(39 days)
Not Found
No
The description focuses on data transfer and basic data management, with no mention of AI, ML, or related concepts.
No
The device is described as an optional software accessory for data management, transferring data from monitoring devices to a computer for review and analysis, rather than directly providing therapy.
No
The device is described as software that aids in reviewing, analyzing, and evaluating historical test results from other medical devices to support health management. It does not perform a direct diagnostic function itself, but rather manages data from diagnostic devices.
No
The summary explicitly states that testing included "validation of hardware (data transfer through the cable)" and describes the software as an "optional software accessory" for use with specific hardware devices (blood glucose meters and blood pressure monitors). This indicates a dependency on and interaction with hardware components beyond just running on a general-purpose computer.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software's intended use is for reviewing, analyzing, and evaluating historical test results from blood glucose and blood pressure monitors. It's an aid for data management and supporting health management.
- Device Description: The software transfers data from the meters to a computer for enhanced data management.
- Lack of Diagnostic Function: The software itself does not perform any diagnostic testing on biological samples (like blood). It processes data generated by devices that may be used in diagnostic processes (like blood glucose meters), but the software's function is data management and analysis of existing results, not generating new diagnostic information from a sample.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This software does not fit that definition.
N/A
Intended Use / Indications for Use
The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.
Product codes (comma separated list FDA assigned to the subject device)
NBW, DXN, FLL
Device Description
The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) blood glucose meters, b) blood glucose plus blood pressure monitors, and c) blood pressure monitors. When use with one of these devices, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
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
home and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of Health Care System Software included validation of hardware (data transfer through the cable) and software validation. Results demonstrate that the system meets 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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8. 510 (k) Summary
MAY 1 3 2011
- Submitter Information Company name . Contact person Teling Hsu Address Phone
FAX E-mail Date Prepared
- Name of Device Trade Names Product code Classification Names and Regulations
TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Rd. Wuqu Township, Taipei County 24888, Taiwan (+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com.tw March 30th, 2011
Health Care System Software NBW; DXN; FLL
a) Calculator/data processing module for clinical use, Class I, 21 CFR 862.2100 b) Glucose Test System, Class II, 21 CFR 862.1345 c) Noninvasive Blood Pressure Measurement System, Class II, 21 CFR 870.1130, d) General Hospital, Class II, 21 CFR 880.2910
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number
Clever Chek Health Care System Software Data management software TaiDoc Technology Corporation K070941
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4. Device Description
The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) blood glucose meters, b) blood glucose plus blood pressure monitors, and c) blood pressure monitors. When use with one of these devices, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
5. Intended Use
The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.
6. Comparison to Predicate Device
The Health Care System Software is substantially equivalent to the Clever Chek Health Care System Software (K070941). Both management software programs can be described as follows:
- have the same intended use and intended users
- have the same data presentation
- have same programming language
- data transferred from the device cannot be changed or modified in any way.
The modifications include:
- -Added temperature data tabular display setting
- -Added temperature graph display setting
- -Added temperature data printer setting
2
7. Performance Studies
Testing of Health Care System Software included validation of hardware (data transfer through the cable) and software validation. Results demonstrate that the system meets its intended use.
8. Conclusion
Health Care System Software is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 3 2011
Mr. Teling Hsu Regulatory Affairs Specialist TaiDoc Technology Corporation 6F, No, 127, Wugong 2nd Road Wugu Township Taipei County Taiwan 24888
Re: K110948
Trade/Device Name: Health Care System Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, DXN, FLL Dated: May, 4, 2011 Received: May 6, 2011
Dear Mr. 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. 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.
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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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K110948
Device Name: Health Care System Software
Indications for Use:
The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.
Prescription Use_ _ _ Over-The-Counter Use _ X AND/OR 21 CFR 801 Subpart D) (21 CFR 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 (OIVD)
Rhit C. Aly 5/12/16
Division Sign-Off
Division Sign-Off Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K110948