(250 days)
Intended for measuring the concentration of carrbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status.
Not Found
This response is based on the provided text, which is an SMDA Summary of Safety and Effectiveness Information for the Vacu•Med, Gold Edition, Carbon Dioxide Gas Analyzer (K973544).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of measurement of expired CO2 gases equivalent to the predicate device. | Calibration accuracy of the Vacumetrics Gold Edition Carbon Dioxide Gas Analyzer is equivalent to the accuracy of the PHYSIO-DYNE Easi-Lab Gas Analyzer. The device functions with an accuracy of 0.1% CO2. |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size used for the comparative performance test. It only mentions "conditions of the test" and "the data." The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set. The study focuses on comparing the new device's calibration accuracy against a predicate device.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as a specific "ground truth" was not established by multiple experts. The comparative test likely relied on a direct comparison of measurements between the two devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study was a direct comparison of a single device (the Vacu•Med Gold Edition) against a predicate device (PHYSIO-DYNE Easi-Lab Gas Analyzer) for calibration verification. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was conducted in the sense that the device's accuracy was tested directly against a predicate device for its intended function (measuring CO2 gases). This isn't an "algorithm only" in the modern AI sense, but rather a direct measurement of the device's functional output. The performance (accuracy of 0.1% CO2 and equivalence to the predicate) is reported for the device itself.
7. Type of Ground Truth Used
The "ground truth" for this study was the performance of a legally marketed predicate device (PHYSIO-DYNE Easi-Lab, K922660). The goal was to demonstrate substantial equivalence, meaning the new device performed as accurately as the established device.
8. Sample Size for the Training Set
No training set is mentioned. This device is a gas analyzer, and the study did not involve machine learning or AI that would typically require a training set. The evaluation was based on a direct comparative performance test.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
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973544
MAY 2 6 1998
Attachment VII.
SMDA Summary of Safety and Effectiveness Information
In compliance with requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification:
Predicate Device Identification: A claim of substantial equivalence of the 1. Vacu•Med, Gold Edition, Carbon Dioxide Gas Analyzer is made to the:
- PHYSIO-DYNE Easi-Lab, K922660. ●
This device was marketed after May 28, 1976 and has received FDA clearance to market since that date.
Biocompatibility Assessment: Environmental testing has been performed for the 2. intended use for this device, a summary of the tests and results is included in Attachment V.
Summary of Comparative Information: 3.
Functional / performance Comparison of Vacu•Med, Gold Edition Carbon Dioxide Gas Analyzer, product code 17515A, and PHYSIO-DYNE Easi-Lab, product code XXXX was performed.
Test results: A comparative performance test of the Vacumetrics Gold Edition Carbon Dioxide Gas Analyzer to the PHYSIO-DYNE Easi-Lab Gas Analyzer was completed. The purpose of the test was calibration verification. Under conditions of the test, the data shows that the calibration accuracy of the Vacumetrics Gold Edition Carbon Dioxide Gas Analyzer is equivalent to the accuracy of the PHYSIO-DYNE Easi-Lab Gas Analyzer.
CONCLUSION
The Vacu. Med, Gold Edition Carbon Dioxide Gas Analyzer functions well in the measurement of expired CO2 gases with an accuracy of 0.1% CO2. It may be concluded that in terms of analyzing accuracy, the Vacumetrics Gold Edition Oxygen Gas Analyzer is substantially equivalent to the PHYSIO-DYNE Easi-Lab Gas Analyzer.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is 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 right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 26 1998
Vacumetrics Inc./Vacu●Med Division c/o Ms. Rae Nadine Smith Druq & Device Clinical Services, Inc. 2225 East Murray Holladay Road, Suite 207 Salt Lake City, UT 84117
Re: K973544 Vacu●Med Gold Edition Carbon Dioxide (CO₂) Gas Analyzer Model 17515A Requlatorv Class: II (two) Product Code: 73 CCK February 26, 1998 Dated: February 27, 1998 Received:
Dear Ms. Smith:
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 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, Druq, 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 A substantially equivalent determination assumes compliance to 895. 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 requlatory 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.
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Page 2 - Ms. Rae Nadine Smith
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 requlation (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | ___ of ___ |
|---|---|
| ------ | ------------ |
510(k) Number (if known): __ New Submission
Device Name: __Gold Edition Carbon Dioxide Gas Analyzer
Indications For Use:
.. .
Intended for measuring the concentration of carrbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
m. Pazand 5/26/98
for WYS
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| 510(k) Number | |
| OR | |
| Over-The-Counter Use |
(Optional Format 1-2-96)
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).