(101 days)
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 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 provided text describes a 510(k) premarket notification for the Medtronic LIFENET Exchange System. However, it does not contain specific acceptance criteria, performance metrics, or details about a study to prove the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices for its intended use as a data transmission system for 12-Lead ECGs and other physiological data.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Functionality in transmitting 12-Lead ECGs and other physiological data. | The device "performs and functions in the same manner as the currently marketed predicate data transmission systems." |
| Compatibility with the LIFEPAK 12 device. | Documentation includes "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." |
| Safety and effectiveness as a data transmission system. | "The information in this 510(k) demonstrates that the LIFENET® Exchange System... is substantially equivalent to the predicate data transmission systems with respect to safety, effectiveness and performance." |
2. Sample size used for the test set and the data provenance
- Not explicitly mentioned. The document focuses on demonstrating substantial equivalence through similar technological characteristics and performance claims, rather than detailing a specific clinical or technical test set with sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not explicitly mentioned. The concept of "ground truth" for a specific test set is not detailed in this 510(k) summary, as the primary focus is on functional equivalence.
4. Adjudication method for the test set
- Not explicitly mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not described. This device is a data transmission system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense of an algorithm's diagnostic performance. The device's "performance" refers to its ability to reliably transmit data, which is a standalone function. The "study" mentioned refers to verification and validation (V&V) of its components and overall system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly mentioned in the context of diagnostic "ground truth." For a data transmission system, the "truth" would likely be the accurate and timely transmission of the physiological data created by other medical devices (e.g., the LIFEPAK 12 ECG).
8. The sample size for the training set
- Not applicable/Not mentioned. This device is a data transmission system; it does not employ a "training set" in the context of machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned.
In summary: The provided 510(k) summary for the LIFENET Exchange System focuses on demonstrating substantial equivalence to existing predicate devices (LIFEPAK 12 data transmission and Phillips 12-Lead Transfer Station) by highlighting similar technological characteristics and functional performance in data transmission. It refers to general "verification and validation" activities but does not offer granular details about specific acceptance criteria, comprehensive studies with sample sizes, expert involvement, or ground truth methodologies that would typically be described for a diagnostic or algorithmic device.
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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 andeffectiveness information is being submitted inaccordance with the requirements of 21 C.F.R.§ 807.92. |
|---|---|
| Submitter | Medtronic Emergency Response Systems, Inc.11811 Willow Road NortheastP.O. Box 97006Redmond, Washington 98073-9706Registration Number: 3015876 |
| Contact Person | Teresa DavidsonTelephone: (425) 867-4733Fax: (425) 867-4154 |
| Date Prepared | October 5, 2005 |
| Name | LIFENET® Exchange System |
| Common Name | System, Network and Communication,Physiological Monitors |
| DeviceClassification | Classification: Class IIProduct Code: MSXClassification Panel: Cardiovascular DeviceRegulation Number: 870.2300 |
| SubstantialEquivalence | The features and functions of the LIFENETExchange System, an optional data transmissionsystem is substantially equivalent to the existing datatransmission functionality previously cleared for theLIFEPAK® 12 device and the Phillips 12-LeadTransfer Station. |
| Intended Use | The LIFENET Exchange System is anoptional data transmission system thatprovides the capability to transmit 12-LeadECG reports and other physiological data toa receiving device at a remote location. Datais received from the field and can be used fordiagnosis, disposition, and therapy decisionsby qualified medical personnel. |
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| K052854 p2/2 | |
|---|---|
| Medtronic Emergency Response SystemsLIFENET Exchange System,510(k) Premarket Notification | |
| The users of the LIFENET ExchangeSystem are Advanced Life Supportproviders (e.g. Emergency MedicalTechnicians) and Basic Life Supportproviders (e.g. paramedics) in a variety ofhospital and pre-hospital settings. | |
| The system is used in various areas of thehospital such as critical areas (emergencydepartments, critical care, operating room,etc.) and general duty floors (e.g.medical/surgical, clinics, physician offices,cardiac catherization labs). The system isalso used for hospital transport (air andground ambulance, in- hospital transport,etc). | |
| TechnologicalCharacteristics | The LIFENET® Exchange System performs andfunctions in the same manner as the currentlymarketed predicate data transmission systems.Both predicate systems and the subject system usesimilar data transmission and communicationtechnologies. |
| PerformanceInformation | This 510(k) includes documentation related to theverification and validation of the individual systemcomponents and the overall V&V of the LIFENETExchange System, including the LIFEPAK 12 toensure device compatibility. |
| Conclusion | The information in this 510(k)demonstrates that the LIFENET®Exchange System, an optional datatransmission system is substantiallyequivalent to the predicate datatransmission systems with respect tosafety, effectiveness and performance. |
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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.
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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 (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
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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
§ 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).