WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM

K073573 · Agamatrix · NBW · Jan 30, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073573
• Device Name: WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Agamatrix
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 30, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The WaveSense™ KeyNote Codeless Blood Glucose Monitoring System is intended to quantitatively measure blood glucose levels, also known as blood sugar, from fresh capillary whole blood samples taken from the fingertips, palm, or forearm. The WaveSense™ KeyNote Codeless Blood Glucose Monitoring System test strips are for in vitro diagnostic (outside of the body) use only. The WaveSense™ KeyNote Codeless Blood Glucose Monitoring System is not intended for use with neonates.

Device Story

Portable, battery-operated blood glucose meter; uses test strips to analyze fresh capillary whole blood samples from fingertips, palm, or forearm. Device measures glucose levels quantitatively; provides results to patients or healthcare professionals for diabetes management. Modification of WaveSense Jazz system; excludes meal tagging and positive feedback features; includes shell redesign. Used in home or clinical settings; provides immediate feedback for clinical decision-making regarding glycemic control.

Clinical Evidence

Bench testing only; design control verification and validation activities performed to assess impact of modifications.

Technological Characteristics

Portable, battery-operated meter. In vitro diagnostic system. Complies with ISO 15197:2003, ISO 14971:2000, IEC 61010-1, IEC 61010-2-101, and IEC 61000-4-3. Codeless technology.

Indications for Use

Indicated for quantitative blood glucose measurement in fresh capillary whole blood from finger, palm, or forearm. For OTC home use by persons with diabetes or clinical use by healthcare professionals to monitor diabetes control effectiveness. Contraindicated for neonates.

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 k073573

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.) k072413
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:

A. An engineering change in the mechanical appearance.
B. Removal of two user interface applications: meal tagging and positive feedback.
C. Re-naming the device.

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