ZOLL ePCR iOS 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). ZOLL ePCR iOS is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. ZOLL ePCR iOS is indicated for use by health care providers whenever there is a need for generation of a patient record.

Device Description

The proposed ZOLL ePCR iOS is a software-only product. ZOLL ePCR iOS 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 integrated into a patient care report (patient electronic medical record). ZOLL ePCR iOS is non-alarming software that runs on various iOS devices (iOS is the Apple operating system for use on iPads and iPhones).

AI/ML Overview

This document does not contain the detailed acceptance criteria or a study proving the device meets those criteria in the format requested. The document is a 510(k) premarket notification letter from the FDA to ZOLL Medical Corporation for their ZOLL ePCR iOS device.

Here's what can be extracted and what is missing:

Information Present in the Document:

Device Name: ZOLL ePCR iOS
Intended Use: "ZOLL ePCR iOS 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). ZOLL ePCR iOS is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. ZOLL ePCR iOS is indicated for use by health care providers whenever there is a need for generation of a patient record." (Page 3 & 5)
Predicate Device: ZOLL RescueNet ePCR (K103473), cleared on 05/13/2011. (Page 5)
Technological Characteristics Comparison: The ZOLL ePCR iOS is similar to the predicate device, but uses a different operating system (iOS vs. Microsoft Windows). Both are software-only products for data collection, storage, and printing, and synchronize to a data server. (Page 5)
Performance Testing Mention: The document states, "Extensive performance testing ensures that ZOLL ePCR iOS performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications." (Page 5)

Information NOT Present in the Document (and therefore cannot be provided in the requested table/format):

Specific Acceptance Criteria: The document does not list quantitative or qualitative acceptance criteria for the device's performance. It only generally states that testing ensures it performs "as well as the indicated predicate device and meets all of its functional requirements and performance specifications."
Reported Device Performance: No specific performance metrics (e.g., accuracy, reliability rates, speed) are provided.
Sample Size for Test Set: Not mentioned.
Data Provenance (country, retrospective/prospective): Not mentioned.
Number of Experts for Ground Truth & Qualifications: Not mentioned.
Adjudication Method: Not mentioned.
MRMC Comparative Effectiveness Study Details: Not mentioned. The document primarily focuses on substantial equivalence to a predicate, not necessarily a comparative effectiveness study against human readers.
Standalone Performance: While it mentions "software-only product," it doesn't detail standalone performance metrics. The intended use clearly involves a human user (caregiver).
Type of Ground Truth Used: Not mentioned.
Sample Size for Training Set: Not mentioned (as this device focuses on data collection/storage, not typically an AI model that requires a training set in the conventional sense).
How Ground Truth for Training Set was Established: Not applicable given the nature of the device as described.

This 510(k) summary is a regulatory document confirming substantial equivalence to a predicate device, which allows the new device to be marketed. It generally does not include the granular details of performance studies as would be found in a clinical trial report or a more extensive engineering report. It relies on the assertion that "Extensive performance testing" was conducted.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.

ZOLL Medical Corporation, Worldwide Headquarters Shannon Duhamel Regulatory Affairs Specialist 269 Mill Road Chelmsford, Massachusetts 01824-4105

September 1, 2023

Re: K131919

Trade/Device Name: ZOLL ePCR iOS Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray Tube Display Regulatory Class: Class II Product Code: DXJ

Dear Shannon Duhamel:

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 December 17, 2013. 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2013

ZOLL Medical Corporation Ms. Shannon Duhamel Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824

Re: K131919

Trade/Device Name: ZOLL ePCR iOS Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: II Product Code: DXJ, NSX Dated: November 21, 2013 Received: November 22, 2013

Dear Ms. Duhamel:

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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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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,

Kwame O. Ulmer
-s FDA

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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): ZOLL ePCR iOS Device Name:

Intended Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ X (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)

FDA

Digitally signed by Richard C. Chapman Date: 2013.12.17 12:50:56 -05'00'

Page 1 of 1

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Image /page/4/Picture/1 description: The image shows the word "ZOLL" in bold, black letters. The letters are blocky and sans-serif. A small registered trademark symbol is located to the right of the second "L".

DEC 1 7 2013

EC 17 2013

ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A.

978-421-9655 978-421-0025 Main Fax

510(k) Summary:

Submitter's Name and Address:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655

Contact Person:

Shannon Duhamel

(978) 421-9574

Date Summary Prepared:

June 24, 2013

Device:

ZOLL ePCR iOS

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:

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Intended Use:

Substantial Equivalence:

The features and functions of the proposed ZOLL ePCR iOS are substantially equivalent to the predicate device, ZOLL RescueNet ePCR (K103473), cleared for use on 05/13/2011.

Comparison of Technological Characteristics

ZOLL ePCR iOS features and functions are similar to the predicate device, Zoll RescueNet ePCR, except that the proposed device uses a different operating system. ZOLL ePCR iOS is a software application designed for use on iOS devices whereas the indicated predicate device operates on a tablet or webbased Microsoft Windows system.

Both ZOLL ePCR iOS and the indicated predicate device are software-only products intended for the collection, storage and printing of patient data, including data that is entered by a user (caregiver) and data collected from other medical devices. Both ZOLL ePCR iOS and the indicated predicate device are indicated for use by health care providers whenever there is a need for generation of a patient record. Both the proposed device and the indicated predicate device are designed to synchronize to a data server using a wireless or network connection to import or access saved PCRs for completion at a convenient time. No new issues of safety or effectiveness are raised by this premarket notification.

Performance Testing:

Extensive performance testing ensures that ZOLL ePCR iOS performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications.

Conclusion

The information provided in this 510(k) submission demonstrates that the features and functions of the proposed ZOLL ePCR iOS are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.

ર-Σ

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).