MaxO2ME

K153659 · Maxtec, LLC · CCL · Jun 10, 2016 · Anesthesiology

Device Facts

• Record ID: K153659
• Device Name: MaxO2ME
• Applicant: Maxtec, LLC
• Product Code: CCL · Anesthesiology
• Decision Date: Jun 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

MaxO2ME is a handheld oxygen analyzer/monitor measuring 0-100% oxygen concentration. Device utilizes a MAX-550E galvanic fuel cell sensor to output voltage proportional to oxygen concentration; microprocessor processes signal for display and alarm functions. Operated in pre-hospital, hospital, and sub-acute settings by clinicians. Features include user-adjustable high/low oxygen alarms with visual (flashing LED) and audible indicators, self-diagnostic circuitry, and calibration reminder. Output is displayed on an LCD screen; healthcare providers use this data to monitor delivered oxygen levels. Device is not life-supporting; provides continuous monitoring to ensure oxygen delivery remains within set clinical parameters.

Clinical Evidence

No human clinical testing was performed. Bench testing included ISO 80601-2-55 (respiratory gas monitors), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm performance (IEC 60601-1-8), sensor performance, gas leakage, interfering gas effects, temperature compensation, and measurement accuracy. All tests met acceptance criteria.

Technological Characteristics

Galvanic fuel cell (MAX-550F) oxygen sensor; 4 AA alkaline battery power; LCD display with backlight; 15mm T-adapter interface. Dimensions: 3.6" x 5.8" x 1.2". Operates 15°C–40°C. Microprocessor-based circuitry for signal processing, self-diagnostics, and alarm management. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-8.

Indications for Use

Indicated for continuous monitoring of delivered oxygen concentration in patients ranging from newborns to adults in pre-hospital, hospital, and sub-acute settings. Not for life support.

Regulatory Classification

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.

Predicate Devices

• Precision PM5900 (K063096)

Reference Devices

• MiniOX (K961644)
• Maxtec components (K131252)
• Envitec Tee adapter (K122290)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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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#### 510(k) Summary June 10, 2016 Page 1 of 5

| Official Contact: | Bruce Brierley<br>President<br>Maxtec LLC<br>2305 South 1070 West<br>Salt Lake City, Utah 84119<br>Tel – 385-549-8070 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | MaxO2ME |
| Common/Usual Name: | Oxygen analyzer |
| Classification Name: | 21CFR 868.1720<br>Class II<br>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.

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#### 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

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#### 510(k) Summary June 10, 2016

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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, < 30 ● days)
Animal - No animal testing was performed.

Clinical - No human clinical testing was performed.

#### Substantial Equivalence Conclusion-

It is sponsor's opinion that the MaxO2ME oxygen analyzer based upon the comparative testing is substantially equivalent to the predicate device.

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# 510(k) Summary

| Attributes | Proposed<br>MaxO2ME | Predicate<br>Precision Medical – PM5900 (K063096) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The MaxO2ME oxygen monitor is intended for continuous<br>monitoring of the concentration of oxygen being delivered to<br>patients ranging from newborns to adults. It can be used in the<br>pre-hospital, hospital and sub-acute settings. The MaxO2ME is<br>not intended as a life supporting device. | Intended to measure the concentration of oxygen being<br>delivered to the patient. The oxygen monitor is not intended as<br>a life supporting device |
| Environments of Use | Pre-hospital, hospital and sub-acute settings | Variety of medical applications such as anesthesiology (e.g.,<br>anesthesia machines), Respiratory devices (e.g., respirators,<br>ventilators, pediatric incubators), and oxygen therapy (e.g.,<br>oxygen tents). Can be considered Pre-hospital, hospital and<br>sub-acute settings |
| Patient Population | The MaxO2ME may be used on equipment where one desires to<br>measure and monitor the delivered oxygen concentration. This<br>is independent of a patient population. | Not specific but includes reference to pediatrics and incubators<br>which would imply newborns and older |
| Measurement Range | 0.0 to 100% | 0.0 to 100% |
| Resolution | 0.1% | 0.1% |
| Accuracy and Linearity | ±1% of full scale at constant temperature, RH and pressure<br>when calibrated at fill scale | ±1% of full scale at constant temperature, RH and pressure<br>when calibrated at fill scale |
| Total Accuracy | ±3% Actual oxygen level over full operating temperature range | ±3% Actual oxygen level over full operating temperature range |
| Response Time | 90% of final value in approx. 15 seconds at 23°C | 90% of final value in 12 seconds at 25°C<br>Reference device - MiniOX – K961644<br>90% in 20 to 30 seconds |
| Warm-up Time | None required | None required |
| Operating Temperature | 15°C – 40°C (59°F – 104°F) | 10°C – 45°C (50°F – 113°F) |
| Storage Temperature | -15°C – 50°C (5°F – 122°F) | -15°C – 50°C (5°F – 122°F) |
| Atmospheric Pressure | 800 – 1012 mBars | Up to 8,000 ft. |
| Humidity | 0-95% (non-condensing) | 0-95% (non-condensing) |
| Power requirements | 4 – AA Alkaline batteries | 4 – AA Alkaline batteries |
| Battery Life | Approx. 5000 hours, typical use | Approx. 1,500 – 2,000 hours, typical use |
| Low Battery Indications | “LOWBAT” icon on LCD display | Icon on LCD display |
| Sensor Type | Maxtec MAX-550F galvanic fuel cell | Galvanic fuel cell |
| Attributes | Proposed<br>MaxO2ME | Predicate<br>Precision Medical – PM5900 (K063096) |
| Expected Sensor Life | > 1,500,000 % O2 Hours, over 2 years typical application | > 1,000,000% O2 Hours |
| Alarm Systems | High/Low alarms, flashing yellow LEDs<br>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)<br>Reference device - MiniOX – K961644<br>15 – 99% |
| High Oxygen Alarm Range | 16% - 100% (>1% higher than low alarm) | 18% - 99% (>1% higher than low alarm) inconsistent<br>Summary shows 19-99%, literature shows 18-100%<br>Reference device - MiniOX – K961644<br>16 - 100% |
| Accuracy | Exact to display alarm value | Exact to display alarm value |
| Materials | The materials in the gas pathway are considered as Externally<br>communicating, Tissue contact, and Duration of Use –<br>prolonged (> 24 hours, < 30 days)<br><br>The components of the sensor and diffuser are identical to the<br>Maxtec components cleared under K131252 and Tee adapter is<br>identical to Envitec K122290.<br>These components have similar intended use, population,<br>environment of use and type of patient contact | |
| Dimensions | 3.6"(W) x 5.8"(H)x1.2"(D) | 3.6"(W) x 5.4"(H)x1.7"(D) |
| Weight | Approx. 0.89 lbs. | Approx. 1.11 lbs. |
| Cable length | 9 ft. | 10 ft. |
| Accessories | Diverter<br>Tee adapter (15 mmm x 22 mm fittings)<br>Mounting brackets<br>DC power adapter | Diverter<br>Tee adapter (15 mmm x 22 mm fittings)<br>Mounting brackets<br>DC power adapter |

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## 510(k) Summary June 10, 2016
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