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The 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 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 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 systems consist of an electro-optical medical device designed to measure and compute the changes in the ratio between 1302 and 1202 concentrations in the patient's exhalation, software, and a test kit.

The IDkit Hp® One test kit consists of:

• . One Package Insert
• One Tablet of 13C-enriched urea,75mg .
• One packet of 4.3g of Powder Citrica (citric acid). .
• One IDcircuit™ nasal cannula ●
• . One straw for stirring and drinking

Using a nasal cannula for breath collection directly from the patient's nostrils enables point of care testing. The BreathID® Hp continually measures and computes the ratio between 13CO2 and 12CO2 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 "3C-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.

This document is a Special 510(k) submission for a labeling modification to an already cleared medical device, the BreathID® Hp System. A Special 510(k) is used when a modification to a cleared device does not affect its intended use, fundamental scientific technology, or safety/effectiveness profiles. This means the core performance characteristics of the device itself are not being re-evaluated in this submission, but rather the interpretation and communication of its results under specific circumstances (patients on PPIs).

Therefore, the submission does not contain information about the original acceptance criteria and the study that proved the device met those criteria. It focuses solely on the rationale for the labeling change.

Here's what can be extracted from the document:

1. Context of the Submission:

• Trade/Device Name: BreathID® Hp System
• Regulation Number: 21 CFR 866.3110 (Campylobacter Fetus Serological Reagents - note: this seems like a misclassification in the document for an H. pylori urea breath test, as H. pylori is a specific bacterial infection, not related to Campylobacter Fetus. This might be a generic regulation listed or an artifact. The actual product code aligns with urea breath tests.)
• Regulation Name: Test, urea (breath or blood)
• Regulatory Class: Class I, reserved
• Product Code: MSQ, JJQ
• Predicate Device: BreathID® Hp System (K173772)
• Purpose of this 510(k): To obtain marketing clearance for a labeling modification of the BreathID® Hp System (K173772). This modification is solely to the package insert which is included in the IDkit Hp® One, the test kit used as part of this cleared 510(k) device, while the Intended Use and Indication for Use remain unchanged. The modified labeling informs clinicians that for patients taking proton pump inhibitors (PPIs), a positive result could be considered as indicative of the presence of urease enzyme associated with H. pylori.

2. What is Unchanged from the Cleared Device (K173772):

• Intended Use / Indication for Use: "The 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 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 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."
• Device Description: The system consists of an electro-optical medical device designed to measure and compute changes in the 13CO2 and 12CO2 ratio, software, and a test kit (IDkit Hp® One).
• Measurement Method: 13C measurement based on Molecular Correlation Spectroscopy™ (MCS) technology.
• Test Kit and Ingested Drug: The IDkit Hp® One test kit (13C urea tablet and citric acid powder approved in NDA-21-314), the procedure for ingestion of test substrate, and the breath collection method remain unchanged.
• Technological Characteristics: Remain unchanged.
• Performance Testing: "Performance characteristics remain unchanged." This explicitly states that no new performance testing (like sensitivity/specificity studies) was conducted for this submission because the underlying technology and operation are identical.

3. What is Changed (Labeling Modification):

The modification addresses the interpretation of results for patients using Proton Pump Inhibitors (PPIs), which were previously a known cause of false negative results. The new labeling clarifies that:

• Old Warning Removed: "Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingesting these medications within two weeks prior to performing the breath test mav produce false negative test results."
• New Statements Added/Revised:
  • False negative results may still be caused by PPIs within two weeks prior to testing.
  • If a negative result is obtained from a patient ingesting a PPI within two weeks, it may be a false-negative and the test should be repeated two weeks after discontinuing PPIs.
  • Crucially: "A positive result for a patient on a PPI could be considered as indicative of the presence of urease associated with H. pylori." (This is the core change, allowing interpretation of positive results even with PPI use, whereas previously any use of PPIs within the window could make results unreliable).

Addressing your specific questions based on the provided text:

Since this is a Special 510(k) for a labeling change on a previously cleared device, the document does not contain the details of the original performance studies. The submission explicitly states "Performance characteristics remain unchanged," indicating no new studies were performed to demonstrate that the device meets new acceptance criteria. Instead, it reinterprets existing performance for a specific clinical scenario.

Therefore, most of your questions cannot be answered from this specific document.

