(86 days)
The Exalenz BreathID® Hp System is intended for use to continually and 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 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 System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.
The device is for use by trained health care professionals. To be administered under a physician's supervision.
The BreathID® Hp System is a non-invasive breath test system for detecting the presence of Helicobacter pylori (H. pylori). The system consists of an electro-optical medical device with embedded software designed to measure and compute the changes in ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, and a test kit. The IDkit Hp™ One kit consists of:
- A 75mg 13C-urea tablet
- A 4.3g package of powdered Citrica (citric acid)
- One IDcircuit™ nasal cannula
- Drinking straw
- Package Insert (Instructions for Use)
- Quick User Guide
The BreathID® Hp System measures and computes the ratio between 13CO2 and 1202 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2 ratio before and after ingestion of 13C-urea is used to compute the Delta over Baseline (DOB).
The 13C measurement method for both the subject and the cleared (predicate) versions of the BreathID® Hp System is based on Molecular Correlation Spectroscopy™ (MCS) technology. MCS technology is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.
The Exalenz BreathID® Hp System's acceptance criteria and performance are detailed below, based on the provided document. The primary purpose of this 510(k) submission was to expand the indication for use to include pediatric patients (ages 3-17). The subject device and predicate device are identical in their technological characteristics and use.
1. Table of Acceptance Criteria and Reported Device Performance
The core of the device's performance relies on its ability to accurately detect H. pylori. The clinical study focused on safety and the agreement with a stool antigen test in a pediatric population.
| Metric | Acceptance Criteria (Pre-defined Success Criteria) | Reported Device Performance |
|---|---|---|
| Safety | Confirmation of the safety of the 13C-urea substrate (75mg 13C-urea and 4g citric acid) in the pediatric population. | One adverse event (vomiting) in 53 subjects (1.89%), which resolved the same day. No reportable major safety concerns. |
| Positive Percent Agreement (PPA) | Not explicitly stated as a numerical acceptance criterion for this specific pediatric study, but implied to provide further evidence of performance when compared to a stool antigen test. | 93.3% [95% CI: 68.05%; 99.83%] compared to the stool antigen test. |
| Negative Percent Agreement (NPA) | Not explicitly stated as a numerical acceptance criterion for this specific pediatric study, but implied to provide further evidence of performance when compared to a stool antigen test. | 100% [95% CI: 86.77%; 100%] compared to the stool antigen test. |
Note: The document states that "These study results met the predefined success criteria for confirming the safety of the 13 C-urea substrate in the pediatric population, and for providing further evidence of BreathID Hp System performance in this population taking into consideration prior supportive clinical performance in the adult population." While specific numerical performance criteria for PPA and NPA in the pediatric study are not listed in the provided sections, the successful outcome statement implies they were deemed acceptable in the context of supporting an expanded indication of use. The device uses a predefined cutoff of 5.0 DOB per mil for positive/negative determination.
2. Sample Size and Data Provenance
- Test Set Sample Size: 53 subjects were enrolled for safety assessment, and 41 subjects completed the full study protocol for evaluable breath and stool test endpoints during the clinical validation.
- Data Provenance: The study was a "multi-center, non-randomized, open label study" conducted at "6 clinical sites that were geographically diverse." The country of origin of the data is not explicitly stated, but the mention of "6 clinical sites" suggests a prospective collection of data.
3. Number and Qualifications of Experts for Ground Truth
- The document does not specify the number of experts used to establish ground truth for the test set.
- The ground truth for the performance assessment was established by comparing the BreathID® Hp System results to an "FDA cleared H. pylori stool antigen test," which was analyzed by a central laboratory. Expert qualifications are not mentioned in this context.
4. Adjudication Method
- The adjudication method for the test set is not explicitly described. For the performance assessment, the BreathID® Hp System results were compared against an "FDA cleared H. pylori stool antigen test" result, implying this served as the comparative standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is an automated diagnostic system, not one that relies on human interpretation that would be assisted by AI.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The "Clinical Validation" section describes a study where the BreathID® Hp System's results were directly compared (algorithm only, without human-in-the-loop performance) to a stool antigen test. The system applies a predefined threshold of 5 DOB to determine a positive or negative result.
7. Type of Ground Truth Used
- The primary ground truth used for assessing device performance was an FDA cleared H. pylori stool antigen test. This is a laboratory-based diagnostic test.
8. Sample Size for the Training Set
- The document does not provide information on the sample size for a training set. The submission focuses on expanding the indications for use for an existing device (predicate device K130524), and the study conducted was for clinical validation in a pediatric population, not for training a new algorithm. It's likely the underlying algorithm was trained on data prior to the predicate device's clearance.
9. How Ground Truth for the Training Set was Established
- The document does not provide this information, as the study described was for clinical validation of an expanded indication rather than for initial algorithm development or training.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter 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.(b)
Classification. Class I (general controls).