NIOX MINO MODEL 09-1000

K101034 · Aerocrine AB · MXA · Sep 2, 2010 · Clinical Toxicology

Device Facts

• Record ID: K101034
• Device Name: NIOX MINO MODEL 09-1000
• Applicant: Aerocrine AB
• Product Code: MXA · Clinical Toxicology
• Decision Date: Sep 2, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3080
• Device Class: Class 2
• Attributes: 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 with assurance that such measurements are repeatable and 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 User Manual and by 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 MINO is a portable, hand-held airway inflammation monitor for point-of-care use. It measures fractional nitric oxide (FENO) in expired human breath. The device features a sampling/gas conditioning system, an electrochemical sensor, and a touch-screen man-machine interface (MMI) to guide patients through standardized breathing maneuvers. Ambient air is filtered to remove NO contamination; internal flow control maintains exhalation at 50 ml/s. The device processes signals to output FENO concentration in parts per billion (ppb). Physicians, nurses, or technicians use these results to evaluate asthma patients' response to anti-inflammatory therapy. The device includes an external quality control program and internal supervision of ambient humidity. Modifications in this version include USB data transfer, internal patient data storage, and an exchangeable NO-scrubber.

Clinical Evidence

Clinical validation study AER-039, a randomized, single-center study, compared the modified NIOX MINO to the NIOX Flex Nitric Oxide Monitoring system using a 10-second exhalation mode. Results demonstrated agreement within specified tolerances: < 10 ppb for values ≤ 50 ppb and < 20% for values > 50 ppb. Bench testing verified performance using gas mixtures of NO in N2, confirming linearity (r² > 0.998), lowest detection limit of 5 ppb, and precision/accuracy within established limits.

Technological Characteristics

Nitric oxide measurement instrument; includes internal memory for data storage; USB connectivity; replaceable nitric oxide scrubber; internal humidity monitoring sensor; daily internal negative control check.

Indications for Use

Indicated for children (approx. 7-17 years) and adults (18+) with asthma to measure fractional exhaled nitric oxide (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 MINO (K072816)
• NIOX Nitric Oxide Breath Analyzer (K072816)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k101034

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.) Aerocrine NIOX MINO-k072816
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. Increase the number of tests possible to perform with the instrument from 1500 to 3000 measurements.
2. Add monitoring of ambient humidity with the instrument.
3. Change negative control perform weekly externally to daily internal negative control check. Positive control perform daily remains unchanged.
4. Change Nitride Oxide scrubber from "permanent" format to "replaceable" format.
5. Patient data storage changed from external smart cards to internal memory.
6. Data transfer changed from irDA communication to USB standard.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance 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.