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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the RescueNet ePCR device:

Based on the provided FDA 510(k) summary for RescueNet ePCR (K103473), the information regarding acceptance criteria and a detailed study proving performance is very limited. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical performance study with specific acceptance criteria.

However, I can extract the relevant (and often limited) information and structure it according to your requested format.

Acceptance Criteria and Device Performance Study for RescueNet ePCR (K103473)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Functional Equivalence	Device performs for collection, storage, and printing of patient data.	Performs for collection, storage, and printing of patient data.	Stated as "features and functions are similar" to predicate.
Data Input Methods	Accepts user-entered data (caregiver) and captured data from specified medical devices.	Accepts user-entered data and captured data from specified medical devices.	Directly stated in description and intended use.
Output Type	Integrates data into a patient care report (patient electronic medical record).	Integrates data into a patient care report (patient electronic medical record).	Directly stated in description and intended use.
Intended Use Environment	Use by qualified medical personnel providing direct patient care in the pre-hospital environment.	Indicated for use by qualified medical personnel providing direct patient care in the pre-hospital environment.	Direct matching of intended use.
Software Classification	Non-alarming software.	Non-alarming software.	Stated in description.
Safety and Effectiveness	No new issues of safety or effectiveness are raised compared to the predicate device.	Performance testing demonstrates substantial equivalence regarding performance, safety, and effectiveness.	This is a claim made by the manufacturer based on their internal testing and comparison to the predicate. Specific metrics are not provided.
Predicate Equivalence	Substantially equivalent to Philips Medical Systems IntelliVue Clinical Information Portfolio (K100272).	Features and functions are substantially equivalent.	This is the primary basis of the 510(k) clearance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document states "Extensive performance testing," but does not provide details on the number of cases, data points, or scenarios used in the testing.
Data Provenance: Not specified. It's highly likely that this involved internal testing and validation by ZOLL Medical Corporation, but the country of origin of any test data or whether it was retrospective or prospective is not mentioned. Given the nature of a software-only device for data management, the "data" would likely refer to simulated scenarios, test cases, and possibly real-world data processed through the software.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not specified. The document does not describe the establishment of a "ground truth" in the traditional sense of a clinical diagnostic study. The testing likely focused on functional verification and validation (e.g., data input accuracy, report generation accuracy, integration with other devices), rather than diagnostic accuracy against a clinical gold standard.

4. Adjudication Method for the Test Set

Not specified. This information is not relevant or not provided for the type of performance testing described in the summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study was not conducted or mentioned. The device is a data collection and management software, not a diagnostic imaging or interpretive device that would typically involve human readers evaluating cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, effectively. The device itself is a "software-only product." The performance testing described focuses on the software's ability to collect, store, and print data, and integrate with other medical devices. The evaluation is implicitly standalone in that it assesses the software's functionality and accuracy in its designed tasks. However, its intended use always involves a "user (caregiver)" for data entry and interaction.

7. The type of ground truth used

Not explicitly defined as "ground truth" in the diagnostic sense. For functional validation of a data management system, the "ground truth" would likely be:
- Defined specifications and requirements: The software must correctly perform actions as per its design.
- Source data accuracy: Data received from medical devices or entered by users must be stored and presented accurately.
- Output accuracy: Printed reports must accurately reflect the stored data.
- Predicate device's known performance: The primary comparison is to a legally marketed predicate device, implying its performance serves as a de facto "ground truth" for what is acceptable.

8. The Sample Size for the Training Set

Not applicable/Not specified. This device is a data collection and management system, not a machine learning or AI algorithm that typically has a "training set." Its development would involve traditional software engineering and testing methodologies.

9. How the ground truth for the training set was established

Not applicable. As there is no "training set" for this type of software, no ground truth was established for it.

Summary of the Study:

The document describes a performance testing study conducted by ZOLL Medical Corporation to demonstrate that RescueNet ePCR's "features and functions are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device (Philips Medical Systems IntelliVue Clinical Information Portfolio K100272)."

The study primarily focused on functional equivalence, safety, and effectiveness through internal performance testing. It aimed to prove that the proposed device performs the same intended uses and does not raise new questions of safety or effectiveness compared to the predicate. The details of this "extensive performance testing" such as specific methodologies, sample sizes (e.g., number of test cases, simulated data inputs), or detailed quantitative results are not provided in this 510(k) summary. The conclusion is a qualitative assertion that the testing demonstrates substantial equivalence.

Summary

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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

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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.

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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

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Section 4 - Indications for Use

510(k) Number (if known): Device Name: RescueNet ePCR

Intended Use:

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

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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:

Intended Use:

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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.

Regulation Number and Section

§ 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).