← Product Code [MSX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX) · K052854 # LIFENET EXCHANGE SYSTEM (K052854) _Medtronic Emergency Response Systems, Inc. · MSX · Jan 20, 2006 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K052854 ## Device Facts - **Applicant:** Medtronic Emergency Response Systems, Inc. - **Product Code:** [MSX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX.md) - **Decision Date:** Jan 20, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2300 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Software as a Medical Device ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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
effectiveness information is being submitted in
accordance with the requirements of 21 C.F.R.
§ 807.92. | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Medtronic Emergency Response Systems, Inc.
11811 Willow Road Northeast
P.O. Box 97006
Redmond, Washington 98073-9706
Registration Number: 3015876 | | Contact Person | Teresa Davidson
Telephone: (425) 867-4733
Fax: (425) 867-4154 | | Date Prepared | October 5, 2005 | | Name | LIFENET® Exchange System | | Common Name | System, Network and Communication,
Physiological Monitors | | Device
Classification | Classification: Class II
Product Code: MSX
Classification Panel: Cardiovascular Device
Regulation Number: 870.2300 | | Substantial
Equivalence | The features and functions of the LIFENET
Exchange System, an optional data transmission
system is substantially equivalent to the existing data
transmission functionality previously cleared for the
LIFEPAK® 12 device and the Phillips 12-Lead
Transfer Station. | | 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. | {1}------------------------------------------------ | | K052854 p2/2 | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Medtronic Emergency Response Systems
LIFENET Exchange System,
510(k) Premarket Notification | | | The users of the LIFENET Exchange
System are Advanced Life Support
providers (e.g. Emergency Medical
Technicians) and Basic Life Support
providers (e.g. paramedics) in a variety of
hospital and pre-hospital settings. | | | The system is used in various areas of the
hospital such as critical areas (emergency
departments, critical care, operating room,
etc.) and general duty floors (e.g.
medical/surgical, clinics, physician offices,
cardiac catherization labs). The system is
also used for hospital transport (air and
ground ambulance, in- hospital transport,
etc). | | Technological
Characteristics | The LIFENET® Exchange System performs and
functions in the same manner as the currently
marketed predicate data transmission systems.
Both predicate systems and the subject system use
similar data transmission and communication
technologies. | | Performance
Information | This 510(k) includes documentation related to the
verification and validation of the individual system
components and the overall V&V of the LIFENET
Exchange System, including the LIFEPAK 12 to
ensure device compatibility. | | Conclusion | The information in this 510(k)
demonstrates that the LIFENET®
Exchange System, an optional data
transmission system is substantially
equivalent to the predicate data
transmission systems with respect to
safety, effectiveness and performance. | {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. 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. {3}------------------------------------------------ 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 (240) 276-0210. 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/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 {4}------------------------------------------------ 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K052854](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K052854) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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