MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY

K033688 · Micro Direct, Inc. · NRH · May 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033688
• Device Name: MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
• Applicant: Micro Direct, Inc.
• Product Code: NRH · Clinical Chemistry
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1820
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The Micro H₂ is intended to be 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.

Device Story

System comprises hand-held electrochemical hydrogen breath monitor (K963376) connected via serial cable to PC running Hydra Software Utility. Device measures expired hydrogen gas following lactose ingestion. Software automatically acquires, logs, and organizes sequential breath measurement data from monitor. Used in clinical settings by professionals. Output provides data management and analysis to assist in lactose malabsorption diagnosis.

Clinical Evidence

No clinical data provided; reliance on previously cleared predicate device (K963376).

Technological Characteristics

Handheld hydrogen monitor; electrochemical micro fuel cell sensing principle; 9V alkaline battery power; 0-500 ppm measurement range; 1 ppm resolution; +/- 10% or 2 ppm accuracy. Connectivity via serial communications cable to Windows-based PC. Software-based data management and visualization.

Indications for Use

Indicated for screening and diagnosis of lactose malabsorption in patients following lactose ingestion after a fasting period. For professional use only.

Regulatory Classification

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).

Predicate Devices

• Micro H2 Breath Monitoring Device (K963376)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE AND INSTRUMENT TEMPLATE

A. 510(k) Number:
K033688

B. Purpose for Submission:
Clearance of data management software for their cleared H₂ breath meter (K963376)

C. Analyte:
Breath hydrogen gas

D. Type of Test:
Electrochemical

E. Applicant:
Micro Direct, Inc.

F. Proprietary and Established Names:
Micro H2 Breath Monitoring Device with Hydra Software Utility

G. Regulatory Information:
1. Regulation section:
21 CFR § 862. 1820, Xylose test system
2. Classification:
Class I
3. Product Code:
NRH, System, breath management
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
The Micro H₂ is intended to be 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.
2. Indication(s) for use:
See intended use above.
3. Special condition for use statement(s):
For professional use only

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4. Special instrument Requirements:
Micro H2 Breath Monitoring Device
Personal computer using Windows OS

I. Device Description:
The device consists of a hand-held hydrogen breath monitor (cleared as K963376) that is connected to a personal computer (PC) via a serial communications cable. A software utility on the PC then acquires and logs successive breath measurement data from the hydrogen monitor. The software also has data analysis and organization functions.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Micro H2 Breath Monitoring Device
2. Predicate K number(s):
K963376
3. Comparison with predicate:
The device and the predicate share the same intended use, methodology, and performance. The only difference is the addition of a software utility to aid the user in data recording, management, and analysis.

K. Standard/Guidance Document Referenced (if applicable):
FDA Guidance Document - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
ISO 13485:1996
EN 1441
ISO 14971-1, Part 1
IEC/EN 60601-1-4, Part 1 number 4

L. Test Principle:
Same as in K963376.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable in this submission. See K963376.
b. Linearity/assay reportable range:
Not applicable in this submission. See K963376.
c. Traceability (controls, calibrators, or method):
Not applicable in this submission. See K963376.
d. Detection limit:
Not applicable in this submission. See K963376.
e. Analytical specificity:
Not applicable in this submission. See K963376.
f. Assay cut-off:
Not applicable in this submission. See K963376.

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2. Comparison studies:
a. Method comparison with predicate device:
Not applicable in this submission. See K963376.
b. Matrix comparison:
Not applicable in this submission. See K963376.

3. Clinical studies:
a. Clinical sensitivity:
Not applicable in this submission. See K963376.
b. Clinical specificity:
Not applicable in this submission. See K963376.
c. Other clinical supportive data (when a and b are not applicable):
Not applicable in this submission. See K963376.

4. Clinical cut-off:
Not applicable in this submission. See K963376.

5. Expected values/Reference range:
Not applicable in this submission. See K963376.

N. Instrument Name:
Hydra Software Utility for use with the Micro H₂ Breath Monitoring Device

O. System Descriptions:
1. Modes of Operation:
Automatic – automatically acquires breath H₂ measurements from monitor
2. Software: Operating system – Microsoft Windows (multiple versions)
Microsoft Access-based database for data storage

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes 3 or No

3. Sample Identification:
Manual – patient ID entered manually, but software automatically logs sequential breath measurements for the patient

4. Specimen Sampling and Handling:
Not applicable, patient breathes directly into monitoring device

5. Assay Types:
Chemistry

6. Reaction Types:
Electrochemical

7. Calibration:
The software utility requires no calibration

8. Quality Control:
Quality control procedures are recommended for the monitor. No quality control by the user is necessary for the software utility

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P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "L. Performance Characteristics" Section Of The SE Determination Decision Summary:
Not applicable

Q. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.