BreathID® Smart System

K223185 · Meridian Bioscience Israel , Ltd. · MSQ · Nov 10, 2022 · Microbiology

Device Facts

• Record ID: K223185
• Device Name: BreathID® Smart System
• Applicant: Meridian Bioscience Israel , Ltd.
• Product Code: MSQ · Microbiology
• Decision Date: Nov 10, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3110
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The BreathID® Hp Lab System or the BreathID® Smart System is intended for use to noninvasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System or BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit Hp® kit, and the BreathID® Hp device, Auto Sampler and Lab Application. The BreathID® Smart System consists of the appropriate IDkit Hp® kit and the BreathID® Smart device. To be administered by trained personnel as ordered by a licensed healthcare practitioner.

Device Story

Non-invasive breath test system for H. pylori detection; measures 13CO2/12CO2 ratio in exhaled breath. Input: breath samples collected in bags before and after 13C-urea ingestion. Operation: Molecular Correlation Spectroscopy (MCS) uses infrared spectrometry to measure light absorbance by CO2; computes Delta over Baseline (DOB) ratio. Output: DOB value and positive/negative determination based on >5 DOB cutoff. Used in clinical settings by trained personnel. Modified version updates control unit OS from Windows CE to Windows 10. Benefits: enables batch processing of multiple samples; aids in diagnosis and monitoring of H. pylori infection.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of hardware/software modifications.

Technological Characteristics

Spectrophotometer for clinical use; internal control unit; OS upgrade; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for initial diagnosis and post-treatment monitoring of H. pylori infection in adults and pediatric patients ages 3-17 years.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Predicate Devices

• BreathID® Smart System (K220494)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K223185

B Applicant

Meridian Bioscience Israel Ltd.

C Proprietary and Established Names

BreathID Smart System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| MSQ | Class I, reserved | 21 CFR 866.3110 - Campylobacter Fetus Serological Reagents | MI - Microbiology |
| JJQ | Class I | 21 CFR 862.2300 - Colorimeter, photometer, or spectrophotometer for clinical use | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS I device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for upgrading the OS and one of the internal control unit for BreathID Smart System.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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