ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM

K131419 · I-Sens, Inc. · NBW · Aug 9, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131419
• Device Name: ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ACURA PLUS 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 such as the 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 ) 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. The ACURA PLUS Multi Blood Glucose Test Strips are for use with the ACURA PLUS Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

Device Story

ACURA PLUS Multi Blood Glucose Monitoring System; modification of previously cleared ACURA PLUS (K103278). Device measures glucose in capillary whole blood; used by healthcare professionals and patients for diabetes management. Modification adds multiple-patient use capability; includes validated cleaning/disinfection instructions using Clorox Germicidal wipes. System maintains fundamental scientific technology of predicate. Output used by clinicians/patients for glucose monitoring and diabetes management decisions.

Clinical Evidence

Bench testing only. Disinfection efficacy study performed using Clorox Germicidal Wipes against Hepatitis B virus (HBV) demonstrated complete inactivation of live virus. Durability testing confirmed that 10,950 cleaning/disinfection cycles (simulating 3 years of multiple-patient use) had no adverse effect on meter performance or external materials.

Technological Characteristics

Glucose monitoring system; electrochemical sensing principle. Materials validated for robustness against Clorox Germicidal wipes (EPA# 61619-12). Designed for multiple-patient use in professional settings. No change to fundamental scientific technology from predicate.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from fingertips and alternative sites (forearm, palm, thigh, calf) in patients requiring diabetes control monitoring. Contraindicated for neonates and for diabetes diagnosis or screening. Alternative site testing restricted to steady-state conditions.

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 Blood Glucose Monitoring System (k103278)

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 k131419

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. k103278; ACURA PLUS Blood Glucose Monitoring System

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:

1. To add an additional name to their cleared system: ACURA PLUS Multi Blood Glucose Monitoring System
2. Add validated cleaning and disinfection instructions for multiple-patient use to the labeling

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.

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Infection Control Studies: The proposed device system is intended for multiple-patient use only. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal wipes (EPA# 61619-12). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 10,950 cleanings and disinfection cycles with the Clorox Germicidal wipes. 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.