(153 days)
Not Found
No
The summary describes a device that measures nitric oxide in breath and provides performance metrics related to linearity, precision, and accuracy, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device measures Nitric Oxide in breath to evaluate a patient's response to anti-inflammatory therapy, but it does not directly provide therapy or treatment.
Yes
The device measures fractional exhaled nitric oxide (FENO) to evaluate a patient's response to anti-inflammatory therapy for asthma, which is a diagnostic purpose to assess therapeutic effect.
No
The device description explicitly states it is a "hand held device intended to measure fractional exhaled nitric oxide in human breath," indicating it is a physical hardware device, not software only.
Based on the provided information, the NIOX MINO® is likely an IVD (In Vitro Diagnostic).
Here's why:
- Measures a substance in a human sample: The device measures Nitric Oxide (NO) in human breath. Breath is considered a human sample.
- Used for diagnostic purposes: The intended use states that the measurement of FENO provides the physician with a means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to other assessments. While not a standalone diagnostic for asthma itself, it is used to assess the effectiveness of treatment, which is a diagnostic purpose related to the patient's condition.
- Complies with a relevant CFR section: The device description mentions complying with 21 CFR 862.3080. This specific CFR section is titled "Nitric oxide (exhaled) test system," which falls under the category of "Clinical Chemistry and Clinical Toxicology Devices" within the FDA's regulations. Devices in this category are typically IVDs.
While the device doesn't process images or use AI/ML, and the sample is breath rather than blood or urine, the core function of measuring a substance in a human sample for diagnostic purposes aligns with the definition of an IVD. The reference to a specific CFR section for exhaled nitric oxide test systems further strengthens this conclusion.
N/A
Intended Use / 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 User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists or 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.
Product codes (comma separated list FDA assigned to the subject device)
MXA
Device Description
NIOX MINO® Airway Inflammation Monitor is a hand held device intended to measure fractional exhaled nitric oxide in human breath in ppb levels (parts per billion), complying with 21 CFR 862.3080.
NIQX MINO Airway Inflammation Monitor is manufactured by Aerocrine AB, Sweden. For NIOX MINO Airway Inflammation Monitor, Aerocrine AB claims substantial equivalence to the predicate device NIOX® Nitric Oxide Monitoring System (K021133).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Suitable for children, approximately 7 - 17 years, and adults 18 years and older.
Intended User / Care Setting
Used by trained physicians, nurses, respiratory therapists or laboratory technicians. NIOX MINO® should not be used in critical care, emergency care or in anaesthesiology.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive performance testing has been performed to support substantial equivalence. Linearity, precision and accuracy has been evaluated according to laboratory standard NCCLS EP9-P The variation between individual instruments during long-time use under various climate conditions has been studied.
The results from the performance testing support substantial equivalence between NIOX MINO and NIOX.
Multi-center clinical studies have been performed to validate the intended use and verify substantial equivalence to the predicate device.
Clinical studies demonstrated that 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 antiinflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FENO levels. NIOX MINO has been shown to be suitable for children, 7 - 17 years, and adults 18 years and older.
It has been demonstrated that only one measurement is sufficient in NIOX MINO to obtain reliable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: Squared correlation coefficient r^2 >= 0.998.
Precision:
Analytical precision: = 30 ppb.
Clinical precision:
§ 862.3080 Breath nitric oxide test system.
(a)
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.(b)
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.
