(309 days)
The Connect App for iHealth Next is intended for use in home settings as an aid for people to view vital signs which are measured by iHealth devices (noninvasive blood pressure monitor and pulse oximeter).
The Connect App for iHealth Next should not be used to either self-diagnose a disease state or exclude it. Please consult your physician if you find the reading is above a normal threshold.
The Connect App for iHealth Next is a software for using it with health devices, including iHealth medical devices such as Blood Pressure Monitor and pulse oximeter, etc. It can also be used with non-medical devices, such as active monitor, weight scale, etc.
The Connect App for iHealth Next can:
(1) Connect to blood pressure monitor and control the meter to complete measurement, and the data can be transferred to the Connect App for iHealth Next;
(2) Connect to pulse oximeter and transfer data from the pulse oximeter to the Connect App for iHealth Next.
This document describes the Connect App for iHealth Next, a data management software. No specific acceptance criteria for diagnostic or prognostic performance are described in the provided text, as this device primarily focuses on data management and control of other medical devices. Therefore, a comprehensive table of acceptance criteria and reported device performance related to diagnostic accuracy cannot be generated from this submission.
However, the document does describe validation activities for other aspects of the device:
1. A table of acceptance criteria and the reported device performance
As mentioned above, no specific diagnostic or prognostic acceptance criteria are provided in the text. However, a "Performance summary" section mentions non-clinical tests performed:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Software validation according to FDA guidance | "The result conforms that the proposed device is as safe and effective as the predicate device." |
| Usability for lay users and professionals in intended environments | "The study results demonstrate that the Connect App for iHealth Next are understood by a variety of users, and provide sufficient information for the safe and effective use of the device." |
| Wireless coexistence in intended environments | "Wireless coexistence test has been performed to verify that the proposed device can be used in intended environments." |
2. Sample size used for the test set and the data provenance
- Usability Study: 20 lay users and 20 professionals participated in the usability study. The provenance is not explicitly stated but implies testing in "their actual use environment such as home, hospital, clinic and office etc."
- For software validation and wireless coexistence, specific sample sizes (e.g., number of test cases) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as the device is data management software, and the "ground truth" for the usability study would be user feedback and successful task completion, not diagnostic ground truth established by medical experts for a clinical condition. The participants were "20 lay users and 20 professionals," with no further qualification details provided.
4. Adjudication method for the test set
Not applicable. The usability study involved observing user interaction and feedback, not a traditional adjudication process for clinical endpoints.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or described. This device is data management software, not an AI-powered diagnostic tool requiring human reader comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is software for managing data and controlling medical devices. Its "performance" revolves around software functionality, usability, and wireless connectivity, which were tested in a standalone manner (without continuous human interaction to refine its core functions) but with human users evaluating its user-facing aspects.
7. The type of ground truth used
- Software Validation: The "ground truth" for software validation would be adherence to specified requirements and established software engineering best practices, verified through testing against expected outputs.
- Usability Study: The "ground truth" was defined by successful task completion, understanding of warnings/precautions, and overall user experience as observed and reported by participants (lay users and professionals) against predetermined critical tasks and usability goals.
8. The sample size for the training set
Not applicable. This device is software for data management and device control, not a machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable (see point 8).
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April 16, 2019
Andon health Co., Ltd Yi Liu President No.3 Jinping Street, Ya An Road, Nankai District Tianjin, P.R. China Tianjin, 300190 CN
Re: K181541
Trade/Device Name: Connect App for iHealth Next Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, MNW, DOA Dated: March 15, 2019 Received: March 18, 2019
Dear Yi Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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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 information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No.3 Jinping Street, Ya An Road, Nankai District, Tianjin,P.R. China |
| Phone number: | 86-22-87611660 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Preparation: | 6/6/2018 |
2.0 Device information
| Trade name: | Connect App for iHealth Next |
|---|---|
| Common name: | Data management software |
| Classification name: | Data management software |
3.0 Classification
Production code: DXN, MNW, DQA Regulation number: 21 CFR 870.2770, 21 CFR 870.1130, 21 CFR 870.2700, Classification: II Panel: 870 Cardiovascular
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd.
Device: Apps-Health01
510(k) number: K122098
5.0 Device description
The Connect App for iHealth Next is a software for using it with health devices,
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including iHealth medical devices such as Blood Pressure Monitor and pulse oximeter, etc. It can also be used with non-medical devices, such as active monitor, weight scale, etc.
