(146 days)
Not Found
No
The summary focuses on data management, display, and transmission, with no mention of AI/ML algorithms or related concepts.
No.
The device is described as a mobile application for reviewing and monitoring vital signs and health data, not for treating or curing a medical condition.
No
The S Health is intended for "reviewing and monitoring vital signs" and "effective health management," which implies data aggregation and display, not diagnosis. It relies on "optional add-on devices" for data collection and does not independently perform diagnostic functions.
Yes
The device description explicitly states "The S Health is application software for mobile device." While it interacts with optional add-on devices for data input, the core device being described and submitted for 510(k) is the software application itself. The performance studies focus on data transmission and user interface usability, consistent with a software-only device.
Based on the provided information, the S Health application is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to help users review and monitor vital signs and other data from optional add-on devices for health management. It acts as a data aggregator and display tool.
- Device Description: It's described as application software that records and displays information from various sources (pedometer, exercise, food intake, weight, blood glucose, blood pressure).
- Lack of Direct Measurement/Analysis of Biological Samples: IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. The S Health application itself does not perform these tests. It receives data from other devices that may or may not be IVDs (e.g., a blood glucose meter is an IVD, but a weight scale is not).
- Focus on Data Management: The performance studies focus on data accuracy transmission and user ease of use in managing the data, not on the diagnostic accuracy of the application itself.
- Predicate Devices: The predicate devices listed are also remote patient monitoring systems and health management applications, not IVD devices.
In summary, the S Health application functions as a data management and display tool for health-related information collected from other sources. It does not perform in vitro diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The S Health is a mobile application intended for use in home to help people in reviewing and monitoring vital signs such as non-invasive blood pressure, blood glucose, weight and other data from optional add-on devices for effective health management. The user also can share the data via sharing functions (Email and SMS).
Product codes (comma separated list FDA assigned to the subject device)
DRG, DXN, NBW, FRI
Device Description
The S Health is application software for mobile device. This mobile application helps users to care their personal health better by recording and displaying information such as comfort level (temperature and humidity), step count (pedometer), how much user exercises (calories burnt), the food user may consume (calories intake), weight, blood glucose level, and blood pressure in an effective and user friendly interface.
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
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)
Samsung Electronics Co, Ltd. conducted bench testing to demonstrate data accuracy transmission for each meter. Memory data rollover was also tested by adding ten (10) data points to meters that were pre-loaded with full memory. Test results show that all the measurement values, data, and time properly downloaded from the meters to the software. Memory data rollover also functioned properly where the new measurement values replaced the oldest glucose values.
In addition, a study intended to assess lay users’ performance in using the S Health was conducted. Overall, they rated the S Health at 100% for overall program as easy or somewhat easy. There were no users that rated the software program as somewhat difficult or difficult. 100% of them also responded that they are satisfied with the S Health and its manual.
The study results supports that the S Health is effective and provides accurate data management system as other predicate devices in the market.
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.
K083862, K130676, K122098, K130535
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
510(k) Summary
0
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
Applicant / Submitter: 1.
Samsung Electronics Co., Ltd. 129, Samsung-ro. Yeongtong-gu. Suwon-si. Republic of Korea 443-742
DEC 0 4 2013
Tel : +82-31-301-7374 Fax : +82-31-301-1768
Submission Correspondent: 2.
Priscilla Chung LK Consulting Group USA. Inc. 1515 E. Katella Ave. Unit 2115. Anaheim, CA 92805 Phone: 714-202-5789. Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
Device: 3.
r
| Proprietary Name: | S Health |
|---|---|
| Common Name: | Healthcare Data Management Mobile Application |
| Classification Name: | Transmitters And Receivers, Physiological Signal, |
| Radiofrequency | |
| System, Measurement, Blood-Pressure, Non-Invasive | |
| System, Test, Blood Glucose, Over The Counter | |
| Scale, Stand-On, Patient | |
| Classification: | Class II, |
| 21 CFR 870.2910 | |
| 21 CFR 870.1130 | |
| 21 CFR 862.1345 | |
| 21 CFR 880.2700 | |
| Classification Product Code: | DRG, DXN, NBW, FRI |
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K132148 Page 2 of 3
4. Predicate Device:
MedApps 2.0 - Remote Patient Monitoring System (K083862) by MedApps, Inc. Ambio Remote Health Monitoring System (K130676) by Arrayent Health LLC /dba Ambio Health
Apps-Health01 (K122098) by Andon Health Co., Ltd.
iBGStar Diabetes Manager Application (K130535) by AgaMatrix. Inc.
ર. Device Description:
The S Health is application software for mobile device. This mobile application helps users to care their personal health better by recording and displaying information such as comfort level(temperature and humidity), step count (pedometer), how much user exercises (calories burnt), the food user may consume (calories intake), weight, blood glucose level, and blood pressure in an effective and user friendly interface.
ે. Intended Use:
The S Health is a mobile application intended for use in home to help people in reviewing and monitoring vital signs such as non-invasive blood pressure, blood glucose, weight and other data from optional add-on devices for effective health management. The user also can share the data via sharing functions (Email and SMS).
7. Performance Data(Non-Clinical):
Samsung Electronics Co, Ltd. conducted bench testing to demonstrate data accuracy transmission for each meter. Memory data rollover was also tested by adding ten (10) data points to meters that were pre-loaded with full memory. Test results show that all the measurement values, data, and time properly downloaded from the meters to the software. Memory data rollover also functioned properly where the new measurement values replaced the oldest glucose values.
In addition, a study intended to assess lay users' performance in using the S Health was conducted. Overall, they rated the S Health at 100% for overall program as easy or somewhat easy. There were no users that rated the software program as somewhat difficult or difficult. 100% of them also responded that they are satisfied with the S Health and its manual.
The study results supports that the S Health is effective and provides accurate data management system as other predicate devices in the market.
8. Substantial Equivalence
The predicate devices and S Health are optional software accessories for use with blood glucose, blood pressure, and weight with data management capability.
There are some minor differences between the subject device and the predicate device in software operation options, settings and some other features, but it does not constitute a new intended use. Despite the differences, the validation testing results presented in this 510K supports that the S Health is safe and effective as the predicate devices.
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K132148 Page 3 of 3
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9. Conclusion:
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Based on the testing results. Samsung Electronics concludes that the S Health is safe and effective also, substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
December 4, 2013
Samsung Electronic Con. Ltd. % Priscilla Chung Official Correspondent LK Consulting Group 1515 E Katella Ave. Unit 2115 Anaheim, CA 92805 US
Re: K132148 Trade/Device Name: S Health Regulation Number: 21 CFR 870.2910 Regulation Name: Healthcare Data Management Mobile Application Regulatory Class: Class II Product Code: DRG, NBW, DXN, FRI Dated: November 4, 2013 Received: November 7, 2013
Dear Priscilla Chung:
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. 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
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Page 2 - Priscilla Chung
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDeyices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Owen P. Faris -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K _
Device Name: S Health
Indication for use:
The S Health is a mobile application intended for use in home to help people in reviewing and monitoring vital signs such as non-invasive blood pressure, blood glucose, weight and other data from optional add-on devices for effective health management. The user also can share the data via sharing functions (Email and SMS).
Prescription Use_ (Part 21CFR801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)