(329 days)
No
The document describes a software application for collecting, storing, and displaying vital sign data from connected medical devices. It explicitly states it is not interpretive and does not mention any AI or ML capabilities.
No
The device is described as collecting, storing, and transmitting vital sign measurements and motivational content; it explicitly states it is "not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data." This indicates it does not provide therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "The LG SmartHealth is not interpretive, nor is it intended for diagnosis or as a substitute for medical care..."
Yes
The device is described as an application ("app") that operates on a commercially available smartphone and connects to separate, commercially available wireless medical devices. The 510(k) summary focuses on the software's functionality, connectivity, data handling, and usability, without describing any proprietary hardware components included with the LG SmartHealth itself.
Based on the provided text, the LG SmartHealth device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed in vitro (outside the body).
- LG SmartHealth's Function: The LG SmartHealth device collects vital sign measurements from external medical devices (glucose meters, blood pressure cuffs, weight scales, etc.). It stores, displays, and transmits this information. It does not perform any tests on biological samples itself.
- Intended Use: The intended use clearly states it's for collecting and reviewing vital sign measurements and engaging in video conferences. It explicitly states it is "not interpretive, nor is it intended for diagnosis or as a substitute for medical care."
Therefore, the LG SmartHealth acts as a data collection, storage, and communication platform for vital sign data obtained from other devices, rather than performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The LG SmartHealth is intended to collect vital sign measurement devices intensurement devices intended for use in the home . Patients can review the stored vital sign measurement information and motivational content from caregivers(or nurse). Patients can also engage in video conferences with caregivers(or nurse).
The LG SmartHealth is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
The LG SmartHealth is contraindicated for patients requiring direct-medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
Product codes
DRG
Device Description
The LG SmartHealth application is software planned to operate on the Android operating system (OS) that can be loaded as an application or "app" on a commercially available smartphone. LG intended the software to work on the Android OS, as well as to operate on smartphones as well. The scalability and differences between many smartphones today are not too great to allow this flexibility and option.
The LG SmartHealth application connects to commercially available wireless medical devices that are commonly used by patients in a home-care setting. These "sensor devices" are FDA cleared or FDA registered (Exempt) devices that can communicate with the LG SmartHealth application software loaded on the smartphone using Bluetooth connectivity. To avoid wireless interference and confusion on the part of the patient, serial readings are performed (i.e. only one Bluetooth sensor used at a time) and MAC address filtering is used for the various medical devices. The LG SmartHealth application plans to support the following sensor available medical devices, some initially, and others as the technology becomes available:
- Glucose meters or glucometers
- Blood pressure cuffs
- Weight scales
- Body fat readers
- Activity monitors
On each screen of the LG SmartHealth application software a help button is present, which when pressed provides step-by-step based help to guide a patient through an interaction.
The medical device takes a reading depending on the frequency previously established and the LG SmartHealth application software fetches the information for the reading automatically. The LG SmartHealth application software stores and displays the information on the smartphone and transmits the information to the server. The LG SmartHealth application encrypts the information in preparation for transmit using SHA256 bit encryption, complying with HIPAA requirements.
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
Patient in Home Setting
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
Non-Clinical Performance Data: The device's software development, verification, and validation were carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The LG SmartHealth device passed all testing and supports the claims of substantial equivalence and safe operation.
Validation activities included a usability study of the LG SmartHealth under actual use. The study demonstrated:
- Comprehension of the study nurses and participants with the LG SmartHealth,
- Appropriate human factors related to the LG SmartHealth, and
- Ease of use of the LG SmartHealth.
Clinical Performance Data: There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The verification and validation testing of the device's software was found to be acceptable and supports the claims of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2014
LG Electronics c/o Ms. Diane Sudduth Senior Consultant, RA/Q/A 816 Congress Avenue, Suite 1400 Austin, TX 78701
Re: K133997
Trade/Device Name: LG SmartHealth Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: November 19, 2014 Received: November 20, 2014
Dear Ms. Sudduth:
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 or any Federal statutes and regulations administered by other Federal agencies. You must
1
Page 2 - Ms. Diane Sudduth
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 (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
LG SmartHealth
Indications for Use (Describe)
The LG SmartHealth is intended to collect vital sign measurement devices intensurement devices intended for use in the home . Patients can review the stored vital sign measurement information and motivational content from caregivers(or nurse). Patients can also engage in video conferences with caregivers(or nurse).
