(33 days)
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.
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.
The provided document is a 510(k) summary for a medical device called the "iHealth View Wireless Blood Pressure Wrist Monitor (BP7S)". It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailing a specific study proving the device meets acceptance criteria. As such, information on specific acceptance criteria and a study to prove them is limited.
However, I can extract the available information related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a tabular format alongside device performance for a specific study. Instead, it refers to performance standards that the device conforms to. The closest information is under "Accuracy" in the technological characteristics comparison table.
| Performance Metric | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | IEC 80601-2-30 (implied by "Same as predicate" for accuracy) | $\pm$ 3mmHg |
| Pulse Accuracy | IEC 80601-2-30 (implied by "Same as predicate" for accuracy) | $\pm$ 5% |
2. Sample Size and Data Provenance for Test Set
The document does not specify a sample size for a test set or the data provenance (country of origin, retrospective/prospective). The non-clinical tests mentioned are adherence to electrical safety and electromagnetic compatibility standards, and performance characteristics according to a blood pressure monitor standard. These are general compliance tests for the device, not a specific clinical performance study with a test set of patient data.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The tests mentioned are compliance tests against established engineering and medical device standards.
4. Adjudication Method for Test Set
Not applicable. There is no mention of a test set requiring adjudication in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
Yes, implicitly. The "Non-clinical Tests" and "Performance summary" sections indicate that the device's performance was evaluated against recognized standards (IEC 80601-2-30 for "Safety and performance characteristics"). While not a dedicated "standalone performance study" in the context of AI algorithms, these tests assess the device's functionality and accuracy independently.
7. Type of Ground Truth Used
The ground truth for the device's accuracy claims (pressure $\pm$ 3mmHg, pulse $\pm$ 5%) would typically be based on reference measurements from a validated, calibrated standard or method, as outlined in the IEC 80601-2-30 standard for automated sphygmomanometers. This standard specifies clinical investigation requirements for blood pressure device accuracy. The document states the device "conforms to" this standard, implying that the ground truth methodology prescribed by the standard was followed for these accuracy claims.
8. Sample Size for Training Set
Not applicable. This device is a traditional medical device (blood pressure monitor) governed by engineering and performance standards, not an AI/machine learning algorithm requiring a "training set" in the computational sense.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this device.
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Public Health Service
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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, TianjinP.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 deviceBP7 (K121470) | Subject deviceBP7S(K152379) |
|---|---|---|
| Intended use andindication for use | For use by medical professionals or at homeand is a non-invasive blood pressuremeasurement system intended to measurethe diastolic and systolic blood pressures andpulse rate of an adult individual by using anon-invasive technique in which an inflatablecuff is wrapped around the wrist. The cuffcircumference is limited to 13.5cm-22cm. | Same as predicate |
| Method ofmeasurement | 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 $\pm$ 3mmHgPulse $\pm$ 5% | Same as predicate |
| Range ofmeasurement | Cuff pressure Range0 ~ 300 mmHgDetermination Range40 ~ 260 mmHg | Cuff pressure Range0 ~ 300 mmHgDetermination Range40 ~ 260 mmHg |
| StorageEnvironment | -20~55°C<95%RH | -20~55°C≤85%RH |
| OperatingEnvironment | 5~40°C<90%RH | 10℃~40℃≤85%RH |
| Data transmission | Bluetooth | Same as predicate |
| Measurementdisplay | iOS device | 1. iOS device orAndroid device,2. LED display onblood pressuremeter, |
| Software platform | iOS | iOS and Android |
| PerformanceStandard | ISO 80601-2-30 | Same as predicate |
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 BP7S Wireless Blood Pressure Wrist Monitor bring new questions of safety and effectiveness.
9.0 Performance summary
iHealth View BP7S Wireless Blood Pressure Wrist Monitor conforms to the following standards:
- AAMI ANSI ES 60601-1:2005/(R) 2012 And C1:2009(R)2012 And A2:2010 (Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)
- · IEC60601-1-2 Edition 3: 2007-03, (Medical electrical equipment -- Part 1-2:
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General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests)
- IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010(Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of of of automated sphygmomanometers)AAMI IEC80601-2-30:2002, Manual, electronic or automated sphygmomanometers.
10.0 Comparison to the predicate device and the conclusion
iHealth View BP7S Wireless Blood Pressure Wrist Monitor is substantially equivalent to KD-972 blood pressure monitor whose 510(K) number is K121470
The new device BP7S is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only their data transmission function, the MCU, the memory function and the appearance 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.
§ 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).