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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vacu•Med, Gold Edition, Oxygen Gas Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance
Calibration Accuracy: Must be equivalent to the predicate device (PHYSIO-DYNE Easi-Lab Gas Analyzer).	"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."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a numerical sample size for the test set. It mentions "A comparative performance test," but details like the number of tests conducted, the duration of tests, or the amount of data collected are not provided.

Data Provenance: Not explicitly stated. The context implies the testing was conducted by the manufacturer, Vacumetrics Inc. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This device is an analyzer for a physical measurement (oxygen gas), not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for calibration accuracy would be a known, highly accurate reference standard for oxygen concentration.

4. Adjudication Method for the Test Set:

Not applicable, as expert consensus or adjudication is not relevant for calibrating a gas analyzer against a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not applicable to a device measuring oxygen gas concentration, as it does not involve human readers interpreting cases.

6. Standalone Performance Study:

Yes, a standalone performance test was done, focusing on "calibration verification" of the Vacu•Med Gold Edition Oxygen Gas Analyzer. The study compared its accuracy directly to the predicate device.

7. Type of Ground Truth Used:

The "ground truth" implicitly used for the test set was the performance/accuracy of the predicate device (PHYSIO-DYNE Easi-Lab Gas Analyzer). The study's objective was to demonstrate equivalence in calibration accuracy, meaning the predicate device served as the reference standard for "correct" performance.

8. Sample Size for the Training Set:

Not applicable. This device is a measurement instrument and would typically not involve a "training set" in the machine learning sense. Its functionality is based on established physical principles of gas analysis rather than an algorithm trained on data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reasons as point 8.

Summary

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K973545

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.

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.

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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.

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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 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

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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)

Over-The-Counter Use __
(Optional Format 1-2-96)
In, Cazanal for Cuyς
5/26/98

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).