(250 days)
None
No
The device description explicitly states that the digital meter display "does not utilize any software," and there are no mentions of AI, DNN, or ML in the document. The performance study focuses on calibration accuracy compared to a predicate device, not on any AI/ML-driven analysis.
No.
The device measures expired oxygen gases but does not provide any therapy or treatment.
No
Explanation: The device measures expired oxygen gases, which is a measurement rather than a diagnosis. Its intended use is to measure, and the performance study focuses on calibration verification, not diagnostic accuracy.
No
The device description explicitly states it incorporates hardware components such as a housing, a commercially available oxygen paramagnetic gas analyzer, a power supply, and a digital meter display.
Based on the provided information, the Vacumetrics Gold Edition Oxygen Gas Analyzer is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is intended to "measure expired Oxygen Gases." Measuring gases from the body (like expired breath) falls under the scope of in vitro diagnostics, as it involves analyzing a sample taken from the body to provide information about a physiological state.
- Device Description: While the device uses commercially available components, its function is to analyze a biological sample (expired breath).
- Performance Study: The performance study compares the device to another gas analyzer, which is a common practice for IVD devices to demonstrate equivalence or accuracy in measuring a biological parameter.
- Predicate Device: The predicate device, the PHYSIO-DYNE Easi-Lab Gas Analyzer (K922660), is also likely an IVD device given its function of analyzing gases.
In summary, the core function of the device - measuring a gas from the body (expired breath) - aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of the Gold Edition VacuMed Oxygen Gas Analyzer are to measure expired Oxygen Gases.
Product codes (comma separated list FDA assigned to the subject device)
73 CCL
Device Description
The Vacumetrics Gold Edition Oxygen Gas Analyzer is a device that incorporates a Vacu. Med designed oxygen gas analyzer housing, with a commercially available oxygen paramagnetic gas analyzer (Servomex 1155B), a commercially available power supply (Condor), and other commercially available components to include a commercially available digital meter display which does not utilize any software.
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)
Test results: A comparative performance test of the Vacumetrics Gold Edition Oxygen 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 Oxygen Gas Analyzer is equivalent to the accuracy of the PHYSIO-DYNE Easi-Lab Gas Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
PHYSIO-DYNE Easi-Lab, K922660
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).
0
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, Oxygen 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.
2. Statement of Biocompatibility.
The Vacumetrics Gold Edition Oxygen Gas Analyzer is a device that incorporates a Vacu. Med designed oxygen gas analyzer housing, with a commercially available oxygen paramagnetic gas analyzer (Servomex 1155B), a commercially available power supply (Condor), and other commercially available components to include a commercially available digital meter display which does not utilize any software.
Environmental testing has been performed for the intended use for this device; a summary of the tests and results is included in Attachment V.
3. Comparative Information Summary of Functionality/Performance:
Functional / Performance Comparison of Vacu•Med, Gold Edition Oxygen Gas Analyzer, product code 17518A, and PHYSIO-DYNE Easi-Lab, product code XXXX .
Test results: A comparative performance test of the Vacumetrics Gold Edition Oxygen 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 Oxygen Gas Analyzer is equivalent to the accuracy of the PHYSIO-DYNE Easi-Lab Gas Analyzer.
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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circular emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 1998
Vacumetrics Inc./Vacu●Med Division c/o Ms. Rae Nadine Smith Drug & Device Clinical Services, Inc. 2225 East Murray Holladay Road, Suite 207 Salt Lake City, UT 84117
K973545 Re: Vacu Med Gold Edition Oxygen (O2) Gas Analyzer Model 17518A Regulatory Class: II (two) Product Code: 73 CCL 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 Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory 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.
2
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 regulation (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 Also, please note the regulation entitled, (301) 594-4639. "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.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Callahan, Ph.D. Thomas J. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
K973545
510(k) Number (if known) New Submission
Device Name: Gold Edition VacuMed Oxygen Gas Analyzer
Indications for Use
The indications for use of the Gold Edition VacuMed Oxygen Gas Analyzer are to measure expired Oxygen Gases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of DCRH. Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
In, Cazanal for Cuyς
5/26/98
| (Division Sign-Off) |
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| Division of Cardiovascular, Respiratory, |
| and Neurological Devices |
510(k) Number_________________________________________________________________________________________________________________________________________________________________