MODIFICATION TO: APEXPRO TELEMETRY SYSTEM by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

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 and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.

Device Description

The ApexPro Telemetry System is composed of six major components:

The patient worn data acquisition transmitters
The receiver antenna system infrastructure
The receivers
The receiver subsystem
A computer platform running the ApexPro Telemetry Application
A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)

AI/ML Overview

The provided regulatory submission (K032369) for the ApexPro Telemetry System does not contain the detailed information required to fill out the requested table and study specifics regarding acceptance criteria and performance against those criteria.

The document is a 510(k) summary and the FDA's clearance letter. It primarily states that the device is "as safe, as effective, and performs as well as the predicate devices" (K021325 ApexPro Telemetry System) and "complies with the voluntary standards as detailed in Section 9 of this submission." However, Section 9 (which would likely contain the standards and test data) is not included in the provided text.

Based on the provided text, here's what can be extracted and what is missing:

Information NOT available in the provided text:

Specific Acceptance Criteria (quantitative thresholds for performance).
Reported Device Performance (quantitative results against acceptance criteria).
Details of the study that proves the device meets acceptance criteria. This includes:
- Sample size for the test set and its provenance.
- Number of experts for ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.

Information AVAILABLE from the provided text:

The "Test Summary" section mentions the types of quality assurance measures applied, but these are general development and testing practices, not specific performance study details:

Requirements specification review
Code inspections
Software and hardware testing
Safety testing
Environmental testing
Final validation

The "Conclusion" states: "The results of these measurements demonstrated that the ApexPro System is as safe, as effective, and performs as well as the predicate devices." This is a qualitative statement of equivalence, not a quantitative report of performance against specific criteria.

Therefore, I cannot populate the table or provide the detailed study information as requested, as that specific data is not present in the provided FDA submission excerpts. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to voluntary standards, rather than providing a detailed performance study with specific acceptance criteria and results within this summary document.

To answer your request thoroughly, I would need access to "Section 9 of this submission" or specific test reports from GE Medical Systems Information Technologies for K032369.

Summary

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K032369
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AUG 1 5 2003

Section 2 Summary 510(k) Summary of Safety and Effectiveness July 30, 2003 Date: Submitter: GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223 USA Diana M. Thorson Contact Person: Regulatory Affairs Specialist GE Medical Systems Information Technologies Phone: 714-247-4135 Fax: 714-247-4155 Device: Trade Name: ApexPro Telemetry System Common/Usual Name: Telemetry Monitoring System Classification Names: 21 CFR 870.1025 Detector and Alarm, Arrhythmia 21 CFR 870.2910 Transmitters & Receivers, Physiological Signal, Radio Frequency Predicate Device: K021325 ApexPro Telemetry System Device Description: The ApexPro Telemetry System is composed of six major components: ● The patient worn data acquisition transmitters The receiver antenna system infrastructure . ● The receivers . The receiver subsystem A computer platform running the ApexPro Telemetry . Application . A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application) Intended Use: 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 and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display. Technology: The ApexPro employs the same functional technology as the predicate devices. The system architecture has taken advantage of

GE Medical Systems Information Technologies Confidential

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K032369
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improvements in signal processing technology as well as advances in RF component technologies to improve performance and level of integration.

Test Summary: The ApexPro complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:

Requirements specification review .
. Code inspections
. Software and hardware testing
. Safety testing
. Environmental testing
. Final validation

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

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three human profiles facing right, with flowing lines beneath them.

AUG 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Ms. Diana M. Thorson Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K032369

Trade Name: ApexPro Telemetry System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm. Regulatory Class: Class III (three) Product Code: MHX Dated: July 30, 2003 Received: August 1, 2003

Dear Ms. Thorson:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 -- Ms. Diana M. Thorson

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 set 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

J. R. Zukerman, M.D.

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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K032369

Page 1 of 1

510(k) Number (if known):

510(k) filed on July 29, 2003

ApexPro Telemetry System Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

NOC
(Division Sign-Off)

(Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K030369

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.