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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the iCare App, focusing on its substantial equivalence to a predicate device. It primarily details regulatory information, device description, and non-clinical test summaries. It does not contain information about a study that proves the device meets specific performance acceptance criteria for a medical diagnostic or screening function.

The iCare App is classified as a "Medical Device Data System" (MDDS) that transmits, displays, and stores data from connected medical devices. Its function is to aid users and healthcare professionals in viewing test results for health management. It explicitly states: "Both devices make no interpretation, evaluation, medical judgments, or recommendations for treatment." This means the app itself doesn't perform diagnostic functions that would require specific performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested criteria, such as acceptance criteria for diagnostic performance, a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not provided in this document because the device is a data management system, not a diagnostic algorithm.

Here's a breakdown of the applicable information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of quantitative performance acceptance criteria for diagnostic accuracy, sensitivity, or specificity, because the iCare App is an MDDS for data management, not a diagnostic tool. Instead, acceptance criteria are implied through the successful completion of non-clinical tests that demonstrate the basic functionality, safety, and effectiveness for its intended use as a data display and storage system.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Software Verification & Validation	Compliance with FDA guidance for "moderate" level of concern software; no minor injury to patient/operator due to failure or latent flaw.	"Software verification and validation has been performed according to FDA guidance... The iCare App software was considered a 'moderate' level of concern...". All tests passed.
Wireless Coexistence Test	Ability to be used in intended environments without harmful interference.	"Wireless coexistence test has been performed to verify that the subject device can be used in intended environments." All tests passed.
Cybersecurity	Adherence to FDA guidance for cybersecurity; appropriate risk-based assessment and testing.	"Cybersecurity activities were conducted in accordance with FDA Guidance... The iCare App underwent appropriate risk-based cybersecurity assessment and testing..." All tests passed.
Usability Testing	Safe and effective use by lay users with provided labeling.	"Usability testing was conducted in accordance with FDA guidance... 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." All tests passed.

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not applicable for diagnostic performance as the device is not a diagnostic algorithm. The document mentions non-clinical testing (software, wireless, cybersecurity, usability) but does not specify "test set" sizes in the context of clinical data for diagnostic performance.
Data Provenance: Not applicable in the context of clinical diagnostic data. The document focuses on the technical aspects of the software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable, as the device does not perform diagnostic interpretations requiring expert-established ground truth for clinical cases.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable, as there is no clinical test set requiring ground truth adjudication for diagnostic performance.

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

MRMC Study: No, an MRMC study was not done. The iCare App is an MDDS and does not involve AI assistance for human readers in a diagnostic capacity. It makes "no interpretation, evaluation, medical judgments, or recommendations for treatment."
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: No, a standalone performance study in the context of diagnostic accuracy was not done. The device's function is data transmission, display, and storage, not diagnostic algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable for clinical diagnostic performance. For the software verification and validation, the "ground truth" would be the successful execution against specified requirements and accepted software engineering practices and FDA guidance.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document does not describe a machine learning model that was trained on a dataset. The iCare App is a software application for data management, not an AI/ML algorithm requiring a training set of clinical data for diagnostic purposes.

9. How the ground truth for the training set was established

Ground Truth Establishment for Training Set: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

{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)

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

{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 DeviceiCare	Predicate DeviceConnect App foriHealth Next	Comparison
	Regulatory and Intended Use Comparison
510(k) Number	N/A	K181541	N/A
Product CodeandClassificationName	MWI, DXN, OCH, PUH,OUG, NBW	MWI, DXN, MNW,DQA	Similar: the connected devices are thesame, OCH is product code forsportoximeter, and PUH is new productcode for body analyzer exempt from510(k).DQA is product code for medicaloximeter needs 510(k), and MNW isproduct code for body analyzer needs510(k).OUG and NBW is applicable to iCarewith glucose data transmission, displayand storage.
Class	Class II	Class II	Same
Regulation	MWI: Sec. 870.2300Cardiac monitor (includingcardiotachometer and ratealarm).DXN: Sec. 870.1130Noninvasive bloodpressure measurementsystem.OCH: Sec. 870.2700Oximeter.PUH: Sec. 870.2770	MWI: Sec. 870.2300Cardiac monitor(includingcardiotachometer andrate alarm).DXN: Sec. 870.1130Noninvasive bloodpressuremeasurement system.MNW: Sec. 870.2770Impedanceplethysmograph.DQA: Sec. 870.2700	OUG and NBW is added for the glucosemeter data transmission, display andstorage.

	plethysmograph.	Physiological signalamplifier.
	OUG: 880.6310 Medicaldevice data systemNBW: 862.1345 Glucosetest system
Indications forUse	The iCare APP isintended for use in thehome and clinical settingsas an aid for users andtheir healthcareprofessionals to view testresults which aremeasured by iHealthdevices to better manageusers' health and getfeedback from theirprofessional care team.The iCare APP can alsoconnect to medicaldevices and/or non-medical devices and getdata from devices duringmeasurement or from thedata stored in thememory of the device forenhanced datamanagement. Data canbe transmitted, displayed,and stored in the APP.	The Connect App foriHealth Next isintended for use inhome settings as anaid for people toview vital signs whichare measured byiHealth devices(noninvasive bloodpressure monitor andpulse oximeter).The Connect App foriHealth Next shouldnot be used to eitherself-diagnose adisease state orexclude it.Please consult yourphysician if you findthe reading is abovea normal threshold.	Similar: Both devices are used tomanage patient data. Both devicesmake no interpretation, evaluation,medical judgments, orrecommendations for treatment. Clinicaljudgment and experience are requiredto check and interpret the informationtransmitted, and they are not intendedas a substitute for medical care.
PatientPopulation	Home users	Home user	Same
PrescriptionUse (Rx)/ OverThe Counter(OTC)	OTC	OTC	Same
Technological and Performance Characteristics
FundamentalTechnology	Software Only	Software Only	Same
SoftwarePlatform	iOS and Android	iOS and Android	Same
UserInterfaces	Patient Portal	Patient Portal	Same
BiometricParameters	Blood Pressure, Weight,Blood Glucose, and PulseOximeterBlood Glucoseconcentration	Blood Pressure,Weight, PulseOximeter	Similar: Other biometric parameters areeither not medical devices or class I or II510(k) exempt.The subject device can also beidentified as MDDS, with function ofdisplay and store blood glucose resultfrom glucose meter.
DataCollection	Wireless Bluetooth andmanual entry	Wireless Bluetooth	Similar: Manual entry is not a medicaldevice 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.

Regulation Number and Section

§ 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).