The LG SmartHealth is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
The LG SmartHealth is contraindicated for patients requiring direct-medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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"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) Summary
for
LG SmartHealth
1. Submission Sponsor
LG Electronics 38 Baumoe-ro, Seocho-gu Seoul, 137-724 Korea Phone: +82-2-526-4527 Fax: +82-2-526-4370 Contact: Chang Hee Lee, Chief Research Engineer
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (561) 305-5075 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Dr. Diane Sudduth, Senior Consultant, QA Email: project.management@emergogroup.com
3. Date Prepared
December 21, 2013
4. Device Identification
| Trade/Proprietary Name: | LG SmartHealth |
|---|---|
| Common/Usual Name: | Remote Patient Monitoring System |
| Classification Name: | Transmitters and Receivers, Physiological Signal |
| Radiofrequency | |
| Classification Regulation: | 870.2910 |
| Product Code: | Product Code DRG |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
5. Legally Marketed Predicate Device(s)
Intel Health Guide Express (K103276)
5
6. Device Description
The LG SmartHealth application is software planned to operate on the Android operating system (OS) that can be loaded as an application or "app" on a commercially available smartphone. LG intended the software to work on the Android OS, as well as to operate on smartphones as well. The scalability and differences between many smartphones today are not too great to allow this flexibility and option.
The LG SmartHealth application connects to commercially available wireless medical devices that are commonly used by patients in a home-care setting. These "sensor devices" are FDA cleared or FDA registered (Exempt) devices that can communicate with the LG SmartHealth application software loaded on the smartphone using Bluetooth connectivity. To avoid wireless interference and confusion on the part of the patient, serial readings are performed (i.e. only one Bluetooth sensor used at a time) and MAC address filtering is used for the various medical devices. The LG SmartHealth application plans to support the following sensor available medical devices, some initially, and others as the technology becomes available:
- -Glucose meters or glucometers
- -Blood pressure cuffs
- -Weight scales
- -Body fat readers
- -Activity monitors
On each screen of the LG SmartHealth application software a help button is present, which when pressed provides step-by-step based help to guide a patient through an interaction.
The medical device takes a reading depending on the frequency previously established and the LG SmartHealth application software fetches the information for the reading automatically. The LG SmartHealth application software stores and displays the information on the smartphone and transmits the information to the server. The LG SmartHealth application encrypts the information in preparation for transmit using SHA256 bit encryption, complying with HIPAA requirements.
7. Indication for Use Statement
The LG SmartHealth is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers (or nurse). Patients can also engage in video conferences with caregivers (or nurse).
The LG SmartHealth is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
The LG SmartHealth is contraindicated for patients requiring direct-medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing
6
its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
8. Substantial Equivalence Discussion
The comparison chart below provides evidence to facilitate the substantial equivalence determination between LG SmartHealth to the predicate device (K103276) with respect to intended use, technological characteristics and principles of operation.
| Features and
Specifications | Intel® Health Guide Express
(K103276) | LG SmartHealth
(Subject Device) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | | |
| Intended Use/ Indications for
Use | The Intel® Health Guide Express is intended
to collect vital sign measurements from
physiological measurement devices
intended for use in the home.
Patients can review the stored vital sign
measurement information and receive
educational and motivational content from
caregivers. Patients can also engage in
video conferences with caregivers and
answer the caregivers' questions by
participating in surveys.
The Intel® Health Care Management Suite
allows the caregiver to review patient data
and initiate video conferencing with
patients, or select and send educational and
motivational content to patients.
The Intel® Health Guide Express is not
interpretive, nor is it intended for diagnosis
or as a substitute for medical care, and it is
not intended to provide real time data. It is
made available to patients when time-
critical care is not required.
The Intel® Health Guide Express is
contraindicated for patients requiring direct-
medical supervision or emergency
intervention. It is intended for patients who
are willing and capable of managing its use.
