CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0

K070941 · Taidoc Technology Corporation · NBW · Jun 21, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070941
• Device Name: CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for 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.

Device Story

Clever Chek Health Care System Software is an optional data management accessory for specific TaiDoc blood glucose and blood pressure monitoring devices. It functions by transferring stored test data from the meter's memory to a computer. Used in home and clinical settings by patients and healthcare professionals, the software provides a platform to review, analyze, and evaluate historical test results. This enhanced data management capability assists in health management by allowing users and clinicians to visualize trends in glucose and blood pressure data. The software does not modify the transferred data, ensuring integrity of the original test results.

Clinical Evidence

Bench testing only. Validation included verification of hardware data transfer via cable, software functionality, and user evaluation to confirm the system meets its intended use.

Technological Characteristics

Software-based data management system. Operates via data transfer from compatible blood glucose and blood pressure meters to a computer. Connectivity via cable. No modification of transferred data allowed. Rule-based data processing for historical review and analysis.

Indications for Use

Indicated for users of Clever Chek blood glucose meters, blood glucose plus blood pressure monitors, and blood pressure monitors in home and clinical settings to facilitate review, analysis, and evaluation of historical test results for health management.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Camit Diabetes Management Software (k001907)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k070941

B. Purpose for Submission:
Addition of software allowing data transfer and viewing from device to personal computer.

C. Manufacturer and Instrument Name:
TaiDoc Technology Corporation, CLEVER CHEK Health Care System Software

D. Type of Test or Tests Performed:
This device does not directly test glucose. This is an accessory to previously cleared TaiDoc glucose and glucose/blood pressure monitors (k061181, k062235, k063212, k070239, k070472, k062800, k070641, k051703).

E. System Descriptions:

1. 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 used 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.

2. Principles of Operation:
The Clever Chek Health Care System Software provides users the ability to export data from compatible TaiDoc meters to a computer via a cable connecting to the computer’s required 9-pin (RS232) port. The export of the data allows the data to be viewed only in the Clever Chek software. Aside from the ability to export the data stored in the meter’s memory, the software also allows the setting of the meter’s time and the ability to clear the meter’s memory.

3. Modes of Operation:
Wired data transfer of stored glucose and blood pressure measurements as well as setting of time and memory clearing on the meter.

4. Specimen Identification:
For an example, see k062800.

5. Specimen Sampling and Handling:
For an example, see k062800.

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6. Calibration:
For an example, see k062800.

7. Quality Control:
For an example, see k062800.

8. Software:
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X or No ☐

F. Regulatory Information:

1. Regulation section:
21 CFR § 862.1345, Glucose Test System
21 CFR § 870.1130, Noninvasive blood pressure measurement system

2. Classification:
Class II

3. Product code:
NBW
DXN

4. Panel:
75 (Clinical Chemistry)
74 (Cardiovascular)

G. Intended Use:

1. Indication(s) 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 used 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.

2. Special Conditions for Use Statement(s):
None.

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:
Camit Diabetes Management Software, k001907

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2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Same intended use | Same intended use |
| Data Use | Data transferred from the device cannot be changed or modified. | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Meter Compatibility | For use with TaiDoc meters | For use with Roche meters |

I. Special Control/Guidance Document Referenced (if applicable):

1) Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2) IEC 601-1-4, Safety Requirements for Programmable Electronic Medical Systems
3) EN 60601-1-4, Medical electrical equipment part 1-4: general requirements for safety – collateral standard: Programmable electrical medical systems

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

The sponsor validated overall software usage and data transfer functionality. Software usage validation entailed testing each of the software’s design requirements to ensure that they were met. Data transfer was tested by transferring sets of data (from both the glucose and blood pressure aspects of the device) from the meter to the software and checking that the data was downloaded in its entirety, was able to be viewed and graphed by the software, and that the data points (measurement results and time tested) that were transferred to the software matched the original data taken from the meter.

For an example of performance of the glucose meter, strips, and blood pressure monitor, see k062800.

b. Precision/Reproducibility:

For an example of performance of the glucose meter, strips, and blood pressure monitor, see k062800.

c. Linearity:

For an example of performance of the glucose meter, strips, and blood

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pressure monitor, see k062800.

d. Carryover:
For an example of performance of the glucose meter, strips, and blood pressure monitor, see k062800.

e. Interfering Substances:
For an example of performance of the glucose meter, strips, and blood pressure monitor, see k062800.

2. Other Supportive Instrument Performance Data Not Covered Above:
None.

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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