ZOLL RESCUENETLINK

K111296 · Zoll Medical Corporation, World Wide Headquarters · MSX · Oct 27, 2011 · Cardiovascular

Device Facts

• Record ID: K111296
• Device Name: ZOLL RESCUENETLINK
• Applicant: Zoll Medical Corporation, World Wide Headquarters
• Product Code: MSX · Cardiovascular
• Decision Date: Oct 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

RescueNet Link is intended for use in the collection and display of data that is entered by a user (caregiver), or captured from specified medical devices or from a vehicle navigation system. RescueNet Link is indicated for use by health care providers whenever there is a need for collection and display of patient, care reporting and transport data.

Device Story

RescueNet Link is a software-only EMS data system comprising MobileLink and FieldLink components. MobileLink resides in ambulances, collecting/integrating data from ZOLL patient monitors/defibrillators (E Series), electronic patient care reporting (ePCR) systems, and vehicle navigation systems via hardwired or wireless connections. It displays this data on a touch screen for caregivers. MobileLink transmits data via cellular/internet to a central FieldLink server. FieldLink provides web-based access for hospital emergency department staff to view real-time ambulance location, patient status, and charting information. The system is non-alarming. It facilitates clinical decision-making by providing remote visibility into patient status and transport progress, potentially improving care coordination between EMS and receiving facilities.

Clinical Evidence

Bench testing only. Performance testing demonstrated that the device meets all functional requirements and performance specifications, confirming substantial equivalence to the predicate device.

Technological Characteristics

Software-only system utilizing general-purpose, commercially available computer hardware, networking, and communications equipment. Operates via cellular/internet connectivity. Non-alarming. Designed for integration with ZOLL E Series monitor/defibrillators, RescueNet ePCR, and RescueNet Navigator systems.

Indications for Use

Indicated for use by health care providers for the collection and display of patient, care reporting, and transport data in pre-hospital and in-hospital settings.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Physio-Control (K102757)

Submission Summary (Full Text)

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September 8, 2023

ZOLL Medical Corporation, World Wide Headquarters Charles W. Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, Massachusetts 01824-4105

Re: K111296

Trade/Device Name: ZOLL RescueNet Link Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MSX

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 October 27, 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, [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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

OCT 2 7 2011

ZOLL Medical Corporation c/o Mr. Charles W. Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, MA 01824

Re: K11296

Trade/Device Name: ZOLL RescueNet Link Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MSX, NSX Dated: August 29, 2011 Received: August 31, 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/CDRH0ffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

KK
/ R / R Z

Bram D. Zuckerman, M.D. Director Division of Cardiovascular 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): KII 2 96 RescueNet Link Device Name:

## Indications For Use:

RescueNet Link is intended for use in the collection and display of data that is entered by a user (caregiver), or captured from specified medical devices or from a vehicle navigation user (caregiver), or ouplarou from opson on opeon thealth care providers whenever there is a system. TNCBodonot Link lolay of patient, care reporting and transport data.

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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K111296

Page 1 of 1

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111296 p1 1/3
OCT 27 2011

## 510(k) Summary:

Submitter's Name and Address:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 [phone]

Contact Person:

Charles W. Kolifrath

[phone]

Date Summary Prepared:

August 29, 2011

Device:

RescueNet Link

Classification:

System, Network and Communication, Physiological Monitors. Product Code MSX. Device Class II.

Software, Transmission and Storage, Patient Data. Product code: NSX. Device Class: Not Classified.

#### Description:

The proposed RescueNet Link is a software-only product.

The ZOLL RescueNet Link system is an Emergency Medical Services (EMS) data system that electronically captures and displays patient monitoring, charting and ambulance location and navigation system data within the ambulance and communicates it for display to other locations throughout the pre-hospital and inhospital system of care. The system is comprised of two computer hardware/software based components, MobileLink and FieldLink. Both components use general purpose, commercially available computers, networking and communications hardware combined with software supplied by ZOLL.

The MobileLink component resides within each EMS ambulance where it collects, integrates and displays patient monitoring, care reporting and ambulance location and navigation data on a large, easy to read touch screen display. Patient, care and transport data collected by MobileLink are transmitted to a central FieldLink server via cellular/internet connections. This server

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provides a distribution point from which internet accessible web pages displaying the information collected within each ambulance can be viewed. The FieldLink server also provides each receiving hospital with web pages showing information about the MobileLink-equipped ambulances currently on route to the medical facility and monitoring and charting information about the patients they are transporting.

RescueNet Link is non-alarming software.

### Intended Use:

The RescueNet Link system including its MobileLink and FieldLink subsystems is intended to be used for the following purposes:

### MobileLink

MobileLink is intended to be used for collecting and displaying manually entered information and electronic data output by a ZOLL patient monitor/defibrillator, and by ZOLL patient charting systems and vehicle navigation systems used in EMS ambulances. The system displays information collected within the ambulance and transmits selected portions of that information via cellular/internet connections for display at central EMS headquarters and hospital emergency departments.

MobileLink is intended to be used for the wireless collection of data from ZOLL's E Series monitor/defibrillator. It is also intended to be used for collecting data (either hardwired or wirelessly) from ZOLL RescueNet ePCR electronic patient care reporting system and ZOLL RescueNet Navigator vehicle location system.

The MobileLink sub-system is further intended to store and display (on demand) treatment protocols and other documents defined by the ambulance service's Medical Director.

### FieldLink

The FieldLink sub-system is intended to be used by a single EMS agency to collect patient and transmitted from each of its MobileLink equipped emergency vehicles and to provide internet connected web servers that allow hospital emergency department staff to view information related to the ambulances and patients destined for their facility.

#### Indications For Use:

RescueNet Link is intended for use in the collection and display of data that is entered by a user (caregiver), or captured from specified medical devices or from a vehicle navigation system. RescueNet Link is indicated for use by health care providers whenever there is a need for collection and display of patient, care reporting and transport data.

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## Substantial Equivalence:

The features and functions of the proposed RescueNet Link are substantially The leatures and functions of the physic of the Physio-Control equivalent to the (K102757, cleared for use on 11/5/2010).

. K111296 pg 3/3

# Comparison of Technological Characteristics

RescueNet Link features and functions are similar to the corresponding features RescueNet Link loature and farrodicate device. Both RescueNet Link and the and functions of the indicated products intended for the collection Indicated predicate device are contracts on a user (caregiver) and data collected of data, including uuta that is only issues of safety or effectiveness are raised by this premarket notification.

## Performance Testing:

Extensive performance testing ensures that RescueNet Link performs as well as Extensive performanoo tooling ond meets all of its functional requirements and performance specifications.

#### Conclusion

Performance testing of RescueNet Link demonstrates that its features and f chomanos are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.