(121 days)
The BreathID Hp Lab System or 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 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 BreathD Hp Lab System consists of the appropriate IDkit Ho 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.
The BreathID® Hp Lab System and the BreathID® Smart System are two non-invasive breath test systems for detecting the presence of Helicobacter pylori (H. pylori) based on the same technology. The systems consist of an electro-optical medical device designed to measure and compute the changes in the ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, an Auto Sampler, software, and a test kit.
The IDkit Hp™ Two test kit consists of:
- One 75mg 13C-urea tablet .
- One packet of 4.3g powdered Citrica (citric acid) .
- One drinking straw .
- One drinking cup .
- One Package Insert (Instructions for Use) .
- One Quick User Guide ●
- Two Breath Sample Bags (one Baseline and one Post Ingestion) .
- Four bar code labels ●
- One large Sample Transport Bag ●
Using bags for breath collection enables off-site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The BreathID® Hp Lab System and the BreathID® Smart System measure and compute the ratio between 13CO2 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 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.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary.
It's important to note that this 510(k) is a Special 510(k) for a labeling modification only. This means the device itself, its technology, and its core performance characteristics (as established in previous clearances K173777 and K193610) remain unchanged. The modification specifically addresses the interpretation of positive results for patients taking proton pump inhibitors (PPIs). Therefore, a detailed "study that proves the device meets the acceptance criteria" in terms of new performance evaluation is generally not part of a Special 510(k) for a labeling change in the way it would be for a de novo device or a significant technology change.
The document states: "Performance characteristics remain unchanged." This implies that the performance data supporting the original clearances (K173777 and K193610) is what demonstrates the device meets its acceptance criteria. No new performance testing was conducted for this specific 510(k).
Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for a labeling modification related to PPIs and states performance characteristics remain unchanged, the document does not present new acceptance criteria or device performance data for this submission. The original devices were cleared based on their ability to non-invasively measure changes in the ¹³CO₂/¹²CO₂ ratio indicative of urease production associated with H. pylori.
The core intent of the device is to diagnose H. pylori infection. Therefore, for a diagnostic device like this, common performance metrics would typically include:
- Sensitivity: The ability to correctly identify patients with H. pylori.
- Specificity: The ability to correctly identify patients without H. pylori.
- Accuracy: The overall correctness of the test.
However, the provided text does not contain any specific numerical acceptance criteria or reported device performance values for sensitivity, specificity, or accuracy for either the original devices or for this labeling change. These would have been documented in the original 510(k) submissions (K173777 and K193610).
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):
| Acceptance Criteria (Inferred from device function) | Reported Device Performance (Not provided in this document, refers to prior clearances) |
|---|---|
| Ability to detect H. pylori infection (Sensitivity) | Not updated by this submission; performance established in K173777 & K193610. |
| Ability to rule out H. pylori infection (Specificity) | Not updated by this submission; performance established in K173777 & K193610. |
| Consistency/Precision of ¹³CO₂/¹²CO₂ ratio measurement | Not updated by this submission; performance established in K173777 & K193610. |
| Safe for use in adult and pediatric patients (3-17) | Not updated by this submission; safety established in K173777 & K193610. |
Study Information (Relevant to the original device clearances, as no new performance study was done for this labeling change)
Since this is a Special 510(k) for a labeling modification, no new clinical performance study was conducted or described in this document. The document explicitly states, "Performance characteristics remain unchanged." Therefore, the following points cannot be answered from the provided text for this 510(k) submission, but would have been part of the original K173777 and K193610 submissions.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a diagnostic breath test system, not an AI-assisted diagnostic imaging or interpretation tool for human readers. It provides a direct numerical output (Delta over Baseline) based on a chemical reaction.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself (the BreathID Hp Lab System or BreathID Smart System) provides a standalone measurement (Delta over Baseline) that is then interpreted by a healthcare practitioner. The performance characteristics remaining unchanged implies that the standalone performance that was established for K173777 and K193610 continues to apply. However, specific standalone performance metrics are not given in this document.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided in this document. For H. pylori breath tests, ground truth is typically established by other diagnostic methods for H. pylori, often invasive (e.g., biopsy with histology or rapid urease test during endoscopy) or non-invasive (e.g., stool antigen test, serology), sometimes with a composite reference standard. This information would be in the original 510(k)s (K173777, K193610).
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The sample size for the training set:
- Not applicable / Not provided. For this type of chemical diagnostic device that measures changes in isotope ratios, there isn't typically a "training set" in the machine learning sense. The device's operation is based on established physical and chemical principles, not on a trained algorithm from a large dataset. The underlying algorithms for calculating the Delta over Baseline are fixed.
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How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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).