(184 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a blood pressure monitor designed for measurement and monitoring, not for treating a condition.
Yes
The device measures blood pressure and pulse rate, providing information that can be used to monitor a patient's health and detect irregular heartbeats, which are indicators of potential medical conditions.
No
The device description explicitly mentions hardware components like an inflatable cuff, pressure sensor, and the device itself is described as an "Electronic Sphygmomanometer" and "Wireless Blood Pressure Monitor," indicating it is a physical device with integrated software.
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 BPM1 is a non-invasive blood pressure measurement system. It measures blood pressure and pulse rate by applying a cuff to the upper arm. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for measuring blood pressure and pulse rate, which are physiological parameters, not diagnostic tests on biological samples.
- Device Description: The description focuses on the oscillometric principle and pressure sensor technology used for measuring blood pressure, not on analyzing biological samples.
Therefore, the BPM1 falls under the category of a non-invasive medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BPM1 (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to 18.9" (22cm-48cm)
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
iHealth BPM1 Wireless 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, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. The new devices can connect to iOS or Andriod devices to show the results.
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 individual
Intended User / Care Setting
professional setting 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 BPM1 Wireless Blood Pressure Monitor bring new questions of safety and effectiveness.
Clinical data have been transferred from the predicates.
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.
Not Found
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).
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2017
Andon Health Co., Ltd Mr. Liu Yi President No 3 Jinping Street Ya An Road Nankai District Tianjin, 300190 CHINA
Re: K162144
Trade/Device Name: iHealth Wireless Blood Pressure Monitor (BPM1) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 23, 2016 Received: December 27, 2016
Dear Mr. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
Sincerely,
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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Indications for Use
510(k) Number (if known) K162144
Device Name
iHealth Wireless Blood Pressure Monitor (BPM1)
Indications for Use (Describe)
The BPM1 (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to 18.9" (22cm-48cm)
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 801 Subpart D) | Over-The-Counter Use (81 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------- | ----------------------------------------------------------- |
_ | 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
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: 7/27/2016 |
2.0 Device information
Trade name: iHealth BPM1 Wireless Blood Pressure Monitor
Device name: iHealth Wireless Blood Pressure Monitor
Classification name: Noninvasive blood pressure measurement system
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Requlation 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
Manufacturer: Andon Health Co., Ltd. Device: KD-936 Fully Automatic Wireless Blood Pressure Monitor 510(k) number: K120672
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Manufacturer: Andon Health Co., Ltd. KD-931 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K102939
5.0 Intended use
BPM1(Electronic Sphygmomanometer) is intended for use in a The professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic and diastolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to18 .9"(22cm-48cm) intended use and the indication for use of The iHealth BPM1 Wireless Blood Pressure Monitor, as described in its labeling are the same as the predicate device KD-927 (K141984).
6.0 Device description
iHealth BPM1 Wireless 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, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. The new devices can connect to iOS or Andriod devices to show the results.
| 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 |
7.0 Summary comparing technological characteristics with predicate device
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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 BPM1 Wireless Blood Pressure Monitor bring new questions of safety and effectiveness.
9.0 Performance summary
iHealth BPM1 Wireless Blood Pressure Monitor conforms to the following standards:
- 60601-1:2005/(R)2012 And A1:2012.C1:2009/(R)2012 And ● IEC 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
- Clinical data have been transferred from the predicates. .
10.0 Comparison to the predicatedeviceand theconclusion
BPM1 Wireless Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-927 whose 510(k) number is K141984.
The new device BPM1 is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards.
Their appearance, the memory capacity, electrical power, memory average function, average measure function and the MCU are different, and a new
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software platform has been added. More over, the new device BPM1 can transmitting data to a mobile device via WiFi.
However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.