The Connect App for iHealth Next can:
(1) Connect to blood pressure monitor and control the meter to complete measurement, and the data can be transferred to the Connect App for iHealth Next;
(2) Connect to pulse oximeter and transfer data from the pulse oximeter to the Connect App for iHealth Next.
| Device type | Model (510K number) | Control description | Control way | Electrical safety and EMC test evidence |
|---|---|---|---|---|
| Bloodpressuremonitor | KD-936(K120672) | a* | b** | c* d* |
| Bloodpressuremonitor | KD-972(K121470) | a* | b** | c* d* |
| Bloodpressuremonitor | BP3L(K152003) | a* | b* | c* d* |
| Bloodpressuremonitor | KN-550BT(K160014) | a** | b* | c* d* |
| Bloodpressuremonitor | BP7S(K152379) | a** | b* | c* d* |
| Pulseoximeter | PO3M(K131111) | a** | b* | c* d* |
Below is detailed control information:
Control description:
the App can control medical devices to start/stop the measurement and receive a* data from blood pressure monitor.
a** the App only receives data from medical devices
b* the medical device can only be controlled by App
- b** the medical device can be controlled both by medical device and by App
Electrical safety test performed in the previous 510Ks
- C* Electrical safety test according to IEC 60601-1:2005+C1:2006,
EMC test performed in the previous 510Ks
- d* EMC test according to IEC 60601-1-2:2007
6.0 Intended use
The Connect App for iHealth Next is intended for use in home settings as an aid for people to view vital signs which are measured by iHealth devices (noninvasive blood pressure monitor and pulse oximeter).
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The Connect App for iHealth Next should not be used to either self-diagnose a disease state or exclude it. Please consult your physician if you find the reading is above a normal threshold.
7.0 Summary comparing technological characteristics with predicate device
| Predicate device | Proposed device | |
|---|---|---|
| Device name | Apps-Health01 | Connect App for iHealth Next |
| Product type | software | software |
| Indications foruse | The Apps-Health01 is intended foruse in home settings as an aid forpeople to review, analyze, andevaluate test results which aremeasured from a blood pressuremonitor or scale. | The Connect App for iHealth NextApp is intended for use in homesettings as an aid for people toview vital signs which aremeasured by iHealth devices. |
| Softwareplatform | iOS | iOS and Android |
| Hardwarerequirements | iPhone, iTouch, iPad | iPhone, iTouch, iPad, mobiledevice with Android system |
| Measurementcontrol | Measurement module with NativeSDK as transfer module | Measurement module |
| Function-basic | Blood pressure: Test or manuallyinput blood pressure data.Weight: Test or manually inputbody composition data. | Connect to blood pressure:complete measurement andtransfer test dataConnect to pulse oximeter andtransfer test data |
Specification Comparison table
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| Function-other | My calorie Trends: View your calories consumed vs. calories burned.Reminders: Set reminders(Medicine/Measure blood pressure /Measure weight/Sport) to stay focused on your goals.My plan: Add and modify your weight goals.My BP trends: View your blood pressure trends.My weight Trends: View your weight data.History: view of your historical data.My Diary: Log food and activities to stay on track. | Check FAQ |
|---|---|---|
| MeterCompatibility | Scales, Blood Pressure Monitor | Blood Pressure Monitor,Pulse Oximeter,Weight scaleActive monitor |
| Connectionwith peripheraldevice by | Bluetooth (HS5 with WIFI additionally, KD-931 by apple 30PIN) | BluetoothBluetooth Low EnergyAudio |
| Performancetest provided | Software validation | Software validation |
8.0 Performance summary
Non-clinical test
Software validation
Software validation has been performed according to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". And the result conforms that the proposed device is as safe and effective as the predicate device.
Usability study
Usability test has been performed according to FDA guidance "Apply for applying human factors and usability engineering to medical devices".
20 lay users and 20 professionals participated in this study on their actual use environment such as home, hospital, clinic and office etc.,
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in order to verify that:
- user can choose the device correctly, >
-
user can operate the device in proper environment as intended,
- user can get all the warning and precaution as intended, >
- user can download and run the app correctly, and >
-
user can operate the device correctly,
The following main critical tasks were identified in this study,
- & Read App operation guide and medical device labeling
- < Download and run the App
- � Connect medical device to App
- � Complete measurement
The study results demonstrate that the Connect App for iHealth Next are understood by a variety of users, and provide sufficient information for the safe and effective use of the device.
Wireless Coexistence test
Wireless coexistence test has been performed to verify that the proposed device can be used in intended environments.
Clinical test
This section is not applicable.
9.0 Comparison to the predicate device and the conclusion
The Connect App for iHealth Next is similar with the predicate device Apps-Health01. The new device can be used with more medical devices such as the pulse oximeter. Additionally, the proposed device can also be installed in Android mobile devices.
The tests and data in this submission demonstrate that the proposed device is as safe and effective as the predicate device.
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).