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 Description

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.

AI/ML Overview

The provided 510(k) summary (K973984) is for a medical device called the "RAC 2A," which is a module housing designed to interface a Smart Anesthesia Multi-gas (SAM) module with Marquette's Eagle display system. The device acts as a component within a larger system.

After reviewing the document, it is not possible to provide a detailed description of acceptance criteria and a study that proves the device meets them in the format requested. The document does not contain the level of detail necessary for such a response.

Here's why and what information is available:

1. A table of acceptance criteria and the reported device performance:

Not provided in the document. The summary states, "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." However, it does not specify what those requirements (acceptance criteria) were or present the detailed performance results in any measurable format.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not provided in the document. There is no mention of sample sizes for any testing, nor information about data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable/Not provided. This device is a module housing, not a diagnostic or AI-driven system that requires expert interpretation to establish ground truth for a test set. The document focuses on the device's functional and safety performance as an interface.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. As above, this type of adjudication is typically for diagnostic interpretation studies, which is not relevant to this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not provided. This is not an AI-assisted diagnostic device, so an MRMC comparative effectiveness study would not be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This device is a hardware component. There is no "algorithm only" performance to evaluate in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/Not provided. Ground truth, in the sense of a definitive diagnostic label, is not relevant for a module housing component. Testing would likely involve functional verification against engineering specifications and safety standards.

8. The sample size for the training set:

Not applicable/Not provided. There is no indication that this device uses a training set, as it is a hardware component and not an AI/ML algorithm.

9. How the ground truth for the training set was established:

Not applicable/Not provided. As above, there is no training set mentioned or implied.

Summary of available relevant information from the document:

Device Name: RAC 2A (module housing)
Intended Use: To house a SAM (Smart Anesthesia Multi-gas) module and provide an interface to the Eagle display, allowing the module's patient information to be displayed on the monitor.
Testing Performed: "Various reliability and software testing was performed."
Conclusion of Testing: "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."
Predicate Devices: Eagle patient monitors (K960272, K960418, K961139), Tram-rac (K900598), Tram-rac / SAM module (K943977, K950581).
Classification: Class II (Product Code: 73 CCK)

The document is a 510(k) summary for a hardware component where the primary focus is on demonstrating substantial equivalence to predicate devices through functional and reliability testing, rather than an AI/ML or diagnostic device that would require detailed clinical study results with ground truth establishment.

Summary

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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.

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:

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

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)

000001

Regulation Number and Section

§ 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).