Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

Q: Who is the manufacturer of Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK?

Andon Health Co, Ltd. filed the 510(k) submission for Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK (K181541).

Q: What is the FDA product code for Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K181541 · Andon Health Co, Ltd. · MWI · Apr 16, 2019 · Cardiovascular

Device Facts

Record ID	K181541
Device Name	Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
Applicant	Andon Health Co, Ltd.
Product Code	MWI · Cardiovascular
Decision Date	Apr 16, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Software as a Medical Device

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). 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.

Device Story

Connect App for iHealth Next is mobile software (iOS/Android) for home use; interfaces with iHealth blood pressure monitors and pulse oximeters via Bluetooth/BLE/Audio. App initiates/stops measurements on connected devices; receives, displays, and stores vital sign data. Users view historical data and trends. Intended as an aid for viewing measurements; not for diagnostic purposes. Healthcare providers do not interact with the app directly; patients use it to monitor their own health data. Output affects clinical decision-making only if patient shares data with physician. Benefits include convenient data tracking and visualization of vital signs.

Clinical Evidence

No clinical data. Evidence consists of software validation per FDA guidance, usability testing with 40 participants (20 lay users, 20 professionals) in home/clinical environments, and wireless coexistence testing.

Technological Characteristics

Software-based data management system. Operates on iOS and Android mobile platforms. Connectivity via Bluetooth, Bluetooth Low Energy, and Audio. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC) as inherited from connected peripheral devices. Software validation performed per FDA guidance.

Indications for Use

Indicated for home users to view vital signs (blood pressure, pulse oximetry) measured by iHealth devices. Not for self-diagnosis or disease exclusion.

Regulatory Classification

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.

Predicate Devices

Apps-Health01 (K122098)

Reference Devices

KD-936 (K120672)
KD-972 (K121470)
BP3L (K152003)
KN-550BT (K160014)
BP7S (K152379)
PO3M (K131111)

Related Devices

K243146 — iCare APP · Ihealth Labs, Inc. · Feb 3, 2025
K122098 — APPS-HEALTH01 · Andon Health Co, Ltd. · Mar 21, 2013
K152003 — iHealth BP3L Wireless Blood Pressure Monitor · Andon Health Co, Ltd. · Sep 24, 2015
K120325 — CONNECTED CARE MOBILE APPLICATION · Watermark Medical · Jul 18, 2012
K132148 — S HEALTH · Samsung Electronics Co., Ltd. · Dec 4, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ 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 - < 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. {7}------------------------------------------------ è-¦å'Šï¼šå½"剺版本的 Acrobat 或 Adobe Reader丕æ" 挤本表â‰ã€' 请啇级至最新版本以获得完全支挕。