(171 days)
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
The provided text describes the acceptance criteria and the study for the KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor.
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to compliance with particular standards, which implicitly define the acceptance criteria for certain performance aspects. The device characteristics are compared to those of a predicate device (iHealth View BP7S Wireless Blood Pressure Wrist Monitor, K152379) and a previous device (KD-972, K121470).
| Feature / Acceptance Criteria | Reported Device Performance (KD-721/723) |
|---|---|
| Pulse Rate Range | 40 - 180 times/min |
| Pulse Rate Accuracy | Within ±5% |
| Systolic Range | 60 - 260 mmHg |
| Diastolic Range | 40 - 199 mmHg |
| Pressure Accuracy | Within ±3 mmHg |
| Cuff Pressure Range | 0 - 300 mmHg |
| Overpressure Limit | 300 mmHg |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2:2014 |
| Electrical Safety | Complies with IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 |
| Safety & Performance Characteristics | Complies with IEC 80601-2-30:2009 & A1:2013 |
2. Sample size used for the test set and the data provenance:
The document states that the clinical test report of KD-972 (cleared in 2012 as K121470) was used for evaluating KD-721/723. This implies retrospective use of clinical data.
The document states that KD-972 conformed to ANSI/AAMI/ISO 81060-2:2009 & 2013. These standards typically outline the requirements for clinical validation studies for automated sphygmomanometers, which involve a specific number of subjects. However, the exact sample size for the test set is not explicitly stated in the provided text. The data provenance is not specified beyond being from a previous device's clinical trial conforming to international standards (ANSI/AAMI/ISO 81060-2), which generally requires multi-center data from diverse populations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Clinical validation studies for blood pressure monitors generally involve trained observers (often medical professionals) to perform reference measurements.
4. Adjudication method for the test set:
The document does not specify the adjudication method used for the test set.
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:
This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool that involves human readers interpreting output. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done through the reference to the KD-972 clinical test report, which conformed to ANSI/AAMI/ISO 81060-2:2009 & 2013. This standard specifically outlines the requirements for evaluating the accuracy of automated sphygmomanometers, which inherently tests the algorithm's performance in measuring blood pressure values.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for blood pressure monitors in clinical validation studies conforming to ANSI/AAMI/ISO 81060-2 is typically established through auscultatory measurements performed by trained observers using a mercury sphygmomanometer or an equivalent reference device, often in a double-blinded protocol to minimize bias. This is a form of expert reference measurement.
8. The sample size for the training set:
The document states that the algorithm version (BPM-WAU V2.0-201109) is the same for KD-721/723 and the previously cleared KD-972. This implies that the algorithm was trained prior to the KD-972 clearance (K121470 in 2012). The sample size for the training set is not provided in this document, as the focus is on the clinical validation of the device using an existing algorithm.
9. How the ground truth for the training set was established:
Given that the algorithm is based on "oscillometric and silicon integrates pressure sensor technology" and is a "fully automatic" device, the ground truth for its original training would have been established through a combination of simulated data and clinical data where reference blood pressure measurements (e.g., auscultatory method by trained experts) were used to optimize the algorithm's performance in detecting systolic, diastolic, and pulse rate. The specific details of the training data and ground truth establishment are not provided in this document.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
Andon Health Co.,ltd Liu Yi President No 3, Jin Ping St, Ya An Rd Nankai District Tianjin, 300190 CN
Re: K163276
Trade/Device Name: KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 6, 2017 Received: April 10, 2017
Dear Liu Yi:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Hillemann
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-the-Counter Use |
|---|---|
| --------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
ver-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Preparation: | 11/15/2016 |
2.0 Device information
| Trade | name: | KD-721 | and | KD-723 | Fully | Automatic |
|---|---|---|---|---|---|---|
| Electronic Blood Pressure Monitor | ||||||
| Common name: | Noninvasive blood pressure measurement system |
Classification name: Noninvasive blood pressure measurement system
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd. Device: iHealth View BP7S Wireless Blood Pressure Wrist Monitor 510(k) number: K152379
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5.0 Intended use
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.
The intended use and the indication for use of KD-721 and KD-723, as described in its labeling are the same as the predicate device BP7S (K152379).
6.0 Device description
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
7.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Similar |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
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8.0 Discussion of non-clinical and clinical test performed
Non-clinical Tests have been done as follows:
a. Electromagnetic compatibility test according to IEC 60601-1-2;
b. Electrical safety according test to IEC 60601-1;
c. Safety and performance characteristics of the test according to IEC 80601-2-30
None of the test demonstrates that KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness.
Clinical Tests discussion
KD-721/723 and KD-972(cleared in 2012 as K121470) are blood pressure monitors based on oscillometric and silicon integrates pressure sensor technology, when inflating the cuff, systolic and diastolic signal will be collected, using the algorithm to get final value and record. The algorithm version of both the new device and KD-972 is: BPM-WAU V2.0-201109, and the cuff size used is exactly the same, so the clinical test report of KD-972(that conformed to ANSI/AAMI/ISO 81060-2:2009 & 2013) can be used for evaluating KD-721/723.
