OXYCONALPHA WITH OPTION ECG by ERICH JAEGER B.V.

The OxyconAlpha with option ECG 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 OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older,

The OxyconAlpha with option ECG 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 Description

The OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill.

AI/ML Overview

This document is a marketing clearance letter for a medical device (OxyconAlpha with Option ECG) and does not contain the specific information required to complete your request about acceptance criteria and a study that proves the device meets those criteria.

Therefore, I cannot provide:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This letter primarily focuses on the FDA's determination of substantial equivalence (510(k) clearance) to a legally marketed predicate device, indicating that the device can be marketed. It describes the device's intended use and classification but does not detail the specific performance studies and their results.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1999

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

Re: K984465 OxyconAlpha with Option ECG Regulatory Class: III (three) Product Code: 74 LOS, 73 BTY Dated: July 27, 1999 Received: July 30, 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 commorce 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, Deel reclass 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 111 (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 with the Current Coad Mannelent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through perices . inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may 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 (301) 594-4639. Also, please note the regulation cntitled, "Misbrandinq 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

fesanne's AWesterhever for,

Wolf Sapirstein, 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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P.2/2

91027.fda

Re: K984465

Device name: OxyconAlpha with option ECG

Indications For Use:

The OxyconAlpha with option ECG is capable of performing computerized ECG interpretation during resting condition.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Camilla Hiltunen

ivision Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510 (k) Number ... K. 98.44.6.5 ..............................................................................................................................................

Prescription Use........

Regulation Number and Section

N/A