Clinical judgment and experience by a
caregiver are required to check and
interpret the information delivered. | The LG SmartHealth is intended to
collect vital sign measurements
from physiological measurement
devices intended for use in the
home.
Patients can review the stored vital
sign measurement information and
receive educational and
motivational content from
caregivers (or nurse).
Patients can also engage in video
conferences with caregivers (or
nurse).
The LG SmartHealth is not
interpretive, nor is it intended for
diagnosis or as a substitute for
medical care, and it is not intended
to provide real time data. It is
made available to patients when
time-critical care is not required.
The LG SmartHealth is
contraindicated for patients
requiring direct-medical
supervision or emergency
intervention. It is intended for
patients who are willing and
capable of managing its use.
Clinical judgment and experience
by a caregiver are required to
check and interpret the
information delivered. |
| OTC and/or Rx | Rx | Same |
Table 5A – Comparison of Characteristics
7
| User Characteristics | ||
|---|---|---|
| Intended User | Patient in Home Setting | Same |
| Device | ||
| Components | Web based software application Data Transfer Tool (Integrated) | Smart phone app based software application Data Transfer Tool (Integrated) |
| User Interface Device | Computer Device (i.e. desktop, laptop) | Android Device(i.e. Smart phone, tablet) |
| Connectivity to Device | Bluetooth or USB wired | Bluetooth |
| Ability to Update Device Settings | Not available | Automatic deploy |
| Connectivity to Web-based Services | Login Secured by SSL Encryption | Same |
| Operating System | Microsoft Windows 7 (32-bit versions) | Android 2.3.3 or higher |
| Supported Device Types | Medical devices designed for home use: | |
| Blood glucose meter | ||
| Weight scale | ||
| Blood pressure | ||
| Pulse Oximeter | ||
| FEV/PEF | Medical devices designed for home use: | |
| Blood glucose meter | ||
| Weight scale | ||
| Blood pressure | ||
| Temperature | ||
| Activity Monitor | ||
| Software Delivery | Web download for the uploader only | Same |
| Software Features | ||
| Patient Management | Manage patient accounts, filter/sort/search patients, print reports. | The server connected to the mobile device manages patient accounts, filter/sort/search patients |
| Implementation method of collecting data from sensors | Bluetooth or USB wired | Bluetooth |
| Communication frequency | Bluetooth: 2.402 to 2.480 GHz | Same |
| Max data throughput under worst case conditions | Multiply read data can be stored in the medical device and they are resent to the server after recovery of network condition | Same |
| Use of | ||
| thresholds/algorithms for | ||
| determining how | ||
| thresholds are set and | ||
| changed | Thresholds set by healthcare | |
| professional in server software | Same | |
| Communication method | ||
| with server | Connected through internet | Same |
8
The LG SmartHealth is a medical device and has similar indications for use statement as the predicate device. The differences in the indications statement between LG SmartHealth and Intel Health Guide Express do not alter the intended use – both devices have essentially the same intended use.
The device also has similar technological characteristics as the predicate device. Both devices have the same data collection software functionality, communication method of patient device with central server, types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, and communication protocol. Since the comparison of the descriptive characteristics of the proposed and predicate devices may not be sufficiently precise to assure equivalence, performance data are provided. The results of the performance testing demonstrate substantial equivalence.
9. Non-Clinical Performance Data
The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The LG SmartHealth device passed all testing and supports the claims of substantial equivalence and safe operation.
Validation activities included a usability study of the LG SmartHealth under actual use. The study demonstrated:
- Comprehension of the study nurses and participants with the LG SmartHealth,
- Appropriate human factors related to the LG SmartHealth, and ●
- Ease of use of the LG SmartHealth.
10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The verification and validation testing of the device's software was found to be acceptable and supports the claims of substantial equivalence.
9
11. Statement of Substantial Equivalence
The LG SmartHealth has the same or similar intended use as the predicate device and that any technological differences between the LG SmartHealth software and the predicate device do not raise any questions regarding LG SmartHealth')'s safety and effectiveness.
The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.