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.

Device Description

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.

AI/ML Overview

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.

Summary

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K033688

Micro H2 Breath Monitoring Device with Hydra Software Utility 510(k) Summary

Micro Medical Ltd. Submitter's Information: PO Box 6 Rochester Kent, ME1 2AZ United Kingdom Contact Information Micro Direct, Inc. (US Representative for Micro Medical Ltd): Mr. David Staszak 803 Webster Street Lewiston. Maine 04240 207-786-7808 Telephone Number: 207-786-7280 Fax Number: Trade Name: Micro H2 Breath Monitoring Device with HYDRA Software Utility Analyzer, Hydrogen Gas Common Name: Classification Name: Xylose Test System Regulation Number: 21 CFR 862.1820

Predicate Devices, 510(k) Numbers:

Micro H2 K963376 HBT Sleuth, N/A

Indications For Use:

Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.

Target Population: Adult, Child and Infant.

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Device Description:

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 varts 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.

Comparative Summary Tables

Contained in the following table is a predicate-proposed comparative of the proposed Micro H2 device with the Hydra Utility software, the predicate Micro H2 device without the Hydra Utility software Utility, and the predicate Breathe E-Z Systems, Inc. HBT Sleuth™ :

PARAMETER	PREDICATEHBT Sleuth™	PREDICATEK9633765Micro H2 devicewithout Hydra	PROPOSEDK033688Micro H2 device withHydra
Breath HydrogenMeasurement	Expel Breath IntoHandheld Device	Expel Breath IntoHandheld Device	Same as PredicateDevices
Recording Date ofTest, ClinicianName, InstitutionID, Patient ID,DOB, ReportedSymptoms	ManualTranscription(Pen & Paper orGeneric WordProcessing/Spreadsheet ApplicationProgram)	ManualTranscription(Pen & Paper orGeneric WordProcessing/Spreadsheet ApplicationProgram)	Pop-Up MenusPresented to User.Relevant Data Enteredinto Field ThoughMouse DrivenProgram Interface
Plotting BreathHydrogenConcentration as aFunction of Timefor DiagnosticEvaluation	Manual Plotting(Pen & Paper orGeneric WordProcessing/Spread-sheet ApplicationProgram)	Manual Plotting(Pen & Paper orGeneric WordProcessing/Spread-sheet ApplicationProgram)	Breath HydrogenConcentrationAutomatically Plottedas a Function of Timeand GraphicallyDisplayed.
Breath Hydrogen	Manual Timing	Manual Timing	Automatic in Real
PARAMETER	PREDICATE	PREDICATEK9633765	PROPOSEDK033688
	HBT Sleuth™	Micro H₂ devicewithout Hydra	Micro H₂ device withHydra
MeasurementInterval	with Wall Clock orStop Watch	with Wall Clock orStop Watch	Time Mode. HydraProgram Tracks Timeand Prompts for NextMeasurement.
ElectronicArchival/Retrievingof Test Data	Only if Test Data isManually Managedwith WordProcessing/Spread-sheet Application	Only if Test Data isManually Managedwith WordProcessing/Spread-sheet Application	Fully Automaticwithin Hydra UserInterface
Test Protocol	ManuallyDetermined,Managed andAdministered	ManuallyDetermined,Managed andAdministered.	Hydra SoftwareProvided with SeveralSuggested DiagnosticPresets for LactoseMalabsorptionProducing an ElevatedBreath HydrogenConcentration.Clinicians on a PerPatient Basis canManually ModifySuggested Preset TestProtocol Variables.Included withinProtocol Variables areThreshold Parametersthat if Used, ResultantDiagnostic Data isAutomaticallyCompared.
Report Generationand Communication	ManualTranscription(Pen & Paper orGeneric WordProcessing/Spread-sheet ApplicationProgram)	ManualTranscription(Pen & Paper orGeneric WordProcessing/Spread-sheet ApplicationProgram)	Automatic withinHydra User Interface.Depending UponDiagnostic Presets,Measured BreathHydrogen Data isCompared toThresholds and Can beFlagged as a
PARAMETER	PREDICATE	PREDICATE	PROPOSED
	HBT Sleuth™	K9633765Micro H₂ devicewithout Hydra	K033688Micro H₂ device withHydra
			Suggested DiagnosticShould this Feature ofthe Hydra Interface beInvoked.
Power Source	Single Alkaline 9volt	Single Alkaline 9volt PP3	Same as Micro H₂
Environmental:
Storage temperature	Unknown	-20° to +70°	Same as Micro H₂
Storage humidity	15% to 90% non-condensing	30% to 90% RH	Same as Micro H₂
Operatingtemperature	Unknown	15° to 30°	Same as Micro H₂
Operating humidity	15% to 90% non-condensing	30% to 90% RHcontinuous (0 -99% intermittent)	Same as Micro H₂
Performance:
Operating Principle	Electrochemical	Electrochemical	Same as Micro H₂
Type	Micro Fuel Cell	Micro fuel cell	Same as Micro H₂
Range	0 - 500 ppm	0 - 500 ppm	Same as Micro H₂
Resolution	Unknown	1 ppm	Same as Micro H₂
Accuracy	+/- 5%	+/- 10% or 2 ppmwhichever is thegreater	Same as Micro H₂
Display	3.5" by 0.5"	3 1/2 digit LCD	Same as Micro H₂
Operating Pressure	Unknown	Atmospheric+/-10%	Same as Micro H₂
Pressure coefficient	Unknown	0.02% signal permBar	Same as Micro H₂

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 9 2004

Mr. David Staszak Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240

Re: K033688

Trade/Device Name: Micro H2 Breath Monitoring Device with Hydra Software Utility Regulation Number: 21 CFR 862.1820 Regulation Name: Xylose test system Regulatory Class: Class I Product Code: NRH Dated: May 5, 2004 Received: May 6, 2004

Dear Mr. Staszak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, US, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K033688

Micro H2 Breath Monitoring Device with Hydra Software Utility Device Name:

Indications For Use:

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 matuosofpuon, a contacts 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

e of in Vitto Diama

510(k) K033688

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.