LIFENET EXCHANGE SYSTEM

K052854 · Medtronic Emergency Response Systems, Inc. · MSX · Jan 20, 2006 · Cardiovascular

Device Facts

• Record ID: K052854
• Device Name: LIFENET EXCHANGE SYSTEM
• Applicant: Medtronic Emergency Response Systems, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Jan 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The LIFENET Exchange System is an optional data transmission system that provides the capability to transmit 12-Lead ECG reports and other physiological data to a receiving device at a remote location. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

Device Story

LIFENET Exchange System acts as data transmission bridge; inputs 12-Lead ECG and physiological data from field devices (e.g., LIFEPAK 12); transmits data to remote receiving stations; enables qualified medical personnel to review data for diagnosis, disposition, and therapy decisions; used by EMTs/paramedics in pre-hospital and hospital environments; facilitates clinical decision-making by providing remote access to patient physiological status; benefits patients through expedited clinical intervention.

Clinical Evidence

Bench testing only. Documentation provided for verification and validation of individual system components and overall system integration, including compatibility testing with the LIFEPAK 12 device.

Technological Characteristics

Data transmission and communication system; functions as an optional add-on for physiological monitors; utilizes standard data transmission protocols; software-based communication interface; no specific materials or energy sources defined beyond standard electronic hardware.

Indications for Use

Indicated for use by Advanced Life Support providers (e.g., EMTs) and Basic Life Support providers (e.g., paramedics) in hospital and pre-hospital settings, including emergency departments, critical care, ORs, general duty floors, clinics, physician offices, cardiac cath labs, and during air/ground transport.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• LIFEPAK 12 device (data transmission functionality)
• Phillips 12-Lead Transfer Station

Submission Summary (Full Text)

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KC52854
p. 1/2

Medtronic Emergency Response Systems
LIFENET Exchange System, 510(k) Premarket Notification

## SECTION E: 510(k) Summary

JAN 2 C 2006

| 510(k) Summary | This summary of 510(k) safety and<br>effectiveness information is being submitted in<br>accordance with the requirements of 21 C.F.R.<br>§ 807.92. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Medtronic Emergency Response Systems, Inc.<br>11811 Willow Road Northeast<br>P.O. Box 97006<br>Redmond, Washington 98073-9706<br>Registration Number: 3015876 |
| Contact Person | Teresa Davidson<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared | October 5, 2005 |
| Name | LIFENET® Exchange System |
| Common Name | System, Network and Communication,<br>Physiological Monitors |
| Device<br>Classification | Classification: Class II<br>Product Code: MSX<br>Classification Panel: Cardiovascular Device<br>Regulation Number: 870.2300 |
| Substantial<br>Equivalence | The features and functions of the LIFENET<br>Exchange System, an optional data transmission<br>system is substantially equivalent to the existing data<br>transmission functionality previously cleared for the<br>LIFEPAK® 12 device and the Phillips 12-Lead<br>Transfer Station. |
| Intended Use | The LIFENET Exchange System is an<br>optional data transmission system that<br>provides the capability to transmit 12-Lead<br>ECG reports and other physiological data to<br>a receiving device at a remote location. Data<br>is received from the field and can be used for<br>diagnosis, disposition, and therapy decisions<br>by qualified medical personnel. |

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| | ^K052854 ^p2/2 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Medtronic Emergency Response Systems<br>LIFENET Exchange System,<br>510(k) Premarket Notification |
| | The users of the LIFENET Exchange<br>System are Advanced Life Support<br>providers (e.g. Emergency Medical<br>Technicians) and Basic Life Support<br>providers (e.g. paramedics) in a variety of<br>hospital and pre-hospital settings. |
| | The system is used in various areas of the<br>hospital such as critical areas (emergency<br>departments, critical care, operating room,<br>etc.) and general duty floors (e.g.<br>medical/surgical, clinics, physician offices,<br>cardiac catherization labs). The system is<br>also used for hospital transport (air and<br>ground ambulance, in- hospital transport,<br>etc). |
| Technological<br>Characteristics | The LIFENET® Exchange System performs and<br>functions in the same manner as the currently<br>marketed predicate data transmission systems.<br>Both predicate systems and the subject system use<br>similar data transmission and communication<br>technologies. |
| Performance<br>Information | This 510(k) includes documentation related to the<br>verification and validation of the individual system<br>components and the overall V&V of the LIFENET<br>Exchange System, including the LIFEPAK 12 to<br>ensure device compatibility. |
| Conclusion | The information in this 510(k)<br>demonstrates that the LIFENET®<br>Exchange System, an optional data<br>transmission system is substantially<br>equivalent to the predicate data<br>transmission systems with respect to<br>safety, effectiveness and performance. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2006

Medtronic Emergency Response Systems c/o Ms. Teresa M. Davidson Principal Regulatory Affairs Specialist 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073

Re: K052854

Trade Name: LIFENET®Exchange System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MSX Dated: December 20, 2005 Received: December 21, 2005

Dear Ms. Davidson:

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 - Ms. Teresa M. Davidson

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/industry/support/index.html.

Sincerely yours,

B. Himmana for

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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Medtronic Emergency Respon LIFENET Exchange St 510(k) Premarket Nothe

## SECTION D: "Indications for Use" Sheet

## Indications for Use Statement

公

Page 1 of 1

510(k) Number (if known): Not yet assigned

Device Name: LIFENET® Exchange System

Indications for Use:

The LIFENET Exchange System is an optional data transmission system that provides the capability to transmit real time 12-Lead System that provides and other physiological data to a receiving destination at a remote location.

Data received from the field can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

AND/OR Over-The-Counter Use Prescription Use (Part 2) CFF 801 Subpart D) (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) (Optional Format 3-10-98)

B. Kummar
Sign Off

Divisi & Slan-Off Olvision of Cardlovascular Devices 510in Number

D-1