MAXO2 CU

K063488 · Maxtec, Inc. · CCL · Feb 22, 2007 · Anesthesiology

Device Facts

• Record ID: K063488
• Device Name: MAXO2 CU
• Applicant: Maxtec, Inc.
• Product Code: CCL · Anesthesiology
• Decision Date: Feb 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Intended Use

The MaxO2 CU is a continuous use monitor of oxygen concentration in a patient breathing environment. It may be provided with an oxygen concentration dilution method which could be of a flowmeter, manifold or venturi design, which can deliver a set or adjustable FiO2 oxygen concentrations and flow rates to the patient. It is not intended for use with life supporting systems.

Device Story

MaxO2 CU combines continuous oxygen monitor with venturi oxygen dilution system. Device inputs: oxygen gas source. Principle: venturi orifice adjusts flow; oxygen concentration adjusted by drawing oxygen into region surrounding venturi orifice. Output: real-time oxygen concentration displayed on 3-digit LCD. Used in hospitals, sub-acute institutions, homecare, and transport; operated by clinicians. Provides clinicians with visual oxygen concentration data to assist in monitoring patient breathing environments. Benefits: integrated monitoring and delivery in single package; eliminates need for separate assembly of flowmeter, venturi, and analyzer.

Clinical Evidence

Bench testing only. No clinical data provided. Performance metrics include: 0-100% display range, 0.1% resolution, 90% response time in ~15 seconds, accuracy ±3% full scale, linearity error <3% of reading, and drift <1% over 8 hours.

Technological Characteristics

Galvanic fuel cell oxygen sensor. 3-digit LCD display. Powered by 2 replaceable AA batteries. Integrated venturi/flowmeter manifold for oxygen dilution. Materials identical to K040484. Operating range 15-40°C, 0-95% RH non-condensing. Calibration to room air or 100% oxygen. No alarms except low battery.

Indications for Use

Indicated for continuous monitoring of oxygen concentration in patient breathing environments. May be used with oxygen dilution methods (flowmeter, manifold, or venturi) to deliver set or adjustable FiO2 and flow rates. Not for use with life-supporting systems. Suitable for hospital, sub-acute, homecare, and intra-hospital transport settings.

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

• Maxtec - MAXO2 + (K040484)
• Ceramatec - Handi (K973282)
• Sensidyne (K010328)

Submission Summary (Full Text)

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#### 510(k) Summary

#### Non-Confidential Summary of Safety and Effectiveness Page 1 of 2

12-Feb-07

FEB 2 2 2007

| Maxtec, Inc.<br>6526 South Cottonwood 300 West<br>Salt Lake City, UT 84107 | Tel -- 801-266-5300<br>Fax - 801-270-5590 |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Official Contact: | Tod Cook- QA |
| Proprietary or Trade Name: | MaxO2 CU |
| Common/Usual Name: | Oxygen analyzer with flowmeter and gas source |
| Classification Name: | Analyzer, Oxygen, Gaseous-phase |
| Device: | MaxO2 CU |
| Predicate Devices: | Maxtec - MAXO2 + - K040484<br>Ceramatec - Handi - K973282<br>Sensidyne - K010328 |

The MaxO2 CU is a combination of a continuous use oxygen monitor and a venturi oxygen dilution system in one device. An analogous device could be assembled by attaching a wall mount oxygen flow meter to a commercially available venturi and attaching the venturity a standard in-line oxygen analyzer. The MaxO2 CU offers this set-up to the clinician in one package. There are two models, one with adjustable flow and adjustable FiO2. The other has fixed flow and adjustable FiO. The flow adjustment is accomplished by adjusting the flow of oxygen through the venturi orifice. The adjustable oxygen % is accomplished by adjusting the flow of oxygen into the region surrounding the venturi orifice. This oxygen is drawn into the venturi stream in place of room air, increasing oxygen content in the mixture. The oxygen analyzer electronics, sensor, and programming are identical to the MaxQ+ predicate K040484.

| Indications for Use: | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | The MaxO2 CU is a continuous use monitor of oxygen<br>concentration in a patient breathing environment. It may be<br>provided with an oxygen concentration dilution method which<br>could be of a flowmeter, manifold or venturi design, which can<br>deliver a set or adjustable FiO2 oxygen concentrations and flow<br>rates to the patient. It is not intended for use with life supporting<br>systems. |
| Environment of Use -- | Hospital, Sub-acute institutions, Homecare, intra-hospital<br>transport |

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# K063488 – MaxO2 CU 510(k) Response to E-mail of 12-Feb-07

### Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 12-Feb-07

| Device Attributes: | |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Attribute | MaxO2 CU |
| Features | |
| Display range | 0-100% oxygen |
| Display Resolution | 0.1% oxygen |
| Response Time | 90% of final value in ~ 15 seconds @ 23C |
| Accuracy | + 3% full scale |
| Linearity error | < 3% of reading |
| Drift | < 1% oxygen over 8 hours |
| Humidity influence | +3% full scale |
| Humidity conditions | 0-95% RH non-condensing |
| Pressure influence | Proportional to changes in atmospheric pressure |
| Operating temperature | 15 - 40°C |
| Storage temperature | -15 to 55°C |
| Recommended storage temperature | -20 to 55°C |
| Battery power indicator | Indicator on LCD |
| Analyzer life | Battery life - 5000 hours (user replaceable)<br>Sensor life >900,000 % oxygen hours |
| Sensor type | Galvanic fuel cell |
| Power requirement | 2 replaceable AA battery |
| Weight | N/A |
| Display | 3 digit LCD |
| On / Auto-off button | Standard ON/OFF (No auto OFF) |
| Connection or use with other<br>components allowing for adjustment<br>of flow and FiO2 | Yes<br>Built in oxygen diluter (venturi or flowmeter<br>manifold). |
| Calibrations | Calibrate to room air or 100% oxygen |
| Alarms | None<br>Except Low battery |
| Materials | Same as K040484 |
| Performance | None under 514 |

# Differences between Other Legally Marketed Predicate Devices

The MaxO2 CU is viewed as substantially equivalent to the following predicate device – Maxtec Max O2 + - K040484, Ceramatec - Handi - K973282, and Sensidyne - K010328.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### EB 2 2 2007

Maxtec, Incorporated C/O Mr. Paul Dryden ProMedic, Incorporated 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134

Re: K063488

Trade/Device Name: Max02 CU Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: January 23, 2007 Received: January 24, 2007

#### Dear Mr. 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.

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 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.

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#### Page 2 - Mr. Dryden

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); 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.

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### K063488 - MaxO2 CU 510(k) Response to E-mail of 12-Feb-07

#### 4 Indications for Use Statement

Page 1 of 1

510(k) Number:

K063488 (To be assigned)

Device Name: MaxO2 CU

Indications for Use:

The MaxO2 CU is a continuous use monitor of oxygen concentration in a patient breathing environment. It may be provided with an oxygen concentration dilution method which could be of a flowmeter, manifold or venturi design, which can deliver set or adjustable FiO2 oxygen concentrations and flow rates to the patient. It is not intended for use with life supporting systems.

### Prescription Use XX (Part 21 CFR 801 Subpart D)

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 Device Evaluation (ODE)

W. Mala for M. Husband

.... CONSERVED SEQUENCE

K0 63488

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