Assure Prism multi Blood Glucose Monitoring System

K151164 · I-Sens, Inc. · NBW · Aug 7, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151164
• Device Name: Assure Prism multi Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 7, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh, and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes. Assure® Prism multi Blood Glucose Test Strips are for use with the Assure® Prism multi blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

Device Story

System consists of multi-use blood glucose meter, test strips, and control solutions. Operates via electrochemical biosensor technology; glucose oxidase (Aspergillus sp.) reagent on test strip reacts with blood sample to generate small electrical current; meter converts current to glucose concentration. Used in professional healthcare settings for multiple patients; operated by healthcare professionals. Validated for cleaning/disinfection using specific EPA-registered wipes to prevent blood-borne pathogen transmission (e.g., HBV). Output is quantitative glucose concentration displayed to provider to aid diabetes management. Benefits include point-of-care monitoring of glucose levels.

Clinical Evidence

Bench testing only. Disinfection efficacy testing demonstrated complete inactivation of HBV using four specific EPA-registered disinfectant wipes. Robustness testing confirmed no degradation in performance or external materials after 10,950 cleaning and disinfection cycles, simulating 3 years of multiple-patient use.

Technological Characteristics

Electrochemical biosensor; glucose oxidase (Aspergillus sp.) reagent. Amperometric measurement method. Meter designed for multiple-patient use; validated for 10,950 cleaning/disinfection cycles. Connectivity: Standalone meter.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, forearm, palm, thigh, calf) in professional healthcare settings to monitor diabetes control. Contraindicated for neonates and for diabetes diagnosis or screening.

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

• ACURA Plus Multi Blood Glucose Monitoring System (k131419)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Summary

To: THE FILE

RE: DOCUMENT NUMBER K151164

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): **Assure Prism multi Blood Glucose Monitoring System**

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) **ACURA Plus Multi Blood Glucose Monitoring System (k131419).**

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:

i. Incorporating validated cleaning and disinfection procedures for additional disinfectant products into the labeling of the Assure Prism multi Blood Glucose Monitoring System.

ii. Changing the symbols on the meter buttons to use arrows instead of letters.

iii. Changing the brand name of the device and the logo printed on the test strips; previously the device was the ACURA Plus Multi Blood Glucose Monitoring System and the test strips were printed with the logo "ACURA". The device is now named the Assure Prism multi Blood Glucose Monitoring System and the test strips are printed with the logo "ARKRAY".

4. **Comparison Information** (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics (including efficacy of cleaning and disinfection agents on the materials of the meter and robustness of the system to repeated cleaning and disinfection).

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.

**Infection Control Studies:** The Assure Prism Multi Blood Glucose Monitoring System is intended for multiple-patient use. Disinfection efficacy testing was conducted by outside testing facilities and demonstrated complete inactivation of hepatitis B virus (HBV) with: Clorox Germicidal Wipes (EPA registration # 67619-12), Dispatch Hospital Cleaner Disinfectant Towels with Bleach (EPA registration # 56392-8), CaviWipes 1 (EPA registration # 46781-13), and PDI Super Sani-Cloth Germicidal Disposable Wipe (EPA registration # 9480-4). Robustness studies were performed by the sponsor demonstrating

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that there were no changes in the performance or external materials of the meter after 10,950 cleanings and 10,950 disinfection cycles with: Clorox Germicidal Wipes (EPA registration # 67619-12), Dispatch Hospital Cleaner Disinfectant Towels with Bleach (EPA registration # 56392-8), CaviWipes 1 (EPA registration # 46781-13), and PDI Super Sani-Cloth Germicidal Disposable Wipe (EPA registration # 9480-4). The robustness studies were designed to simulate 3 years of multiple-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.