(172 days)
No
The device description and performance studies focus on standard sensor technology, calibration, and alarm functions, with no mention of AI/ML terms or methodologies.
No
The device is an oxygen monitor, not a device that directly treats or provides therapy to a patient.
No
The device monitors the concentration of oxygen being delivered to patients, which is a measurement of a physiological parameter, rather than a diagnosis of a condition or disease.
No
The device description explicitly mentions a "MAX-550E oxygen sensor" and describes hardware components and testing related to the physical device (e.g., gas leakage, temperature compensation, electrical safety, EMC). This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the MaxO2ME oxygen monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MaxO2ME monitors the concentration of oxygen being delivered to patients, which is a gas being supplied externally, not a specimen taken from the patient's body.
- The intended use describes monitoring a gas delivered to the patient. This is a direct measurement of a therapeutic gas, not a diagnostic test performed on a biological sample.
- The device description focuses on measuring gas concentration. It describes a sensor and calibration based on gas samples (room air or 100% oxygen), not on biological samples.
Therefore, the MaxO2ME falls under the category of a medical device used for monitoring a physiological parameter (oxygen concentration in delivered gas) rather than an IVD used for diagnostic testing on biological specimens.
N/A
Intended Use / Indications for Use
The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, and subacute settings. The MaxO2ME is not intended as a life supporting device.
Product codes
CCL
Device Description
The MaxO-ME is a handheld oxygen analyzer/monitor capable of measuring the oxygen concentration from 0% to 100% in a sample gas. A MAX-550E oxygen sensor outputs a voltage which is used by the Max O2ME to determine the concentration of oxygen based on a calibration at room air or 100% oxygen. The MaxO2ME contains alarms that can be controlled by the user to set a maximum or minimum allowable oxygen concentration.
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
newborns to adults
Intended User / Care Setting
pre-hospital, hospital and sub-acute settings
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)
Performance Testing
We performed a number of tests to demonstrate that the proposed device performed as intended.
- . ISO 80601-2-55 Performance of respiratory gas monitors
- ISTA2A Shipping Validation Test Report
- Sensor performance Test Report
- Gas leakage Test Report
- . Interfering gas effects Test Report
- . Temperature compensation Test Report
- Drift of measurement accuracy Test Report
- MaxO2ME Operating and Storage Environment Report
- Device Cleaning Report and Disinfection Test
- . Measurement accuracy Test Report
- IEC 60601-1 Electrical safety
- IEC 60601-1-2 - EMC
- IEC 60601-1-8 - Alarms
- Shelf-life / Real-time
Discussion: In all cases the proposed device passed or meets the acceptance criteria. One can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096).
Biocompatibility - The materials that are in the gas pathway for the oxygen sensor. "Tee" adapter and diverter, are identical to other Maxtec supplied or cleared products which has similar intended use, population, environment of use and type of patient contact. As such no biocompatibility testing was performed.
Animal - No animal testing was performed.
Clinical - No human clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
Maxtec, LLC C/O Paul Dryden Consultant 2305 South 1070 West Salt Lake City, Utah 84119
Re: K153659
Trade/Device Name: MaxO2ME Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL Dated: May 12, 2016 Received: May 13, 2016
Dear Paul Dryden:
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 adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153659
Device Name
MaxO2ME
Indications for Use (Describe)
The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, and subacute settings. The MaxO2ME is not intended as a life supporting device.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary June 10, 2016 Page 1 of 5
| Official Contact: | Bruce Brierley
President
Maxtec LLC
2305 South 1070 West
Salt Lake City, Utah 84119
Tel – 385-549-8070 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | MaxO2ME |
| Common/Usual Name: | Oxygen analyzer |
| Classification Name: | 21CFR 868.1720
Class II
CCL |
| Predicate Device: | Precision PM5900 - K063096 |
| Reference Device: | MiniOX - K961644 |
Device Description:
The MaxO-ME is a handheld oxygen analyzer/monitor capable of measuring the oxygen concentration from 0% to 100% in a sample gas. A MAX-550E oxygen sensor outputs a voltage which is used by the Max O2ME to determine the concentration of oxygen based on a calibration at room air or 100% oxygen. The MaxO2ME contains alarms that can be controlled by the user to set a maximum or minimum allowable oxygen concentration.
Device Features:
- Oxygen sensor of approximately 1,500,000 O2 percent hours and / or 2 years.
- External probe with 10 ft., extendable cable and diverter fitting for standard 15 mm "T" adapter. ●
- Operation using 4 AA alkaline batteries (4 x 1.5 volts) for approximately 5,000 hours of ● performance with typical use.
- Oxygen-specific, galvanic sensor that achieves 90% of final value in approximately 15 seconds at ● room temperature.
- Self-diagnostic check of analog and microprocessor circuitry. ●
- Low battery indication.
