SMARTLOG DIABETES MANAGEMENT SOFTWARE

K133346 · I-Sens, Inc. · NBW · Dec 19, 2013 · Clinical Chemistry

Device Facts

• Record ID: K133346
• Device Name: SMARTLOG DIABETES MANAGEMENT SOFTWARE
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The SmartLog Diabetes Management Software is PC-based software for use with the i-SENS blood glucose meters. The SmartLog Diabetes Management Software is intended for use in the home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for an effective diabetes management program. The SmartLog Diabetes Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.

Device Story

SmartLog Diabetes Management Software; data management tool for blood glucose monitoring; inputs blood glucose data from meters via USB; transforms raw meter data into reports/visualizations for patient/clinician review; used in clinic or home settings; assists in diabetes management decisions; modification includes updated user interface and expanded OS compatibility (Mac and PC).

Clinical Evidence

No clinical data; bench testing and design control verification/validation activities performed to assess impact of UI and OS modifications.

Technological Characteristics

Software-based data management system; connectivity via USB cable; compatible with Mac and PC operating systems; design controls per 21 CFR 820.30.

Indications for Use

Indicated for use by individuals with diabetes and healthcare professionals in home and professional settings to review, analyze, and evaluate blood glucose test results for diabetes 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

• PC care Blood Glucose Data Management Software (k100937)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K133346

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 for the SmartLog Diabetes Management Software:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. PC care Blood Glucose Data Management Software (k100937)
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 modification of the User Interface and expansion of the operating system to include Mac as well as PC.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, operating system environment, and meter connectivity (USB cable).
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.

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 device.