(101 days)
Not Found
Not Found
No
The summary describes a data transmission system and does not mention any AI/ML capabilities or related performance metrics.
No
This device is described as a data transmission system for ECG reports and physiological data, used for diagnosis, disposition, and therapy decisions, but it does not directly apply therapy.
No.
The device transmits data for diagnosis but does not perform the diagnosis itself.
No
The description explicitly states the system transmits data from "the field" and mentions compatibility with the LIFEPAK 12 device, which is a hardware device (defibrillator/monitor). The summary also includes verification and validation of "individual system components" and "overall V&V of the LIFENET Exchange System, including the LIFEPAK 12," indicating hardware is involved.
Based on the provided information, the LIFENET Exchange System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- LIFENET Exchange System Function: The LIFENET Exchange System transmits physiological data, specifically 12-Lead ECG reports and other physiological data, which are collected from the patient's body, not from a specimen taken from the body.
- Intended Use: The intended use describes the transmission of data for diagnosis, disposition, and therapy decisions, but this data is derived from the patient directly, not from an in vitro test.
The system acts as a data transmission and management tool for physiological data, not a device that performs tests on biological specimens.
N/A
Intended Use / 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.
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.
Product codes
MSX
Device Description
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.
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
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).
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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