SIREN EPCR SUITE

K131272 · Medusa Medical Technologies, Inc. · DXJ · Jan 3, 2014 · Cardiovascular

Device Facts

• Record ID: K131272
• Device Name: SIREN EPCR SUITE
• Applicant: Medusa Medical Technologies, Inc.
• Product Code: DXJ · Cardiovascular
• Decision Date: Jan 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2450
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for 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.

Device Story

Siren ePCR Suite is a software-only medical data collection system; operates on commercial off-the-shelf hardware (desktop/tablet PCs). Inputs include manual user entry and data captured from medical devices (e.g., monitor/defibrillators). System stores, prints, and integrates data into electronic patient care reports (ePCR). Used by paramedics/EMTs in pre-hospital settings. Features include data encryption, audit trails for database changes, and interfaces with CAD/dispatch, billing, and hospital systems via HL7. Facilitates clinical documentation and record generation; benefits include standardized patient data management and improved information exchange between pre-hospital providers and hospitals.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical software verification and validation testing, including hazard analysis and risk mitigation, confirming the device performs as intended.

Technological Characteristics

Software-only system; runs on Windows XP/7 or Windows Server 2003/2008. Connectivity via internet for data sync; supports HL7 interoperability. Features include data encryption, electronic signature support, and integration with external drug monograph databases (e.g., MicroMedix). Non-alarming software.

Indications for Use

Indicated for use by qualified medical personnel (paramedics/EMTs) providing direct patient care in pre-hospital environments to document care and generate patient records.

Regulatory Classification

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.

Predicate Devices

• RescueNet ePCR (K103473)

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone] 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: [phone] Office Phone: [phone] Fax: [phone] Contact: Diane Sudduth, Senior Consultant, QA Email: [e-mail]

#### 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

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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 | Predicate<br>RescueNet ePCR | New Device<br>Siren ePCR Suite™ |
| 510(k) Number | K103473 | Not assigned |
| Product Code | DJX<br>NSX | DJX<br>NSX |
| Regulation Number | 870.2450<br>Null | 870.2450<br>Null |
| Regulation Name | Display, Cathode Ray Tube,<br>Medical | Display, Cathode Ray<br>Tube, Medical |
| Indications for Use | Software, Transmission and<br>Storage, Patient Data<br>RescueNet ePCR is intended for<br>the collection, storage and<br>printing of patient data that is<br>entered by a user (caregiver), or<br>captured from specified medical<br>devices, and integrated into a<br>patient care report (patient<br>electronic medical record). | Software, Transmission and<br>Storage, Patient Data<br>Siren ePCR Suite™ is intended<br>for the collection, storage and<br>printing of patient data that is<br>entered by a user (paramedic),<br>or captured from specified<br>medical devices, and integrated<br>into a patient care report<br>(patient electronic medical record). |
| Manufacturer | Zoll Medical Corporation | Medusa Medical Technologies Inc. |
| Trade Name | Predicate<br>RescueNet ePCR | New Device<br>Siren ePCR Suite™ |
| | RescueNet ePCR is intended for use<br>by qualified medical personnel providing direct<br>patient care in the pre-hospital environment to document the<br>care provided. RescueNet ePCR<br>is indicated for use by health<br>care providers whenever there<br>is a need for generation of a<br>patient record. | record). Siren ePCR Suite™ is<br>intended for use by qualified<br>medical personnel providing<br>direct patient care in the pre-<br>hospital environment to<br>document the care provided.<br>Siren ePCR Suite™ is indicated<br>for use by health care providers<br>whenever there is a need for<br>generation of a patient record. |
| Material | Software | Software |
| System Requirements | | |
| Compatible operating<br>system (software only) | Windows XP Professional | Field User: Windows XP or XP<br>Tablet Edition SP3 or Windows<br>7 SP1; SQL Express 2005 SP3<br><br>Server: Windows Server 2003<br>R2 SP3; SQL Server 2005 SP3 /<br>SQL Server 2008 SP3<br><br>.NET Framework |
| Web-Based Application<br>(Locally installed vs.<br>vendor server based) | WebPCR module provides a<br>web based access when<br>connected to web browser or<br>WebPCR server. | Web based Administration and<br>Workflow. Store and forward<br>communication from tablet to<br>server. |
| Hardware | | |
| Compatibility and system<br>requirements | | |
| Desktop PC | Yes | Yes |
| Tablet PC | Yes | Yes |
| Pocket PC/Palm device<br>compatible | Yes | No |
| Internet connection<br>required at all time or<br>only during data sync | Only during data sync from<br>mobile devices | Only during data sync from<br>mobile devices |
| Printer compatibility | Yes, can print locally or across a<br>network | Yes, can print locally or across a<br>network |
| Wireless access supported<br>(ie Verizon/sprint WWAN) | Yes | Yes |
| Manufacturer | Zoll Medical Corporation | Medusa Medical Technologies Inc. |
| Trade Name | Predicate<br>RescueNet ePCR | New Device<br>Siren 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-Control<br>LifePak 11 monitor/defibrillator,<br>LifePak 12/15<br>monitor/defibrillator,<br>LifePak 500<br>monitor/defibrillator;<br>Philips<br>HeartStart MRx;<br>Zoll<br>1600,<br>AED Plus/AED Pro,<br>M Series/E Series | Physio-Control<br>LifePak 12/15<br>monitor/defibrillator<br>Philips<br>HeartStart MRx<br>Zoll<br>M 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 Technologies<br>Inc. |
| Trade Name | Predicate | New Device |
| | RescueNet ePCR | Siren ePCR Suite™ |
| Additional Features | | |
| Electronic Signature<br>Support | Yes | Yes |
| Ability to link reference<br>documents (protocols) | Yes | Yes |
| Ability to populate patient<br>info from previous patient<br>contact | Yes | Yes |
| Drug Monograph<br>database | No | Yes via integration with existing<br>commercial drug monograph<br>providers (MicroMedix) |
| Use environment | EMT, paramedic | EMT, paramedic |
| Intended users<br>(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.