(177 days)
The Micro H2 is a hand held hydrogen monitor used in the screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines. This increased level of hydrogen is expired and can be measured after ingestion of lactose following a period of fasting.
Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
Target Population: Adult, Child and Infant.
The Micro H2 Breath Monitoring device is a battery operated hand held hydrogen breath monitor. Clinicians using this device have a patient expel their breath into an inlet port through a disposable mouthpiece adapter. The hydrogen concentration is then displayed in parts per million (ppm). The software utility, product name Hydra, will be supplied to purchasers of the breath hydrogen monitoring device. At the clinician's discretion, they can install Hydra on a Windows based PC. Thereafter, the handheld Micro H2 device can be connected to the PC via a serial communications cable to acquire and log successive breath hydrogen measurements during a diagnostic procedure.
Here's an analysis of the provided text regarding the Micro H2 Breath Monitoring Device with Hydra Software Utility, focusing on acceptance criteria and study details:
Summary of Device and Indication:
The Micro H2 Breath Monitoring Device with Hydra Software Utility is a handheld hydrogen monitor used in the screening and diagnosis of lactose malabsorption. This condition is identified by increased hydrogen levels in the breath after lactose ingestion, following a period of fasting. The Hydra software utility allows for data acquisition, logging, plotting, and report generation on a Windows-based PC.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K033688) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance acceptance criteria through a dedicated clinical study for the Hydra software utility. The acceptance criteria for the core hydrogen monitoring function (Micro H2 device) are based on the performance of its predicate devices. The Hydra software itself primarily offers enhancements in data management, visualization, and reporting, rather than directly impacting the core measurement accuracy.
Therefore, the table below outlines the performance characteristics of the Micro H2 device, which the proposed device (with Hydra) claims to be the "Same as Micro H₂" for, and implicitly, these are the de facto acceptance criteria for the measurement aspect, as they are consistent with a legally marketed predicate. For the Hydra software's new functionalities, the acceptance is based on functional equivalence and verification.
| Acceptance Criteria (from Predicate Micro H2) | Reported Device Performance (Proposed Micro H2 with Hydra) |
|---|---|
| Performance: | |
| Operating Principle: Electrochemical | Same as Micro H₂ (Electrochemical) |
| Type: Micro fuel cell | Same as Micro H₂ (Micro fuel cell) |
| Range: 0 - 500 ppm | Same as Micro H₂ (0 - 500 ppm) |
| Resolution: 1 ppm | Same as Micro H₂ (1 ppm) |
| Accuracy: +/- 10% or 2 ppm whichever is the greater | Same as Micro H₂ (+/- 10% or 2 ppm whichever is the greater) |
| Display: 3 1/2 digit LCD | Same as Micro H₂ (3 1/2 digit LCD) |
| Operating Pressure: Atmospheric +/- 10% | Same as Micro H₂ (Atmospheric +/- 10%) |
| Pressure coefficient: 0.02% signal per mBar | Same as Micro H₂ (0.02% signal per mBar) |
| New/Enhanced Functionality (Introduced by Hydra software): | |
| Recording Date of Test, Clinician Name, Institution ID, Patient ID, DOB, Reported Symptoms: Manual Transcription | Pop-Up Menus Presented to User. Relevant Data Entered into Field Through Mouse Driven Program Interface |
| Plotting Breath Hydrogen Concentration as a Function of Time for Diagnostic Evaluation: Manual Plotting | Breath Hydrogen Concentration Automatically Plotted as a Function of Time and Graphically Displayed. |
| Breath Hydrogen Measurement Interval: Manual Timing with Wall Clock or Stop Watch | Automatic in Real-Time Mode. Hydra Program Tracks Time and Prompts for Next Measurement. |
| Electronic Archival/Retrieving of Test Data: Only if Test Data is Manually Managed with Word Processing/Spreadsheet Application | Fully Automatic within Hydra User Interface |
| Test Protocol: Manually Determined, Managed and Administered | Hydra Software Provided with Several Suggested Diagnostic Presets for Lactose Malabsorption. Clinicians on a Per Patient Basis can Manually Modify Suggested Preset Test Protocol Variables. Included within Protocol Variables are Threshold Parameters that if Used, Resultant Diagnostic Data is Automatically Compared. |
| Report Generation and Communication: Manual Transcription | Automatic within Hydra User Interface. Depending Upon Diagnostic Presets, Measured Breath Hydrogen Data is Compared to Thresholds and Can be Flagged as a Suggested Diagnostic Should this Feature of the Hydra Interface be Invoked. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not detail a specific clinical test set or sample size to prove the device meets acceptance criteria in a traditional sense (e.g., patient-based clinical trial data). This document is a pivotal submission for demonstrating substantial equivalence to previously approved devices (K963376 and HBT Sleuth™).
The core performance of the Micro H2 device itself is claimed to be "Same as Micro H₂" (referring to the predicate K9633765 Micro H2 device). This implicitly relies on the proven performance of the predicate device. For the new functionalities introduced by the Hydra software, the evidence would typically come from software verification and validation (V&V) activities, such as functionality testing, integration testing, and system testing, rather than a clinical 'test set' with patient data.
Therefore:
- Sample Size for the Test Set: Not specified in this 510(k) summary as a dedicated clinical test set. The performance claims rely on the predicate device's existing validation.
- Data Provenance: Not applicable for a new clinical test set. The performance characteristics of the device component (Micro H2) are derived from a previously cleared device. The software functions would be validated through technical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. As noted above, the submission relies on substantial equivalence to existing devices and likely software V&V for the new software features, not a new clinical study requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. Given that a dedicated clinical test set with expert ground truth isn't detailed, there's no mention of an adjudication method.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. The device is a diagnostic tool for hydrogen breath testing, and the Hydra software primarily automates data handling and report generation, rather than providing AI-assisted diagnostic interpretation that would typically necessitate an MRMC
study. The "Suggested Diagnostic" feature in Hydra automatically compares data to thresholds but does not involve complex AI interpretation requiring human reader comparison with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The 510(k) summary does not describe a standalone algorithm performance study in the way typically seen for AI/ML devices. The "Hydra Software Utility" enhances the existing Micro H2 device by automating data management, plotting, and report generation based on pre-defined thresholds. It allows for "Resultant Diagnostic Data [to be] Automatically Compared" to "Threshold Parameters," and can "Flagged as a Suggested Diagnostic." This suggests an algorithmic comparison, but the study supporting this automation (likely software V&V) is not detailed here in terms of standalone performance metrics like sensitivity/specificity on a labelled dataset. Its primary role is to streamline the clinician's workflow and provide suggested diagnostics based on pre-set rules, not to provide an independent, unassisted diagnosis.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given the nature of the device and the 510(k) submission, the ground truth for the performance characteristics (like accuracy, range, resolution of hydrogen measurement) is implicitly tied to the established methods and validation of the predicate Micro H2 device. For the software's functionalities, the "ground truth" would be the successful execution of the specified functions (e.g., correct plotting of data, accurate entry of patient ID, proper comparison against predefined thresholds) as tested during software verification and validation, rather than clinical ground truth like pathology or expert consensus on patient cases.
8. The Sample Size for the Training Set
The 510(k) summary does not mention a training set. This is consistent with the device not being an adaptive AI/ML model that would typically require a training set. The Hydra software is a rule-based utility for data management and simplified analysis.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for an AI/ML model, the establishment of ground truth for a training set is not applicable to this submission.
§ 862.1820 Xylose test system.
(a)
Identification. A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.