(147 days)
Not Found
No
The summary describes a data transmission and management system for ECG and patient data, with no mention of AI or ML capabilities for analysis or interpretation.
No. Although the data it transmits can be used for therapy decisions, the device itself is a data transmission and reception system and does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel." This indicates the device is used in the diagnostic process.
Yes
The device description explicitly states that the proposed RescueNet 12-Lead is a "software-only product" and describes it as a "web-based management system."
Based on the provided information, the RescueNet 12-Lead (RN12L) System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- RescueNet 12-Lead Function: The RescueNet 12-Lead system is a data transmission and reception system. It receives and routes physiological data (specifically 12-Lead ECG reports and other patient care system data) from external devices to a remote location for display.
- No Sample Analysis: The system itself does not perform any analysis on biological samples. It is a software system that handles and displays data generated by other devices (monitor/defibrillators and other patient care systems).
While the data it handles (ECG reports) is used for diagnosis, disposition, and therapy decisions, the RescueNet 12-Lead system's role is in the transmission and display of this data, not in the in vitro analysis of a biological sample.
N/A
Intended Use / Indications for Use
The RescueNet 12-Lead (RN12L) System is a data transmission and reception system that provides the capability to receive 12-Lead ECG reports, other physiological data, patient demographic, and EMS agency information from authorized monitor/defibrillators and other patient care systems and route it to a receiving destination at a remote location for display on an Internet Browser. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
MSX, NSX
Device Description
The proposed RescueNet 12-Lead is a software-only product.
RescueNet 12-Lead is a web-based management system that uses a web browser to provide quick, easy access to 12-Lead records sent from ZOLL defibrillators, and physiological and patient data from other patient care systems. With RescueNet 12-Lead, users can view, distribute, close, add notes, and print 12-Lead records, and can search for Inbox and/or closed 12-Lead records, and run reports.
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 personnel
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)
Extensive performance testing ensures that RescueNet 12-Lead performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications.
Performance testing of RescueNet 12-Lead demonstrates that its features and functions are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K121865 pg 1 of 2
NOV
20
2012
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Charles W. Kolifrath
(978) 421-9786
Date Summary Prepared:
June 4, 2012
Device:
RescueNet 12-Lead
Classification:
System, Network and Communication, Physiological Monitors. Product Code MSX. Device Class II. Software, Transmission and Storage, Patient Data. Product code: NSX. Device Class: Not Classified.
Description:
The proposed RescueNet 12-Lead is a software-only product.
RescueNet 12-Lead is a web-based management system that uses a web browser to provide quick, easy access to 12-Lead records sent from ZOLL defibrillators, and physiological and patient data from other patient care systems. With RescueNet 12-Lead, users can view, distribute, close, add notes, and print 12-Lead records, and can search for Inbox and/or closed 12-Lead records, and run reports.
Indications For Use:
The RescueNet 12-Lead (RN12L) System is a data transmission and reception system that provides the capability to receive 12-Lead ECG reports, other physiological data, patient demographic, and EMS agency information from authorized monitor/defibrillators and other patient care systems and route it to a receiving destination at a remote location for display on an Internet Browser. Data is received from the field and can be used for diagnosis, disposition, and
1
therapy decisions by qualified medical personnel.
Substantial Equivalence:
The features and functions of the proposed RescueNet 12-Lead are substantially equivalent to the corresponding features and functions of the Physio-Control LIFENET System (K102757, cleared for use on 11/5/2010).
Comparison of Technological Characteristics
RescueNet 12-Lead features and functions are similar to the corresponding features and functions of the indicated predicate device. Both RescueNet 12-Lead and the indicated predicate device are software-only products intended for the collection and transmission of data from other medical devices. No new issues of safety or effectiveness are raised by this premarket notification.
Performance Testing:
Extensive performance testing ensures that RescueNet 12-Lead performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications.
Conclusion
Performance testing of RescueNet 12-Lead demonstrates that its features and functions are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-C Silver Spring, MD 20993-002
NOV
20
2012
ZOLL Medical Corporation c/o: Chuck Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, MA 01824-4105
Re: K121865
Trade Name: RescueNet 12-Lead Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor including cardiotachometer and rate alarm Regulatory Class: II (two) Product Code: MSX Dated: November 9, 2012 Received: November 13, 2012
Dear Mr. Kolifrath:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
3
Page 2 - Mr. Kolifrath
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.
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,
Owen P Faris -S
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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Section 4 - Indications for Use
510(k) Number (if known): RescueNet 12-Lead Device Name:
Indications For Use:
The RescueNet 12-Lead (RN12L) System is a data transmission and reception system that provides the capability to receive 12-Lead ECG reports, other physiological data, patient demographic, and EMS agency information from authorized monitor/defibrillators and other patient care systems and route it to a receiving destination at a remote location for display on an Internet Browser. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.
X Prescription Use (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)
Owen P. Faris -S
2012.11.20
10:52:31 -05'00'
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