9.0 Performance summary
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- · IEC 60601-1-2:2014.Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
10.0 Comparison to the predicate device and the conclusion
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Our device KD-721 and KD-723 Fully Automatic Electronic are substantially equivalent to iHealth BP7S Wireless Blood Pressure Wrist Monitor whose 510(k) number is K152379.
| Item | Predicate Device | Subject Device | Device | Comparison |
|---|---|---|---|---|
| Name andmode | BP7S WirelessBloodPressure WristMonitor | KD-721 WirelessBloodPressure WristMonitor | KD-723 WirelessBloodPressure WristMonitor | The name is differentbecause the model isdifferent. |
| Intended Use | Monitor anddisplay diastolic,systolic bloodpressure and pulserate | Monitor anddisplay diastolic,systolic bloodpressure and pulserate | Monitor anddisplay diastolic,systolic bloodpressure andpulse rate | Same |
| Rx or OTC | OTC | OTC | OTC | Same |
| Population | Adult | Adult | Adult | Same |
| Cuff Location | Wrist | Wrist | Wrist | Same |
| Physical Attributes | ||||
| Weight | About 114g(include cuff) | About 67g(exclude batteries) | About 69g(excludebatteries) | The weight and isdifferent, because theappearance is changed. |
| Dimensions | 72mmX74mmX17.6mm | 78mm×60mm×28mm | 80mm×60mm×22mm | But the test conform thatthis does not impactsafety and effectiveness. |
| Memory | NA | 2×60 times | 2×60 times | Although the memoryfunction is changed, thereis no impact on safety andeffectiveness for thischange. |
| DisplayedCalculatedParameters | SYSDIAPulseIHB | SYSDIAPulseIHB | SYSDIAPulseIHB | Same |
| Displaycomponent | 1 LCD2 Display on SmartPhone | 1 LCD2 Display on SmartPhone | 1 LCD2 Display onSmart Phone | Same |
| Averagefunction | No averagefunction | average value ofall the resultsmeasured from 5o'clock to 9 o'clockin last 7 days | Averaging all theresults | Although the averagefunction is changed , thiswill not impact on safetyand effectiveness. |
| OtherDisplayed | DateTime | DateTime | DateTime | Same |
| Information | ||||
| MemoryBattery usageBluetooth symbolcharge symbolsync symbol(Displayed ondevice) | MemoryBattery usageBluetooth symbolBlood pressureclassification(Displayed ondevice) | MemoryBattery usageBluetooth symbolBlood pressureclassification(Displayed ondevice) | ||
| OtherFeatures | Transmit data tosmart phone viaBluetoothWHO classification | Transmit data tosmart phone viaBluetoothJNC classification | Transmit data tosmart phone viaBluetoothWHOclassification | Same data transmissionThe classification ofKD-721 is different, butthis change will not affectsafety and effectiveness. |
| Apps on smart phone | ||||
| Function onapp | Storage test result/Read memories inApp/Deletememories in app/Draw table andgraph/Set alarm inapp/Set thepersonalinformation in app/Share history datain app | Storage anddisplay test resultsonly | Storage anddisplay testresults only | The new device can onlystore test results anddisplay, but this changewill not affect safety andeffectiveness |
| Electrical Power | ||||
| Battery | 1*3.7V Li-ion400mAh | 2x1.5V SIZE AAA | 2x1.5V SIZE AAA | The battery is changed, tbut this will not affectsafety and effectiveness. |
| Environmental Operation | ||||
| Temperature | 10~40°C | 10~40°C | 10~40°C | Same |
| Humidity | ≤85% | ≤85% | ≤85% | Same |
| Environmental Storage | ||||
| Temperature | -20~55°C | -20~50°C | -20~50°C | Although the storagetemperature of KD-721and KD-723 is changed,this will not affect safetyand effectiveness |
| Humidity | ≤85% | ≤85% | ≤85% | Same |
| Performance | NIBP | |||
| Pulse Rate | 40 --- | 40 --- | 40 --- | Same |
| Range | 180times/min | 180times/min | 180times/min | Same |
| Pulse RateAccuracy | Within ±5% | Within ±5% | Within ±5% | Same |
5- 4
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K163276
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K163276
| KD-721 and 723 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files |
|---|
| ----------------------------------------------------------------------------------- |
| Technique/Method | Oscillometric | Oscillometric | Oscillometric | Same |
|---|---|---|---|---|
| Measure process | Measure during inflating | Measure during inflating | Measure during inflating | Same |
| Systolic Range | 60-260mmHg | 60-260mmHg | 60-260mmHg | Same |
| Diastolic Range | 40-199mmHg | 40-199mmHg | 40-199mmHg | Same |
| Pressure Accuracy | Within ±3mmHg | Within ±3mmHg | Within ±3mmHg | Same |
| Cuff Pressure Range | 0-300mmHg | 0-300mmHg | 0-300mmHg | Same |
| Overpressure Limit | 300mmHg | 300mmHg | 300mmHg | Same |
| Microprocess or | MB9AFB44N | цPD78F0485 | цPD78F0485 | Although the MCU is different, this change will not affect safety and effectiveness |
| Algorithm | Amplitude | Amplitude | Amplitude | Same |
KD-721 and KD-723 is very similar with its predicate device in the intended use, the design principle, the data transmission mode, the material, the performance and the applicable standards. Only their appearance, the memory capacity, the average function, the power and the MCU are different.
However, the test in this submission provides demonstrates that these small differences do not raise any new questions 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).