Fenom Pro is a portable, non-invasive device to measure fractional exhaled nitric oxide (FENO) in human breath. FENO is increased in some airway inflammatory processes, such as asthma, and decreases in response to anti-inflammatory treatment. Fenom Pro measures fractional exhaled nitric oxide according to guidelines established by the American Thoracic Society.

Measurement of FENO by Fenom Pro is a non-invasive quantitative 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 therapeutic effect in patients with elevated FENO measurements are to be used as an adjunct to established clinical assessments. Fenom Pro is suitable for adults and children 6 years and older.

Fenom Pro should be used in a point-of-care healthcare setting under professional supervision. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.

Device Description

Fenom Pro is a non-invasive point-of-care breath analyzer for the quantitative measurement of fractional exhaled nitric oxide (FENO) in expired human breath.

Fenom Pro is comprised of four major components. The main unit contains a touch screen interface for the user and houses the nitric oxide sensor and pneumatics needed to sample the patient's breath. The patient exhales into the Fenom Pro though a single use disposable mouthpiece which is attached to the handpiece. The handpiece is connected to the main unit via a breath tube.

For testing, the patient inhales to total lung capacity and then slowly exhales into the mouthpiece for 6 or 10 seconds, depending on the mode of operation. Approximately 28 seconds after a successful breath maneuver, the FENO concentration is displayed in parts per billion (ppb) on the device touch screen. The device has a daily quality control procedure to ensure consistent device performance.

AI/ML Overview

The Fenom Pro device, a breath nitric oxide test system, was evaluated for performance against specified acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance:

Criteria	Acceptance Criteria	Reported Device Performance
Precision	<5 ppb NO for concentrations ≤50 ppb. <10% for NO concentrations >50 ppb.	<5 ppb NO for concentrations ≤50 ppb. <10% for NO concentrations >50 ppb.
Accuracy	± 5 ppb NO for concentrations ≤50 ppb. ± 10% for NO concentrations >50 ppb.	± 5 ppb NO for concentrations ≤50 ppb. ± 10% for NO concentrations >50 ppb.
Linearity	Slope: 1.0 ± 0.05, r2: ≥ 0.998	Slope: 1.0 ± 0.05, r2: ≥ 0.998
Detection Level	10 ppb	10 ppb
Measurement Range	10-200 ppb NO	10-200 ppb NO
Analysis Time	Approximately 30 seconds	Approximately 30 seconds
Breath Sample Conditioning	Not explicitly stated as acceptance criteria, but a difference in technology was noted compared to the predicate	Not explicitly stated as accepted, but the device's technological difference is "None" compared to predicate's "Reduced humidity"
Test Principle	Not explicitly stated as acceptance criteria, but a difference in technology was noted compared to the predicate	Not explicitly stated as accepted, but the device uses "Amperometric Sensor Technology" compared to predicate's "Potentiometric Sensor Technology"
Measurement Mode	Not explicitly stated as acceptance criteria, but a difference in technology was noted compared to the predicate	Not explicitly stated as accepted, but the device has "6 second and 10 second breath maneuver" compared to predicate's "10 second breath maneuver"

Sample size used for the test set and data provenance:
- The document states that "Clinical studies were performed to evaluate the clinical precision and clinical accuracy of the candidate device." However, specific sample sizes for these clinical studies are not provided in the summary.
- The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not provided in the summary.
Adjudication method for the test set: Not provided in the summary.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No MRMC study was mentioned. The device measures fractional exhaled nitric oxide (FENO) which is a quantitative measurement, not typically subject to subjective interpretation by multiple human readers in the same way as imaging studies. The indications for use state that FENO measurements are to be used as an adjunct to established clinical assessments, implying a standalone measurement rather than an AI-assisted human reading.
Standalone (algorithm only without human-in-the-loop performance) study: Yes, the device is described as measuring FENO quantitatively. The non-clinical and clinical studies performed (precision, accuracy, linearity, etc.) relate to the device's standalone performance in measuring FENO.
Type of ground truth used: For quantitative measurements like FENO, the ground truth would typically be established by highly accurate reference methods or calibration gases with known nitric oxide concentrations for non-clinical studies. For clinical studies, comparison to a gold standard FENO measurement device or clinical outcomes (e.g., response to anti-inflammatory treatment) would be used to establish clinical accuracy and precision. The summary implies that "studies were performed to evaluate performance with regards to the specificity (interference), precision, accuracy, linearity, effect of temperature and humidity, detection limit and stability" for non-clinical data, and "clinical precision and clinical accuracy" for clinical data. The exact nature of the "ground truth" (e.g., comparison to a specific reference method) for each of these studies is not detailed.
Sample size for the training set: Not applicable based on the provided information. This device is a measurement system and the information provided does not indicate the use of machine learning models requiring a specific "training set" in the common sense for AI/ML devices.
How the ground truth for the training set was established: Not applicable, as no training set for an AI/ML model is indicated.

