K Number
K102757
Device Name
LIFENET SYSTEM
Date Cleared
2010-11-05

(43 days)

Product Code
Regulation Number
870.2300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 Description
The system is an optional data transmission system that is used in conjunction with 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. 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, 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.
More Information

No Reference Devices were found.

No
The description focuses on data transmission and management, with no mention of AI or ML algorithms for analysis or interpretation.

No
The device is described as a data transmission system for diagnosis and disposition decisions, not for delivering therapy.

No

The device description clearly states it is an "optional data transmission system" that "is used in conjunction with monitoring devices." Its primary function is to transmit data, and while that data "can be used for diagnosis," the system itself does not perform the diagnosis. The diagnosis is made by "qualified medical personnel" based on the transmitted data.

No

The device description explicitly states it is an "optional data transmission system that is used in conjunction with monitoring devices," implying it interacts with and relies on external hardware (monitoring devices) to function. While it provides data transmission and management features, it is not solely software operating independently.

Based on the provided information, the LIFENET System is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The LIFENET System transmits real-time physiological data (like ECG reports) from monitoring devices attached to the patient. It's a data transmission and management system, not a system that analyzes biological samples.
  • The intended use focuses on transmitting and managing data for diagnosis, disposition, and therapy decisions. While this data is used for medical purposes, the system itself is not performing the diagnostic test on a biological sample.

The LIFENET System is a medical device, but its function is related to data communication and management, not the in vitro analysis of biological specimens.

N/A

Intended Use / 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.

Product codes

MSX

Device Description

The system is an optional data transmission system that is used in conjunction with 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. 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, 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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. 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, and cardiac catheterization labs). The system is also used for hospital transport (air and ground ambulance, in-hospital transport, etc).

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K093925

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).

0

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
the Legally
Marketed Device
(Predicate
Device) | LIFENET System (K093925)
Classification name: Cardiac monitor (including cardiotachometer and rate alarm)
Device class: II
Product Code: MSX
Classification Panel: Cardiovascular Device
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

1

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.

2

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.

3

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

4

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