OXYCON PRO

K992214 · Erich Jaeger B.V. · BZC · Feb 22, 2000 · Anesthesiology

Device Facts

• Record ID: K992214
• Device Name: OXYCON PRO
• Applicant: Erich Jaeger B.V.
• Product Code: BZC · Anesthesiology
• Decision Date: Feb 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1880
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Oxycon Pro is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The Oxycon Pro interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The Oxycon Pro interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older. The Oxycon Pro is capable of performing computerized ECG interpretation during resting condition. The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar areas. It is intended to be used by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

Device Story

Oxycon Pro is a software-driven diagnostic system for exercise testing and resting ECG analysis. Inputs include gas exchange data via mouthpiece/face mask and cardiac signals via ECG electrodes; system interfaces with external ergometers or treadmills. Device processes physiological data to calculate ventilation, oxygen uptake, CO2 excretion, heart rate, and ST-segment parameters. Used in hospitals, clinics, and rehabilitation facilities by physicians or qualified healthcare professionals. Output displayed on screen, printed, or stored on hard disk for clinical review. Assists clinicians in evaluating human response to physical stress and cardiac function. Benefits include objective assessment of cardiopulmonary performance and automated ECG interpretation.

Clinical Evidence

No clinical data provided; device cleared based on substantial equivalence to existing marketed devices.

Technological Characteristics

Software-driven system; interfaces with peripheral ergometers/treadmills; inputs via mouthpiece/face mask and ECG electrodes. Performs computerized ECG interpretation and gas exchange analysis. Intended for professional clinical settings.

Indications for Use

Indicated for patients aged 4 years and older undergoing exercise testing or resting ECG analysis. Used to measure physiological responses to workload, including gas exchange (ventilation, O2 uptake, CO2 excretion) and cardiac parameters (ECG, heart rate). Not for home use.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2000

Mr. Leo den Bakker Erich Jaeger B.V. Regulierenring 11 NL-3981 LA Bunnik THE NETHERLANDS

K992214 Re: Oxycon Pro. Regulatory Class: II (two) Product Code: 73 BZC, 74 MWI, 74 MLC, 74 DPS November 18, 1999 Dated: Received: November 29, 1999

Dear Mr. Bakker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Leo den Bakker

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ja. Wintersheimer for,

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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91103.fda (revision of 90531.fda) - Tab 3

K992214 Re:

Device name: Oxycon Pro

## Indications For Use:

The Oxycon Pro is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes.

The Oxycon Pro interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The Oxycon Pro interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older.

The Oxycon Pro is capable of performing computerized ECG interpretation during resting condition.

The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar areas. It is intended to be used by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510 (k) Number ... ... ...................................................................

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