WowGoHealth Blood Glucose Monitoring System

K171785 · Biotest Medical Corporation · NBW · Sep 15, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171785
• Device Name: WowGoHealth Blood Glucose Monitoring System
• Applicant: Biotest Medical Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 15, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHealth Blood Glucose Monitor and the WowGoHealth Blood Glucose Test Strip. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used by a single person and should not be shared. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Wow GoHealth Blood Glucose Monitoring System (Model GSH-BGM902) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

Device Story

System comprises blood glucose meter, test strips, lancing device, and lancets. Input: fresh capillary whole blood sample applied to test strip. Principle: amperometric measurement using FAD-glucose dehydrogenase; electrical current proportional to glucose concentration. Meter calculates and displays glucose concentration (mg/dL or mmol/L) on LCD. Used at home by patients for self-testing. Features Bluetooth 4.0/BLP for wireless transmission of test results to mobile app; manual entry fallback if transmission fails. Meter stores results in memory. Patients perform maintenance via weekly cleaning/disinfection using Clorox Bleach Germicidal Wipes. Benefits: enables convenient, wireless tracking of blood glucose levels to support diabetes management.

Clinical Evidence

Bench testing only. Verification and validation activities included risk analysis per ISO 14971, software V&V, EMC/FCC testing, and usability testing for the Bluetooth data transmission feature. Robustness testing confirmed device integrity after multiple cleaning/disinfection cycles using Clorox Bleach Germicidal Wipes.

Technological Characteristics

Blood glucose monitoring system; electrochemical sensing principle. Features Bluetooth connectivity for data transmission. Housing material validated for robustness against 1100 cleaning/disinfection cycles. Powered by internal battery. Form factor: handheld meter.

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

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

• SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (K141351)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k171785

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:

SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S); K141351

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 the following item(s):

a. A change in the name of the device from the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) to the WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902).
b. Reposition of the control test flag ("cotr") on meter display
c. Replaced the RS232 cable with Bluetooth mediated data transmission functionality
d. Change of meter's housing color from black to white.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics (including robustness of the system to repeated cleaning and disinfection), specifications and performance characteristics of the WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902).

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.

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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The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended for single-patient use only. Disinfection efficacy studies described for the predicate device (SuperCheck Plus Blood Glucose Monitoring System, Model 5228-S (K141351) using Clorox Bleach Germicidal Wipes (EPA registration number 67619-12) demonstrated complete inactivation of live Hepatitis B Virus (HBV) on the materials of the meter. Robustness accuracy studies performed for the WowGoHealth Blood Glucose Monitoring System demonstrate that there was no change in performance or in the external materials of the meter after 1100 cleaning and 1100 disinfection cycles designed to simulate 3 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

This device was cleared after the FDA issued final guidance documents for prescription use blood glucose monitoring systems (BGMS) and over-the-counter use blood glucose monitoring systems (SMBG). However, the recommendations in the guidance documents were not followed for this device since the studies were performed prior to the finalization of the guidance documents.

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