(79 days)
Not Found
No
The description focuses on data management, analysis, and reporting of historical data, which are standard software functionalities and do not explicitly mention or imply the use of AI/ML algorithms for tasks like prediction, classification, or pattern recognition beyond basic data aggregation and visualization.
No
The device is a data management software system used in hospitals or health institutes to review and analyze patient historical data. It explicitly states that it "may not be used as a substitute for direct medical intervention or emergency care" and that interpretation of its information "requires clinical judgment by an appropriate healthcare professional," indicating it is not directly therapeutic.
No
The device is a data management software system designed to review and analyze patient historical data, particularly quality control data and blood glucose measurements. It does not directly diagnose or provide diagnostic information but rather helps healthcare professionals manage and interpret existing data for health management.
Yes
The device is described solely as a "data management software" and its functions are related to managing and analyzing data from other devices. There is no mention of any hardware components being part of the device itself.
Based on the provided information, the FORA POCT Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The system is described as a "data management software" for reviewing and analyzing patient historical data transmitted from meters. It explicitly states it "may not be used as a substitute for direct medical intervention or emergency care" and that "Interpretation of the information collected and transmitted requires clinical judgment by an appropriate healthcare professional." This indicates it's a tool for managing and presenting data, not for performing diagnostic tests itself.
- Device Description: The description focuses on managing quality control data, blood glucose measurements, stock control, meter settings, and generating reports. It helps healthcare professionals "make management and improvement decisions" and "do health management effectively" through evaluating historical results. This aligns with a data management function, not a diagnostic one.
- Lack of Diagnostic Function: The system doesn't perform any tests on biological samples to determine the presence or absence of a disease or condition. It processes data from diagnostic devices (like blood glucose meters), but it is not the diagnostic device itself.
- Predicate Device: The predicate device, AtLast® Data Management Software (DMS), is also a data management system, further supporting the classification of the FORA system as a data management tool rather than an IVD.
In summary, the FORA POCT Management System is a software designed to manage and analyze data generated by other devices (likely IVDs, such as blood glucose meters). It does not perform diagnostic testing itself and is therefore not an IVD.
N/A
Intended Use / Indications for Use
The FORA POCT Management System is a data management software and designed for using in hospital or health institute environment. Patient historical data transmitted is able to be reviewed and analyzed in this system.
The FORA POCT Management 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JOP
Device Description
The FORA POCT Management System is designed for using in hospital or health institute environment. The system provides management on quality control data, Blood Glucose Measurement, Stock Control, Meter Setting, Operator and Operation Units with multiple reporting options and tools.
The information uploaded from meters is arranged and analyzed by graphs and summarizes tables according to various groups of functions. It allows the user to make management and improvement decisions more effectively.
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
hospital or health institute environment
healthcare professional
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)
Testing of FORA POCT Management System indicates that the system meets the acceptable criteria.
FORA POCT Management System demonstrates satisfactory performance and is suitable for its intended use.
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.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Section 8.
JUL - 6 2011
510(k) Summary
Page 1-of-2
1. Submitter Information
Company name Contact person Address
| Phone |
|---|
| FAX |
| Date Prepared |
2. Name of Device
Trade Names Common Names
Classification
Product Code
3. Predicate Device Trade/Proprietary Name: Common/Usual Name:
Submitter 510 (k) Number TaiDoc Technology Corporation Teling Hsu 3F, 5F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan (886-2) 6625-8188 #1176 (886-2) 6625-0288 teling.hsu@taidoc.com.tw April 12, 2011
FORA POCT Management System Diabetes Data Management Software Program Class II Device (21 CFR 862.1345) Class I Device (21 CFR 862.2100) NBW, JQP
AtLast® Data Management Software (DMS) Diabetes Data Management software Program Amira Medical K010605
4. Device Description
The FORA POCT Management System is designed for using in hospital or health institute environment. The system provides management on quality control data, Blood Glucose Measurement, Stock Control, Meter Setting, Operator and Operation Units with multiple reporting options and tools.
The information uploaded from meters is arranged and analyzed by graphs and summarizes tables according to various groups of functions. It allows the
1
user to make management and improvement decisions more effectively.
Through evaluation of the historical test results, healthcare professionals can do health management effectively.
5. Intended Use
The FORA POCT Management System is data management software. Patient historical data transmitted is able to be reviewed and analyzed in this system.
The FORA POCT Management System may not be used as a substitute for direct medical intervention. Interpretation of the information collected and transmitted requires clinical judgment by an appropriate healthcare professional.
6. Comparison to Predicate Device
The FORA POCT Management System is substantially equivalent to the AtLast® Data Management Software (K010605).
7. Performance Studies
Testing of FORA POCT Management System indicates that the system meets the acceptable criteria.
8. Conclusion
FORA POCT Management System demonstrates satisfactory performance and is suitable for its intended use.
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Taidoc Technology Corporation c/o Teling Hsu Regulatory Affairs Specialist 3f,5f, No.127 Wugong 2nd Rd., Wugu Township Taipei County, 24888 TW - CHINA (TAIWAN)
1JUL 0 6 2011
Re: K111029
Trade/Device Name: FORA POCT Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, JOP Dated: April 12, 2011 Received: April 13. 2011
Dear: Ms. Hsu:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (1 - 1 1 1 TH als 60 ) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of prevents 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 tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: 11:5
Enclosure
4
Section 7.
Indications for Use
510(k) Number: K H1029 Device Name: FORA POCT Management System
Indications for Use:
The FORA POCT Management System is a data management software and designed for using in hospital or health institute environment. Patient historical data transmitted is able to be reviewed and analyzed in this system.
The FORA POCT Management 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.
Prescription Use __ X ________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)
And/Or
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 In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Kill 029
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