Siren ePCR Suite™ is intended for the collection, storage and printing of patient data that is entered by a user (paramedic), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). Siren ePCR Suite™ is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. Siren ePCR Suite™ is indicated for use by health care providers whenever there is a need for generation of a patient record.

Device Description

Siren ePCR Suite™ is a software-only product. Siren ePCR Suite™ 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). Siren ePCR Suite™ is non-alarming software that runs on a variety of commercial off-the-shelf hardware.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Siren ePCR Suite™" device. It focuses on establishing substantial equivalence to a predicate device ("RescueNet ePCR"). This type of submission generally does not include detailed performance studies with acceptance criteria, sample sizes, or expert adjudication in the way that an AI/ML device would be proven to meet performance claims.

Based on the provided text, the device is a software-only product classified as a "Medical Cathode-ray Tube Display" (regulatory class II) with the product codes DXJ and NSX. Its intended use is for the collection, storage, and printing of patient data entered by paramedics or captured from specified medical devices, integrated into a patient care report in a pre-hospital environment.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) against which the device's performance was measured for clinical effectiveness. The "reported device performance" is primarily framed around the comparison of technological characteristics to a predicate device and the successful completion of non-clinical software testing.

The acceptance criteria mentioned are general:

"The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended."
"The testing results supports that all specifications have met the acceptance criteria of each module and interaction of processes."
"Siren ePCR Suite™ device passed all testing and supports the claims of substantial equivalence and safe operation."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. This was a non-clinical software verification and validation study, not a clinical study involving patient data with a test set in the conventional sense of AI/ML performance evaluation. The "test set" refers to software testing scenarios, not a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Given that this was a functional software verification and validation, ground truth would be established by reference to the software design specifications and expected system behavior, rather than expert consensus on medical cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No mention of an adjudication method for a test set, as no clinical test set for diagnostic or predictive performance was used.

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. The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This device is a data collection and storage system, not an AI/ML device designed to assist human readers or perform diagnostic interpretations.

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

No. The device is a "software-only product" for data collection, storage, and printing, running on commercial off-the-shelf hardware. Its function is to facilitate the documentation of care by qualified medical personnel, not to provide standalone analytical performance in the way an AI/ML algorithm would.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" was the device's "established Software Design Specifications." The software was tested to ensure it performed as intended according to these specifications and to mitigate identified hazards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed using a training set.

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

Not applicable. As there was no training set, there was no ground truth for a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Medusa Medical Technologies Inc. c/o Dr. Diane Sudduth Senior Consultant QA Emergo Group, Inc. 816 Congress Ave., Suite 1400 Austin. Texas 78701

September 1, 2023

Re: K131272

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

Dear Dr. Diane Sudduth:

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 January 3, 2014. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

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

January 3, 2014

Medusa Medical Technologies, Incorporated C/O Dr. Diane Sudduth Senior Consultant, QA Emergo Group, Incorporated 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K131272

Trade/Device Name: Medical Technologies, Inc. Siren ePCR Suite Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: II Product Code: DXJ, NSX Dated: November 18, 2013 Received: November 19, 2013

Dear Dr. Sudduth:

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 (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 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/Resourcesfor You/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/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,

Mary S. Runner -S

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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Indications for Use Statement

510(k) Number (if known): K131272

Device Name: Siren ePCR Suite™

Indications for Use:

Prescription Use_ ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman Date: 2014.01.02 1 1:33:26 -05'00'

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Medusa Medical Technologies Inc. Traditional 510(k) Premarket Submission Siren ePCR Suite™

EMERGO GROUP

510(k) Summary

1. Submission Sponsor

Medusa Medical Technologies Inc. Suite 140-36 Solutions Dr Halifax, Nova Scotia B3S 1N2 Canada Phone: (902) 429-1200 Fax: (902) 484-5583 Contact: Craig Fraser, VP of Sales and Product Management

2. Submission Correspondent

Emergo Group, Inc. 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (561) 305-5075 Office Phone: (512) 327-9997 Fax: (512) 327-9998 Contact: Diane Sudduth, Senior Consultant, QA Email: project_management@emergogroup.com

3. Date Prepared

May 2, 2013

4. Device Identification

Medusa Medical Technologies, Inc. Siren ePCR Suite™ Trade/Proprietary Name: Common/Usual Name: Siren ePCR Display, Cathode Ray Tube, Medical Classification Name: Classification Regulation: 870.2450 DX1: NSX Product Code: Device Class: Class II Classification Panel: Cardiovascular; General Hospital

5. Predicate Devices

K103473 Zoll Medical Corporation - RescueNet ePCR

6. Device Description

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electronic medical record). Siren ePCR Suite™ is non-alarming software that runs on a variety of commercial off-the-shelf hardware.

7. Intended Use

Siren ePCR Suite™ is intended for the collection, storage and printing of patient data that is entered by a user (paramedics), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). Siren ePCR Suite™ is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. Siren ePCR Suite™ is indicated for use by health care providers whenever there is a need for generation of a patient record.

8. Comparison of Technological Characteristics

The following table compares the Siren ePCR Suite™ to the predicate device with respect to intended use, overall technological and functional characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.

The Siren ePCR Suite™ is similar in design and function to the predicate device for the modes of operation and use.

