(364 days)
Not Found
No
The summary describes a device that measures FeNO using an electrochemical sensor and processes the results with dedicated software. There is no mention of AI or ML in the device description, intended use, or performance studies. The software is described as a charting program for retrospective data collection.
No
The device measures FeNO to evaluate the therapeutic effect of anti-inflammatory treatment for asthma, but it does not administer therapy or directly treat the condition.
Yes
The device measures Fractional Exhaled Nitric Oxide (FeNO), which is used to evaluate an asthma patient's response to anti-inflammatory therapy. This measurement provides information about a medical condition and is used to aid in the management of treatment, fulfilling the definition of a diagnostic device.
No
The device description explicitly states that the NObreath® system is comprised of a main unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, and a disposable patient mouthpiece with filter, in addition to software. This indicates it is a hardware device with accompanying software, not a software-only medical device.
Based on the provided information, the NObreath® device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. These tests are performed in vitro (outside the body).
- NObreath® Function: The NObreath® measures Fractional Exhaled Nitric Oxide (FeNO) directly from the patient's breath, which is a sample collected from the body, but the measurement itself is performed on the exhaled air, not on a biological sample like blood or urine. The process is non-invasive and involves the patient directly interacting with the device by exhaling.
- Intended Use: The intended use describes the device as a "portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath." This aligns with a device that measures a physiological parameter directly from the body, rather than performing a test on a biological sample.
While the measurement of FeNO provides information about a patient's condition (inflammation related to asthma), the method of obtaining this information is through direct measurement of exhaled breath, not through an in vitro test on a biological sample.
N/A
Intended Use / Indications for Use
The NObreath® is a portable. non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a 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.
The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.
NObreath® is intended for children, 7- 17 years, and older. NObreath® 12 second test mode is for age 7 and up
NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.
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. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.
NObreath® should not be used in critical care, emergency care or in anesthesiology.
Product codes
MXA
Device Description
NObreath® is a portable system for the non-invasive, quantitative measurement of the fraction of exhaled nitric oxide (NO) in expired human breath (FeNO). The NObreath® system is comprised of the main unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, disposable patient mouthpiece with filter. The device can connect to the PC via a standard USB cable or wirelessly via Bluetooth.
For testing, the patient inhales deeply and slowly exhales for 10 or 12 seconds through the patient filter. In approximately 12 seconds the NO concentration is displayed in parts per billion (ppb). Results are processed using dedicated software. The device has built-in system control procedures and a calibration to be performed every 12 months.
Wireless Bluetooth Low Energy (BLE) is used as a means of communication between the monitor and FeNOchart™ software running on a PC. The FeNOchart™ software is a charting program that retrospectively collects data from the NObreath® monitor when it is not monitoring. It is not time critical, there are no alarms
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human breath (exhaled)
Indicated Patient Age Range
children, 7- 17 years, and adults 18 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
Two clinical studies were performed:
Clinical precision: A mixed study population of 76 participants, including 24 pediatric participants (ages 7-17 years) and 52 adults (18 years +), obtained two NObreath® measurements with the assistance of three healthcare professionals, for a total of six NObreath® evaluations per participant. The clinical precision study was designed to capture the accuracy and precision of the NObreath® device, with FeNO values covering potential clinical practice ranges. The within-subject precision (Mean SD (ppb) and Mean CV (%)) was assessed. Key results showed varying precision depending on the FeNO concentration:
- 0 to =50 ppb (N=12): 1.4078969 ppb SD, 1.89% CV
Data from three subjects with large variation were excluded from the table, but their %CVs were 10.24%, 21.54%, and 14.17%.
Clinical efficacy: A longitudinal study with 186 patients (n=95 18+ years, n=91 7 to 17 years) where FeNO measurements, spirometry, and asthma control questionnaires were completed at baseline and two weeks later after therapeutic agents were administered. For patients with elevated initial FeNO (ATS guidelines: >25ppb for adults, >20ppb for children, total n=139), there was a fall in mean FeNO measured by NObreath®.
Key results:
- Mean change in FeNO: -13.7 ppb (-27.7%) with a mean SD of 17.8.
- Mean ACQ score fell by -29.7% after corticosteroids.
- Mean FEV1 change was 10.1% after corticosteroids.
Key Metrics
For Clinical Precision Study:
- Within Subject Mean SD (ppb) (0.8034172 to 1.4078969 depending on concentration range)
- Within Subject Mean CV (%) (1.89% to 13.35% depending on concentration range)
For Clinical Efficacy Study:
- Mean change in FeNO: -13.7 ppb (-27.7%)
- Mean SD of FeNO change: 17.8
- ACQ: Mean ACQ score fell by -29.7%
- FEV1: Mean FEV1 change of 10.1%
Predicate Device(s)
Circassia AB NIOX VERO (K170983)
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
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December 17, 2021
Bedfont Scientific Ltd % Paul Dryden ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K203695
Trade/Device Name: NObreath® Regulation Number: 21 CFR 862.3080 Regulation Name: Breath Nitric Oxide Test System Regulatory Class: Class II Product Code: MXA Dated: September 13, 2021 Received: September 14, 2021
Dear Paul Dryden:
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.
1
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 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 medical devices and radiation-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.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203695
Device Name NObreath®
Indications for Use (Describe)
The NObreath® is a portable. non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a 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.
The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.
NObreath® is intended for children, 7- 17 years, and older. NObreath® 12 second test mode is for age 7 and up
NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.
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. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.
NObreath® should not be used in critical care, emergency care or in anesthesiology.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Date Prepared:
13-Dec-21
Sponsor
Bedfont Scientific Ltd Station Road, Harrietsham Maidstone, Kent, ME17 1JA, England
Sponsor Contact:
Louise Bateman Quality and Regulatory Affairs Manager Tel: +44 (0) 1622 851122
Submission Correspondent
ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 Attn.: Paul Dryden
| Proprietary or Trade Name: | NObreath® |
|---|---|
| Common/Usual Name: | Nitric Oxide Breath Test |
| Regulation Number: | 21CFR 862.3080 |
| Regulation Code: | System, test, breath nitric oxide |
| Product Code: | MXA |
| Regulatory Class: | II |
| Predicate Device: | Circassia AB NIOX VERO (K170983) |
Device Description:
NObreath® is a portable system for the non-invasive, quantitative measurement of the fraction of exhaled nitric oxide (NO) in expired human breath (FeNO). The NObreath® system is comprised of the main unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, disposable patient mouthpiece with filter. The device can connect to the PC via a standard USB cable or wirelessly via Bluetooth.
For testing, the patient inhales deeply and slowly exhales for 10 or 12 seconds through the patient filter. In approximately 12 seconds the NO concentration is displayed in parts per billion (ppb). Results are processed using dedicated software. The device has built-in system control procedures and a calibration to be performed every 12 months.
Wireless Bluetooth Low Energy (BLE) is used as a means of communication between the monitor and FeNOchart™ software running on a PC. The FeNOchart™ software is a charting program that retrospectively collects data from the NObreath® monitor when it is not monitoring. It is not time critical, there are no alarms
4
Principles of Operation:
The measurement principle is based on American Thoracic Society guidelines (ATS/ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005. Am J Respir Crit Care Med. 2005;171:912-930). The last fraction of the exhalation is evaluated for average NO concentration. NO is measured using electrochemical detection.
Indications for Use:
The NObreath® is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a 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.
The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.
NObreath® is intended for children, 7- 17 years, and adults 18 years and older. NObreath® 12 second test mode is for age 7 and up
NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.
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. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.
NObreath® should not be used in critical care, emergency care or in anesthesiology.
Patient Population:
NObreath® is intended for children, 7- 17 years, and adults 18 years and older. NObreath® 12 second test mode is for age 7 and up NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.
Environments of Use:
Point-of-care healthcare setting under professional supervision.
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510(k) Summary Page 4 of 7
Table 1 - Table of the Similarities and Differences of Predicate vs. Proposed
Device
| Device | Predicate Circassia NIOXVERO | |
|---|---|---|
| 510(k) | Proposed Bedfont | |
| NObreath® Nitric Oxide test | K170983 | |
| Procode | MXA - Breath nitric oxide test | |
| system CFR – 862-3080 | MXA - Breath nitric oxide test | |
| system CFR – 862-3080 | ||
| Indications for Use | The NObreath® is a portable, non-invasive device for the | |
| measurement of Fractional Exhaled Nitric Oxide (FeNO) in | ||
| human breath. The production of nitric oxide is often found | ||
| to be increased in inflammatory conditions such as asthma. | ||
| Measurement of FeNO by NObreath® is a 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. |
The fractional NO concentration in expired breath (FeNO),
can be measured by NObreath® according to guidelines for
NO measurement established by the American Thoracic
Society.
Measurement of FeNO by NObreath® 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.
NObreath® is intended for children, 7- 17 years, and adults
18 years and older. Nobreath® 12 second test mode is for
age 7 and up | NIOX VERO® measures Nitric Oxide (NO) in human
breath. Nitric Oxide is frequently increased in some
airway inflammatory processes such as asthma. The
fractional NO concentration in expired breath (FeNO), can
be measured by NIOX VERO according to guidelines for
NO measurement established by the ATS.
Measurement of FeNO by NIOX VERO 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 VERO is suitable for children, 7- 17 years, and
adults 18 years and older.
NIOX VERO 10 second test mode is for age 7 and up.
NIOX VERO 6 second test mode is for ages 7-10 only
who cannot successfully complete a 10 second test.
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. The NIOX
VERO is intended for prescription use and should only be |
| | | |
| | NObreath® 10 second test mode is for ages 7-10 only who
cannot successfully complete a 12 second test. | used as directed in the NIOX VERO User Manual by
trained healthcare professionals. |
| | 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. The
NObreath® cannot be used with infants or by children
under the age of 7 as measurement requires patient
cooperation.
NObreath® should not be used in critical care, emergency
care or in anesthesiology. | NIOX VERO cannot be used with infants or by children
under the age
of 7 as measurement requires patient cooperation.
NIOX VERO should not be used in critical care, emergency
care or in anesthesiology |
| Intended Users | Trained medical personnel | Trained medical personnel |
| Target Population | Children, 7-17 years, and adults 18 years and older | Children, 7-17 years, and adults 18 years and older |
| Environments of use | Point of care healthcare settings | Point of care healthcare settings |
| Results type | Quantitative | Quantitative |
| Technology | Electrochemical sensor technology | Electrochemical sensor technology |
| Sensor Calibration | Every 12 months or factory calibrated sensor replacement | Factory calibrated |
| Measurement Range | 5-500 ppb NO | 5-300 ppb NO |
| Limit of Detection | 5 ppb | 5 ppb |
| Analysis time | 12 sec | 25 sec |
| Patient sampling | 12 sec - adults
10 sec – 7-17 yrs | 10 sec adults
6 sec – 7-17 yrs |
| Accuracy | ± 5 ppb of measured value ≤ 50 ppb
- 10% of measured value > 50 ppb | ± 5 ppb of measured value 30 ppb |
| Altitude | Up to 6300 feet | Not listed |
| Precision | ± 5 ppb of measured value ≤ 50 ppb - 10% of measured value > 50 ppb | 30 ppb |
| Patient interface | Mouthpiece with integral filter | Mouthpiece |
| | Proposed Bedfont
NObreath® Nitric Oxide test | Predicate Circassia NIOXVERO |
| Standards used for
testing | ANSI / AAMI /ES 60601-
1:2005+A1:2012 IEC 60601-1-
2:2014
AIM Standard 7351731: 2017
ISO 10993-5, -10
ISO 18562-1, -3 | AAMI ANSI ES 60601-1: 2005 +A1: 2012
IEC 60601-1-6
CLSI EP5-A2 Vol 24 No. 25
CLSI EP6-A vol 23, no. 16 |
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510(k) Summary Page 5 of 7
7
510(k) Summary Page 5 of 7
Substantial Equivalence Rationale
The Bedfont NObreath® is substantially equivalent to the predicate device because:
Indications –
- The NObreath® is a portable nitric oxide test for measuring FeNO. . Discussion - The indications for use are similar to the predicate K170983.
Environment of Use -
- Both devices have the same environments of use . Discussion - The environments of use and personnel are similar to the predicate.
Technology -
The technology is electrochemical sensor technology. . Discussion - This technology is equivalent for both devices.
Non-clinical Testing Summary -
Biocompatibility of Materials - the following testing was performed:
- Cytotoxicity ●
- Sensitization ●
- Irritation / intracutaneous reactivity .
- Acute Systemic toxicity ●
- Material Mediated Pyrogenicity .
- ISO 18562 testing: Gas emission VOC, PM2.5 and PM10 ●
- Inorganic gases CO, CO2, Ozone ●
8
Discussion - The materials in contact were found non-cytotoxic, non-sensitizers, nonirritants, and passed systemic toxicity and pyrogenicity.
Electrical, EMC, EMI testing -
- The candidate device was evaluated per ANSI/AAMI/ES 60601-1. IEC 60601-1-2 and AIM ● Standard 7351731: 2017 and the device performed as intended and met the requirements. Discussion - The proposed device met the requirements of the standards.
Bench testing -
- . Bench testing including analytical performance testing such as precision and linearity was performed to verify the performance to specifications of the proposed device. Testing includes IEC 60601-1, IEC 60601-1-2, software verification and system verification.
Discussion - Upon completion of the tests, the candidate device was found to have met its performance requirements.
Clinical testing -
Two clinical studies were performed:
Clinical precision ●
In one of the studies conducted, the clinical precision, as it relates to user bias of the NObreath®, was evaluated in a mixed study population of 76 participants - including 24 paediatric participants (ages 7-17 years) and 52 adults (18 years +). Participants were asked to obtain two NObreath® measurements with the assistance of three health care professionals (HCPs), for a total of six NObreath® evaluations per participant.
The clinical precision study was designed to capture the accuracy and precision of the NObreath device, therefore FeNO values acquired by subjects covered potential FeNO values which would be observed in clinical practice. The within subject precision* was assessed from this study population and is presented in the table below:
| Median
Concentrations | N | Within Subject
Mean SD
(ppb) | Within Subject
Mean CV (%) | 95% CI for CV
(%) |
|--------------------------|----|------------------------------------|-------------------------------|----------------------|
| 0 to =50 | 12 | 1.4078969 | 1.89% | 1.29%; 2.48% |
*Three subjects in the clinical precision study had a large variation between the measurements. One subject was from median concentration bin of >= 50 ppb and two subjects were from the median concentration bin of 40 to 25ppb for adults and >20ppb for children (total n=139),there was a fall in mean FeNO measured by NObreath® in patients with elevated FeNO levels for combined adult and paediatric treatment population (n=139).
Results showed a mean change of -13.7 ppb (-27.7%) with a mean SD of 17.8.
The Decline in FeNO was accompanied by the following changes in subjective and objective asthma measures.
The following secondary outcome measures showed the following after 2 weeks of corticosteroid therapy that accompanied the fall in FeNO described above.
ACQ: Mean ACQ score fell by -29.7% after corticosteroids
FEV1: There was a mean FEV1 change of 10.1% after corticosteroids
Discussion of Differences
The differences between the subject and predicate device include:
- Broader detection range 5-500 ppb vs. 5-300 ppb. This does not affect performance or . safety.
- Slightly longer measurement time for adults and pediatric vs. predicate. This ● difference does not introduce any new concerns of safety and effectiveness.
- Replacement factory calibrated sensor or factory calibration vs. at the factory. This is a . convenience feature for the user.
- Performance specifications were similar. ●
The differences do not raise any new concerns of safety or effectiveness and thus the subject device can be considered to be substantially equivalent to the predicate.
Substantial Equivalence Conclusion:
The sponsor has demonstrated through performance testing, design and features and non-clinical and clinical testing that the proposed device is substantially equivalent to the predicate device.