(171 days)
No
The summary describes a standard oscillometric blood pressure monitor using a fixed algorithm (BPM-WAU V2.0-201109) and does not mention any AI/ML components or training/test data.
No.
The device is a diagnostic tool for measuring blood pressure and pulse rate, not a device intended for treating a disease or condition.
Yes
Explanation: The device measures blood pressure and pulse rate, providing physiological information that can be used to monitor a patient's health and potentially identify abnormalities (like irregular heartbeat). Though not diagnosing a specific condition, it provides data essential for medical assessment, fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "Fully Automatic Electronic Blood Pressure Monitor" and describes hardware components like an inflatable cuff, pressure sensor technology, and an LCD display. It also mentions testing according to standards for electrical safety and electromagnetic compatibility, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor measures blood pressure and pulse rate by using a cuff wrapped around the wrist. This is a non-invasive measurement performed directly on the body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it's a "non-invasive blood pressure measurement system."
Therefore, this device falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DXN
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.
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
Intended User / Care Setting
medical professionals or at home
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human profiles facing right. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
1
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
2
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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3
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
4
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 |
5
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
6
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 and | ||||
| mode | BP7S Wireless | |||
| Blood | ||||
| Pressure Wrist | ||||
| Monitor | KD-721 Wireless | |||
| Blood | ||||
| Pressure Wrist | ||||
| Monitor | KD-723 Wireless | |||
| Blood | ||||
| Pressure Wrist | ||||
| Monitor | The name is different | |||
| because the model is | ||||
| different. | ||||
| Intended Use | Monitor and | |||
| display diastolic, | ||||
| systolic blood | ||||
| pressure and pulse | ||||
| rate | Monitor and | |||
| display diastolic, | ||||
| systolic blood | ||||
| pressure and pulse | ||||
| rate | Monitor and | |||
| display diastolic, | ||||
| systolic blood | ||||
| pressure and | ||||
| pulse 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 | |||
| (exclude | ||||
| batteries) | The weight and is | |||
| different, because the | ||||
| appearance is changed. | ||||
| Dimensions | 72mmX74mmX17. | |||
| 6mm | 78mm×60mm | |||
| ×28mm | 80mm×60mm | |||
| ×22mm | But the test conform that | |||
| this does not impact | ||||
| safety and effectiveness. | ||||
| Memory | NA | 2×60 times | 2×60 times | Although the memory |
| function is changed, there | ||||
| is no impact on safety and | ||||
| effectiveness for this | ||||
| change. | ||||
| Displayed | ||||
| Calculated | ||||
| Parameters | SYS | |||
| DIA | ||||
| Pulse | ||||
| IHB | SYS | |||
| DIA | ||||
| Pulse | ||||
| IHB | SYS | |||
| DIA | ||||
| Pulse | ||||
| IHB | Same | |||
| Display | ||||
| component | 1 LCD | |||
| 2 Display on Smart | ||||
| Phone | 1 LCD | |||
| 2 Display on Smart | ||||
| Phone | 1 LCD | |||
| 2 Display on | ||||
| Smart Phone | Same | |||
| Average | ||||
| function | No average | |||
| function | average value of | |||
| all the results | ||||
| measured from 5 | ||||
| o'clock to 9 o'clock | ||||
| in last 7 days | Averaging all the | |||
| results | Although the average | |||
| function is changed , this | ||||
| will not impact on safety | ||||
| and effectiveness. | ||||
| Other | ||||
| Displayed | Date | |||
| Time | Date | |||
| Time | Date | |||
| Time | Same | |||
| Information | ||||
| Memory | ||||
| Battery usage | ||||
| Bluetooth symbol | ||||
| charge symbol | ||||
| sync symbol | ||||
| (Displayed on | ||||
| device) | Memory | |||
| Battery usage | ||||
| Bluetooth symbol | ||||
| Blood pressure | ||||
| classification | ||||
| (Displayed on | ||||
| device) | Memory | |||
| Battery usage | ||||
| Bluetooth symbol | ||||
| Blood pressure | ||||
| classification | ||||
| (Displayed on | ||||
| device) | ||||
| Other | ||||
| Features | Transmit data to | |||
| smart phone via | ||||
| Bluetooth | ||||
| WHO classification | Transmit data to | |||
| smart phone via | ||||
| Bluetooth | ||||
| JNC classification | Transmit data to | |||
| smart phone via | ||||
| Bluetooth | ||||
| WHO | ||||
| classification | Same data transmission | |||
| The classification of | ||||
| KD-721 is different, but | ||||
| this change will not affect | ||||
| safety and effectiveness. | ||||
| Apps on smart phone | ||||
| Function on | ||||
| app | Storage test result/ | |||
| Read memories in | ||||
| App/Delete | ||||
| memories in app/ | ||||
| Draw table and | ||||
| graph/Set alarm in | ||||
| app/Set the | ||||
| personal | ||||
| information in app/ | ||||
| Share history data | ||||
| in app | Storage and | |||
| display test results | ||||
| only | Storage and | |||
| display test | ||||
| results only | The new device can only | |||
| store test results and | ||||
| display, but this change | ||||
| will not affect safety and | ||||
| effectiveness | ||||
| Electrical Power | ||||
| Battery | 1*3.7V Li-ion | |||
| 400mAh | 2x1.5V SIZE AAA | 2x1.5V SIZE AAA | The battery is changed, t | |
| but this will not affect | ||||
| safety 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 storage |
| temperature of KD-721 | ||||
| and KD-723 is changed, | ||||
| this will not affect safety | ||||
| and effectiveness | ||||
| Humidity | ≤85% | ≤85% | ≤85% | Same |
| Performance | NIBP | |||
| Pulse Rate | 40 --- | 40 --- | 40 --- | Same |
| Range | 180times/min | 180times/min | 180times/min | Same |
| Pulse Rate | ||||
| Accuracy | Within ±5% | Within ±5% | Within ±5% | Same |
5- 4
7
K163276
8
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.