BGM009 Plus Blood Glucose Monitoring System

K170267 · Apex BioTechnology Corp. · NBW · Mar 9, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170267
• Device Name: BGM009 Plus Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 9, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BGM009 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It 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 diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The BGM009 Blood Glucose Test Strips are to be used with the BGM009 and BGM009 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Device Story

BGM009 Plus Blood Glucose Monitoring System; modified version of BGM009 (K141036). Modification includes name change, removal of voice feature, replacement of speaker with buzzer on PCBA, and corresponding software updates. Device used for blood glucose monitoring; single-patient use. Output provided via display; buzzer provides audible feedback. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data. Bench testing only; disinfection efficacy studies (using Clorox Healthcare Bleach Germicidal Wipes) and durability testing (1825 cleaning/disinfection cycles) performed to validate performance and material integrity.

Technological Characteristics

Glucose test system; uses electrochemical test strips. System is a handheld meter. Software-based algorithm for glucose calculation. No voice feature included. Operates on capillary whole blood samples.

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

• BGM009 Blood Glucose Monitoring System (K141036)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k170267

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: BGM009 Blood Glucose Monitoring System (k141036).
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 BGM009 Blood Glucose Monitoring System to the BGM009 Plus Blood Glucose Monitoring System.
b. Removal of the voice feature that includes language and volume change settings.
c. Replacement of the speaker to buzzer on the printed circuit board assembly (PCBA).
d. Software has been modified:

1. To support removal of voice feature
2. Remove language selection function
3. Change volume selection function to buzzer setting mode

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 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 BGM009 Plus Blood Glucose Monitoring System is intended for single-patient use only. Disinfection efficacy studies described for the predicate device (k141036 for BGM009 Blood Glucose Monitoring System) using Clorox Healthcare Bleach Germicidal Wipes (EPA registration number 67619-12-5813) demonstrated complete inactivation of live Hepatitis B Virus (HBV) on the materials of the meter. Studies described for the predicate device also demonstrate that there was no change in performance or in the external materials of the meter after 1825 cleaning and 1825 disinfection cycles (3650 cleanings total) designed to simulate cleaning and disinfection 7 times per week for 5 years. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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