Here's what can be inferred or directly stated, and what cannot:

1. A table of acceptance criteria and the reported device performance:

   • Cannot be provided from this document. This information would be in the original 510(k) submission for K173772. This current document states that performance characteristics remain unchanged, meaning the device still meets the original acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Cannot be provided from this document. This would be in the original K173772 submission. No new clinical studies were conducted for this labeling change.

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):

   • Cannot be provided from this document. This would be in the original K173772 submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Cannot be provided from this document. This would be in the original K173772 submission.

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 diagnostic test (urea breath test, non-imaging) and does not involve "human readers" or "AI assistance" in the typical sense of imaging analysis for which MRMC studies are performed. Its output is interpretable directly as positive or negative based on the device's measurement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Partially applicable/inferred. For a diagnostic test like this, the device itself provides the measurement. The "standalone" performance would be its sensitivity and specificity against a "true" H. pylori status. This data would have been part of the original K173772 clearance. The current submission implies that the device's measurement capabilities remain the same.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Cannot be provided from this document but can be inferred. For H. pylori breath tests, the ground truth is typically established by other diagnostic methods for H. pylori, such as biopsy with histology, rapid urease test (RUT), or culture, or a combination (composite reference standard). This information would be in the original K173772 submission.

8. The sample size for the training set:

   • Not applicable. This product is a diagnostic device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's parameters are likely calibrated and validated, but not "trained" on data in the same way.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

In summary, this document is an administrative update for a minor change in labeling interpretation, not a re-clearance or new performance study for the device itself. To get the requested information about device performance and the original studies, one would need to access the original 510(k) submission document (K173772).

Ask a specific question about this device

The BreathID® Hp Lab System or the 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 BreathID® Hp Lab System consists of the appropriate IDkit Hp® 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 modified BreathID® Smart 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 the ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, an integrated Auto Sampler, integrated software, and a test kit.

The IDkit Hp® Two test kit consists of:

• One 75mg 13C-urea tablet .
• One packet of 4.3g of 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 .
• A 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 modified BreathID® Smart System measures and computes the ratio between 13CO2and 12CO2 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2ratio 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® Smart 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 provided text describes a Special 510(k) submission for a modified BreathID® Smart System where the primary change is an update to the operating system from Windows CE 6 to Windows 10. The original BreathID® Smart System (K220494) is the predicate device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format with performance results for the modified device compared to a specific benchmark. Instead, it focuses on demonstrating equivalence to the predicate device. The key performance metric mentioned is "Delta over Baseline (DOB)" and a positive/negative determination based on a cutoff of ">5 DOB."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: "The comparison test included 80 measurements on each system..." This refers to the comparison between the modified and predicate systems, not necessarily a clinical test set from patients. The exact nature of these "measurements" (e.g., how many unique samples, how many replicates) is not fully detailed, but they involved "contrived gases."
• Data Provenance: The "measurements" used contrived gases. This indicates an in vitro or laboratory-based testing approach, not data from human patients. Therefore, information about country of origin or retrospective/prospective nature for patient data is not applicable to this specific comparison test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided. The comparison test utilized "contrived gases simulating different levels of 13CO2," suggesting an engineered ground truth rather than a clinical ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. The test set involved contrived gases and a direct comparison between the modified and predicate devices, not subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The device is a diagnostic testing system (BreathID®) that provides a quantitative output (DOB) and a positive/negative determination. It does not involve human readers interpreting images or data that would be assisted by AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the testing described appears to be a standalone performance evaluation. The "comparison test" was performed directly between the predicate and modified systems using controlled inputs (contrived gases), without human intervention in the diagnostic decision-making process beyond operating the device. The device itself performs the measurement and computes the DOB.

7. Type of Ground Truth Used:

For the comparison test discussed, the ground truth was based on contrived gases simulating different levels of 13CO2. This allowed for controlled evaluation of the system's ability to measure and compute 13CO2concentrations accurately. For the clinical efficacy of the device as a whole for H. pylori, the text states it uses 13C-urea, which is a known and approved method (NDA 21-314).

8. Sample Size for the Training Set:

This information is not provided. The document describes a Special 510(k) for a modification (OS change) to an already cleared device, not the development of a completely new algorithm requiring a training set. The underlying "MCS technology" is already established.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as a training set for a new algorithm associated with this modification is not mentioned.

Ask a specific question about this device

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):

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.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided in this document. This information would be in the original 510(k)s (K173777, K193610).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not provided in this document. This information would be in the original 510(k)s (K173777, K193610).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not provided in this document. This information would be in the original 510(k)s (K173777, K193610).

4. 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.

5. 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.

6. 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).

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable. See point 8.

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