(78 days)
The Clever Chek 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, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Clever Chek 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.
The Clever Chek 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, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
Here's a breakdown of the acceptance criteria and study information for the Clever Chek Health Care System Software (K070941), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Fulfillment: The system should meet its intended use | Demonstrated: Testing (hardware validation, software validation, user evaluation) demonstrated that the system meets its intended use. |
| Data Integrity: Data transferred from the device cannot be changed or modified in any way. | The device meets this criterion as it's explicitly stated as a feature of both the proposed device and its predicate, contributing to substantial equivalence. |
| Satisfactory Performance: | Demonstrated: The device demonstrated "satisfactory performance." |
| Suitability for Intended Use: | Demonstrated: The device is "suitable for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It vaguely refers to "Testing... included validation of hardware (data transfer through the cable) software and user evaluation."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Given the nature of the device (data management software for blood glucose and blood pressure monitors), the "ground truth" would likely be the raw, accurate readings from the meters themselves, rather than interpretations by medical experts.
4. Adjudication Method
The document does not describe an adjudication method. This is likely because the "ground truth" for this type of device would be the direct data from the connected medical devices, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is software for data management, not an interpretive diagnostic tool that human readers would use to assess cases for improved effectiveness.
6. Standalone Performance Study
A standalone performance study was done. The "Performance Studies" section states, "Testing of Clever Chek Health Care System Software included validation of hardware (data transfer through the cable) software and user evaluation. It demonstrated that the system meets its intended use." This indicates the software was tested on its own to confirm its functionality and adherence to its intended purpose.
7. Type of Ground Truth Used
The type of ground truth used was the raw data generated by the associated medical devices (blood glucose meters and blood pressure monitors). The software's function is to transfer and display this data accurately, without modification.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. Given that this is a data management software, it's unlikely to rely on traditional machine learning models that require a separate training set. Its validation would focus on data transfer accuracy, software functionality, and user interface.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a traditional "training set" in the context of machine learning, the document does not describe how ground truth for a training set was established. The "ground truth" pertinent to this device's function would be the accurate transmission and display of data from the aformentioned medical devices.
{0}------------------------------------------------
510 (k) Summary
JUN 2 1 2007
Page 1-of-2
- Submitter Information Company name Contact person Address
Phone FAX E-mail Date Prepared
- Name of Device Trade Names
Common Names Classification Names and Regulations
TaiDoc Technology Corporation Erica Li 4F, No. 88, Sec. 1, Kwang-Fu Rd, San-Chung, Taipei County, 241, Taiwan (886-2) 6635-8080 (886-2) 6635-5959 erica@taidoc.com Mar 30th , 2007
Clever Chek Health Care System Software Data management software
a) Calculator/data processing module for clinical use, Class I, 21CFR862.2100 b) Glucose Test System, Class II, 21CFR862.1345 c) Noninvasive Blood Pressure Measurement System, Class II, 21CFR870.1130,
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number
Camit Diabetes Management Software Data management software Roche Diagnostics Corporation K001907
{1}------------------------------------------------
4. Device Description
The Clever Chek 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, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
5. Intended Use
The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for people with diabetes 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 Clever Chek Health Care System Software is substantially equivalent to the Camit Diabetes Management Software (K001907). Both management software programs can be described as follows:
-
have the same intended use.
-
data transferred from the device cannot be changed or modified in any way.
7. Performance Studies
Testing of Clever Chek Health Care System Software included validation of hardware (data transfer through the cable) software and user evaluation. It demonstrated that the system meets its intended use.
8. Conclusion
Clever Chek Health Care System Software demonstrates satisfactory performance and is suitable for its intended use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
TaiDoc Technology Corporation c/o Ms. Erica (Pi-Shiou) Li Management Representative 4F, No. 88, Sec. 1, Kwang-Fu Rd. San-Chung, Taipei County Taiwan 241
JUN 2 1 2007
K070941 Trade/Device Name: Clever Chek Health Care System Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, DXN Dated: March 30, 2007 Received: April 04, 2007
Dear Ms. Li:
Re:
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. Ilsting 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mains of substantial equivalence of your device to a legally promarket notification - results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific intoniation actuation of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0490. Also, please note the V III Diagnostic Dones Bradian by reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the 1 ou may oounn only. Echerational and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.v.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number: K070941
Device Name: Clever Chek Health Care System Software
Indications for Use:
The Clever Chek 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, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Clever Chek 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.
AND/OR
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CL
Page 1 of
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) k07099
§ 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.