ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM

K072543 · Lifescan, Inc. · NBW · Oct 5, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072543
• Device Name: ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The OneTouch® Sclect™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Select™ System is intended for self-testing outside the body (in vitro diagnostic use) by pcople with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Select™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Device Story

System measures glucose in fresh capillary whole blood; consists of meter, test strips, control solutions, and lancing device. User applies blood sample to test strip; meter performs electrochemical analysis to quantify glucose concentration. Used by patients at home or clinicians in clinical settings. Output displayed on meter screen to aid diabetes management. Modifications from predicate include ergonomic/physical design, hardware/firmware updates, electrode layout changes, and addition of second control solution level.

Clinical Evidence

No clinical data provided. Substantial equivalence established via design control activities, risk analysis, and verification/validation testing of modifications.

Technological Characteristics

Electrochemical glucose monitoring system. Components: meter, test strips, control solutions, lancing device. Modifications include updated ergonomic design, hardware/firmware, and electrode layout. Complies with ISO 15197:2003(E) for analytical performance.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for people with diabetes (home use) and healthcare professionals (clinical setting) to monitor diabetes control. Indicated for use on finger, forearm, or palm.

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

• OneTouch® Ultra® 2 Blood Glucose Monitoring System (K072543)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k072543

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

1. The name and 510(k) number of Lifescan, Inc.'s Previously Cleared Device, "OneTouch® Ultra® 2 Blood Glucose Monitoring System," cleared under k053529. (For a preamendments device, a statement to this effect has been provided.)
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.
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 ergonomic/physical design, electronic/hardware and software/firmware changes. Test Strip – modification to the electrode orientation and addition of an arrow to aid in user strip insertion, blue top tape color for OneTouch® Select™ Test Strip identification. Control Solution – name change and introduction of a second level. Labeling – product name change, modifications to instructions for use.

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

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 should include:

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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"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? | | | 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? | | | If NO = Request Data |
| 9. Data Demonstrate Equivalence? | | | 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:
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:
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: