← Product Code [MXA](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA) · K243926

# Vivatmo pro-S (K243926)

_Bosch Healthcare Solutions GmbH · MXA · Sep 11, 2025 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K243926

## Device Facts

- **Applicant:** Bosch Healthcare Solutions GmbH
- **Product Code:** [MXA](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA.md)
- **Decision Date:** Sep 11, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3080
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology
- **Attributes:** Pediatric

## Indications for Use

Vivatmo pro-S nitric oxide test 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 often decreases in response to anti-inflammatory treatment. Measurement of FeNO by Vivatmo pro-S 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 therapeutic effect in patients with elevated FeNO levels. FeNO measurements are to be used as an adjunct to established clinical assessments. Vivatmo pro-S is suitable for children, approximately 7-17 years, and adults 18 years and older. Testing using the Vivatmo pro-S should only be done in a point-of-care healthcare setting under professional supervision. Vivatmo pro-S should not be used in critical care, emergency care or in anesthesiology.

## Device Story

Vivatmo pro-S is a portable, handheld, non-invasive point-of-care device for measuring FeNO in human breath. It utilizes a disposable mouthpiece (Oxycap) containing a potassium permanganate converter to transform nitric oxide in exhaled breath into nitrogen dioxide. This gas is detected by a Chemical field effect transistor (Chem-FET) sensor, where adsorption on the sensor layer changes binding energy, generating an electrical signal converted into a quantitative FeNO measurement. Operated by healthcare professionals in clinical settings, the device provides quantitative results to assist in evaluating asthma treatment efficacy. It is a modified version of the predicate Vivatmo pro, lacking the base station for visualization and data storage, but retaining identical handheld measurement performance. The device aids clinicians in assessing eosinophilic airway inflammation and therapeutic response.

## Clinical Evidence

No new clinical data provided. Analytical performance, clinical accuracy, precision, linearity, and specificity were established in the predicate device (K233775) and are not impacted by the current modifications.

## Technological Characteristics

Handheld device with Chem-FET sensor; disposable mouthpiece with potassium permanganate converter. Quantitative measurement of FeNO. Factory calibrated. Battery-powered. Point-of-care use. Software-driven handheld unit.

## Regulatory 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.

## Special Controls

*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.

## Predicate Devices

- Vivatmo pro ([K233775](/device/K233775.md))

## Submission Summary (Full Text)

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>
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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K243926

B Applicant

Bosch Healthcare Solutions GmbH

C Proprietary and Established Names

Vivatmo pro-S

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  MXA | Class II | 21 CFR 862.3080 - Breath Nitric Oxide Test System | CH - Clinical Chemistry  |

## II Submission/Device Overview:

A Purpose for Submission:

Modification to previously cleared device.

B Measurand:

Fractional exhaled nitric oxide

C Type of Test:

Chemical field effect transistor (Chem-FET)

## III Intended Use/Indications for Use:

A Intended Use(s):

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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See Indications for Use below.

## B Indication(s) for Use:

Vivatmo pro-S nitric oxide test 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 often decreases in response to anti-inflammatory treatment. Measurement of FeNO by Vivatmo pro-S 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 therapeutic effect in patients with elevated FeNO levels. FeNO measurements are to be used as an adjunct to established clinical assessments.

Vivatmo pro-S is suitable for children, approximately 7-17 years, and adults 18 years and older. Testing using the Vivatmo pro-S should only be done in a point-of-care healthcare setting under professional supervision. Vivatmo pro-S should not be used in critical care, emergency care or in anesthesiology.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

Regardless of displayed measured results, monitor signs or symptoms of chest tightness, shortness of breath, coughing or wheezing for decisions about treatment. Do not use the device for subjects suffering from acute upper or lower respiratory infection disease or with current serious medical conditions (other than asthma).

Vivatmo pro-S should not be used in critical care, emergency care or in anesthesiology. The following conditions can influence correct measurement of results and shall be avoided: smoking or tobacco consumption for at least 1 hour before the measurement, eating or drinking at least 1 hour before the measurement, especially nitrate rich food (e.g., spinach), strenuous exercise, use of rescue inhaler or leukotriene modifier 1 h before measurement.

The device is not indicated for children under 7 years of age including infants, or by patients who are unable to understand and execute the instructions given by healthcare providers, as measurement requires patient cooperation.

## D Special Instrument Requirements:

Vivatmo pro-S

## IV Device/System Characteristics:

## A Device Description:

The Vivatmo pro device is comprised of the following main components:

1. A Vivatmo pro-S handheld which holds the measuring module with electronics, display and a battery including software to drive the handheld.

2. A Vivatmo Oxycap, which is a disposable mouthpiece to prepare the exhaled air for the measurement. It is available in two different pack sizes:

a. Vivatmo pro Oxycap (50 pieces)
b. Vivatmo me Oxycap (5 pieces)

K243926 - Page 2 of 6

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3. A Vivatmo pro Level 0 is a disposable mouthpiece with filters, desiccant and reagent to remove NO to facilitate a measurement with 0 ppb FeNO for QC purposes.

## B Principle of Operation:

Vivatmo pro-S nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath.

The measurement procedure of the Vivatmo pro-S generates the fraction of the exhaled breath (FeNO). The last 3 second fraction of a 10 second exhalation is evaluated for average NO concentration. The exhalation flow is controlled to 50 ml/s ±5 ml/s at an applied pressure of 10 to 20 cm H2O.

The measurement method of Vivatmo pro-S is Chemical field effect transistor (Chem-FET). The measurement sample is internally taken after a bypass time period and directly forwarded onto the sensor. The nitrogen dioxide molecules are adsorbed on the sensor layer and the change in the binding energy creates an electrical signal, which is transferred into a quantifiable measurement signal. The nitrogen dioxide is converted from Nitric oxide in the breath by a potassium permanganate converter in the disposable mouthpiece.

NO2 is measured using Chem-FET detection with NO2 molecules accumulated to a sensitive layer changing the electrical field of the capacitor. The drop of voltage is proportional with the number of NO2 molecules accumulated.

## C Instrument Description Information:

1. Instrument Name:
Vivatmo pro-S

2. Specimen Identification:
The healthcare professional assists the patient, who performs the test in real-time and is identified by patient name.

3. Specimen Sampling and Handling:
The user obtains a breath sample by having the subject exhale into the device.

4. Calibration:
The manufacturer performs calibration for each Vivatmo pro-S device. Recalibration by the user is not needed.

5. Quality Control:
QC is recommended weekly or after 50 measurements.

K243926 - Page 3 of 6

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V Substantial Equivalence Information:

A Predicate Device Name(s):
Vivatmo pro

B Predicate 510(k) Number(s):
K233775

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K243926 | K233775  |
| --- | --- | --- |
|  Device Trade Name | Vivatmo pro-S | Vivatmo pro  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | Device intended to measure fractional exhaled nitric oxide (FeNO) in human breath | Same  |
|  Sample Type | Exhaled human breath | Same  |
|  Intended Use Setting | Point-of-care healthcare setting under professional supervision | Same  |
|  Measurement range | 5–300 ppb NO | Same  |
|  Detection Limit | 5 ppb NO | Same  |
|  Analysis Time | Approximately 5 seconds | Same  |
|  Number of measurements | 5000 measurement trials | 5000 measurement trials  |
|  General Device Characteristic Differences |  |   |
|  Power source | 4 AAA batteries 1.5 V | Rechargeable Li-ion battery 3.6 V  |
|  Base station | N/A | Part of Vivatmo pro system  |
|  PC Connection | N/A | Ethernet and WLAN through Basestation  |

VI Standards/Guidance Documents Referenced:

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

K243926 - Page 4 of 6

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VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
Established in k233775 and not impacted by the modifications.

2. Linearity:
Established in k233775 and not impacted by the modifications.

3. Analytical Specificity/Interference:
Established in k233775 and not impacted by the modifications.

4. Assay Reportable Range:
Established in k233775 and not impacted by the modifications.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The device is traceable to commercially available material.

6. Detection Limit:
Established in k233775 and not impacted by the modifications.

7. Assay Cut-Off:
Not applicable.

8. Accuracy (Instrument):
Established in k233775 and not impacted by the modifications.

9. Carry-Over:
Established in k233775 and not impacted by the modifications.

B Comparison Studies:

1. Method Comparison with Predicate Device:
Not applicable.

2. Matrix Comparison:

K243926 - Page 5 of 6

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Not applicable. The assay can be run using breath samples only.

## C Clinical Studies:

1. **Clinical Sensitivity:**
Not applicable.

2. **Clinical Specificity:**
Not applicable.

3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**
Clinical Accuracy: Established in k233775 and not impacted by the modifications.

## D Clinical Cut-Off:

Not applicable.

## E Expected Values/Reference Range:

In the labeling, the sponsor instructs the user to refer to the Official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications.

## F Other Supportive Instrument Performance Characteristics Data:

Not applicable.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

K243926 - Page 6 of 6

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K243926](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/K243926)

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