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 Description

NIOX MINO is a small, hand-held, portable system for the non-invasive, online, quantitative measurement of fractional nitric oxide (NO) concentration in expired human breath (FeNO) measured in parts per billion (ppb). The device is intended for routine clinical use and laboratory assessments of the patient's condition.

Measurement of changes in FeNO concentration is used in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. All results are to be interpreted in conjunction with other clinical and laboratory assessments of the patient's condition.

The NIOX MINO unit includes a sampling and gas conditioning system. The valves and pumps of the instrument are automatically controlled to handle the inhaled sample appropriately via the instrument electronics and software program. Filtering of inhaled air eliminates contamination from ambient NO levels. A built-in flow control keeps exhalation standardized at 50 ml/s.

Results are processed using dedicated software and are expressed as the NO concentration in ppb. In order to verify the device's performance and reliability of measurements, there are builtin system control procedures and a special designed External Quality Test Program to be performed on a daily basis.

NIOX Panel is an optional software program accessory which provides an additional display for operating the NIOX MINO Airway Inflammation Monitor by allowing the user to operate the instrument from their personal computer (PC). Interaction with the NIOX Panel is performed with common human interface devices such as keyboards, mice, etc. A USB interface is used for communication with connected NIOX MINO instruments. Instrument supervision and measurement analysis is still performed by the NIOX MINO instrument, however. The NIOX Panel merely serves as an additional interface to the instrument thus, complementing the instrument's LCD screen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NIOX® Panel, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the NIOX® Panel as a software accessory that offers an alternative interface for the existing NIOX MINO® device. It asserts that the fundamental technological characteristics and measurement performance of the core device (NIOX MINO®) remain unchanged. Therefore, the "acceptance criteria" for the NIOX® Panel are implicitly tied to demonstrating that this new interface does not degrade the already established performance of the NIOX MINO®.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Technological Characteristics	Analytical principle of electrochemical detection remains the same.	The analytical principle remains the same.	The core measurement technology of the NIOX MINO® is unchanged.
	NO sensor design and signal processing remains the same.	The NO sensor design and signal processing remain the same.	No changes to the sensor or how it converts signals.
	Principle for sample collection and handling inside the instrument remains the same.	The principle for sample collection and handling remains the same.	The physical interaction with the patient and sample preparation within the device are unaffected.
	Format of the measurement result remains unchanged.	The format of the measurement result remains unchanged.	The output (e.g., ppb) is the same.
Measurement Performance	Precision specifications remain the same.	Specifications are the same.	Implicitly, the NIOX Panel does not negatively impact precision.
	Linearity specifications remain the same.	Specifications are the same.	Implicitly, the NIOX Panel does not negatively impact linearity.
	Accuracy specifications remain the same.	Specifications are the same.	Implicitly, the NIOX Panel does not negatively impact accuracy.
	Detection limit specifications remain the same.	Specifications are the same.	Implicitly, the NIOX Panel does not negatively impact the detection limit.
Intended Use	Intended Use remains unchanged.	The Intended Use for NIOX MINO when used with NIOX Panel remains unchanged.	The clinical purpose and patient population are not altered by the new display option.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study or a specific test set with a sample size for the NIOX® Panel. This submission is a Special 510(k), which is typically used for modifications to a legally marketed device that do not significantly alter its fundamental safety or effectiveness. The core argument is that the NIOX® Panel is only an alternative interface and does not change the underlying measuring capabilities of the NIOX MINO®. Therefore, a new clinical performance study with a test set is not deemed necessary and is not reported.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As noted above, a new clinical performance study with a test set requiring expert-established ground truth is not described in this Special 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool that would involve human readers interpreting cases. The NIOX® Panel is a display accessory for a quantitative breath test device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This pertains to the NIOX MINO® in general, rather than specifically the NIOX® Panel. The NIOX MINO® is a standalone device that provides a quantitative measurement (FeNO in ppb). The NIOX® Panel acts solely as an additional display interface; it doesn't represent a separate algorithm or standalone performance independent of the NIOX MINO®'s existing measurement capabilities. The original predicate device (NIOX MINO® K101034) would have demonstrated its standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the original NIOX MINO® device, the ground truth for establishing its performance (precision, accuracy, linearity, etc.) would likely have involved:

Reference standards/calibrators: Using gases with known, certified concentrations of nitric oxide.
Comparison to established laboratory methods: Correlating FeNO measurements with gold-standard laboratory techniques for NO measurement.
Clinical correlation: Demonstrating the device's ability to measure changes in FeNO in asthma patients responding to anti-inflammatory therapy, likely against clinical outcomes and other diagnostic assessments.

However, for the NIOX® Panel specifically, no new ground truth determination is mentioned beyond ensuring the interface correctly displays the data generated by the NIOX MINO® without alteration or error.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models with training sets.

9. How the Ground Truth for the Training Set was Established

Not applicable. This device does not involve machine learning or AI models with training sets.

