(309 days)
No
The summary describes a software application that connects to and displays data from medical and non-medical devices. There is no mention of AI, ML, or any analytical capabilities beyond data transfer and display.
No
Explanation: The device is intended to view vital signs and transfer data from other iHealth devices; it is explicitly stated that it "should not be used to either self-diagnose a disease state or exclude it," indicating it does not provide therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "The Connect App for iHealth Next should not be used to either self-diagnose a disease state or exclude it." It is an aid for viewing vital signs, not for diagnosis.
Yes
The device description explicitly states it is "a software for using it with health devices" and details its functions as connecting to and transferring data from external medical and non-medical devices. It does not describe any hardware components included as part of the device itself.
Based on the provided text, the Connect App for iHealth Next is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "view vital signs which are measured by iHealth devices (noninvasive blood pressure monitor and pulse oximeter)." This involves displaying data from devices that measure physiological parameters in vivo (on the body), not analyzing samples in vitro (outside the body).
- Device Description: The description focuses on connecting to and transferring data from medical devices like blood pressure monitors and pulse oximeters, which are not IVDs. It also mentions connecting to non-medical devices.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific analytes, which are hallmarks of IVD devices.
The device acts as a data display and management tool for data collected by other medical devices, rather than performing diagnostic testing itself.
No
The provided FDA clearance letter does not contain any mention or indication that the device is authorized under a Predetermined Change Control Plan (PCCP). PCCP authorization would typically be explicitly stated in an FDA clearance document if applicable.
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
DXN, MNW, DOA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home settings
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)
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 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., 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 has been performed to verify that the proposed device can be used in intended environments.
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.
K120672, K121470, K152003, K160014, K152379, K131111
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
§ 870.2300 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG" in blue, and below that is the text "ADMINISTRATION" in blue.
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
1
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
2
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,
3
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 |
|---|---|---|---|---|
| Blood | ||||
| pressure | ||||
| monitor | KD-936 | |||
| (K120672) | a* | b** | c* d* | |
| Blood | ||||
| pressure | ||||
| monitor | KD-972 | |||
| (K121470) | a* | b** | c* d* | |
| Blood | ||||
| pressure | ||||
| monitor | BP3L | |||
| (K152003) | a* | b* | c* d* | |
| Blood | ||||
| pressure | ||||
| monitor | KN-550BT | |||
| (K160014) | a** | b* | c* d* | |
| Blood | ||||
| pressure | ||||
| monitor | BP7S | |||
| (K152379) | a** | b* | c* d* | |
| Pulse | ||||
| oximeter | 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).
4
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 for | ||
| use | The Apps-Health01 is intended for | |
| use in home settings as an aid for | ||
| people to review, analyze, and | ||
| evaluate test results which are | ||
| measured from a blood pressure | ||
| monitor or scale. | The Connect App for iHealth Next | |
| App is intended for use in home | ||
| settings as an aid for people to | ||
| view vital signs which are | ||
| measured by iHealth devices. | ||
| Software | ||
| platform | iOS | iOS and Android |
| Hardware | ||
| requirements | iPhone, iTouch, iPad | iPhone, iTouch, iPad, mobile |
| device with Android system | ||
| Measurement | ||
| control | Measurement module with Native | |
| SDK as transfer module | Measurement module | |
| Function-basic | Blood pressure: Test or manually | |
| input blood pressure data. | ||
| Weight: Test or manually input | ||
| body composition data. | Connect to blood pressure: | |
| complete measurement and | ||
| transfer test data | ||
| Connect to pulse oximeter and | ||
| transfer test data |
Specification Comparison table
5
| 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 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Meter
Compatibility | Scales, Blood Pressure Monitor | Blood Pressure Monitor,
Pulse Oximeter,
Weight scale
Active monitor |
| Connection
with peripheral
device by | Bluetooth (HS5 with WIFI additionally, KD-931 by apple 30PIN) | Bluetooth
Bluetooth Low Energy
Audio |
| Performance
test 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.,
6
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