(33 days)
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No
The document describes standard oscillometric blood pressure measurement technology and does not mention AI or ML.
Yes
This medical device is intended to measure blood pressure, which is used for diagnostic purposes, and helps medical professionals and individuals to monitor their health condition and potentially manage medical conditions, making it a therapeutic device.
Yes
The device measures blood pressure and pulse rate, providing information that can be used to monitor a patient's health and aid in the diagnosis of conditions like irregular heartbeat, even if it doesn't provide a definitive diagnosis itself.
No
The device description explicitly states it is a "Wireless Blood Pressure Wrist Monitor" and describes hardware components like an inflatable cuff and pressure sensor technology. It also mentions testing according to hardware-related standards (IEC 60601-1-2, IEC 60601-1, IEC 80601-2-30). While it interacts with iOS/Android devices, it is not solely software.
Based on the provided information, the iHealth View BP7S Wireless Blood Pressure Wrist Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The iHealth View BP7S measures blood pressure and pulse rate directly from the human body (the wrist) using a non-invasive technique. It does not analyze any biological specimens.
The device is a non-invasive physiological monitoring device, specifically a blood pressure monitor.
N/A
Intended Use / Indications for Use
iHealth View BP7S Wireless Blood Pressure Wrist Monitor is for use by medical professionals or at home and is a noninvasive 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 wrist. The cuff circumference is limited to 13.5cm-22cm.
Product codes
DXN
Device Description
iHealth View BP7S Wireless Blood Pressure Monitors are 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 irregular heartbeat is detected, it can be shown to the user. The new devices achieves its function by an iOS or Andriod devices. .
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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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 BP7S Wireless Blood Pressure Wrist Monitor bring new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure ± 3mmHg Pulse ± 5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2015
Andon Health Co., Ltd Ms. Liu Yi President No 3, Jinping Street Ya' An Rd Nankai District Tianjin, 300190 CN
Re: K152379
Trade/Device Name: iHealth View Wireless Blood Pressure Wrist Monitor (BP7S) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 19, 2015 Received: August 26, 2015
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
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Page 2 - Ms. Liu Yi
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 devicerelated 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 yours,
M.A. Hilleman
for
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) K152379
Device Name
iHealth View Wireless Blood Pressure Wrist Monitor (BP7S)
Indications for Use (Describe)
iHealth View BP7S Wireless Blood Pressure Wrist Monitor is for use by medical professionals or at home and is a noninvasive 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 wrist. The cuff circumference is limited to 13.5cm-22cm.
Type of Use (Select one or both, as applicable)
| For use in identifying a U.S. Vehicle Safety Standard | |
|---|---|
| To correct the information in a U.S. Vehicle Safety Standard |
| | 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: | 08/21/2015 |
2.0 Device information
Trade name: iHealth View Wireless Blood Pressure Wrist Monitor (BP7S)
Device name: Wireless Blood Pressure Monitor
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-972 Fully Automatic Wireless Blood Pressure Wrist Monitor Device: 510(k) number: K121470
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5.0 Intended use
iHealth View BP7S Wireless Blood Pressure Wrist 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 13.5cm-22cm.
The intended use and the indication for use of iHealth BP7S View Wireless Blood Pressure Wrist Monitor, as described in its labeling are the same as the predicate device KD-972(K121470).
6.0 Device description
iHealth View BP7S Wireless Blood Pressure Monitors are 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 irregular heartbeat is detected, it can be shown to the user. The new devices achieves its function by an iOS or Andriod devices. .
| Item | Predicate device
BP7 (K121470) | Subject device
BP7S(K152379) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Intended use and
indication for use | 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 13.5cm-22cm. | Same as predicate |
| Method of
measurement | Oscillometric | Same as predicate |
| Unit Weight | About 106g | About 114g |
| Average function | Yes | No |
7.0 Summary comparing technological characteristics with predicate device
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| Memory function | Yes | No |
|---|---|---|
| Power Supply | 1*3.7V Li-ion 400mAh | Same as predicate |
| Accuracy | Pressure $\pm$ 3mmHg | |
| Pulse $\pm$ 5% | Same as predicate | |
| Range of | ||
| measurement | Cuff pressure Range | |
| 0 ~ 300 mmHg |
Determination Range
40 ~ 260 mmHg | Cuff pressure Range
0 ~ 300 mmHg
Determination Range
40 ~ 260 mmHg |
| Storage
Environment | -20~55°C