OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M

K053407 · Analytical Industries, Inc. · CCL · Apr 5, 2006 · Anesthesiology

Device Facts

• Record ID: K053407
• Device Name: OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
• Applicant: Analytical Industries, Inc.
• Product Code: CCL · Anesthesiology
• Decision Date: Apr 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Intended Use

The Analytical Industries Inc. AII 2000 Series Oxygen Analyzers & Monitors are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.

Device Story

AII 2000 Series Oxygen Analyzers/Monitors are portable, battery-powered devices for measuring oxygen concentration in breathing gas mixtures. The device utilizes a self-contained galvanic fuel cell sensor that generates a signal proportional to the partial pressure of oxygen. A microprocessor converts this signal into a digital reading displayed on a backlit LCD with 0.1% resolution. The device is used in clinical settings to verify or continuously monitor oxygen levels set by external delivery equipment (e.g., blenders, flow meters). The monitor version includes a keypad/menu interface, system diagnostics, and audible/visual alarms for high/low oxygen levels to enhance patient safety. Healthcare providers use the output to ensure accurate oxygen delivery, helping to maintain appropriate patient oxygenation levels.

Clinical Evidence

Bench testing only. Verification and validation of software design and analyzer performance were conducted in accordance with the FDA guidance document 'Software Validation per General Principles of Software Validation; Final Guidance for Industry and FDA Staff' (January 11, 2002).

Technological Characteristics

Galvanic fuel cell oxygen sensor; microprocessor-based signal processing; backlit LCD display (0.1% resolution); keypad/menu interface; battery-powered (2x AA); portable form factor with tripod/dovetail mounting options; visual/audible alarm system (monitor model).

Indications for Use

Indicated for measuring and displaying oxygen concentration in breathing gas mixtures for patients requiring oxygen therapy, where oxygen levels are controlled by external medical devices (e.g., blenders, flow meters). Suitable for spot-checking or continuous monitoring.

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

• Analytical Industries AII 2000 Oxygen Analyzer (K002382)

Reference Devices

• Sensidyne Monitor Analyzer (K000700)

Submission Summary (Full Text)

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## Analytical Industries Inc.

Tel: [phone], Fax: [phone], e-mail: [e-mail] 2855 Metropolitan Place, Pomona, CA 91767 USA

K053407

relationship between the sensor's signal and changes with the

oxygen concentration is both proportional and linear.

10

## 10 510(k) Summary

## [As Required by 21 CFR 807.92]

| Owner / Submitter of 510(k): | Analytical Industries Inc.<br>2855 Metrolpolitan Place<br>Pomona, CA 91767<br>Tel: [phone], fax: [phone]<br>e-mail: [e-mail]; [e-mail] |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 9021044 |
| Contact: | Patrick J. Prindible |
| Date of Summary: | November 30, 2005 |
| Trade Name: | Analytical Industries Inc. |
| Common Name: | Oxygen Analyzer/Monitor |
| Classification Name: | Oxygen Gas Analyzer/Monitor |
| Regulation Number: | 868.1720 |
| Classification Panel: | Anesthesiology |
| Regulatory Class: | IIb |
| Product Code: | 73 CCL |
| Predicate Device(s): | 510(k) #K002382 Analytical Industries AII 2000 Oxygen Analyzer<br>510(k) #K000700 Sensidyne Monitor Analyzer (add'l reference only) |
| Device Description: | The AII 2000 Series Oxygen Analyzers and Monitor can be<br>positioned on a table top or pole (tripod wire stand and V-mount<br>dovetail attachments are mounted on the back of the unit) and are<br>readily portable from one location to another. They provide<br>continuous, fast, reliable and accurate oxygen measurements of up<br>to 100% oxygen levels delivered by medical oxygen delivery<br>equipment and respiratory care systems.<br>The heart of each unit is the oxygen sensor, a self-contained<br>galvanic fuel cell sensor. The sensor is specific to oxygen and The |

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2855 Metropolitan Place, Pomona, CA 91767 USA Tel: [phone], Fax: [phone], e-mail: [e-mail]

> A battery powered state-of-the-art micro-processor converts the sensor's signal output representing the partial pressure of oxygen in the gas stream being analyzed. The resulting oxygen reading is displayed by a large easy to read backlit liquid crystal display (LCD) that has a resolution of 0.1% oxygen. The microprocessor is controlled from a keypad and provides features like system diagnostics, warning indicators, controls and an alarm capability for continuous monitoring that enhance both safety and effectiveness.

- Intended Use: The AII 2000 Series Oxygen Analyzers & Monitor are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.
Comparison of Technological Characteristics:

| Feature | AII 2000A/HC<br>Analyzer | AII 2000M<br>Monitor | AII 2000<br>Analyzer<br>#K002382 | Sensidyne<br>Analyzer<br>#K000700 | Sensidyne<br>Monitor<br>#K000700 |
|------------------------|--------------------------|-------------------------|----------------------------------|-----------------------------------|----------------------------------|
| Intended Use | Spot check | Continuously<br>monitor | Spot check | Spot check | Continuously<br>monitor |
| Oxygen Sensor | Galvanic | Galvanic | Galvanic | Galvanic | Galvanic |
| Range | 0-100% | 0-100% | 0-100% | 0-100% | 0-100% |
| Display Resolution | 0.1% | 0.1% | 0.1% | 0.1% | 0.1% |
| Controls | Keypad | Keypad/Menu | Pushbutton,<br>thumbwheel | Keypad | Keypad/Menu |
| Low Battery<br>Warning | Visual | Visual | Visual | Visual | Visual |
| Low Sensor Warning | Visual | Visual | NA | Unknown | Unknown |
| Alarms | NA | HI LO oxygen | NA | NA | HI LO oxygen |
| Alarm System | NA | Visual/Audible | NA | NA | Visual/Audible |
| Power Source | 2x AA Batteries | 2x AA Batteries | 1x 9V Battery | 2x AA Batteries | 2x AA Batteries |

(in)

Non-clinical Testing Data:

Verification and validation of the software design and analyzer performance was conducted and documentation of both the bench testing and third party testing can be found in Section 9. The bench testing was based on the guidance document "Software Validation per General Principles of Software Validation; Final Guidance for Industry and FDA Staff" issued January 11, 2002.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 4 2006

Mr. Patrick J. Prindible Analytical Industries, Incorporated 2855 Metropolitan Place Pomona, California 91767

Re: K053407

Trade/Device Name: Analytical Industries Incorporated AII 2000 Series Oxygen Analyzer/Monitor Regulation Number: 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL Dated: March 27, 2006 Received: March 28, 2006

Dear Mr. Prindible:

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.

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

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Page 2 -- Mr. Patrick J. Prindible

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- _ . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

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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Tel: [phone], Fax: [phone], e-mail: [e-mail] 2855 Metropolitan Place, Pomona, CA 91767 USA

## 8 Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Analytical Industries Inc. AII 2000 Series Oxygen Analyzer/Monitor

Indications for Use:

The Analytical Industries Inc. AII 2000 Series Oxygen Analyzers & Monitors are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.

Prescription Use __ Yes

AND/OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K053407