(101 days)
Not Found
No
The device description explicitly states that it "does not measure, interpret or make any decisions on the data that it conveys." It acts solely as a communication link.
No
The device is a telehealth gateway intended to transmit medical information, not to provide therapy or treatment. Its function is limited to data communication between patient monitors and healthcare facilities.
No
This device explicitly states: "This device does not measure, interpret or make any decisions on the data that it conveys." It acts as a communication link to transmit data measured by other FDA-approved medical devices.
No
The device description explicitly states it uses RS232 cable or Bluetooth connections to receive data and then transmits it through Ethernet or modem, indicating the presence of hardware components for these connections and transmission. The performance studies also mention compliance with hardware-related standards like IEC/EN 60601-1.
Based on the provided information, the FORA GW 9014/TD-9014 TeleHealth Gateway is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description clearly state that this device transmits data measured by other FDA-cleared medical devices (blood glucose, blood pressure, etc.). It does not perform any tests on biological samples itself.
- The device explicitly states it "does not measure, interpret or make any decisions on the data that it conveys." This is a key characteristic that differentiates it from an IVD, which would typically be involved in the analytical process of a sample.
- The device acts as a communication link. Its primary function is to facilitate the transfer of data from other medical devices to a remote location.
Therefore, the FORA GW 9014/TD-9014 TeleHealth Gateway is a medical device, but it falls under a different classification than an IVD. It is a data transmission or communication device for remote patient monitoring.
N/A
Intended Use / Indications for Use
The FORA GW 9014/TD-9014 TeleHealth Gateway is for use by patients at home or at clinical settings. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. It serves as the remote communication link between various FDA-cleared compatible monitors and the compatible healthcare facility at another location. The healthcare facility could be with the healthcare provider, or at a disease management center, or other out-of-hospital caregivers.
This device is intended to transmit selected medical information (i.e. blood glucose, blood pressure, body weight, body temperature, body fat, and body hydration) measured by FDA approved medical devices via RS232 or wireless connections over the internet or residential telephone line.
This device does not measure, interpret or make any decisions on the data that it conveys.
This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time critical data. This device is not for use in systems which substitute for medical care, or for patients requiring direct medical supervision.
This device is not intended for patients requiring direct medical supervision or emergency intervention. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted.
Product codes
DRG
Device Description
FORA GW 9014/TD-9014 TeleHealth Gateway serves as the communication link between various compatible monitors and the compatible healthcare facility remotely. The healthcare facility may include healthcare providers, physicians, other caregivers, or a disease management center.
The proposed device uses either RS232 cable or Bluetooth connection to receive data from the monitors and then transmit the collected data to the server system through either Ethernet or modem. The healthcare providers can view the patient's test results through the web server at any time.
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
patients at home or at clinical settings / home or 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
Software validation of FORA GW 9014/TD-9014 TeleHealth Gateway and indicates that the proposed device meets the acceptable criteria.
The FORA GW 9014/TD-9014 TeleHealth Gateway meets the requirements of IEC/EN 60601-1, EN 300 328, EN 301 489-17 V1.2.1:2002, and EN 301 489-1 V1.8.1:2008, IEC 61000-4-2, etc.
The consumer study shows the instruction manual of FORA GW 9014 / TD-9014 TeleHealth Gateway is understandable for lay users.
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
K100427
P 1/3
Page 1-of-3
MAY 2 8 2010
510 (k) Summary
- Submitter Information Company name Contact person Address
- Phone FAX E-mail Date Prepared
- Name of Device Trade Names
Common Names Classification Names and Regulations
- Predicate Device Trade/Proprietary Name: Common/Usuai Name: Submitter 510 (k) Number
TaiDoc Technology Corporation Teling Hsu 6F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County, 24888, Taiwan (+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com February 5th, 2010
FORA GW 9014 TeleHealth Gateway / TD-9014 TeleHealth Gateway Telemedicine System
Radiofrequency Physiological Signal Transmitter and Receiver Class II 21 CFR 870.2910
RTX3320 Wireless TeleHealth Gateway Physiological Transmitter and Receiver RTX Healthcare A/S K041816
1
Page 2-of-3
4. Device Description
FORA GW 9014/TD-9014 TeleHealth Gateway serves as the communication link between various compatible monitors and the compatible healthcare facility remotely. The healthcare facility may include healthcare providers, physicians, other caregivers, or a disease management center.
