The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.

The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

The physiological parameters monitored include ECG, non-invasive blood pressure, noninvasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.

Device Description

The ApexPro Telemetry System provides clinicians with patient data while allowing for patient mobility. The system consists of the following main components:
• The patient worn data acquisition transmitters
• Receiver Infrastructures
• Computer platforms hosting the ApexPro Software
• Computer platforms hosting the central station application
• Accessories to the patient-worn data acquisition transmitters
Serviceability tools

AI/ML Overview

The provided text describes a 510(k) submission for the ApexPro Telemetry System, which is a design modification. However, it does not contain a table of specific acceptance criteria or detailed results of a study demonstrating the device meets those criteria, as typically found in a comprehensive clinical or performance validation report.

Instead, it lists the quality assurance measures applied during development and states a general conclusion about its safety and effectiveness compared to a predicate device.

Here's an analysis based on the available information, addressing what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

(Information Not Provided in Detail)

The document does not include a quantifiable table of acceptance criteria or specific performance metrics with reported values. It broadly states:

Acceptance Criteria	Reported Device Performance
Not specified quantitatively in this document. General criteria include compliance with voluntary standards, and demonstrating the device is "as safe, as effective, and performs as well as the predicate device."	Not specified quantitatively in this document. The conclusion states that "The results of these measurements demonstrated that the ApexPro Telemetry System is as safe, as effective, and performs as well as the predicate device."

The "Test Summary" lists types of tests conducted:

Risk Analysis
Requirements Review
Design Reviews
Testing on Unit Level (Module verification)
Integration testing (System Verification)
Final Acceptance testing (Validation)
Performance testing
Safety and environmental testing

These are categories of testing, not specific acceptance criteria or performance results.

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

(Information Not Provided)

The document does not specify the sample size for any test set or the provenance of data (e.g., country of origin, retrospective or prospective).

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

(Information Not Provided)

There is no mention of experts being used to establish ground truth for a test set, nor their number or qualifications. The submission focuses on internal testing and comparison to a predicate device.

4. Adjudication Method for the Test Set

(Information Not Provided)

No adjudication method is described, as the document does not detail a test set requiring expert adjudication.

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 / Information Not Provided)

This device (ApexPro Telemetry System) is a physiological patient monitor, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device and is not mentioned.

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

(Partially Applicable/Implied)

The submission implies that performance testing was done on the system itself (algorithm/device only) to ensure it performs "as well as the predicate device." This would be a form of standalone testing, as it doesn't describe human interaction being part of the primary performance evaluation shown here. The "Performance testing" mentioned in the Test Summary would have evaluated the device's inherent capabilities, including its ability to "detect various ECG arrhythmia events and select physiological parameter limit violations" according to its intended use.

7. The Type of Ground Truth Used

(Implied Standard Device Performance)

For a telemetry system, the "ground truth" for its performance would typically come from:

Known, validated physiological signals: Using signal generators or previously recorded, carefully annotated cardiac or physiological waveforms to test the device's detection and measurement accuracy (e.g., against established medical standards for arrhythmia detection).
Comparison to a predicate device: The document explicitly states the system "employs the same functional technology as the predicate devices" and that it was demonstrated to be "as safe, as effective, and performs as well as the predicate device." This indicates the predicate device's established performance serves as a benchmark for ground truth.

8. The Sample Size for the Training Set

(Not Applicable / Information Not Provided)

This submission describes a telemetry system, not an AI/machine learning algorithm that typically requires a "training set" in the conventional sense. The "development" process would involve engineering and software validation, not machine learning model training.

9. How the Ground Truth for the Training Set was Established

(Not Applicable / Information Not Provided)

As this is not an AI/ML device that uses a "training set," this question is not applicable.

Summary

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510(k) Summary of Safety and Effectiveness 5

Date:	January 29, 2008	JUN 20 2008
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Bernard SandlerRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (414) 362-2090Fax: (414) 362-2585E-mail: Bernard.Sandler@med.ge.com
Secondary ContactPerson:	Lisa M. BaumhardtRegulatory Affairs Program ManagerGE Medical Systems Information TechnologiesPhone: (414) 362-3242Fax: (414) 362-2585E-mail: Lisa.Baumhardt@med.ge.com
Device Trade Name:	ApexPro Telemetry System
Common /Usual Name:	Telemetry Monitoring System
Classification Names:	21 CFR 870.1025 Physiological Patient Monitor (with arrhythmiadetection or alarms
Predicate Devices:	K032369 ApexPro Telemetry SystemK033365 ApexPro FH Telemetry SystemK980299 Apex OXIMETER
Device Description:	The ApexPro Telemetry System provides clinicians with patientdata while allowing for patient mobility. The system consists ofthe following main components:• The patient worn data acquisition transmitters• Receiver Infrastructures• Computer platforms hosting the ApexPro Software• Computer platforms hosting the central stationapplication• Accessories to the patient-worn data acquisitiontransmittersServiceability tools

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Intended Use:

The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are tvpically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

The physiological parameters monitored include ECG, noninvasive blood pressure, non-invasive temperature and Sp02. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.

Technology:

The ApexPro Telemetry Svstem emplovs the same functional technology as the predicate devices.

Test Summary:

The subject of this 510(k) is a design modification for the ApexPro Telemetry System. The ApexPro Telemetry System complies with the voluntary standards as detailed in Section 9 (Declaration of Conformity and Summary Reports) of this submission. The following quality assurance measures were applied to the development of the ApexPro Telemetry System:

Risk Analysis .
Requirements Review .
Design Reviews �
Testing on Unit Level (Module verification) .
Intearation testina (System Verification) .
Final Acceptance testing (Validation) .
Performance testing .
Safety and environmental testing .

Conclusion:

The results of these measurements demonstrated that the ApexPro Telemetry System is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. To the left of the symbol is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is in all caps and is arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2008

GE Medical Systems Information Technologies c/o Mr. Bernard Sandler Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K080251

Trade Name: ApexPro Telemetry Systems Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with arrhythmia detector or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: May 23, 2008 Received: May 27, 2008

Dear Mr. Sandler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Bernard Sandler

Please be advised that FDA's issuance of a substantial equivalence detcrmination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
elmee

-Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4

K080251 510(k) Number:

Device Name:

ApexPro Telemetry System

Indications for Use:

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

elamell

n of Cardiovascular Devices

K68025) 510/k) Number

Page 18

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.