APEXPRO TELEMETRY SYSTEMS

K080251 · Ge Medical Systems Information Technologies · MHX · Jun 20, 2008 · Cardiovascular

Device Facts

• Record ID: K080251
• Device Name: APEXPRO TELEMETRY SYSTEMS
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

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, 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.

Device Story

ApexPro Telemetry System enables continuous monitoring of ambulating patients in clinical settings. System components include patient-worn data acquisition transmitters, receiver infrastructure, and computer platforms hosting ApexPro software and central station applications. Inputs include ECG, non-invasive blood pressure, non-invasive temperature, and SpO2 signals. The system processes physiological data to detect ECG arrhythmia events and parameter limit violations. Data is transmitted via Ethernet to computer platforms for processing and over the Unity Network to clinical information systems for display. Clinicians view output at central stations to inform medical decision-making. System allows patient mobility, potentially enhancing effectiveness of medical procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including risk analysis, requirements review, design reviews, module verification, system integration testing, final acceptance testing, performance testing, and safety/environmental testing.

Technological Characteristics

System includes patient-worn transmitters, receiver infrastructure, and computer platforms. Monitors ECG, NIBP, temperature, and SpO2. Connectivity via Ethernet and Unity Network. Software-based processing for arrhythmia detection and limit monitoring. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for ambulating patients in hospital or clinical sub-acute care settings requiring physiological monitoring under direct supervision of a licensed healthcare practitioner.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ApexPro Telemetry System (K032369)
• ApexPro FH Telemetry System (K033365)
• Apex OXIMETER (K980299)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness 5

| Date: | January 29, 2008 | JUN 20 2008 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA | |
| Contact Person: | Bernard Sandler<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Secondary Contact<br>Person: | Lisa M. Baumhardt<br>Regulatory Affairs Program Manager<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Device Trade Name: | ApexPro Telemetry System | |
| Common /Usual Name: | Telemetry Monitoring System | |
| Classification Names: | 21 CFR 870.1025 Physiological Patient Monitor (with arrhythmia<br>detection or alarms | |
| Predicate Devices: | K032369 ApexPro Telemetry System<br>K033365 ApexPro FH Telemetry System<br>K980299 Apex OXIMETER | |
| Device Description: | The ApexPro Telemetry System provides clinicians with patient<br>data while allowing for patient mobility. The system consists of<br>the following main components:<br>• The patient worn data acquisition transmitters<br>• Receiver Infrastructures<br>• Computer platforms hosting the ApexPro Software<br>• Computer platforms hosting the central station<br>application<br>• Accessories to the patient-worn data acquisition<br>transmitters<br>Serviceability tools | |

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#### 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 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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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 [phone]. 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 [phone] or [phone] 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:

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.

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

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