MX 300 OXYGEN MONITOR

K024155 · Teledyne Analytical Instruments · CCL · Jul 17, 2003 · Anesthesiology

Device Facts

• Record ID: K024155
• Device Name: MX 300 OXYGEN MONITOR
• Applicant: Teledyne Analytical Instruments
• Product Code: CCL · Anesthesiology
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MX300 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.

Device Story

MX300 Oxygen Monitor measures oxygen concentration in gas mixtures; used in anesthesia and respiratory therapy. Device provides continuous monitoring for adult, pediatric, and neonatal patients. Clinicians use output to assess oxygen levels in medical gas delivery systems. Benefits include real-time monitoring to ensure appropriate oxygen concentration for patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen gas analyzer; gaseous phase; 21 CFR 868.1720; Class II; Product Code CCL.

Indications for Use

Indicated for continuous measurement and display of oxygen concentration in gas mixtures for adult, pediatric, and neonatal patients in anesthesia and respiratory therapy 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 17 2003

Mr. Ray Khajavi Director Teledyne Instruments 16830 Chestnut Street City of Industry, California 91748-1020

Re: K024155

Trade/Device Name: MX300 Oxygen Monitor Regulation Number: 21 CFR 868.1720 Regulation Name: Analyzer, Gas, Oxygen, Gaseous Phase Regulatory Class: II Product Code: CCL Dated: June 24, 2003 Received: June 25, 2003

Dear Mr. Khajavi:

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. Ray Khajavi

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/dsma/dsmamain.html.

Sincerely yours,

Susa Russer

Susan Runner, DDS, MA Interim 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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## MX300 Indications for Use

## 510(k) Number: KO24155

The MX300 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 4

OR

Over the Counter Use ______

Susan Rury

(Division Sign-Off) (Division Sign-Old)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K024155