(170 days)
Not Found
No
The summary describes a data collection and reporting system, with no mention of AI/ML terms, image processing, or performance metrics typically associated with AI/ML models.
No
The device is described as software for collecting and managing patient data and does not provide any treatment or therapy.
No
The device collects, stores, and prints patient data and integrates it into a patient care report; it does not perform diagnostic functions.
Yes
The device description explicitly states that RescueNet ePCR is a "software-only product" and runs on "commercial off-the-shelf hardware," indicating it does not include proprietary hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection, storage, and printing of patient data entered by a user or captured from medical devices to create a patient care report. This is focused on documenting patient care, not on performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The device is described as a software-only medical data collection system. It collects and integrates data, but it doesn't perform any diagnostic tests itself.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological tests, or providing diagnostic information based on such tests.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
RescueNet ePCR is intended for the collection, storage and printing of patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). RescueNet ePCR is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. RescueNet ePCR is indicated for use by health care providers whenever there is a need for generation of a patient record.
Product codes
DXJ, NSX
Device Description
The proposed RescueNet ePCR is a software-only product. RescueNet ePCR is a medical data collection system used to collect, store and print patient data that is entered by a user (caregiver), or captured from specified medical devices, and is integrated into a patient care report (patient electronic medical record). RescueNet ePCR is non-alarming software that runs on a variety of commercial off-the-shelf hardware.
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 providing direct patient care in the pre-hospital environment
health care providers
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
Extensive performance testing ensures that RescueNet ePCR performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications.
Performance testing of RescueNet ePCR 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in a sans-serif font.
September 8, 2023
ZOLL Medical Corporation, Worldwide Headquarters Charles W. Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, Massachusetts 01824-4105
Re: K103473
Trade/Device Name: RescueNet ePCR Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray Tube Display Regulatory Class: Class II Product Code: DXJ
Dear Charles W. Kolifrath:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 13, 2011. Specifically, FDA is updating this SE Letter to remove the secondary product code NSX as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Aneesh Deoras, OHT2: Office of Cardiovascular Devices, 240-402-4363, Aneesh.Deoras@fda.hhs.gov.
Sincerely,
Aneesh S. Deoras -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 3 2011
Mr. Charles W. Kolifrath Regulatory Affairs Manager Zoll Medical Corporation 269 Mill Road Chelmsford. Massachusetts 01824
Re: K103473
Trade/Device Name: RescueNet ePCR Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray Tube Display Regulatory Class: II Product Code: DXJ, NSX Dated: May 6, 2011 Received: May9, 2011
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.
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.
2
Page 2- Mr. Kolifrath
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 vours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4 - Indications for Use
510(k) Number (if known): Device Name: RescueNet ePCR
Intended Use:
RescueNet ePCR is intended for the collection, storage and printing of patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). RescueNet ePCR is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. RescueNet ePCR is indicated for use by health care providers whenever there is a need for generation of a patient record.
Prescription Use X (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)
Weekly Cen for RZC 5/13/2011
Division Sign-Off
Oivision of Anesthesiology, General Hospital ·fection Control, Dental Devices
· 10(k) Number:
Page 1 of 2
4
KID3473
MAY 1 3 2011
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:
November 23, 2010
Device:
RescueNet ePCR
Classification:
Classification Product Code:
21 CFR 870.2450. Display, Cathode Ray Tube, Medical. Product code: DXJ. Device Class: 2.
Secondary Product Code:
Software, Transmission and Storage, Patient Data. Product code: NSX. Device Class: Not Classified.
Description:
The proposed RescueNet ePCR is a software-only product. RescueNet ePCR is a medical data collection system used to collect, store and print patient data that is entered by a user (caregiver), or captured from specified medical devices, and is integrated into a patient care report (patient electronic medical record). RescueNet ePCR is non-alarming software that runs on a variety of commercial off-the-shelf hardware.
Intended Use:
RescueNet ePCR is intended for the collection, storage and printing of patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). RescueNet ePCR is intended for use by qualified medical personnel
5
providing direct patient care in the pre-hospital environment to document the care RescueNet ePCR is indicated for use by health care providers provided. whenever there is a need for generation of a patient record.
Substantial Equivalence:
The features and functions of the proposed RescueNet ePCR are substantially equivalent to the corresponding features and functions of the Philips Medical Systems IntelliVue Clinical Information Portfolio (K100272, cleared for use on 4/14/2010).
Comparison of Technological Characteristics
RescueNet ePCR features and functions are similar to the corresponding features and functions of the indicated predicate device. Both RescueNet ePCR and the indicated predicate device are software-only products intended for the collection and storage of patient data, including data that is entered by a user (caregiver) and data collected from other medical devices. Both RescueNet ePCR and the indicated predicate device are indicated for use by health care providers whenever there is a need for generation of a patient record. No new issues of safety or effectiveness are raised by this premarket notification.
Performance Testing:
Extensive performance testing ensures that RescueNet ePCR performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications.
Conclusion
Performance testing of RescueNet ePCR 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.