Oh'Care Lite Smart Blood Glucose Monitoring System

K182286 · Osang Healthcare Co. , Ltd. · NBW · Sep 19, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182286
• Device Name: Oh'Care Lite Smart Blood Glucose Monitoring System
• Applicant: Osang Healthcare Co. , Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 19, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Oh’Care Lite Smart Blood Glucose Monitoring System is intended for single patient home use.

Device Story

System measures glucose concentration in fresh capillary whole blood; utilizes electrochemical biosensor technology where test strip generates electrical current proportional to glucose level; meter processes current to display quantitative glucose result. Used by patients with diabetes at home for self-monitoring. Includes meter, test strips, control solution, lancing device, and Bluetooth module for wireless data transfer. Provides immediate feedback to patient to aid in diabetes management. Device is for single-patient use only.

Clinical Evidence

No clinical data. Bench testing only; verification and validation activities confirmed performance, functionality, and reliability. Disinfection study validated CaviWipes (EPA 46781-8) for complete inactivation of live virus on meter surface.

Technological Characteristics

Electrochemical glucose monitoring system. Features Bluetooth Low Energy (BLE) connectivity. Meter housing materials validated for durability against 10,950 disinfection cycles using Metrex CaviWipes. Form factor: handheld meter.

Indications for Use

Indicated for single patient home 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

• GluNEO Lite Blood Glucose Monitoring System and GluNEO Lite Professional Blood Glucose Monitoring System (K132966)

Submission Summary (Full Text)

{0}

SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: k182286

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device: k132966, GluNEO Lite Blood Glucose Monitoring System (For a preamendments device, a statement to this effect has been provided.)

2. Applicant’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:
1) Addition of Bluetooth Low Energy capability
2) Change in meter housing colors from white and gray to black
3) Change in device name from GluNEO Lite Blood Glucose Monitoring System to Oh’Care Lite Smart Blood Glucose Monitoring System

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

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 applicant’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 applicant 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.

The Oh’Care Lite Smart Blood Glucose Monitoring System is intended for single patient home use. Disinfection efficacy studies were previously conducted under k103021 on materials comprising the

{1}

meter housing and demonstrated complete inactivation of hepatitis B Virus (HBV) with Metrex CaviWipes disinfecting towelettes (EPA Reg# 46781-8). Robustness studies were performed by the sponsor demonstrating that there was no change in performance or in the external materials of the meter after 10,950 cleaning and disinfection cycles with the CaviWipes towelettes. The studies support single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

2