(78 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the description focuses on direct physiological measurements and comparisons to a predicate device.
No.
The device is used for diagnostic and assessment purposes (e.g., screening, differentiating diseases, classifying severity, assessing dyspnea, nutritional assessment), and for guiding patient management and exercise prescriptions. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states that 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 activities. Additionally, the predicate device is a "Desktop Diagnostic System."
No
The device description explicitly states it provides "breath by breath measurements of flow, oxygen uptake and carbon dioxide production," which requires hardware components like sensors and analyzers, not just software.
Based on the provided information, the Ultima system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The Ultima system directly measures physiological parameters during exercise (oxygen uptake, carbon dioxide production, flow). It's assessing the body's function in real-time, not analyzing a sample taken from the body.
- The intended uses describe assessing physiological function and guiding patient management based on those measurements. This aligns with a diagnostic device that measures the body's response, not an IVD that analyzes a biological sample.
- The device description focuses on breath-by-breath measurements of gases and flow. This is consistent with a cardiopulmonary exercise testing system, not an IVD.
Therefore, the Ultima system falls under the category of a diagnostic device that assesses physiological function, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ultima system 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 Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.
The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.
Product codes
BZL
Device Description
The Ultima system is a cardiopulmonary exercise system 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing of 11 systems has shown the Ultima system 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 3% variability for VO2, VCO2 and tidal volume.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Special Summary Medgraphics Ultima System
SEP - 6 2006
| Date of Summary | June 19, 2006 |
|---|---|
| Company Name | Medical Graphics Corporation |
| 350 Oak Grove Parkway | |
| St. Paul, MN 55127 | |
| Contact Name | Lynn Brosious |
| Classification name: | 73BZLOxygen Uptake |
| Computer | |
| Product Name: | Ultima System |
| CFR section: | 868.1730 Oxygen Uptake |
| Computer | |
| Device Class: | Class IIa |
Predicate Device: Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer, K955432 manufactured by Medical Graphics Corporation, 350 Oak Grove Parkway, St. Paul, MN 55127.
Description: The Ultima system is a cardiopulmonary exercise system that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.
Intended Use: Medgraphics Ultima system 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 testing of 11 systems has shown the Ultima system 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 3% variability for VO2, VCO2 and tidal volume.
Conclusion: The Medgraphics Ultima system is substantially equivalent to the predicate device.
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Page 65 of 67
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Medical Graphics Corp. c/o Ms. Lynn Brosious Quality and Regulatory Affairs 350 Oak Grove Parkway St. Paul, MN 55127
Re: K061731
Trade Name: MedGraphics Ultima System Regulation Number: 21 CFR 868.1730 Regulation Name: Oxygen Uptake Computer Regulatory Class: Class II (two) Product Code: BZL Dated: August 28, 2006 Received: August 28, 2006
Dear Ms. Brosious:
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. Lynn Brosoius
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 (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 vours.
Bfmmman for
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 Ultima System
Indications for Use:
The Ultima system 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 Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.
The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.
Prescription Use X X 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)
Bhummer
Division Sign-Off
vision Sign-Off) Division of Cardiovascular Devices 510(k) Number KOS1731