Summary

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K123683

Sundbybergsvägen 9
P.O. 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

Aerocrine

DEC 2 7 2012

NIOX® Panel - Special 510(k) SUMMARY

Doc ID: RFD-000197-00 Date Summary was Prepared: November 19, 2012

This Special 510(k) application is for the following product: NIOX® Panel as an optional accessory allowing an additional display for the NIOX MINO® Airway Inflammation Monitor.

Predicate Device:	NIOX MINO® Airway Inflammation Monitor
510(k) Clearance Number:	K101034
510(k) Holder/Submitter:	Aerocrine ABSundbybergsvägen 9SE-17173 Solna, SwedenPhone: +46-8-629-0780Fax: +46-8-629-0781
Contact Person:	Kathleen Rickard, MD
Regulation Name:	Breath Nitric Oxide Test System
Regulatory Class:	Class II
Product Code:	MXA
CFR Section:	21 CFR 862.3080

Device Description

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NIOX Panel is an optional software program accessory which provides an additional display (see Figure 1) for operating the NIOX MINO Airway Inflammation Monitor by allowing the user to operate the instrument from their personal computer (PC) (see Figure 2). Interaction with the NIOX Panel is performed with common human interface devices such as keyboards, mice, etc. A USB interface is used for communication with connected NIOX MINO instruments. Instrument supervision and measurement analysis is still performed by the NIOX MINO instrument, however. The NIOX Panel merely serves as an additional interface to the instrument thus, complementing the instrument's LCD screen.

Image /page/1/Figure/1 description: The image shows a screen capture of a device, possibly a phone or tablet. The top of the screen displays status icons and the time, 22:34 pm. Below this, there is an image of a person using a medical device, with the number 3 in a circle in the upper left corner. The number 751203-8933 is printed below the image.

Image /page/1/Figure/2 description: The image shows the text "Figure 1: NIOX Panel Application Window". The text is in a bold, sans-serif font. The text is centered on the page and is the only element in the image. The figure number is 1.

Figure 2: Human Interface with NIOX MINO Airway Inflammation Monitor

Image /page/1/Figure/4 description: The image shows a diagram of a person, a laptop, a USB symbol, a line, and a device. The laptop is connected to the device via a USB cable. The device has a screen with some icons and numbers on it. The diagram seems to illustrate a connection between a person, a computer, and a device.

RFD-000197-00 510(k) Summary for NIOX Panel

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Intended Use

The Intended Use for NIOX MINO when used with NIOX Panel remains unchanged:

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.

Technological Characteristics

The technological characteristics remain unchanged from that of the predicate device:

1. The analytical principle of electrochemical detection remains the same.
1. The NO sensor design and signal processing remains the same.
1. The principle for sample collection and sample handling inside the instrument remains the same.
1. The format of the measurement result remains unchanged.
1. The measurement performance (precision, linearity, accuracy, detection limit) specifications remain the same.

Proposed Device Modifications

The NIQX Panel software offers the option of an alternative interface with a PC for interacting with the NIOX MINO device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 27, 2012

Dr. Kathleen Rickard Aerocrine AB Sundbybergsvagen 9 SE-17173 Solna, Sweden

Re: K123683

Trade/Device Name: NIOX MINO Airway Inflammation Monitor Regulation Number: 21 CFR 862.3080 Regulation Name: Breath Nitric Oxide test system Regulatory Class: II Product Code: MXA Dated: November 29, 2012 Received: November 30, 2012

Dear Dr. Rickard:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano

Courtney H. Lias, Ph.D For: Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics

and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123683

Device Name: NIOX® Panel as an optional software accessory allowing an additional Display for the NIOX MINO® Airway Inflammation Monitor

Indications for Use:

NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently NOX MII (0 measuratory processes such as asthma. The fractional NO moreason in some inframmatory peNO), can be measured by NIOX MINO according to concelines 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 nicillou to measure the attereater inflammatory pharmacological therapy, as an indication occurs arter treatment with elevated FeNO levels. NIOX MINO is suitable of the morapy and other mandely 7 - 17 years, and adults 18 years and older.

FeNO measurements provide the physician with means of evaluating an asthma patient's I CNO measurements provide are papy, as an adjunct to the established clinical and lesponse to and minaminastyma. NIOX MINO should only be used as directed in the iaboratory assessments in astrimal NIOX MINO Quality Control Test User Manual, by NIOX MINO User Manadi and the MIT HI the MI therapists and laboratory technicians. NIOX MINO trannot be used with infants or by children approximately under the age of 7, as cannot be used with miants of of one in NOX MINO should not be used in critical care, emergency care or in anaesthesiology.

Prescription Use x __ (21 CFR Part 801 Subpart D) Over the Counter Use_ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

enise Dhrisolefs
Division Signoff

Office of In Vitro Diagnostics and Radiological Health

510(k) K123683

Regulation Number and Section

§ 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.