VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER

K973544 · Vacumed, Div. of Vacumetrics, Inc. · CCK · May 26, 1998 · Anesthesiology

Device Facts

• Record ID: K973544
• Device Name: VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER
• Applicant: Vacumed, Div. of Vacumetrics, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: May 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended 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.

Device Story

Vacu•Med Gold Edition Carbon Dioxide Gas Analyzer measures CO2 concentration in gas mixtures; aids assessment of patient ventilatory, circulatory, and metabolic status. Device operates by analyzing expired gases; provides quantitative output for clinical evaluation. Used by healthcare professionals in clinical settings to inform respiratory and metabolic management decisions.

Clinical Evidence

Bench testing only. Comparative performance testing was conducted to verify calibration accuracy against the predicate device (PHYSIO-DYNE Easi-Lab). Results confirmed the subject device achieves equivalent accuracy of 0.1% CO2.

Technological Characteristics

Gas analyzer for CO2 concentration measurement; accuracy of 0.1% CO2. Device is a standalone unit. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring monitoring of ventilatory, circulatory, and metabolic status via measurement of expired CO2 gas concentrations.

Regulatory Classification

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.

Predicate Devices

• PHYSIO-DYNE Easi-Lab (K922660)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

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.

{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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{3}------------------------------------------------

| Page | ___ of ___ |
|------|------------|
|------|------------|

K973544

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) | <span style="text-decoration: underline;">✓</span> |
|---------------------------------------|----------------------------------------------------|
| 510(k) Number | |
| OR | |
| Over-The-Counter Use | |

(Optional Format 1-2-96)