(200 days)
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No
The summary describes a device that measures physiological parameters during exercise and calculates derived values. There is no mention of AI or ML in the intended use, device description, or the specific sections for AI/ML information. The device is explicitly stated as not being intended for diagnostic interpretation, which is a common application area for AI/ML in medical devices.
No
The device is used to calculate pulmonary function values and measure gas exchange parameters in response to exercise, but it is not intended for diagnostic use or to provide therapy. Its purpose is to quantify and analyze physiological responses.
No
The "Intended Use / Indications for Use" section explicitly states, "The device is not intended for use as a diagnostic pulmonary-function interpretation calculator." While it measures physiological parameters, it's for investigational exercise measurements and not for diagnostic interpretation.
No
The device description explicitly states it "interfaces to a testsubject via mouthpiece or a face mask and to peripheral equipment such as a bicycle ergometer or treadmill." This indicates the device includes hardware components for data acquisition and interfacing, not just software.
Based on the provided text, the OxyconAlpha is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- OxyconAlpha's Function: The OxyconAlpha directly measures physiological responses of a living human subject during exercise (ventilation, oxygen uptake, carbon dioxide production, heart rate). It interfaces with the subject via a mouthpiece or mask and with exercise equipment.
- Lack of Specimen Analysis: There is no mention of the OxyconAlpha analyzing any biological specimens.
Therefore, the OxyconAlpha falls under the category of a physiological monitoring or measurement device, not an IVD.
N/A
Intended Use / Indications for Use
The OxyconAlpha is used as a predictive pulmonary function value calculator (Product code BTY). It is a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters.
It is the intention to determine on patients a cardiopulmonary limitation and to test on sport athlets their training level. The different load levels for both groups can be generated over a bicycle ergometer or over a treadmill. The patient population is age 4 and older. The environment of use is indoor.
The OxyconAlpha interfaces to a testsubect via mouthpiece or a face mask. The OxyconAlpha interfaces to peripheral equipment and is therefore available in a variety of configurations from a standard controlled ergospirometry unit to a fully expandable laboratory system with blood pressure monitor, treadmill and ergometer. The OxyconAlpha interacts with the ECG signal (recorded by another device) only to the extent of extracting the patient's heart rate from the ECG signal. Other uses such as displaying or further analyzing the ECG waveforms are not included in the present submittal.
The device is not intended for use as a diagnostic pulmonary-function interpretation calculator.
Product codes
73 BTY
Device Description
OxyconAlpha, Modified with Windows 95 System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
age 4 and older
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 1998
Mr. Leo den Bakker Erich Jaeger B.V. Regulierenring 11 NL-3981 LA Bunnik THE NETHERLANDS
Re: K980094 OxyconAlpha, Modified with Windows 95 System Regulatory Class: II (two) Product Code: 73 BTY Dated: April 28, 1998 Received: May 1, 1998
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 leqally 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 Regulation (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.
1
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 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Callahan, Ph.D. Thomas J. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K980094 510(k) Number (if known):
Device Name:
OxyconAlpha, Modified with Windows 95 system
Indications For Use:
The OxyconAlpha is used as a predictive pulmonary function value calculator (Product code BTY). It is a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters.
It is the intention to determine on patients a cardiopulmonary limitation and to test on sport athlets their training level. The different load levels for both groups can be generated over a bicycle ergometer or over a treadmill. The patient population is age 4 and older. The environment of use is indoor.
The OxyconAlpha interfaces to a testsubject via mouthpiece or a face mask. The OxyconAlpha interfaces to peripheral equipment and is therefore available in a variety of configurations from a standard controlled ergospirometry unit to a fully expandable laboratory system with blood pressure monitor, treadmill and ergometer. The OxyconAlpha interacts with the ECG signal (recorded by another device) only to the extent of extracting the patient's heart rate from the ECG signal. Other uses such as displaying or further analyzing the ECG waveforms are not included in the present submittal.
The device is not intended for use as a diagnostic pulmonary-function interpretation calculator.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
l (Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
Prescription Use
Use
(Per 21 CFR 801.109)
510(k) Number. OR Over-The-Counter
(Optional Format 1-2-96)