NIOX VERO Airway Inflammation Monitor

K150233 · Aerocrine AB · MXA · Feb 26, 2015 · Clinical Toxicology

Device Facts

• Record ID: K150233
• Device Name: NIOX VERO Airway Inflammation Monitor
• Applicant: Aerocrine AB
• Product Code: MXA · Clinical Toxicology
• Decision Date: Feb 26, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3080
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

NIOX VERO® 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 VERO according to guidelines for NO measurement established by the American Thoracic Society. Measurement of FeNO by NIOX VERO 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 VERO 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. The NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX VERO should not be used in critical care, emergency care or in anesthesiology.

Device Story

Portable monitor measures fraction of exhaled nitric oxide (FeNO) in human breath; indicates airway inflammation. Patient exhales into device for 10 seconds; electrochemical sensor generates electrons proportional to NO molecules; results displayed in ppb. Used by trained healthcare professionals in clinical settings. Device includes sampling system, gas conditioning, and man-machine interface. Built-in flow control standardizes exhalation at 50 ml/s. Optional NIOX Panel PC application enables data management via USB or Bluetooth. Provides objective data to physicians for evaluating asthma treatment efficacy. Subject device activates pre-existing, previously inactive Bluetooth module for wireless data transmission; otherwise identical to predicate.

Clinical Evidence

No new clinical data provided. Device relies on previously established clinical performance of the predicate. Verification and validation for Bluetooth functionality were previously completed; wireless coexistence testing confirmed no interference risks in clinical settings.

Technological Characteristics

Portable electrochemical sensor system. Measures NO via electrolyte-based chemical reaction. Standardized flow control (50 ml/s). Connectivity: USB and Bluetooth (wireless serial). Power: Rechargeable battery/AC adapter. Software: Dedicated processing firmware. No changes to hardware or software architecture from predicate; only factory configuration change to enable Bluetooth.

Indications for Use

Indicated for children (approx. 7-17 years) and adults (18+) with asthma to measure FeNO as an adjunct to clinical/laboratory assessments for evaluating response to anti-inflammatory therapy. Contraindicated for infants, children under 7, and use in critical care, emergency care, or anesthesiology.

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 VERO® Airway Inflammation Monitor (K133898)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification
OIR Review Summary (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER K150233

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:

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 VERO Airway Inflammation Monitor; K133898

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 activation of Bluetooth technology on the device.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use and 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 (Failure Mode and Effect 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.