K973984 · Marquette Medical Systems, Inc. · CCK · Jan 16, 1998 · Anesthesiology
Device Facts
Record ID
K973984
Device Name
RAC 2A MODULE HOUSING
Applicant
Marquette Medical Systems, Inc.
Product Code
CCK · Anesthesiology
Decision Date
Jan 16, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.1400
Device Class
Class 2
Indications for Use
The RAC 2A adds modularity to the Marquette Eagle configured product line. It is used to house the module [SAM (Smart Anesthesia Multi-gas) module] and provides an interface to the Eagle display. The module's patient information may be displayed on the Marquette Eagle monitor. This device is intended to be used by personnel trained in the use of the equipment. It is intended to be used within the hospital/facility environment.
Device Story
RAC 2A is a module housing unit designed to add modularity to the Marquette Eagle patient monitor product line. It functions as a physical interface, housing the SAM (Smart Anesthesia Multi-gas) module and connecting it to the Eagle monitor display. Used in hospital/facility environments by trained clinical personnel, the device enables the transmission and visualization of patient data from the SAM module onto the Eagle monitor. It does not perform independent physiological monitoring but serves as a conduit for data integration, allowing clinicians to view anesthesia gas information alongside other patient vitals, thereby facilitating clinical decision-making during patient care.
Clinical Evidence
No clinical data. The submission relies on bench testing, including reliability and software testing, to demonstrate that the device meets its intended use and performs substantially equivalent to predicate devices.
Technological Characteristics
The RAC 2A is a modular housing unit providing a physical and electrical interface between the SAM module and the Eagle monitor. It is a component of the Marquette Eagle configured product line. No specific materials or energy sources are detailed beyond its role as a system interface. Software is present to facilitate data communication between the module and the display.
Indications for Use
Indicated for use in hospital/facility environments by trained personnel to house the SAM (Smart Anesthesia Multi-gas) module and interface it with the Marquette Eagle monitor for patient information display.
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.
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K9m3984
# 510(k) Summary of Safety and Effectiveness
JAN | 6 |998
#### 1. Submitter
Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223 USA
Establishment Registration Number 2124823
Contact Name / Telephone Number Dianne Schmitz Corporate Regulatory Affairs Marquette Medical Systems
Phone: (414) 362-3230
Date: 10 October 97
### General Information 2.
Trade/Proprietary Name Marquette's name for this device is the RAC 2A.
# Common/Usual Name
This device is commonly known as a module housing.
## Device Classification
This device is viewed as a component of a system. The RAC 2A adds modularity to Marquette's Eagle configured product line. It is used to house the module [SAM (Smart Anesthesia Multi-gas) module] and provides an interface to the Eagle display. Therefore, the submitted device may take on the same classification level as the predicate Eagle patient monitor and module.
FDA determined the predicate devices to be: Eagle patient monitors have been determined to be Class III devices; the SAM modules have been determined.to be Class II devices.
## Performance Standards
Performance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission.
### Legally Marketed Predicate Device(s) 3.
This submission is being filed as a modification to an existing device. It is being filed in support of the position that the proposed modified device, the RAC 2A, which interfaces a module to a Marquette Eagle monitor, is substantially equivalent to devices already in legal commercial distribution: Eagle patient
000006
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monitors: K960272, K960418, K961139; Tram-rac: K900598; Tram-rac / SAM module: K943977, K950581.
### Device Description and Intended Use 4.
This device is viewed as a component of a system. The RAC 2A adds modularity to Marquette's Eagle configured product line. It is used to house the module [SAM (Smart Anesthesia Multi-gas) module] and provides an interface to the Eagle display. The RAC 2A is intended to allow the module's patient information to be displayed on the Eagle monitor display.
### 5. Test Summary & Conclusion
Various reliability and software testing was performed on the product, and the results indicated that the RAC 2A met the requirements of its intended use. Marquette Medical Systems has demonstrated that use of the RAC 2A is as safe and effective, and performs substantially equivalent its predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 1998
Ms. Dianne Schmitz Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223
Re: K973984 RAC 2A Regulatory Class: II (two) Product Code: 73 CCK Dated: October 17, 1997 October 20, 1997 Received:
Dear Ms. Schmitz:
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, Drug, and Cosmetic Act (Act). Yoll 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 Requlation (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 requlations.
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Page 2 - Ms. Dianne Schmitz
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 (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.gov/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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510(k) Number (if known):
Unknown; 510(k) filed on October 17, 1997
Device Name: RAC 2A
Indications For Use:
The RAC 2A adds modularity to the Marquette Eagle configured product line. It is used to house the module [SAM (Smart Anesthesia Multi-gas) module] and provides an interface to the Eagle display. The module's patient information may be displayed on the Marquette Eagle monitor.
This device is intended to be used by personnel trained in the use of the equipment. It is intended to be used within the hospital/facility environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. Ruy
(Division Sign-Off)
- Division of Cardiovascular, Respiratory
and Neurological Devices
510(k) Number
-
Kan
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
000001
