FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM

K051802 · Abbott Diabetes Care, Inc. · NBW · Aug 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051802
• Device Name: FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The FreeStyle Connect Blood Glucose Monitoring System is intended for invitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

Device Story

The FreeStyle Connect Blood Glucose Monitoring System is a portable device for quantitative glucose measurement. It utilizes coulometric biosensor technology via test strips containing glucose dehydrogenase (GDH) enzyme. The system accepts fresh capillary, venous, arterial, or neonatal whole blood samples. The device measures glucose electrochemically; the biosensor recognizes glucose in the sample, producing an electrical signal proportional to the glucose concentration. Used in home and professional clinical settings by patients or healthcare providers. The output is a numerical blood glucose level displayed on the monitor, which assists in monitoring glucose levels and clinical decision-making.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance of modified device with new sensing strip.

Technological Characteristics

Glucose monitoring system utilizing electrochemical sensing strips. Modification limited to integration of sensing strip cleared in K050500. Fundamental scientific technology unchanged.

Indications for Use

Indicated for quantitative blood glucose measurement in fresh capillary, venous, arterial, and neonatal whole blood samples. For in vitro diagnostic use in home and professional settings.

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

• Precision PCx Blood Glucose Monitor (K022941)
• FreeStyle 600 Blood Glucose Test Strips (K050500)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K051802

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.)
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 :

incorporation of a new glucose sensing strip. The strip was reviewed and cleared in K050500.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and _internal design documents provided by the company provide a reasonable assurance that this device will work as indicated.

4. 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.

5. 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.