This device is viewed as a component of a system. The APEX Oximeter adds modularity to Marquette's CD Telemetry System product line. The Apex Oximeter is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. 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 APEX OXIMETER adds modularity to Marquette's telemetry product line. It is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. The oxygen saturation calculations for the Apex Oximeter is performed identically to the method used in the Nonin 8500 series hand held pulse oximeter. The oximeter generates serial communications with a custom protocol to communicate with the CD Telemetry System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the KC180299 APEX OXIMETER, based on the provided text:

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, not a detailed study report. As such, it does not contain the granular level of detail typically found in a comprehensive clinical or performance study. The information below is extracted directly from the text; many common elements of a detailed study will be marked as "Not provided" because the document does not include them.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on substantial equivalence to predicate devices (Nonin Model 8500 and 9500 pulse oximeters) and general statements about meeting requirements. The "reported device performance" is a high-level conclusion rather than specific metrics.

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Overall Performance: Device is safe and effective and performs substantially equivalent to predicate devices.	"Various reliability and software testing was performed on the product, and the results indicated that the APEX OXIMETER met the requirements of its intended use."
Oxygen Saturation Calculation: Identical to the method used in the Nonin 8500 series hand held pulse oximeter.	The device uses the "identically" method used in the Nonin 8500 series.
Intended Use: Portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate.	"met the requirements of its intended use."

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided. The document mentions "Various reliability and software testing" but does not specify sample sizes for these tests or for any patient data.
- Data Provenance: Not provided. Country of origin or whether the data was retrospective or prospective is not mentioned.
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 provided. The document does not describe the establishment of a ground truth in the context of expert review for a test set. The primary method of demonstrating performance is substantial equivalence to predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No expert-based adjudication method is described.
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
- No. This is a pulse oximeter, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The "various reliability and software testing" would assess the device's (algorithm's) performance in a standalone context to ensure it met its functional requirements and performed identically to the predicate device in its oxygen saturation calculations. The device itself is a standalone measurement tool, although it communicates with a telemetry system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the oxygen saturation calculation is based on the identical method used by the predicate device, the Nonin 8500 series pulse oximeter. For other functional aspects (reliability, software performance), the ground truth would be defined by the technical specifications and requirements the device was designed to meet. No independent expert consensus, pathology, or outcomes data is explicitly mentioned as being used to establish ground truth for this device's performance validation beyond its equivalence to the predicate.
The sample size for the training set
- Not applicable/Not provided. This device is a pulse oximeter, and its core function is based on established biophysical principles and algorithms, not machine learning that requires a "training set" in the modern sense of AI/ML development.
How the ground truth for the training set was established
- Not applicable/Not provided, as there is no "training set" in the context of AI/ML. The device's foundational "ground truth" for oxygen saturation measurement is essentially derived from the established and validated performance of its predicate devices, whose methods it duplicates.

Summary

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KC180299

APR 2 4 1998 510(k) Summary of Safety and Effectiveness

Submitter 1.

Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223 USA

Establishment Registration Number 2124823

Contact Name / Telephone Number David Wahlig Corporate Regulatory Affairs Marquette Medical Systems

Phone: (414) 362-2090 ·

Date: 26 January 98

2. General Information

Trade/Proprietary Name

Marquette's name for this device is the APEX OXIMETER.

Common/Usual Name

This device is commonly known as pulse oximeter.

Device Classification

FDA determined the predicate devices to be: Nonin Model 8500 Hand Held Pulse Oximeter and Nonin Model 9500 Finger Clip Pulse Oximeter were determined to be Class II devices. The CD Telemetry System was determined to be a Class III.

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.

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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 APEX OXIMETER, is substantially equivalent to devices already in legal commercial distribution: Nonin Model 8500 Hand Held Pulse Oximeter (K893221); Nonin Model 9500 Finger Clip Pulse Oximeter (K942248); Marquette CD Telemetry System (K891104).

Device Description and Intended Use 4.

This device is viewed as a component of a system. The APEX OXIMETER adds modularity to Marquette's telemetry product line. It is intended for portable patient monitoring of ambulating patient's oxygen saturation and pulse rate. The oxygen saturation calculations for the Apex Oximeter is performed identically to the method used in the Nonin 8500 series hand held pulse oximeter. The oximeter generates serial communications with a custom protocol to communicate with the CD Telemetry System

Test Summary & Conclusion 5.

Various reliability and software testing was performed on the product, and the results indicated that the APEX OXIMETER met the requirements of its intended use. Marquette Medical Systems has demonstrated that use of the APEX OXIMETER is as safe and effective, and performs substantially equivalent its predicate devices.

0000006

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 1998

Mr. David Wahliq Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223

Re: K980299 APEX Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: January 26, 1998 Received: January 27, 1998

Dear Mr. Wahlig:

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). 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 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 regulation (21 CFR Part 820) and that, through periodic (25) --inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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 - Mr. David Wahlig

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 (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):

Device Name: APEX Oximeter

Unknown;

y in

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)

Um. P

(Division Sign-Off) Division of Cardiovascular, Re and Neurological Device 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

000004

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).