(19 days)
No
The summary describes a system for direct measurement of physiological parameters and does not mention any AI or ML components.
No
The device assesses cardiac and pulmonary function and evaluates the efficiency of prescribed therapy, but it does not directly provide therapy itself.
Yes
The text explicitly states the system "can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management." These are all diagnostic functions.
No
The device description explicitly states it is a "cardiopulmonary exercise or resting metabolic measurement system with an integrated touch screen computer," indicating it includes hardware components for direct measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Express Series directly measures physiological parameters like oxygen uptake and carbon dioxide production during exercise or rest. It does not analyze samples taken from the body.
- Intended Use: The intended uses described (assessing cardiac/pulmonary function, nutritional assessment, cardiac output) are based on real-time physiological measurements, not the analysis of biological samples.
Therefore, the Express Series falls under the category of a medical device that performs physiological measurements, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Express Series uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.
The Express Series uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.
The Express Series can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.
Product codes
BZL
Device Description
The Express Series is a cardiopulmonary exercise or resting metabolic measurement system with an integrated touch screen computer that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Laboratory and clinical testing of 10 systems has shown the Express Series to have substantial equivalence in performance and precision to the predicate device. Tandem gas exchange system validator studies performed with the predicate device produced comparative data output with less than 5% variability for VO2, VCO2 and tidal volume.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1730 Oxygen uptake computer.
(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).
0
APR 1 6 2007
510(k) Special Summary Medgraphics Express Series
Date of Summary March 27, 2007 Company Name Medical Graphics Corporation 350 Oak Grove Parkway St. Paul, MN 55127 Contact Name Mary E. Donlin Classification name: 73BZLOxygen Uptake Computer Product Name: Express Series CFR section: 868.1730 Oxygen Uptake Computer Device Class: Class IIa
Predicate Device: Medgraphics Ultima System K061731 manufactured by Medical Graphics Corporation, 350 Oak Grove Parkway, St. Paul, MN 55127.
Description: The Express Series is a cardiopulmonary exercise or resting metabolic measurement system with an integrated touch screen computer that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.
Intended Use: Medgraphics Express Series is intended for medical applications requiring a non-invasive assessment of the cardiopulmonary response to exercise or measurement of energy expenditure using indirect calorimetry.
Comparison: Direct comparison with the predicate device was made with acceptable conclusions.
Discussion: Laboratory and clinical testing of 10 systems has shown the Express Series to have substantial equivalence in performance and precision to the predicate device. Tandem gas exchange system validator studies performed with the predicate device produced comparative data output with less than 5% variability for VO2, VCO2 and tidal volume.
Conclusion: The Medgraphics Express Series is substantially equivalent to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 16 2007
MedGraphics c/o Mary E. Donlin 350 Oak Grove Parkaway St. Paul, MN 55127
Re: K070858
Trade/Device Name: Cardio-Pulmonary Exercise Stress System Regulation Number: 21 CFR 868.1730 Regulation Name: Oxygen uptake computer Regulatory Class: Class II Product Code: BZL Dated: March 21, 2007 Received: March 28, 2007
Dear Ms. Donlin:
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.
2
Page 2 -Ms. Donlin
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 (QS) 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/zimmermanfr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number ( if known): K
Device Name: Medgraphics Express Series
Indications for Use:
The Express Series uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.
The Express Series uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.
The Express Series can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.
Prescription Use _______ AND/OR Over the Counter use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE TO USE ANOTHER PAGE IF NEEDED)
B.Bammma
4/24-28
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