(126 days)
Not Found
No
The summary describes a mobile application for data management and communication, with no mention of AI or ML capabilities for analysis, interpretation, or prediction.
No.
The iCare App is a mobile application that allows users to view and manage health data from connected iHealth devices. It functions as a data management and communication tool, not as a device that directly provides therapy or treatment.
No
The device is described as an app that allows users and healthcare professionals to view test results from iHealth devices and manage health data. It connects to medical and non-medical devices to collect and display data. Its primary function is displaying, storing, and organizing data from other measuring devices, not performing diagnostic measurements itself.
Yes
The device is described as a "mobile application on both Android and iOS platforms" and its functionality is entirely software-based, focusing on data management, display, and communication. While it connects to external medical and non-medical devices for data acquisition, the 510(k) summary describes the App itself as the device, and the performance studies focus on software verification/validation, wireless coexistence, cybersecurity, and usability of the software. There is no mention of hardware components being part of the submitted device.
Based on the provided information, the iCare App itself is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use of the iCare App is to view, manage, and track test results obtained from other iHealth devices (which may or may not be IVDs themselves, depending on their function). It also facilitates communication with healthcare professionals and provides health information. It does not perform the diagnostic test itself.
- Device Description: The description focuses on the app's functionality as a data management and communication tool. It connects to devices that perform the measurements (blood sugar, blood pressure, etc.), but the app's role is to receive, display, and store this data.
- Lack of Diagnostic Function: The app does not perform any analysis or interpretation of biological samples or data to diagnose a disease or condition. The diagnostic function resides in the connected devices.
- Clinical Test Section: The "Clinical Test" section is marked as "not applicable," which is consistent with a device that is not performing a diagnostic function requiring clinical validation of its diagnostic accuracy.
- Predicate Device: The predicate device (Connect App for iHealth Next) also appears to be a similar data management and communication app, not an IVD.
In summary, the iCare App acts as a data aggregator, display, and communication platform for results generated by other devices. It does not perform the in vitro diagnostic testing itself.
N/A
Intended Use / Indications for Use
The iCare App is intended for use in the home and clinical settings as and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team.
The iCare App can also connect to medical devices and or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DXN, OCH, PUH, OUG
Device Description
The iCare APP is a mobile application on both Android and iOS platforms.iCare allows users to better manage their own health by enabling them to measure their vital signs, access their results and relevant health information with just their smart device and internet connection, and receive feedback from their professional care team.
iCare includes a patient darshboard featuring the Home, Health, Plus, Education, and Profile tabs. Accessory devices can be connected to the system to allow for collection of blood sugar, blood pressure, blood oxygen, and/or weight measurements. The patient darshboard functionality includes the ability to start measuring, allows users to view and track measurements, and export testing schedules for blood sugar, blood pressure, blood oxygen, and weight measurements; send messages to their professional care team; view previous appointment history information; view medication instructions; add entries to the food diary and review feedback from their registered dietician; set timers; and access articles and videos about health knowledge.
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 and clinical 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 Verification and Validation: Performed according to FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The iCare App software was considered a "moderate" level of concern.
Wireless Coexistence Test: Performed to verify that the subject device can be used in intended environments.
Cybersecurity: Activities were conducted in accordance with FDA Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." The iCare App underwent appropriate risk-based cybersecurity assessment and testing.
Usability Testing: Conducted in accordance with FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices". The test result demonstrates that the iCare App can be used by lay users with only provided labeling, the device is safe and effective for the intended use.
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
§ 870.2300 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 3, 2025
iHealth Labs, Inc. Tianvang Liu Director of Medical Devices 880 W Maude Ave Sunnyvale, California 94085
Re: K243146
Trade/Device Name: iCare APP Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, OCH, PUH, OUG Dated: September 30, 2024 Received: September 30, 2024
Dear Tianyang 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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-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
Robert T. Kazmierski -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243146
Device Name iCare App
Indications for Use (Describe)
The iCare App is intended for use in the home and clinical settings as and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team.
The iCare App can also connect to medical devices and or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summarv
1. Submitter Information
Name: iHealth Labs, Inc. Address: 880 W Maude Ave, Sunnyvale, CA 94085 Phone Number: 1-855-816-7705 Contact: Tianyang Liu Date of Preparation: September 30, 2024
2. Device Information
Trade name: iCare APP
3. Classification
Product Code and Regulation Number: MWI: Sec. 870.2300 Cardiac monitor (including cardiotachometer and rate alarm). DXN: Sec. 870.1130 Noninvasive blood pressure measurement system. OCH: Sec. 870.2700 Oximeter. PUH: Sec. 870.2770 Impedance plethysmograph. OUG: Sec. 880.6310 Medical device data system Class Classification: II Panel: 870 Cardiovascular
4. Predicate Device Information
Manufacturer: Andon Health Co., Ltd. Device: Connect App for iHealth Next 510(k) Number: K181541
5. Device Description
The iCare APP is a mobile application on both Android and iOS platforms.iCare allows users to better manage their own health by enabling them to measure their vital signs, access their results and relevant health information with just their smart device and internet connection, and receive feedback from their professional care team.
iCare includes a patient darshboard featuring the Home, Health, Plus, Education, and Profile tabs. Accessory devices can be connected to the system to allow for collection of blood sugar, blood pressure, blood oxygen, and/or weight measurements. The patient darshboard functionality includes the ability to start measuring, allows users to view and track measurements, and export testing schedules for blood
5
sugar, blood pressure, blood oxygen, and weight measurements; send messages to their professional care team; view previous appointment history information; view medication instructions; add entries to the food diary and review feedback from their registered dietician; set timers; and access articles and videos about health knowledge.
