(29 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and basic data processing (classification, averaging, irregular heartbeat detection). There is no mention of AI, ML, or related concepts.
No
The device is intended to measure blood pressure and pulse rate, not to treat or cure a disease or condition. It is a diagnostic/monitoring device.
Yes.
The device measures and classifies blood pressure, detects irregular heartbeats, and displays these findings to the user, which are all diagnostic functions.
No
The device description explicitly mentions an "inflatable cuff" and "silicon integrates pressure sensor technology," indicating the presence of hardware components beyond just software. It also mentions being manufactured according to IEC 80601-2-30, which is a standard for automated non-invasive sphygmomanometers, further confirming it's a hardware device with software functionality.
Based on the provided information, the iHealth Track Blood Pressure Monitor (KN-550BT) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The iHealth Track Blood Pressure Monitor is a non-invasive device that measures blood pressure and pulse rate directly from the upper arm. It does not analyze any biological specimens.
The device description clearly states its function is to measure blood pressure and pulse rate using a cuff wrapped around the arm, which is a physical measurement, not an in vitro analysis.
N/A
Intended Use / Indications for Use
iHealth Track Blood Pressure Monitor(KN-550BT) is for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the usper arm. The cuff circumference is limited to 22cm-48cm.
Product codes
DXN
Device Description
iHealth Track Blood Pressure Monitor(KN-550BT) is 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, 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. More over, it also obtains the function of averaging the measurement results. The new devices achieves its function by LCD or iOS/Andriod devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
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 KN-550BT Track Blood Pressure Monitor bring new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human figures, one behind the other, with their arms raised.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2016
Andon Health Co., Ltd Ms. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, 300190 CN
Re: K160014
Trade/Device Name: iHealth Track Blood Pressure Monitor (KN-550BT) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 30, 2015 Received: January 4, 2016
Dear Ms. 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 yours.
Mitchell Stein
for 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) K160014
Device Name
iHealth Track Blood Pressure Monitor (KN-550BT)
Indications for Use (Describe)
iHealth Track Blood Pressure Monitor(KN-550BT) is for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the usper arm. The cuff circumference is limited to 22cm-48cm.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K160014
Page 1 of 4
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: | 12/15/2015 |
2.0 Device information
Trade name: iHealth Track Blood Pressure Monitor (KN-550BT)
iHealth Track Blood Pressure Monitor Device name:
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. KD-927 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K141984
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K160014 Page 2 of 4
5.0 Intended use
iHealth Track Blood Pressure Monitor(KN-550BT) is for use by medical professionals or at home and are 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 upper arm. The cuff circumference is limited to 22cm-48cm.
The intended use and the indication for use of iHealth Track Blood Pressure Monitor(KN-550BT), as described in its labeling are the same as the predicate device KD-927 (K141984).
6.0 Device description
iHealth Track Blood Pressure Monitor(KN-550BT) is 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, 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. More over, it also obtains the function of averaging the measurement results. The new devices achieves its function by LCD or iOS/Andriod devices.
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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K160014 Page 3 of 4
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 KN-550BT Track Blood Pressure Monitor bring new questions of safety and effectiveness.
9.0 Performance summary
iHealth Track Blood Pressure Monitor(KN-550BT) 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 60601-1-2:2007/(R)2012, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3)
- · IEC 80601-2-30 Edition 1.1 2013-07, Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers
10.0 Comparison to the predicate device and the conclusion
iHealth Track Blood Pressure Monitor(KN-550BT) is substantially equivalent to Fully Automatic Electronic Blood Pressure Monitor KD-927 whose 510(k) the number is K141984.
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K160014 Page 4 of 4
The new device KN-550BT is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory capacity, electrical power, measure process, average measure function and the MCU are different, and a new software platform has been added.
However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.