The proposed device uses either RS232 cable or Bluetooth connection to receive data from the monitors and then transmit the collected data to the server system through either Ethernet or modem. The healthcare providers can view the patient's test results through the web server at any time.
5. Intended Use
The FORA GW 9014/TD-9014 TeleHealth Gateway is for use by patients at home or at clinical settings. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. It serves as the remote communication link between various FDA-cleared compatible monitors and the compatible healthcare facility at another location. The healthcare facility could be with the healthcare provider, or at a disease management center, or other out-of-hospital caregivers.
This device is intended to transmit selected medical information (i.e. blood glucose, blood pressure, body weight, body temperature, body fat, and body hydration) measured by FDA approved medical devices via RS232 or wireless connections over the internet or residential telephone line.
This device does not measure, interpret or make any decisions on the data that it conveys.
This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time critical data.
This device is not for use in systems which substitute for medical care, or for patients requiring direct medical supervision.
This device is not intended for patients requiring direct medical supervision or emergency intervention. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted.
2
Page 3-of-3
6. Comparison to Predicate Device
The FORA GW 9014/TD-9014 TeleHealth Gateway is substantially equivalent to the RTX3320 Wireless TeleHealth Gateway (K041816).
7. Performance Studies
(
Software validation of FORA GW 9014/TD-9014 TeleHealth Gateway and indicates that the proposed device meets the acceptable criteria.
The FORA GW 9014/TD-9014 TeleHealth Gateway meets the requirements of IEC/EN 60601-1, EN 300 328, EN 301 489-17 V1.2.1:2002, and EN 301 489-1 V1.8.1:2008, IEC 61000-4-2, etc.
The consumer study shows the instruction manual of FORA GW 9014 / TD-9014 TeleHealth Gateway is understandable for lay users.
8. Conclusion
FORA GW 9014/TD-9014 TeleHealth Gateway demonstrates satisfactory performance and is suitable for its intended use. FORA GW 9014/TD-9014 TeleHealth Gateway is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an emblem of an abstract eagle-like figure with three curved lines representing the head, body, and tail. The seal is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
TaiDoc Technology Corporation c/o Mr. Teling Hsu Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd. Rd., Wugu Township Taipei County CHINA (TAIWAN) 24888
MAY 2 8 2010
Re: K100427
Trade/Device Name: FORA GW 9014 TeleHealth Gateway/TD-9014 TeleHealth Gateway Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: April 19, 2010 Received: April 19, 2010
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 market 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, Or us and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA). 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 misleding.
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.
4
Page 2 - Mr. Teling Hsu
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
2 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: K100427
Device Name: FORA GW 9014 TeleHealth Gateway / TD-9014 TeleHealth Gateway
Indications for Use:
The FORA GW 9014/TD-9014 TeleHealth Gateway is for use by patients at home or at clinical settings. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. It serves as the remote communication link between various FDA-cleared compatible monitors and the compatible healthcare facility at another location. The healthcare facility could be with the healthcare provider, or at a disease management center, or other out-of-hospital caregivers.
This device is intended to transmit selected medical information (i.e. blood glucose, blood pressure, body weight, body temperature, body fat, and body hydration) measured by FDA approved medical devices via RS232 or wireless connections over the internet or residential telephone line.
This device does not measure, interpret or make any decisions on the data that it conveys.
This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time critical data. This device is not for use in systems which substitute for medical care, or for patients requiring direct medical supervision.
This device is not intended for patients requiring direct medical supervision or emergency intervention. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted.
And/Or
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J.K. West
Sian-Off) on of Cardiovascular 510(k) Number
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