
| PatientsContactingMaterials | Patient contact materialsof the cuff supporting theuse of Xuzhou Yongkangelectronicsphygmomanometer:M5303(smalladult)/M5304(adult)/M5305(big adult)provided by XuzhouMaikang Science andTechnology Ltd., andcleared by theCE(Declaration ofConformity for ClassI)/ISO andFDA(K151290). | Patient contact materialsof the cuff have beentested in accordance withISO10993 and FDAguidance. | SE |
| PatientPopulation | Adult | Adult | SE |
| MeasurementsItem | SYS,DYS,Pulse | SYS,DYS,Pulse | SE |
| Display | LCD Digital Display | LCD Digital Display | SE |
| DesignMethod | OscillometricMethod | OscillometricMethod | SE |
| MainComponent | LCD / Key / Cuff / MCU /Pump / Batteries(optional) / ACAdapter(optional) | LCD / Key / Cuff / MCU /Pump / Batteries(optional) / ACAdapter(optional) | SE |
Table2 Performance Comparison
| Item | Proposed Device | Predicate DeviceK170605 | Remark |
|---|---|---|---|
| BP Range | 20-280 mmHg | 0-280 mmHg | Analysis |
| BP Accuracy | $\pm$ 5mmHg | $\pm$ 3 mmHg | Analysis |
| PR Range | 40-199 beats/min | 40 ~ 200 beats/min | Analysis |
| PulseAccuracy | $\pm$ 5% of readingvalue | $\pm$ 5% of readingvalue | SE |
| OperationCondition | 5-40 °C15%-80% RH86kPa~105kPa | 10-40 °C15%-90% RH (nocondensation) | Analysis |
| StorageCondition | -20-55 °C$\le$ 95% RH | -20-55 °C15%-90% RH (no | Analysis |
{7}------------------------------------------------
| 50kPa $\sim$ 105kPa | condensation) | ||
|---|---|---|---|
| Data Storage | SYS, DIA, PR,Measurement Time, No. | SYS, DIA, PR,Measurement Time, No. | SE |
| PerformanceStandard | Comply with IEC80601-2-30 | Comply with IEC80601-2-30 | SE |
| CuffCircumference | 220mm $\sim$ 320mm | 220mm $\sim$ 320mm | Analysis |
| Power Supply | 4 AA batteries orAC Adapter | 4 AA batteries | SE |
Analysis
The proposed device is substantially equivalent to the predicate device. The differences between both devices are insignificant in terms of safety and effectiveness. Based on the nonclinical and clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
| Item | Proposed Device | Predicate DeviceK170605 | Remark |
|---|---|---|---|
| Electrical Safety | Comply with IEC60601-1 | Comply with IEC 60601-1 | SE |
| Home Use | Comply with IEC60601-1-11 | Comply with IEC60601-1-11 | SE |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | SE |
| Biocompatibility | Comply with ISO10993-1, FDAGuidance | Comply with ISO10993-1, FDA Guidance,Tests includedCytotoxicity, Sensitizationand IntracutaneousReactivity | SE |
| Label andLabeling | Conforms to FDARegulatoryRequirements | Conforms to FDARegulatory Requirements | SE |
| Level ofConcern of theSoftware | Moderate | Moderate | SE |
Table3 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
{8}------------------------------------------------
or effectiveness.The differences between both devices are insignificant in terms of safety and effectiveness.
§ 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).