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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).

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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.

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.

Ask a specific question about this device

The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the 1302 / 1202 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. The Exalenz BreathID® Hp System consists of the IDkit:Hp™ 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 modified 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 the ratio between 1302 and 1202 concentrations in the patient's exhalation and a test kit. The test kit consists of:

• IDcircuit™ Oridion Nasal FilterLine™ (nasal cannula) (K980325)
• A 75mq 13C-urea tablet
• A 4.3g package of powdered Citrica (citric acid)
• Drinking straw
• Package Insert (Instructions for Use)

The modified BreathID® Hp System measures and computes the ratio between 1302 and 1202 in the patient's exhalation before and after the ingestion of 13C-urea. The change in the 1302 / 1202 ratio before and after ingestion of 13C-urea is referred to as the Delta over Baseline (DOB).

The basis of the 13C measurement method for both the modified versions of the BreathID® System is a technology called Molecular Correlation Spectroscopy™ (MCS™), MCS™ is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for substantial equivalence in the clinical validation centered on the agreement between the modified BreathID® Hp System and its predicate device (unmodified BreathID® System) for H. pylori diagnosis.

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