FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM

K081715 · Taidoc Technology Corporation · NBW · Dec 17, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081715
• Device Name: FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The FORA TD-4244 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the FORA TD-4244 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. The FORA TD-4244 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Device Story

FORA TD-4244 is a blood glucose monitoring system; utilizes electrochemical biosensor technology to measure glucose levels in capillary whole blood. Device consists of a meter and test strips; requires small blood sample. Designed for home use by patients with diabetes and by healthcare professionals. Features integrated speaking functionality to provide audible step-by-step instructions, assisting visually impaired users. Output is a quantitative blood glucose concentration displayed on the meter screen and announced via voice. Results assist patients and clinicians in monitoring diabetes control programs. Not for diagnostic or screening purposes; not for neonatal use.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation of the new coding feature.

Technological Characteristics

Electrochemical biosensor; quantitative glucose measurement; capillary whole blood input. Includes integrated speaking functionality for accessibility. System components: meter and test strips. Class II device; Product Codes NBW, CGA. Regulation 21 CFR 862.1345.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from finger and alternative sites (palm, forearm, upper-arm, calf, thigh) in patients with diabetes mellitus. Intended for use by healthcare professionals and patients at home. Contraindicated for neonates and for diagnosis or screening of diabetes mellitus. Alternative site testing restricted to steady-state blood glucose conditions.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k081715

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k072784
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for adding code number selection feature for the test strips that differs from predicate device with no code function for the test strips. In comparison to the predicate, there are minor changes in the physical appearance of the meter.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, reagents, test steps, and performance characteristics.

The only differences are, adding code number selection feature, and physical appearance of size and weight of the device.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity included:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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(Reviewer's Signature)

(Date)

Comments:

See the attached email correspondence with the requests to the sponsor for changes in the labeling, making control solutions available to the user, and addition of a statement to the indications for use statement on speaker function.

revised:8/1/03

"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION

| | Yes | No | |
| --- | --- | --- | --- |
| 1. Same Indication Statement? | X | | If YES = Go To 3 |
| 2. Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness? | | X | If YES = Stop NSE |
| 3. Same Technological Characteristics? | X | | If YES = Go To 5 |
| 4. Could The New Characteristics Affect Safety Or Effectiveness? | | | If YES = Go To 6 |
| 5. Descriptive Characteristics Precise Enough? | | X | If NO = Go To 8 |
| | | | If YES = Stop SE |
| 6. New Types Of Safety Or Effectiveness Questions? | | | If YES = Stop NSE |
| 7. Accepted Scientific Methods Exist? | | | If NO = Stop NSE |
| 8. Performance Data Available? | X | | If NO = Request Data |
| 9. Data Demonstrate Equivalence? | X | | Final Decision: SE |

Note: See
http://eroom.fda.gov/eRoomReq/Files/CDRH3/CDRHPremarketNotification510kProgram/0_4148/FLOWCHART%20DECISION%20TREE%20.DOC for Flowchart to assist in decision-making process. Please complete the following table and answer the corresponding questions. "Yes" responses to questions 2, 4, 6, and 9, and every "no" response requires an explanation.

1. Explain how the new indication differs from the predicate device's indication:
2. Explain why there is or is not a new effect or safety or effectiveness issue: Adding coding feature does not bring new safety concerns
3. Describe the new technological characteristics:
4. Explain how new characteristics could or could not affect safety or effectiveness:
5. Explain how descriptive characteristics are not precise enough: New device contains Code selection feature that was not in the predicate device, that the user has to select the specific code for each new strip vial.
6. Explain new types of safety or effectiveness question(s) raised or why the question(s) are not new:
7. Explain why existing scientific methods can not be used:
8. Explain what performance data is needed:
9. Explain how the performance data demonstrates that the device is or is not substantially equivalent: