(177 days)
Not Found
No
The summary describes a device that measures hydrogen concentration and logs data, but there is no mention of AI or ML being used for analysis, interpretation, or any other function.
No.
The device is used for the screening and diagnosis of lactose malabsorption by measuring hydrogen levels, which is a diagnostic function, not a therapeutic one.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The Micro H2 is a hand held hydrogen monitor used in the screening and diagnosis of lactose malabsorption..." This indicates its purpose is to identify or determine a medical condition.
No
The device description explicitly states it is a "battery operated hand held hydrogen breath monitor" and mentions a "handheld Micro H2 device" that connects to a PC, indicating it includes hardware.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used in the "screening and diagnosis of lactose malabsorption." This is a diagnostic purpose.
- Sample Type: The device measures hydrogen levels in "expired breath," which is a biological sample taken from the patient.
- Analysis: The device analyzes the hydrogen concentration in the breath sample to provide a measurement (in ppm) that is used in the diagnostic process.
- Regulatory Restriction: The statement "Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician" is a common indicator of a medical device, and often applies to IVDs.
While the device description focuses on the hardware and software, the core function and intended use clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NRH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, Child and Infant.
Intended User / Care Setting
Clinicians, physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resolution: 1 ppm
Accuracy: +/- 10% or 2 ppm whichever is the greater
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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.
1
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 | PREDICATE
HBT Sleuth™ | PREDICATE
K9633765
Micro H2 device
without Hydra | PROPOSED
K033688
Micro H2 device with
Hydra |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Breath Hydrogen
Measurement | Expel Breath Into
Handheld Device | Expel Breath Into
Handheld Device | Same as Predicate
Devices |
| Recording Date of
Test, Clinician
Name, Institution
ID, Patient ID,
DOB, Reported
Symptoms | Manual
Transcription
(Pen & Paper or
Generic Word
Processing/Spreads
heet Application
Program) | Manual
Transcription
(Pen & Paper or
Generic Word
Processing/Spreads
heet Application
Program) | Pop-Up Menus
Presented to User.
Relevant Data Entered
into Field Though
Mouse Driven
Program Interface |
| Plotting Breath
Hydrogen
Concentration as a
Function of Time
for Diagnostic
Evaluation | Manual Plotting
(Pen & Paper or
Generic Word
Processing/Spread-
sheet Application
Program) | Manual Plotting
(Pen & Paper or
Generic Word
Processing/Spread-
sheet Application
Program) | Breath Hydrogen
Concentration
Automatically Plotted
as a Function of Time
and Graphically
Displayed. |
| Breath Hydrogen | Manual Timing | Manual Timing | Automatic in Real |
| PARAMETER | PREDICATE | PREDICATE
K9633765 | PROPOSED
K033688 |
| | HBT Sleuth™ | Micro H₂ device
without Hydra | Micro H₂ device with
Hydra |
| Measurement
Interval | with Wall Clock or
Stop Watch | with Wall Clock or
Stop Watch | 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/Spread-
sheet Application | Only if Test Data is
Manually Managed
with Word
Processing/Spread-
sheet Application | Fully Automatic
within Hydra User
Interface |
| Test Protocol | Manually
Determined,
Managed and
Administered | Manually
Determined,
Managed and
Administered. | Hydra Software
Provided with Several
Suggested Diagnostic
Presets for Lactose
Malabsorption
Producing an Elevated
Breath Hydrogen
Concentration.
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
(Pen & Paper or
Generic Word
Processing/Spread-
sheet Application
Program) | Manual
Transcription
(Pen & Paper or
Generic Word
Processing/Spread-
sheet Application
Program) | Automatic within
Hydra User Interface.
Depending Upon
Diagnostic Presets,
Measured Breath
Hydrogen Data is
Compared to
Thresholds and Can be
Flagged as a |
| PARAMETER | PREDICATE | PREDICATE | PROPOSED |
| | HBT Sleuth™ | K9633765
Micro H₂ device
without Hydra | K033688
Micro H₂ device with
Hydra |
| | | | Suggested Diagnostic
Should this Feature of
the Hydra Interface be
Invoked. |
| Power Source | Single Alkaline 9
volt | Single Alkaline 9
volt 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 |
| Operating
temperature | Unknown | 15° to 30° | Same as Micro H₂ |
| Operating humidity | 15% to 90% non-
condensing | 30% to 90% RH
continuous (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 ppm
whichever is the
greater | 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 per
mBar | Same as Micro H₂ |
2
3
4
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).
5
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
6
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 ____________________________________________________________________________________________________________________________________________________________________