AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)

K042642 · Ge Medical Systems Information Technologies · MHX · Nov 3, 2004 · Cardiovascular

Device Facts

• Record ID: K042642
• Device Name: AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Aware™ Transport Monitor System (includes Aware POD and Aware Transport Monitor) is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as a hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The Aware POD is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the Aware POD includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Aware Transport Monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Aware POD or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. Both the Aware POD and TRAM acquisition module acquire, process and store information for all aforementioned parameters.

Device Story

Aware Transport Monitor System comprises Aware POD (acquisition module) and Aware Transport Monitor (display/alarm unit). POD acquires/processes physiological signals: 12-lead ECG, respiration, invasive/non-invasive blood pressure, SpO2, temperature, cardiac output. System provides continuous monitoring during intra-facility transport; alerts clinicians via audible/visual alarms for limit violations. Used in high-acuity settings (OR, PACU, ED, ICUs) by trained healthcare personnel. Data transmitted to central processing units for viewing/surveillance. Facilitates uninterrupted patient monitoring during transit; enables timely clinical intervention via alarm notification.

Clinical Evidence

Bench testing only. Evidence includes risk analysis, requirements/design reviews, unit-level module verification, integration/system verification, final acceptance validation, performance, safety, and environmental testing. No clinical study data presented.

Technological Characteristics

Multi-parameter physiological monitor. Components: Aware POD (acquisition) and Aware Transport Monitor (display). Parameters: ECG, IBP, NIBP, SpO2, temperature, respiration. Connectivity: Transmits data to central processing units. Lightweight, rugged form factor for transport. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in professional medical facilities (hospitals, clinics, surgical centers, doctor's offices) for continuous physiological monitoring during bedside care and intra-facility transport. Parameters include ECG, invasive/non-invasive blood pressure, pulse oximetry, temperature, and respiration.

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

• TRAM 2001 Module (K011000)

Submission Summary (Full Text)

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## Section 2 Summary and Certification

:

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 24, 2004 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Andrew Kluessendorf<br>Sr. Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name: | Aware™ Transport Monitor System (includes Aware POD and Aware<br>Transport Monitor) |
| Common/Usual Name: | Physiological Patient Monitor (Multi-parameter Module) |
| Classification Names: | Physiological Patient Monitor |
| Predicate Devices: | K011000 TRAM 2001 Module |
| Device Description: | The Aware™ Transport Monitor System is a complete, high-acuity<br>patient monitoring system composed of two main parts: the Aware POD<br>and Aware Transport Monitor.<br><br>The Aware™ Patient Observation Device (POD) is an acquisition<br>module that measures and processes a patient's physiological<br>parameters. Physiological parameter data acquired by the Aware POD<br>includes 12 Lead ECG, respiration, up to four invasive blood pressure<br>channels (as options), non-invasive blood pressure, Masimo SpO2,<br>dual temperature and cardiac output (optional).<br><br>The Aware™ Transport Monitor is designed to be lightweight, rugged,<br>and provide continuous monitoring capability when coupled with a<br>compatible acquisition module. The Aware Transport Monitor is<br>designed to facilitate quick, simple connection of either the Aware POD<br>or TRAM 2001 module (K011000). The Aware Transport Monitor<br>provides a means to alert the clinician of limit violations via audible and<br>visual alarms. |
| Intended Use: | The Aware™ Transport Monitor System (includes Aware POD and<br>Aware Transport Monitor) is intended for use under the direct<br>supervision of a licensed healthcare practitioner, or by personnel<br>trained in proper use of the equipment in a professional medical facility,<br>such as a hospital, clinic, surgical center or doctor's office. It can be<br>used in multiple areas such as operating room (OR), post anesthesia<br>care unit (PACU), emergency department (ED), critical care, surgical<br>intensive care, respiratory intensive care, coronary care, medical<br>intensive care, pediatric intensive care, or neonatal intensive care. |

K042642
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The Aware POD is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the Aware POD includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

The Aware Transport Monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Aware POD or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. Both the Aware POD and TRAM acquisition module acquire, process and store information for all aforementioned parameters.

#### Technology:

The Aware Transport Monitor System employs the same functional scientific technology as its predicate devices.

## Test Summary:

The Aware Transport Monitor System complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures are applied to the development of the Aware Transport Monitor System:

- Risk Analvsis
- . Requirements Reviews
- Design Reviews
- . Testing on unit level (Module verification)
- . Clinical Use Validation
- . Integration testing (System verification)
- . Final acceptance testing (Validation)
- . Performance testing
- . Safety testing
- . Environmental testing

### Conclusion:

The results of these measurements demonstrated that the Aware Transport Monitor System is as safe, as effective, and performs as well as the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2004

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

Re: K042642

Trade Name: Aware "" Transport Monitor System (includes Aware POD and Aware Transport Monitor) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: II (two) Product Code: MHX Dated: September 24, 2004 Received: September 27, 2004

Dear Mr. Kluessendorf:

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 for acted in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner or prior to may 20, 1977) 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 r ou may, iterere, mains 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. Andrew Kluessendorf

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 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 [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/dsma/dsmamain.html

Sincerely yours,

B/Simmons for

Dr. D. Zuckerman, 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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# Indications for Use

510(k) Number (if known):

Device Name: Aware™ Transport Monitor System (includes Aware POD and Aware Transport Monitor)

Indications for Use:

The Aware™ Transport Monitor System (includes Aware POD and Aware Transport Monitor) is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as a hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care.

The Aware POD is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the Aware POD includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

The Aware Transport Monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Aware POD or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. Both the Aware POD and TRAM acquisition module acquire, process and store information for all aforementioned parameters.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Summa

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