(94 days)
The FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The system serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center
The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results. home users and healthcare professionals can do health management effectively
The FORA TeleHealth System may not be used as a substitute for direct medical intervention or emergency care Interpretation of the information collected and transmitted requires clinical judgment by an appropnate healthcare professional
This system is to be used or prescribed on the order of a physician
FORA TeleHealth System serves as the communication link between FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center
The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results, home users and healthcare professionals can do health management effectively
The provided document is a 510(k) summary for the FORA TeleHealth System. It outlines the device's intended use, comparison to predicate devices, and concludes that it demonstrates satisfactory performance. However, it lacks detailed information regarding specific acceptance criteria and the comprehensive study results that would typically be found in a performance evaluation report.
Based on the information given, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states, "Testing of FORA TeleHealth System and user evaluation indicate that the system meets the acceptable criteria." However, it does not explicitly list the acceptance criteria or provide specific performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in the document) | "the system meets the acceptable criteria" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The general statement "Testing of FORA TeleHealth System and user evaluation" does not give details about the test set's sample size or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The document makes no mention of experts or how ground truth was established for any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. There is no mention of adjudication methods.
5. 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
A multi-reader multi-case comparative effectiveness study is not mentioned. The device is described as a communication link for existing monitoring devices, not an AI diagnostic tool that would typically involve human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm is not explicitly mentioned in the context of the device's function. The "FORA TeleHealth System" is primarily a data transmission and review system, not an algorithm that performs standalone diagnoses or measurements. The "testing" likely refers to the system's ability to accurately transmit data from compatible devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for any testing. Given the system's function as a data relay, the "ground truth" would likely relate to the accuracy of data transmission and display, rather than medical diagnoses.
8. The sample size for the training set
This information is not applicable/not provided. The FORA TeleHealth System is a data transmission and review system. It's not described as a machine learning or AI-based diagnostic tool that would typically have a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as above.
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Attachment 8
ー
JAN 1 6 2009
510 (k) Summary
Submitter Information TaiDoc Technology Corporation Company name Contact person Yuhua Chen Address 6F, No 127, Wugong 2nd Rd , Wugu Township, Taiper County, 248, Tawan Phone (886-2) 6625-8188 FAX (886-2) 6625-0288 yuhua chen@taidoc com E-mail Date Prepared October 9th, 2008
2 Name of Device Trade Names Common Names Classification Names and Regulations
FORA TeleHealth System Telemedicine system
a) Radiofrequency physiological signal transmitter and receiver, Class II, 21CFR870 2910 b) Glucose Test System, Class II, 21CFR862 1345 c) Noninvasive Blood Pressure Measurement System, Class II, 21CFR870 1130,
3 Predicate Device Trade/Proprietary Name Common/Usual Name Submitter 510 (k) Number
Carematix Wellness System Telemedicine system Carematix, Inc K031840
Trade/Proprietary Name BL Healthcare Remote Care Management system Common/Usual Name Telemedicine system BL Healtheare, Inc Submitter 510 (k) Number K051470
Page 1-of-3
K083046
p1/3
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Page 2-of-3
4 Device Description
FORA TeleHealth System serves as the communication link between FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center
The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results, home users and healthcare professionals can do health management effectively
5 Intended Use
The FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The FORA TeleHealth System serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may ınclude healthcare professionals, other caregivers, or a disease management center
The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results, home users and healthcare professionals can do health management effectively
The FORA TeleHealth System may not be used as a substitute for direct medical intervention or emergency care Interpretation of the information collected and transmitted requires clinical judgment by an appropriate healthcare professional
This system is to be used or prescribed on the order of a physician
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Page 3-of-3
6 Comparison to Predicate Device
The FORA TeleHealth System is substantially equivalent to the Carematix Wellness System (K031840) and BL Healthcare Remote Care Management system (K051470)
7 Performance Studies
Testing of FORA TeleHealth System and user evaluation indicate that the system meets the acceptable cnteria
8 Conclusion
FORA TeleHealth System demonstrates satısfactory performance and ıs suitable for its intended use
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Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 5 - 2009
TaiDoc Technology Corporation c/o Ms. Yuhua Chen Assistant Manager 6F, No. 127, Wugong 2nd Rd., Wugu, Taipei County China Taiwan 248
Re: K083046
Trade/Device Name: FORA TeleHealth System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: November 27, 2008 Received: December 1, 2008
Dear Ms. Chen:
This letter corrects our substantially equivalent letter of January 16, 2009.
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 (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.
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Page 2 Ms. Yuhua Chen
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 801); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Arthister
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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Attachment 1
Indications for Use
510(k) Number K083046
Device Name FORA TeleHealth System
Indications for Use
The FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The system serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center
The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results. home users and healthcare professionals can do health management effectively
The FORA TeleHealth System may not be used as a substitute for direct medical intervention or emergency care Interpretation of the information collected and transmitted requires clinical judgment by an appropnate healthcare professional
This system is to be used or prescribed on the order of a physician
Prescription Use _ X AND/OR (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 CRH Office of Device Evaluation (ODE)
Well 167 BZuckerman
(Division Sign-Off) 1/16/09
Division of Cardiovascular Devices
610(k) Number K083046
Page 1 of 1
510(k) Number K083046
t
§ 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).