0
| 5. 510(k) Summary | | Sundbybergsvägen 9
PO Box 1024
SE-171 21 Solna, Sweden
phone +46 8 629 0780
fax +46 8 629 0781
www.aerocrine.com
org.no 556549-1056
VAT No: Reg. Office Stockholm, SE556549105601 | | | |
|---------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------|
| Document template QAF-300079-00 | | Aerocrine | | | |
| Product: | NIOX MINO® | | Structure/module: | | |
| Document ID: | DMD-000139 | Version: | 02 | Author | Johanna Karling |
| Replaces doc: | | Reviewed by: | | | |
| Document status: | Draft | Approved by: | Mats Carlson | Signature: | Date: |
| Registered copy no: | Unsigned paper copies = uncontrolled | Cancelled by: | | | |
| Included in File: | TF | DHF | DMR | CFA | CFB Regulatory submission (register copy in file) |
| List of receivers: | Key words: | | | | |
Proposed draft
Submitter's Identification
| Submitter | Aerocrine AB |
|---|---|
| Address | Sundbybergsvägen 9 |
| PO BOX 1024 | |
| SE-171 21 Solna | |
| Sweden | |
| Phone Number | +46 8 629 07 80 |
| Fax Number | +46 8 629 07 81 |
| Establishment Organization number | 556549-1056 |
| Aerocrine Contact Person: | Johanna Karling |
| QA Director | |
| Phone number | +46 8 629 07 86 |
| E-mail address | johanna.karling@aerocrine.com |
| US Address | Aerocrine Inc |
| 562 Central Avenue | |
| New Providence | |
| New Jersey 07974 | |
| Phone Number | 212-810-2480 |
| Fax Number | 212-656-1723 |
1
| Regulatory contact for this submission | Joel Slomoff, Consultant |
|---|---|
| Phone Number | 202-662-4688 |
| Address | Fulbright & Jaworski L.L.P. |
| 801 Pennsylvania Avenue, N.W | |
| Washington, D.C. 20004-2623 | |
| E-mail address | rslomoff@fulbright.com |
| Summary preparation date: | 2007-09-25 |
| Revised: | 2008-01-03 |
Name of the Device
Trade name Common/Generic Device Name Classification Name Device Class Product Code Regulation number Medical Speciality Owner/Operator Owner/Operator number Establishment Operations
Predicate Device
Trade Name of Predicate Device Common/ Generic Device Name Classification Name Device Class Product Code Regulation number Medical Speciality Owner/Operator Owner/Operator number Establishment Operations 510(k) Number
NIOX MINO® Airway inflammation monitor Breath Nitric Oxide Test System II MXA 21 CFR 862.3080 CH, Clinical Chemistry AEROCRINE AB 9057041 Specification Developer, Manufacturer
NIOX® Nitric Oxide Breath Analyzer Breath Nitric Oxide Test System II MXA 21 CFR 862.3080 CH, Clinical Chemistry AEROCRINE AB 9057041 Specification Developer, Manufacturer K021133
2
Image /page/2/Picture/0 description: The image shows a pepper spray container. The container is gray and has a circular opening in the middle. A black rectangle is visible inside the opening. The container has a rounded shape and a small oval opening at the bottom.
Device Description
NIOX MINO® Airway Inflammation Monitor is a hand held device intended to measure fractional exhaled nitric oxide in human breath in ppb levels (parts per billion), complying with 21 CFR 862.3080.
NIQX MINO Airway Inflammation Monitor is manufactured by Aerocrine AB, Sweden. For NIOX MINO Airway Inflammation Monitor, Aerocrine AB claims substantial equivalence to the predicate device NIOX® Nitric Oxide Monitoring System (K021133).
Figure 1 NIOX MINO® Airway Inflammation Monitor
The intended use for NIOX MINO Airway Inflammation Monitor is the same as the intended use for NIOX, Nitric Oxide Monitoring System. The performance characteristics for NIOX MINO Airway Inflammation Monitor and NIOX Nitric Oxide Monitoring System are substantially equivalent as shown in laboratory and clinical tests.
Intended 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 User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists or 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.
3
Technological characteristics
Table 5-1
| Characteristic | NIOX MINO® | NIOX® |
|---|---|---|
| Device type | Device for regular clinical practice. | |
| Point of care. | Device for regular clinical practice. | |
| Not portable. | ||
| Target population | Suitable for children, 7 - 17 years, and adults 18 years and older. | Suitable for children, 4 - 17 years and adults 18 years and older. |
| Dimensions and weight | Height 240 mm | |
| Width 130 mm | ||
| Depth 100 mm | ||
| Weight 0.8 kg | Height 500 mm | |
| Width 300 mm | ||
| Depth 400 mm | ||
| Weight 40 kg | ||
| Measurement method | Electrochemical detection | Chemiluminescence detection |
| Measurement range | 5 - 300 ppb | 2 - 200 ppb |
| Detection level (analytical sensitivity) | 5 ppb | 2 ppb |
| Linearity | Squared correlation coefficient $r^2 ≥ 0.998$ , | Integral linearity |
| 50 ppb |
Expressed as one standard deviation for concentrations below 50 ppb and coefficient variation for concentrations above 50 ppb.
Clinical precision:
50 ppb. |
| Accuracy | Analytical Accuracy
± 5 ppb or max 15 %
Based on mean of absolute differences from certified gas concentration of Nitric Oxide reference standard. (95% CI) | Analytical accuracy
± 2.5 ppb of measured value 50 ppb
Based on mean of absolute differences from certified gas concentration of Nitric Oxide reference standard. |
| Method Comparison | ± 5 ppb for values