BreathID Smart System

K193610 · Exalenz Bioscience , Ltd. · MSQ · Feb 6, 2020 · Microbiology

Device Facts

• Record ID: K193610
• Device Name: BreathID Smart System
• Applicant: Exalenz Bioscience , Ltd.
• Product Code: MSQ · Microbiology
• Decision Date: Feb 6, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3110
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The Exalenz BreathID® Hp Lab System or Exalenz BreathID® Smart System is intended for use to non-invasively 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 Exalenz BreathID® Hp Lab System or Exalenz 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 Exalenz BreathID® Hp Lab System consists of the appropriate IDkit Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application. The Exalenz 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

BreathID Smart System; integrated configuration of previously cleared BreathID Hp Lab System (K173777). Device analyzes breath samples for H. pylori detection; utilizes infrared spectroscopy to measure carbon isotope ratios. System combines three previously stand-alone components into single integrated unit. Operated by healthcare professionals in clinical settings. Output provides diagnostic information regarding H. pylori status; assists clinicians in determining patient infection status and subsequent treatment decisions.

Clinical Evidence

No new clinical data provided. Substantial equivalence based on design control activities, risk analysis, and verification/validation of the physical integration of existing components.

Technological Characteristics

Molecular Correlation Spectroscopy (MCS) using infrared spectrometry of CO2 discharge lamps. Measures 13CO2/12CO2 ratio. Integrated auto-sampler for 4 pairs of breath bags. Embedded software. Prescription use. Standalone integrated unit.

Indications for Use

Indicated for detection of Helicobacter pylori (H. pylori) in human breath for patients suspected of H. pylori infection.

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

• Exalenz BreathID® Hp Lab System (K173777)

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

K193610

B Applicant

Exalenz Bioscience Ltd.

C Proprietary and Established Names

BreathID Smart System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| MSQ, JJQ | Class I, reserved | 21 CFR 866.3110 | 83 Microbiology |

## 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. (For a pre-amendments device, a statement to this effect has been provided.)
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(S)**, 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 the addition of the BreathID Smart System as a new physical configuration of the cleared BreathID Hp Lab System (k173777) which combines three existing stand-alone components into one integrated device.

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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