OXYCON MOBILE

K023120 · Erich Jaeger GmbH · BZC · Nov 12, 2003 · Anesthesiology

Device Facts

• Record ID: K023120
• Device Name: OXYCON MOBILE
• Applicant: Erich Jaeger GmbH
• Product Code: BZC · Anesthesiology
• Decision Date: Nov 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1880
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Jaeger OXYCON MOBILE pulmonary function mobile test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The OXYCON MOBILE system allows the use of telemetry for the monitoring of metabolic parameters. The OXYCON MOBILE system is intended to use with adults and children over the age of 14 years.

Device Story

Oxycon Mobile is a portable pulmonary function test system; monitors cardio-respiratory and metabolic parameters during physical activity. Utilizes telemetry for data transmission; enables real-time monitoring in stress testing, rehabilitation, and sports medicine settings. Operated by clinicians/technicians; provides metabolic data to assist in physiological assessment and clinical decision-making during exercise. Benefits include mobility for patient during testing, allowing evaluation under realistic stress conditions.

Technological Characteristics

Portable pulmonary function test system; utilizes telemetry for data transmission; designed for metabolic parameter monitoring; intended for use in stress testing and rehabilitation environments.

Indications for Use

Indicated for monitoring cardio-respiratory functions during stress testing, rehabilitation, sports medicine, and related activities in adults and children over 14 years of age.

Regulatory Classification

Identification

A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

Erich Jaeger GmbH c/o Mr. Earl W. Draper SensorMedics, Inc. 22705 Savi Ranch Parkway Yorba Linda, CA 92887

Re: K023120

Trade/Device Name: Oxycon Mobile Regulation Number: 21 CFR 868.1880 Regulation Name: Calculator, Pulmonary Function Data Regulatory Class: II Product Code: BZC Dated: August 13, 2003 Received: August 18, 2003

Dear Mr. Draper:

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. Earl W. Draper

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 (OS) 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.

Ours fs

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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510(k) Number: K023120

Oxycon Mobile Device Name:

Indications For Use:

The Jaeger OXYCON MOBILE pulmonary function mobile test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The OXYCON MOBILE system allows the use of telemetry for the monitoring of metabolic parameters. The OXYCON MOBILE system is intended to use with adults and children over the age of 14 years.

January-27-2003 Tjeu Souren Product Manager

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

fth

(Division Sign - 14) Division of Armsthesiology, General Hospital, Infection Control Dental Devic

510(k) Number: K04

510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)