(569 days)
Not Found
No
The summary describes a device that measures FENO using a nitric oxide sensor and pneumatics. There is no mention of AI, ML, or any algorithms that would suggest the use of such technologies for data analysis or interpretation. The device appears to be a direct measurement system.
No
The device measures FENO to indicate potential inflammation and treatment response, but it does not directly treat or provide therapy.
Yes
The device measures fractional exhaled nitric oxide (FENO), which is "increased in some airway inflammatory processes, such as asthma," and its measurement is used "as an indication of therapeutic effect in patients with elevated FENO measurements are to be used as an adjunct to established clinical assessments." This indicates its role in identifying or monitoring disease.
No
The device description explicitly states that Fenom Pro is comprised of four major components, including a main unit containing a nitric oxide sensor and pneumatics, a handpiece, and a breath tube, in addition to the software interface. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Fenom Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Fenom Pro's Function: The Fenom Pro measures fractional exhaled nitric oxide (FENO) directly from the patient's breath. It does not analyze a specimen taken from the body.
Therefore, while it's a diagnostic tool used in a healthcare setting, it falls outside the typical definition of an IVD.
N/A
Intended Use / Indications for Use
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 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.
Product codes
MXA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human breath
Indicated Patient Age Range
adults and children 6 years and older.
Intended User / Care Setting
point-of-care healthcare setting under professional supervision.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Precision: 50 ppb.
- Accuracy: ± 5 ppb NO for concentrations ≤50 ppb. ± 10% for NO concentrations >50 ppb.
- Linearity: Slope: 1.0 ± 0.05 r2: ≥ 0.998
- Detection Level: 10 ppb
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K213611
Device Name Fenom Pro
Indications for Use (Describe)
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.
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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3
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 110
Pleasanton, CA 94566
Phone: (925) 433-0725
Email: ryan.leard@caireinc.com
Contact: Mr. Ryan Leard, Chief Operating Officer |
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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
4
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.
Intended Use / Indications for Use
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 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.
5
Substantial Equivalence Chart
| Comparison | Subject Device
Fenom Pro™ v2 | Predicate Device
Fenom PRO™ (K182874) | Difference |
|-------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------|
| Class | Class II | Class II | Same |
| Regulation
Number | 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 |
| Sensor
Calibration | Factory Calibrated | Factory Calibrated | Same |
| Measurement
Range | 10-200 ppb NO | 10-200 ppb NO | Same |
| Precision | 50
ppb. | 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 $\pm$ 0.05
r2: ≥ 0.998 | Slope: 1.0 $\pm$ 0.05
r2: ≥ 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 Sample
Conditioning | None | Reduced humidity | Different |
| Test Principle | Amperometric Sensor
Technology | Potentiometric Sensor
Technology | Different |
| Measurement
Mode | 6 second and 10 second breath
maneuver | 10 second breath maneuver | Different |
6
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.