(86 days)
The Exalenz BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 1300/14CO2 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 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.
To be administered by trained personnel as ordered by a licensed healthcare practitioner.
The BreathID® Hp Lab 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 13002 and 1202 concentrations in the patient's exhalation, an Auto Sampler, a Lab Application, and a test kit. The IDkit Hp™ Two kit consists of:
- A 75mg 13C-urea tablet
- A 4.3g package of powdered Citrica (citric acid) ●
- Drinking straw
- Package Insert (Instructions for Use) ●
- Quick User Guide
- 2 Breath Sample Bags (Baseline and Post Ingestion) with bar code labels and a large Sample Transport Bag
Using bags for breath collection along with the Auto Sampler enables off site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The BreathID® Hp Lab System measures and compute the ratio between 13CO2 and 12 CQ2 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 Lab systems 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.
This document describes the 510(k) summary for the Exalenz BreathID® Hp Lab System, specifically focusing on expanding its indications for use to include pediatric patients aged 3-17 years old. The device is identical to its predicate, and the submission primarily addresses the expansion of the patient population.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study
The primary purpose of this 510(k) submission was to expand the indications for use to include pediatric patients. Therefore, the "acceptance criteria" presented below are based on the secondary endpoint of the clinical validation study conducted for this pediatric population expansion, as the device itself is stated to be identical to a previously cleared one for adults. The study aimed to assess performance in pediatrics, supported by existing adult data.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document only provides performance metrics (Positive Percent Agreement and Negative Percent Agreement) against a stool antigen test for the pediatric study. It does not explicitly state pre-defined "acceptance criteria" numerical thresholds for these performance metrics for the pediatric population within this document. Instead, it states that "These study results met the predefined success criteria for confirming the safety... and for providing further evidence of BreathID Hp Lab System performance..." implying that the reported values were acceptable.
| Performance Metric | Acceptance Criteria (Implicit from Study Success Statement) | Reported Device Performance (Pediatric Population) |
|---|---|---|
| Positive Percent Agreement (PPA) | Evidence of performance to support expanded indication. | 93.3% [95% CI: 68.05%; 99.83%] |
| Negative Percent Agreement (NPA) | Evidence of performance to support expanded indication. | 100% [95% CI: 87.23%; 100%] |
Note on "Cut-off Point": The document mentions a "Cut-off Point" of "5.0 DOB per mil (post dose minus pre dose)" for determining positive/negative H. pylori infection. This is a classification threshold for the device's output, not a performance acceptance criterion in the same vein as PPA/NPA.
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- Screened: 54 subjects
- Enrolled (Full Analysis - FA set) for Safety Assessment: 53 subjects
- Completed full study protocol with evaluable breath and stool test endpoints: 42 subjects (This is the effective test set size for performance assessment.)
- Data Provenance: The study was prospective and conducted at 6 clinical sites that were geographically diverse (no specific countries mentioned, but given the FDA submission, it's likely U.S. or international sites adhering to relevant regulations).
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state how many experts were used or their specific qualifications for establishing the ground truth for the test set. The ground truth was established by a central laboratory analyzing stool specimens with an FDA cleared H. pylori stool antigen test. While this implies expert analysis is involved in running and interpreting such a test, specific details about the individuals (e.g., number, board certification, years of experience) are not provided.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established using an FDA-cleared stool antigen test at a central laboratory, which is a definitive clinical test, not based on expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This device is a diagnostic test (breath test) with a determined cut-off for positive/negative results, not an imaging analysis system typically evaluated with MRMC studies for human reader improvement with AI assistance. The study compared the device's results to a established clinical ground truth (stool antigen test).
6. Standalone Performance Study (Algorithm Only)
Yes, the performance metrics (Positive Percent Agreement and Negative Percent Agreement) are presented as standalone performance of the BreathID® Hp Lab System, classifying patients as positive or negative based on its 5 DOB cut-off, compared to the stool antigen test. There is no human-in-the-loop component mentioned in its operation or the reported performance.
7. Type of Ground Truth Used
The type of ground truth used was an FDA cleared H. pylori stool antigen test, analyzed by a central laboratory. This is a laboratory/clinical test result considered a definitive diagnostic marker for H. pylori infection.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. The purpose of this 510(k) was to expand the indication for an already cleared and identical device. The "clinical validation" described is essentially a performance evaluation in the new (pediatric) population, not a de novo algorithm development or training. The device's underlying technology and cutoff (5.0 DOB) were already established and validated in adult populations (as per the predicate device K162150).
9. How Ground Truth for the Training Set Was Established
As there is no clear mention of a "training set" in the context of this 510(k) submission, the establishment of ground truth for a training set is not applicable here. The device's core functionality and diagnostic characteristics were presumably established during the development and clearance of the predicate device (K162150) for adults.
§ 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).