Summary

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June 7, 2023

CAIRE Diagnostics Inc. Ryan Leard Chief Operating Officer 7020 Koll Center Parkway Suite 110 Pleasanton, California 94566

Re: K213611

Trade/Device Name: Fenom Pro Regulation Number: 21 CFR 862.3080 Regulation Name: Breath Nitric Oxide Test System Regulatory Class: Class II Product Code: MXA Dated: November 1, 2022 Received: November 2, 2022

Dear Ryan Leard:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213611

Device Name Fenom Pro

Indications for Use (Describe)

Fenom Pro should be used in a point-of-care healthcare setting under professional supervision. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

The assigned 510(k) number is: K213611

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: 05-JUN-2023

Applicant:	Name: CAIRE Diagnostics Inc.Address: 7020 Koll Center Parkway, Suite 110Pleasanton, CA 94566Phone: (925) 433-0725Email: ryan.leard@caireinc.comContact: Mr. Ryan Leard, Chief Operating Officer
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Device name- trade name and common name, and classification

Trade name:	Fenom Pro
Common Name:	Breath nitric oxide test system
Classification:	21 CFR Part 862.3080

Predicate device:

Trade name: Predicate Manufacturer: Predicate 510(k) Clearance: Fenom Pro™ Nitric Oxide Test Spirosure Inc. K182874

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Device Description

Fenom Pro is a non-invasive point-of-care breath analyzer for the quantitative measurement of fractional exhaled nitric oxide (FENO) in expired human breath.

Intended Use / Indications for Use

Measurement of FENO by Fenom Pro is a non-invasive quantitative method to measure the decrease in FENO concentration in asthma patients that often occurs after treatment with antiinflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FENO levels. FENO measurements are to be used as an adjunct to established clinical assessments. Fenom Pro is suitable for adults and children 6 years and older.

Fenom Pro should be used in a point-of-care healthcare setting under professional supervision. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.

Technological Similarities and Differences to the Predicate

The following Substantial Equivalence Chart describes similarities and differences between Fenom Pro and the predicate.

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Substantial Equivalence Chart

Comparison	Subject DeviceFenom Pro™ v2	Predicate DeviceFenom PRO™ (K182874)	Difference
Class	Class II	Class II	Same
RegulationNumber	21 CFR 862.3080	21 CFR 862.3080	Same
Product Code	MXA	MXA	Same
FDA Branch	Toxicology/Chemistry (75)	Toxicology/Chemistry (75)	Same
Result Type	Quantitative	Quantitative	Same
Test Locale	Point-of-Care, Professional	Point-of-Care, Professional	Same
SensorCalibration	Factory Calibrated	Factory Calibrated	Same
MeasurementRange	10-200 ppb NO	10-200 ppb NO	Same
Precision	<5 ppb NO for concentrations ≤50ppb.<10% for NO concentrations >50ppb.	<5 ppb NO for concentrations ≤50 ppb.<10% for NO concentrations >50 ppb.	Same
Accuracy	$\pm$ 5 ppb NO for concentrations≤50 ppb.$\pm$ 10% for NO concentrations>50 ppb.	$\pm$ 5 ppb NO for concentrations ≤50 ppb.$\pm$ 10% for NO concentrations >50 ppb	Same
Linearity	Slope: 1.0 $\pm$ 0.05r2: ≥ 0.998	Slope: 1.0 $\pm$ 0.05r2: ≥ 0.998	Same
Detection Level	10 ppb	10 ppb	Same
Analysis Time	Approximately 30 seconds	Approximately 30 seconds	Same
Power Supply	100-240V, ~50-60Hz	100-240V, ~50-60Hz	Same
Breath SampleConditioning	None	Reduced humidity	Different
Test Principle	Amperometric SensorTechnology	Potentiometric SensorTechnology	Different
MeasurementMode	6 second and 10 second breathmaneuver	10 second breath maneuver	Different

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Description of Nonclinical Data

Studies were performed to evaluate performance with regards to the specificity (interference), precision, accuracy, linearity, effect of temperature and humidity, detection limit and stability of the candidate device.

Description of Clinical Data

Clinical studies were performed to evaluate the clinical precision and clinical accuracy of the candidate device.

Conclusions:

Based on the information provided in this 510(k), the Fenom Pro is substantially equivalent to the predicate and raises no new issues of safety and effectiveness. The clinical and non-clinical testing performed demonstrates that the proposed device met all test specifications and is safe and effective for its intended use.

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.