- Calibration reminder timer that alerts the operator, using a calibration icon on the LCD display, to ● perform a unit calibration.
- . Adjustable high-level and low-level alarming capability with flashing LED and audible indication of alarm conditions.
- Smart high-low alarm setting to help adjust alarm settings quickly.
- . Back-light display with auto ambient light level detection.
- Sleep Mode operation to extend battery life. ●
Indications for Use:
The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device.
4
Patient Population
The MaxO2ME may be used on equipment where one desires to measure and monitor the delivered oxygen concentration. This is independent of a patient population.
Contraindications
There are no contraindications.
Environments of Use
Pre-hospital, hospital and sub-acute settings
Substantial Equivalence
This discusses how one can find the MaxO2ME substantially equivalent to the predicate Precision Medical PM5900 (K063096).
Indications for Use
Table 1 outlines the indications for use for both devices and one can see that they are similar, namely oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients, not intended as a life supporting device.
Discussion: One can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096). There are no differences which raise any new substantial equivalence concerns.
Environment of Use -Oxygen monitors have commonly been used in pre-hospital and healthcare settings. The reference to the types of equipment that the predicate discloses supports pre-hospital and healthcare setting.
Discussion: One can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096). There are no differences which raise any new substantial equivalence concerns.
Population - The predicate submission does not disclose details on patient population but does include incubators which would suggest newborns.
Discussion: Based upon the available information one can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096). There are no differences which raise any new substantial equivalence concerns.
Performance Specifications - The following is a list of the differences between the proposed device and the predicate.
- . Response time is 15 seconds vs. 12 seconds for the predicate
- o The reference device MiniOX (K961644) has a response time of 20-30 seconds
- . Warm-up time is 3 seconds less for the predicate (12 vs. 15 seconds)
- Operating temperature range is wide by 10 degrees for the predicate vs. the proposed. ●
- Battery life is about 50% less than the proposed device (2000 hours vs. 5000 hours) ●
- The Sensor Life is less for the predicate vs. the proposed ●
- High Oxygen Alarm range is smaller by 3 % points (19-99% vs. 16-100%)
- o The reference device MiniOX (K961644) has the identical high alarm range
- . Size and weight are slightly different
Discussion:
While the subject device has some differences when compared to the Response Time and High Alarm range, the reference device, MiniOX (K961644), which has similar intended use, population and environment has similar Response time and High alarm, which supports that the differences do not raise any new substantial equivalence concerns. The other differences, battery life, warm-up time, sensor
5
510(k) Summary June 10, 2016
Page 3 of 5
life and physical size are similar and the defenses are improvements vs. the predicate. As such they would not raise any new substantial equivalence concerns. One can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096) and reference device MiniOX (K961644).
Non-clinical Testing
Performance Testing
We performed a number of tests to demonstrate that the proposed device performed as intended.
- . ISO 80601-2-55 Performance of respiratory gas monitors
- ISTA2A Shipping Validation Test Report ●
- Sensor performance Test Report ●
- Gas leakage Test Report ●
- . Interfering gas effects Test Report
- . Temperature compensation Test Report
- Drift of measurement accuracy Test Report
- MaxO2ME Operating and Storage Environment Report
- Device Cleaning Report and Disinfection Test
- . Measurement accuracy Test Report
- IEC 60601-1 Electrical safety ●
- IEC 60601-1-2 - EMC
- IEC 60601-1-8 - Alarms
- Shelf-life / Real-time ●
Discussion: In all cases the proposed device passed or meets the acceptance criteria. One can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096).
Biocompatibility - The materials that are in the gas pathway for the oxygen sensor. "Tee" adapter and diverter, are identical to other Maxtec supplied or cleared products which has similar intended use, population, environment of use and type of patient contact. As such no biocompatibility testing was performed.
Per G95-1 and ISO 10993-1:2009, these materials would be considered as:
- Externally communicating, Tissue contact, and Duration of Use prolonged (> 24 hours, 1,500,000 % O2 Hours, over 2 years typical application | > 1,000,000% O2 Hours |
| Alarm Systems | High/Low alarms, flashing yellow LEDs
Nominal 975 Hz audio buzzer (IEC 60601-1-8) | High/Low alarms, flashing yellow LEDs |
| Low Oxygen Alarm Range | 15% - 99% (>1% lower than high alarm) | 15% - 99% (>1% lower than high alarm)
Reference device - MiniOX – K961644
15 – 99% |
| High Oxygen Alarm Range | 16% - 100% (>1% higher than low alarm) | 18% - 99% (>1% higher than low alarm) inconsistent
Summary shows 19-99%, literature shows 18-100%
Reference device - MiniOX – K961644
16 - 100% |
| Accuracy | Exact to display alarm value | Exact to display alarm value |
| Materials | The materials in the gas pathway are considered as Externally
communicating, Tissue contact, and Duration of Use –
prolonged (> 24 hours,