(78 days)
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.
The Ultima system is a cardiopulmonary exercise system that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.
The Medgraphics Ultima System, categorized as an Oxygen Uptake Computer, has been found substantially equivalent to its predicate device, the Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer (K955432).
Here's an analysis of the acceptance criteria and the study that supports the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Equivalence to Predicate Device (K955432) | Direct comparison with the predicate device was made with acceptable conclusions. Laboratory testing of 11 Ultima systems showed substantial equivalence in performance and precision to the predicate device. Tandem gas exchange system validator studies with the predicate device produced comparative data output with less than 3% variability for VO2, VCO2, and tidal volume. |
| Intended Use | The 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. (The study implicitly demonstrates it meets this by showing equivalence to a device with the same intended use). |
| Breath-by-breath measurements of flow, oxygen uptake, and carbon dioxide production | The Ultima system provides these measurements. (Supported by the equivalence study which covers VO2 and VCO2). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 11 Ultima systems were used for laboratory testing.
- Data Provenance: The document does not explicitly state the country of origin. It is implied to be internal laboratory testing conducted by Medical Graphics Corporation. The study is retrospective, as it compares the new Ultima system to a previously marketed predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The study relies on direct comparison to the predicate device's output and internal laboratory testing.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method for the test set. The evaluation focuses on the direct comparison of performance metrics (VO2, VCO2, tidal volume) between the Ultima system and the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a device for physiological measurement (Oxygen Uptake Computer), not an imaging or diagnostic AI system requiring human interpretation comparison. This device provides quantitative data, not interpretations that would be compared to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the study primarily represents standalone algorithm/device performance. The laboratory testing assessed the device's output and precision independently, comparing it to a predicate device. While a human operates the device, the performance evaluation itself is based on the device's measured outputs compared to established benchmarks or the predicate.
7. The Type of Ground Truth Used:
- The ground truth in this study is based on the performance and output of the legally marketed predicate device (Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer, K955432), as well as the inherent physiological measurements (VO2, VCO2, tidal volume) for which the device is designed to accurately measure. The "less than 3% variability" indicates an acceptable deviation from the predicate's established measurements.
8. The Sample Size for the Training Set:
- The document does not mention a separate "training set" in the context of machine learning or AI development. For a physiological measurement device like this, the "training" would typically refer to the calibration, design, and internal validation processes during its development, which are not detailed as a distinct "training set" here.
9. How the Ground Truth for the Training Set Was Established:
- As a "training set" is not explicitly mentioned, the method for establishing its ground truth is not provided. For a device of this nature, the "ground truth" during development and calibration would likely rely on established physiological models, controlled gas mixtures, and comparison to highly accurate reference instruments.
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510(k) Special Summary Medgraphics Ultima System
SEP - 6 2006
| Date of Summary | June 19, 2006 |
|---|---|
| Company Name | Medical Graphics Corporation350 Oak Grove ParkwaySt. Paul, MN 55127 |
| Contact Name | Lynn Brosious |
| Classification name: | 73BZLOxygen UptakeComputer |
| Product Name: | Ultima System |
| CFR section: | 868.1730 Oxygen UptakeComputer |
| 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.
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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
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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
§ 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).