← Product Code [MSX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX) · K102757

# LIFENET SYSTEM (K102757)

_Physio-Control, Inc. · MSX · Nov 5, 2010 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K102757

## Device Facts

- **Applicant:** Physio-Control, Inc.
- **Product Code:** [MSX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX.md)
- **Decision Date:** Nov 5, 2010
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.2300
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Software as a Medical Device

## Indications for Use

The LIFENET System is an optional data transmission system that provides the capability to transmit real time 12-Lead ECG reports 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.

## Device Story

LIFENET System is a data transmission platform for physiological monitoring devices; enables real-time transfer of 12-Lead ECG reports and physiological data from field/pre-hospital settings to remote receiving destinations (hospitals, clinics). Operated by qualified medical professionals (paramedics, EMTs, physicians). New feature 'LIFENET Consult' allows forwarding unaltered patient data to handheld wireless devices for remote review, comment, and clinical decision-making regarding diagnosis, disposition, and therapy. System facilitates communication between field providers and hospital-based clinicians to improve clinical workflow efficiency.

## Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance testing.

## Technological Characteristics

Data transmission and connection system for physiological monitors. Features include real-time data transfer, expanded data management, and wireless consult capabilities. Operates via network communication. Software-based system for data routing and display.

## 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

- LIFENET System ([K093925](/device/K093925.md))

## Submission Summary (Full Text)

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## K102757 PI/>

Physio-Control Inc LIFENET System

510(k) Premarket Notification

NOV - 5 2010

#### SECTION E: 510(K) SUMMARY

.. "

This summary of 510(k) safety and effectiveness information is being submitted in 510(k) Summary accordance with the requirements of 21 C.F.R. § 807.92.

- Submitter Physio-Control, 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 Summary September 22, 2010 Prepared

Device Name LIFENET® System

System, Network and Communication, Physiological Monitors Common Name

Device Classification name: Cardiac monitor (including cardiotachometer and rate alarm) Classification Device Class: II Product Code: MSX Classification Panel: Cardiovascular Device Regulation Number: 21 CFR 870.2300

| Identification of<br>the Legally<br>Marketed Device<br>(Predicate<br>Device) | LIFENET System (K093925)<br>Classification name: Cardiac monitor (including cardiotachometer and rate alarm)<br>Device class: II<br>Product Code: MSX<br>Classification Panel: Cardiovascular Device<br>Regulation Number: 21 CFR 870.2300 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

The system is an optional data transmission system that is used in conjunction with Description monitoring devices. The system provides real time data transfer from the originating/transmitting device to a user selected remote receiving destination (RD). The users of the LIFENET System are qualified medical professionals and include Advanced Life Support providers (e.g. Paramedics) and Basic Life Support providers (e.g. Emergency Medical Technicians) in a variety of hospital and pre-hospital settings.

Final

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Physio-Control Inc LIFENET System 510(k) Premarket Notification

### SECTION E: 510(K) SUMMARY (continued)

Description The system is used in various areas of the hospital such as critical areas (emergency (continued) departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical, clinics, physician offices, and cardiac catheterization labs). The system is also used for hospital transport (air and ground ambulance, in-hospital transport, etc).

> The modified system includes optional data management features that provide the user with expanded data management capabilities and increased efficiencies. Additionally, a new feature, the LIFENET Consult, provides users the capability to forward unattered patient information for review and comment, by initiating a clinician consult. Upon receipt of patient data, health care professionals, using a hand held wireless device are able to view patient information and provide a "consult" reply to the hospital user intended for purposes of diagnosis, disposition, and therapy . decisions.

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

Technological Characteristics of modified and predicate device

The modified LIFENET System performs and functions in the same manner as the predicate system. The modified LIFENET® System continues to use similar data transmission and connection technologies when compared to the previously cleared predicate. Optional data management capabilities have been expanded with the modified system and provide the user with increased system capability and efficiencies.

Conclusion of The information in this 510(k) demonstrates that the modified LIFENET® System is substantially equivalent to the predicate LIFENET System with respect to safety, testing effectiveness, and performance.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Ms. Teresa Davidson Physio-Control, Inc. 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073-9706

2010 NOV

- 5

Re: K102757

> Trade/Device Name: LIFENET® 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: October 20, 2010 Received: October 22, 2010

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 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dunia R. Vahner

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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K102757

Physio-Control Inc LIFENET System 510(k) Premarket Notification

# SECTION D: STATEMENT OF INDICATIONS FOR USE

NOV - 5 2010

. Not yet assigned > K 102757 510(k) Number (if known):

Device Name: LIFENET® System

The LIFENET System is an optional data transmission system that provides the capability to transmit real time 12-Lead ECG reports 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.

Prescription Use V (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) (Optional Format 3-10-98)

DunaR.V.A.Lunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K102757

D-1

Confidential

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K102757](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K102757)

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