(22 days)
The BreathTek™ - UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy.
For these purposes, the test utilizes the UBiT IR spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2content in breath gas.
For administration by health care professionals. To be administered under a physician's supervision.
The scientific basis underlying the BreathTek™ UBT and the BreathTek™ -UBiT® UBT kit is identical. Both kits contain a pouch of Pranactin-Citric drug product, a reconstitution cup, sample collection containers, sample identification labels and a package insert. The parts lists of the two kits differ for types of sample collection containers, the configuration of the barcode labels and the quantity of straws provided. The UBiT version of the kit directly collects breath samples into two 300cc breath bags each fitted with a mouthpiece containing a check valve and the original kit collects breath samples via a straw into glass test tubes. The glass test tubes must be quickly sealed with screw-on caps to contain the breath; the check valve incorporated in the breath bags eliminates this concern. The original kit contains a back-up set of sample collection tubes to compensate for the fragility of the tubes' glass structure. Use of barcode labels will be mandatory for the original kit and optional for the UBiT version.
The two kits will coexist on the market and share the same package insert. The package insert will be modified to include the UBiT version's component list and step-by-step procedure for collecting samples. The package insert will instruct the health care provider to analyze the tube samples using a GIRMS spectrometer and the bag samples using an UBiT IR spectrophotometer.
The provided text describes a 510(k) premarket notification for a medical device called "BreathTek™ - UBiT® UBT for H. pylori." This submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way a clinical trial typically would for a new device's efficacy.
However, based on the information provided, we can infer some aspects and address the questions to the best of our ability within the context of a 510(k) submission for equivalence.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in terms of specific sensitivity, specificity, or other diagnostic metrics for the BreathTek™ - UBiT® UBT for H. pylori. Instead, the submission is focused on demonstrating substantial equivalence to an already marketed device (BreathTek™ UBT for H. pylori).
The core "acceptance criteria" in this context is likely that the modified device (with breath bags) performs equivalently to the predicate device (with glass tubes) such that the diagnostic results regarding H. pylori detection are comparable.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as demonstrated for equivalence) |
|---|---|
| Equivalent sample stability for breath samples. | Human breath samples proven stable for 3 days. |
| Equivalent sample stability for simulated breath samples. | Simulated breath samples proven stable for 7 days. |
| Scientific basis (Pranactin-Citric drug product) is identical. | Confirmed in the discussion of similarities. |
| Comparable diagnostic outcomes in clinical use. | Implied by substantial equivalence to predicate device with an FDA-approved package insert (NDA # 20-586/S-004). No novel clinical performance data is explicitly presented here beyond stability. |
| Proper functioning and safety of new components (breath bags). | Check valve in breath bags eliminates concerns of quick sealing and fragility of glass tubes. Demonstrated through non-clinical testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "Human breath samples" and "simulated breath samples," but does not quantify the number of each.
- Data Provenance: Not explicitly stated. The context of a US-based company submitting to the FDA suggests the testing would adhere to US regulatory standards, but the specific country of origin for the samples is not provided. The testing appears to be prospective as freshly collected "human breath samples" were used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document describes a technical equivalence study focusing on sample collection methods and stability, not a diagnostic accuracy study requiring expert-established ground truth for a test set. The predicate device's diagnostic performance, based on its existing FDA approval (NDA # 20-586/S-004), is referenced.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was not a diagnostic accuracy study involving adjudication of clinical cases.
5. 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 breath test for H. pylori detection, not an AI-assisted diagnostic imaging or interpretation system. Therefore, an MRMC study with AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic test kit that still requires human interaction for sample collection and analysis by a spectrometer, not a standalone algorithmic diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the stability study, the "ground truth" would be the known initial composition of the breath samples (both human and simulated) for the stability measurements. For the diagnostic accuracy of H. pylori, the ground truth would be established through methods typically used for validating such tests, likely via biopsy and histological examination or other established H. pylori detection methods, but this is related to the predicate device's original approval, not explicitly detailed here for the equivalence study.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would require a training set in the conventional sense. The "training" here refers to the development and validation of the collection methods and stability.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML device. For the H. pylori diagnostic capability of the overall system (predicate and proposed), the ground truth for diagnostic accuracy would have been established during the original NDA approval for the Pranactin-Citric drug product and the associated breath test.
§ 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).