(419 days)
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No
The provided 510(k) summary does not mention AI, ML, or related terms, nor does it describe functionalities typically associated with these technologies in medical devices (like image processing or complex data analysis beyond standard physiological monitoring).
No
The device monitors cardio-respiratory functions and metabolic parameters; it does not treat or alleviate symptoms or conditions.
No
Explanation: The device monitors cardio-respiratory functions and metabolic parameters during stress testing and related activities. While monitoring can inform diagnosis, the "Intended Use" section does not explicitly state that the device generates results for diagnostic purposes or for identifying a disease or condition.
Unknown
The provided text describes a "pulmonary function mobile test system" and mentions "telemetry for the monitoring of metabolic parameters." This strongly suggests the involvement of hardware components (sensors, transmitters, etc.) to acquire the physiological data. Without a "Device Description" section, it's impossible to definitively rule out hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring cardio-respiratory functions during activities like stress testing, rehabilitation, and sports medicine. This involves measuring physiological parameters directly from the patient's body (e.g., breathing, heart rate).
- Lack of IVD Characteristics: An IVD device is specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The description of the OXYCON MOBILE does not mention the analysis of any such specimens.
Therefore, the Jaeger OXYCON MOBILE is a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
BZC
Device Description
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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
adults and children over the age of 14 years
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
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§ 868.1880 Pulmonary-function data calculator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
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.
1
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
2
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)