NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR

K123683 · Aerocrine AB · MXA · Dec 27, 2012 · Clinical Toxicology

Device Facts

• Record ID: K123683
• Device Name: NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
• Applicant: Aerocrine AB
• Product Code: MXA · Clinical Toxicology
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3080
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX MINO according to guidelines for NO measurement established by the American Thoracic Society. Measurement of FeNO by NIOX MINO is a quantitative, non-invasive, simple and safe method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. NIOX MINO is suitable for children approximately 7 - 17 years, and adults 18 years and older. FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. NIOX MINO should only be used as directed in the NIOX MINO User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists and laboratory technicians. NIOX MINO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MINO should not be used in critical care, emergency care or in anaesthesiology.

Device Story

NIOX Panel is an optional software accessory for the NIOX MINO Airway Inflammation Monitor. The NIOX MINO system measures fractional nitric oxide (FeNO) in expired breath using electrochemical detection. The device includes a sampling/gas conditioning system, ambient air filtering, and flow control (50 ml/s). The NIOX Panel software allows the NIOX MINO to connect to a PC via USB, providing an additional display and interface for the clinician (physician, nurse, respiratory therapist, or lab technician) to operate the instrument. The NIOX MINO unit retains all primary instrument supervision and measurement analysis functions; the Panel software serves only as a secondary interface. Results are displayed in parts per billion (ppb) to assist clinicians in evaluating asthma patients' response to anti-inflammatory therapy. The device is intended for clinical and laboratory settings.

Clinical Evidence

No clinical data provided. The submission relies on bench testing to demonstrate that the software accessory does not affect the performance, precision, linearity, accuracy, or detection limits of the NIOX MINO monitor.

Technological Characteristics

Electrochemical sensor for NO measurement. Modification adds PC-based software interface for device operation. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for healthcare professionals to measure Nitric Oxide (NO) in human breath to assist in the evaluation of airway inflammation in patients with asthma.

Regulatory Classification

Identification

A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.

Predicate Devices

• NIOX MINO® Airway Inflammation Monitor (K101034)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k123683

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. (For a preamendments device, a statement to this effect has been provided.) NIOX MINO Airway Inflammation Monitor, k101034.
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 adding an optional software accessory that allows the device to be operated from the user's PC. Without this optional accessory, the device is operated by the use of controls and a display panel located on the device itself.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics. Studies performed included usability testing and testing of verifiable requirements.

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.