6. Intended Use
The iCare APP is intended for use in the home and clinical settings as an aid for users and their healthcare professionals to view test results which are measured by iHealth devices to better manage users' health and get feedback from their professional care team.
The iCare APP can also connect to medical devices and/or non-medical devices and get data from devices during measurement or from the data stored in the memory of the device for enhanced data management. Data can be transmitted, displayed, and stored in the APP.
7. Summary Comparing Technological Characteristics with Predicate Device iCare - Substantial Equivalence Comparison Tabular Format
| Feature | Subject Device
iCare | Predicate Device
Connect App for
iHealth Next | Comparison |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Regulatory and Intended Use Comparison | | |
| 510(k) Number | N/A | K181541 | N/A |
| Product Code
and
Classification
Name | MWI, DXN, OCH, PUH,
OUG, NBW | MWI, DXN, MNW,
DQA | Similar: the connected devices are the
same, OCH is product code for
sportoximeter, and PUH is new product
code for body analyzer exempt from
510(k).
DQA is product code for medical
oximeter needs 510(k), and MNW is
product code for body analyzer needs
510(k).
OUG and NBW is applicable to iCare
with glucose data transmission, display
and storage. |
| Class | Class II | Class II | Same |
| Regulation | MWI: Sec. 870.2300
Cardiac monitor (including
cardiotachometer and rate
alarm).
DXN: Sec. 870.1130
Noninvasive blood
pressure measurement
system.
OCH: Sec. 870.2700
Oximeter.
PUH: Sec. 870.2770 | MWI: Sec. 870.2300
Cardiac monitor
(including
cardiotachometer and
rate alarm).
DXN: Sec. 870.1130
Noninvasive blood
pressure
measurement system.
MNW: Sec. 870.2770
Impedance
plethysmograph.
DQA: Sec. 870.2700 | OUG and NBW is added for the glucose
meter data transmission, display and
storage. |
| | | | |
| | plethysmograph. | Physiological signal
amplifier. | |
| | OUG: 880.6310 Medical
device data system
NBW: 862.1345 Glucose
test system | | |
| Indications for
Use | The iCare APP is
intended for use in the
home and clinical settings
as an aid for users and
their healthcare
professionals to view test
results which are
measured by iHealth
devices to better manage
users' health and get
feedback from their
professional care team.
The iCare APP can also
connect to medical
devices and/or non-
medical devices and get
data from devices during
measurement or from the
data stored in the
memory of the device for
enhanced data
management. Data can
be transmitted, displayed,
and stored in the APP. | 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. | Similar: Both devices are used to
manage patient data. Both devices
make no interpretation, evaluation,
medical judgments, or
recommendations for treatment. Clinical
judgment and experience are required
to check and interpret the information
transmitted, and they are not intended
as a substitute for medical care. |
| Patient
Population | Home users | Home user | Same |
| Prescription
Use (Rx)/ Over
The Counter
(OTC) | OTC | OTC | Same |
| Technological and Performance Characteristics | | | |
| Fundamental
Technology | Software Only | Software Only | Same |
| Software
Platform | iOS and Android | iOS and Android | Same |
| User
Interfaces | Patient Portal | Patient Portal | Same |
| Biometric
Parameters | Blood Pressure, Weight,
Blood Glucose, and Pulse
Oximeter
Blood Glucose
concentration | Blood Pressure,
Weight, Pulse
Oximeter | Similar: Other biometric parameters are
either not medical devices or class I or II
510(k) exempt.
The subject device can also be
identified as MDDS, with function of
display and store blood glucose result
from glucose meter. |
| Data
Collection | Wireless Bluetooth and
manual entry | Wireless Bluetooth | Similar: Manual entry is not a medical
device functionality. |
| Educational Articles | Access to patient education articles | None | Similar: Educational article functionality is not a medical device functionality. |
6
7
Note: N/A indicates Not Applicable
8. Performance Summary Non-
Non-Clinical Test
Software Verification and Validation
Software verification and validation has been performed according to FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" . The iCare App software was considered a "moderate" level of concern since a failure or latent flaw in the software could result in minor injury to the patient or operator.
Wireless Coexistence Test
Wireless coexistence test has been performed to verify that the subject device can be used in intended environments.
Cybersecurity
Cybersecurity activities were conducted in accordance with FDA Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." The iCare App underwent appropriate risk-based cybersecurity assessment and testing in accordance with referenced FDA guidance documents.
Usability Testing
Usability testing was conducted in accordance with FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices". The test result demonstrates that the iCare App can be used by lay users with only provided labeling, the device is safe and effective for the intended use.
Clinical Test
This section is not applicable.
9. Comparison to the Predicate Device and the Conclusion
The iCare APP is similar to the predicate device Connect App for iHealth Next. The nonclinical tests all passed the test conditions and demonstrated the iCare APP is as safe and as effective compared to the predicate device.