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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the FORA GW 9014/TD-9014 TeleHealth Gateway, a device designed to transmit medical information. The document focuses on demonstrating substantial equivalence to a predicate device and outlining performance studies.

However, the provided text does not contain detailed information about specific quantitative acceptance criteria or a study with a test set, ground truth, or expert involvement as typically expected for evaluating AI/algorithm-driven medical devices.

Instead, the performance studies mentioned are:

Software validation: This indicates the device "meets the acceptable criteria," but details about these criteria and the specific performance metrics are not given.
Compliance with international standards: 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. This typically concerns electrical safety, electromagnetic compatibility, and radio equipment performance, not clinical performance metrics related to data accuracy or interpretation.
Consumer study: This evaluated the "understandability for lay users" of the instruction manual.

Given the nature of the device (a telehealth gateway for transmission, not analysis or interpretation), the type of performance studies conducted are appropriate for demonstrating its functionality and safety as a communication link. It explicitly states: "This device does not measure, interpret or make any decisions on the data that it conveys." Therefore, comprehensive studies involving ground truth from experts, multi-reader multi-case analyses, or standalone algorithm performance, as would be expected for diagnostic or AI-powered devices, are not applicable to this specific device.

Therefore, many sections of your requested table cannot be filled from the provided text.

Here's a summary of what can be extracted based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Software validation requirements	The software validation of FORA GW 9014/TD-9014 TeleHealth Gateway indicates that the proposed device meets the acceptable criteria. (Specific criteria are not detailed in the document.)
Compliance with safety and EMC standards	Meets the requirements of IEC/EN 60601-1 (medical electrical equipment safety), EN 300 328 (radio equipment, wideband transmission systems), EN 301 489-17 V1.2.1:2002 (EMC for radio equipment), EN 301 489-1 V1.8.1:2008 (general EMC for radio equipment), and IEC 61000-4-2 (electrostatic discharge immunity).
User understandability of instruction manual	The consumer study shows the instruction manual is understandable for lay users.

Details on Studies (Based on available information and interpretations)

Sample size used for the test set and the data provenance: Not applicable in the context of clinical performance evaluation for this device. The "consumer study" would have involved a sample size of "lay users," but the exact number and provenance are not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The device transmits data and does not perform interpretation requiring expert ground truth in a clinical sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not done. This device is purely a communication gateway and does not involve AI for interpretation or improvement of human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. The device's function is communication, not standalone diagnostic or predictive performance. Its "standalone" performance would be its ability to transmit data accurately and reliably, which would be covered by software validation and compliance testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. For the software validation and compliance testing, the "ground truth" would be defined by the specified requirements of the standards and internal validation protocols (e.g., successful transmission, correct protocol implementation, immunity to interference).
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K100427
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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

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Page 2-of-3

4. Device Description

5. Intended Use

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.

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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.

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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.

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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

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Indications for Use

510(k) Number: K100427

Device Name: FORA GW 9014 TeleHealth Gateway / TD-9014 TeleHealth Gateway

Indications for Use:

This device does not measure, interpret or make any decisions on the data that it conveys.

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

Page 1 of

Regulation Number and Section

§ 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).