Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a data collection and reporting system, with no mention of AI or ML capabilities, image processing, or training/test sets typically associated with AI/ML development.

Therapeutic

No
The device is a software-only product for collecting, storing, and printing patient data for patient care reports. It does not provide any therapy or treatment.

Diagnostic

No

This device is described as a "medical data collection system" that gathers and stores patient information from user input or other medical devices to create a patient care report. It does not analyze patient data to determine a medical condition or disease.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Siren ePCR Suite™ is a software-only product."

IVD (In Vitro Diagnostic)

Based on the provided information, Siren ePCR Suite™ is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Siren ePCR Suite™ Function: The description clearly states that Siren ePCR Suite™ is a software-only product intended for the collection, storage, and printing of patient data entered by a user or captured from specified medical devices. It's essentially an electronic patient care report system.
Lack of Specimen Analysis: There is no mention of the device analyzing biological specimens or providing diagnostic information based on such analysis. Its purpose is to document patient care, not to perform laboratory tests.

Therefore, Siren ePCR Suite™ falls under the category of a medical device, but not specifically an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DXJ, NSX

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.

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

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.
Intended users (target population): Professional Users
Use environment: EMT, paramedic

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

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K103473

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

1

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:

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.

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

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

5

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	Predicate
RescueNet ePCR	New Device
Siren ePCR Suite™
510(k) Number	K103473	Not assigned
Product Code	DJX
NSX	DJX
NSX
Regulation Number	870.2450
Null	870.2450
Null
Regulation Name	Display, Cathode Ray Tube,
Medical	Display, Cathode Ray
Tube, Medical
Indications for Use	Software, Transmission and
Storage, Patient Data
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).	Software, Transmission and
Storage, Patient Data
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).
Manufacturer	Zoll Medical Corporation	Medusa Medical Technologies Inc.
Trade Name	Predicate
RescueNet ePCR	New Device
Siren ePCR Suite™
	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.	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.
Material	Software	Software
System Requirements
Compatible operating
system (software only)	Windows XP Professional	Field User: Windows XP or XP
Tablet Edition SP3 or Windows
7 SP1; SQL Express 2005 SP3

Server: Windows Server 2003
R2 SP3; SQL Server 2005 SP3 /
SQL Server 2008 SP3

Table 5A - Comparison of Characteristics

6

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

EMERGO G GROUP

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

•

:

7

•

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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

9

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.