Manufacturer	Zoll Medical Corporation	Medusa Medical Technologies Inc.
Trade Name	PredicateRescueNet ePCR	New DeviceSiren ePCR Suite™
510(k) Number	K103473	Not assigned
Product Code	DJXNSX	DJXNSX
Regulation Number	870.2450Null	870.2450Null
Regulation Name	Display, Cathode Ray Tube,Medical	Display, Cathode RayTube, Medical
Indications for Use	Software, Transmission andStorage, Patient DataRescueNet ePCR is intended forthe collection, storage andprinting of patient data that isentered by a user (caregiver), orcaptured from specified medicaldevices, and integrated into apatient care report (patientelectronic medical record).	Software, Transmission andStorage, Patient DataSiren ePCR Suite™ is intendedfor the collection, storage andprinting of patient data that isentered by a user (paramedic),or captured from specifiedmedical devices, and integratedinto a patient care report(patient electronic medical record).
Manufacturer	Zoll Medical Corporation	Medusa Medical Technologies Inc.
Trade Name	PredicateRescueNet ePCR	New DeviceSiren ePCR Suite™
	RescueNet ePCR is intended for useby qualified medical personnel providing directpatient care in the pre-hospital environment to document thecare provided. RescueNet ePCRis indicated for use by healthcare providers whenever thereis a need for generation of apatient record.	record). Siren ePCR Suite™ isintended for use by qualifiedmedical personnel providingdirect patient care in the pre-hospital environment todocument the care provided.Siren ePCR Suite™ is indicatedfor use by health care providerswhenever there is a need forgeneration of a patient record.
Material	Software	Software
System Requirements
Compatible operatingsystem (software only)	Windows XP Professional	Field User: Windows XP or XPTablet Edition SP3 or Windows7 SP1; SQL Express 2005 SP3Server: Windows Server 2003R2 SP3; SQL Server 2005 SP3 /SQL Server 2008 SP3.NET Framework
Web-Based Application(Locally installed vs.vendor server based)	WebPCR module provides aweb based access whenconnected to web browser orWebPCR server.	Web based Administration andWorkflow. Store and forwardcommunication from tablet toserver.
Hardware
Compatibility and systemrequirements
Desktop PC	Yes	Yes
Tablet PC	Yes	Yes
Pocket PC/Palm devicecompatible	Yes	No
Internet connectionrequired at all time oronly during data sync	Only during data sync frommobile devices	Only during data sync frommobile devices
Printer compatibility	Yes, can print locally or across anetwork	Yes, can print locally or across anetwork
Wireless access supported(ie Verizon/sprint WWAN)	Yes	Yes
Manufacturer	Zoll Medical Corporation	Medusa Medical Technologies Inc.
Trade Name	PredicateRescueNet ePCR	New DeviceSiren ePCR Suite™
Security
Data encryption	Yes	Yes
Ability to lock PCR once completed	Yes	Yes
Tracks changes to module databases, including date, time, computer and user who made the change	Yes	Yes
Data Exchange
Interface to server (Data synchronization)	Yes, wireless or hard wired	Over internet connection
Interface with CAD/Dispatch	Yes	Yes
Interface with Hospitals (Fax, email/etc., direct sync, etc.)	Yes	Yes
Interface with Hospital Pre-Alert	Yes	Yes
Interface with Billing	Yes	Yes
Interface with Medical Equipment	Physio-ControlLifePak 11 monitor/defibrillator,LifePak 12/15monitor/defibrillator,LifePak 500monitor/defibrillator;PhilipsHeartStart MRx;Zoll1600,AED Plus/AED Pro,M Series/E Series	Physio-ControlLifePak 12/15monitor/defibrillatorPhilipsHeartStart MRxZollM Series/E Series
EKG Integration	Yes	Yes
Mobile-to-mobile data transfer	Yes	Yes
Interfaces to electronic record (EHR) / HL7	Yes	Yes
Manufacturer	Zoll Medical Corporation	Medusa Medical TechnologiesInc.
Trade Name	Predicate	New Device
	RescueNet ePCR	Siren ePCR Suite™
Additional Features
Electronic SignatureSupport	Yes	Yes
Ability to link referencedocuments (protocols)	Yes	Yes
Ability to populate patientinfo from previous patientcontact	Yes	Yes
Drug Monographdatabase	No	Yes via integration with existingcommercial drug monographproviders (MicroMedix)
Use environment	EMT, paramedic	EMT, paramedic
Intended users(target population)	Professional Users	Professional Users

Table 5A - Comparison of Characteristics

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Medusa Medical Technologies Inc. Traditional 510(k) Premarket Submission Siren ePCR Suite™

EMERGO G GROUP

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9. Non-Clinical Testing

The device's software development, verification and validation have been carried out in accordance with the FDA's guidance documents. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended.

The device Hazard analysis was completed and risk control implemented to mitigate hazards. The testing results supports that all specifications have met the acceptance criteria of each module and interaction of processes. Siren ePCR Suite™ device passed all testing and supports the claims of substantial equivalence and safe operation.

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a new device is substantially equivalent to a predicate device when the device has the same intended use as the previously cleared predicate device and either (i) the same technological characteristics as the predicate, or (ii) if the new device has different

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technological characteristics, then those differences raise no new issues regarding the safety or effectiveness of the new device.

It has been shown in this 510(k) submission that Siren ePCR Suite™ has the same intended use as the predicate device and that any technological differences between the Siren ePCR Suite™ software and the predicate device do not raise any questions regarding Siren ePCR Suite™'s safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that Siren ePCR Suite™ software is substantially equivalent to the relevant aspects of the predicate device in terms of design, principals of operation, performance characteristics, and intended use. The Siren ePCR Suite™ software, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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).