GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION

K130886 · Glooko, Inc. · NBW · Apr 25, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130886
• Device Name: GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
• Applicant: Glooko, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 25, 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 Glooko device system for Glooko Logbook+ Application is a data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Logbook+ Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform. The Glooko device system for Glooko Loabook+ Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

Device Story

System consists of MeterSync Cable, IR Adapter, and Logbook+ Application. Inputs: blood glucose data from compatible, FDA-cleared commercial meters via cable or infrared. Transformation: data transfer to iOS device; storage; organization into logs; visualization via graphs/statistics; user-added notes/meal tags. Output: digital logbook, glucose trends, and statistics displayed on iOS devices or web browsers. Used in home/professional settings by patients and clinicians. Facilitates diabetes management by enabling data review and communication between patients and providers. Does not provide treatment decisions; not a substitute for professional advice. Data secured via SSL and 256-bit AES encryption.

Clinical Evidence

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

Technological Characteristics

System includes hardware (MeterSync Cable, IR Adapter) and software (Logbook+ Application). Connectivity: 30-pin iOS connector, 3.5mm/2.5mm meter jacks, infrared. Data transmission: wired/IR to iOS device, cloud-based sync across devices/browsers. Security: SSL protocol, 256-bit AES encryption. Software: iOS-based application.

Indications for Use

Indicated for patients with diabetes to download, view, and analyze blood glucose data from blood glucose meters as an aid in data review.

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

• Glooko Device System for Glooko Logbook Application and Glooko Logbook Charts (k122142)

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 k130886

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) for the Glooko Device System for Glooko Logbook+ Application:

1. The name and 510(k) number of the Glooko, Inc.'s previously cleared device, Glooko Device System for Glooko Logbook Application and Glooko Logbook Charts, cleared under k122142. (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 upgrading the data management system operating platform to allow for transmission of data across the internet, as well as viewing of statistics, graphs and charts generated by the data management system App or by web-based programs on Glooko, Inc.'s website, remotely viewable through supported web browsers.

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