EVERON CENTRAL DISPLAY STATION (CDS)

K110521 · Earlysense, Ltd. · MSX · Apr 19, 2011 · Cardiovascular

Device Facts

• Record ID: K110521
• Device Name: EVERON CENTRAL DISPLAY STATION (CDS)
• Applicant: Earlysense, Ltd.
• Product Code: MSX · Cardiovascular
• Decision Date: Apr 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The EverOn Central Display Station (CDS) is intended to provide secondary display of the information as displayed on multiple individual bed side monitoring units, on a central remote screen. The EverOn CDS is not intended to replace any part of the bed-side patient monitoring procedures. The system can be used in hospitals or hospital type and clinic environment.

Device Story

EverOn Central Display Station (CDS) acts as secondary remote display for physiological data and alerts from multiple bedside monitoring units; utilizes wired or wireless LAN communication; PC-based system; retrieves and displays bedside data, reports (.CSV, .PDF), and alert information; formats alert messages for transmission to external devices via TCP/IP; used in hospitals/clinics by healthcare staff; provides centralized oversight of patient status; facilitates remote monitoring and printing of reports; benefits patient by enabling centralized monitoring and timely alert notification.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation included hazard analysis, risk assessment, and full load bench testing to confirm communication integrity between bedside units and CDS via wireless LAN.

Technological Characteristics

PC-based central display system; wired and wireless LAN connectivity; TCP/IP communication; software-based application for data retrieval, display, and alert formatting; complies with IEC 60601-1-4, ISO 14971, and IEC 62304 standards.

Indications for Use

Indicated for use in hospital or clinic environments as a secondary remote display for physiological parameters and alerts originating from bedside monitoring units. Not intended to replace primary bedside patient monitoring procedures.

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

• Masimo Safety Net Patient (PSN) system (K071047)
• EverOn Central Display Station (CDS) (K100376)

Submission Summary (Full Text)

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K110521
page 1 of 3

APR 1 9 2011

510(K) SUMMARY

EarlySense Ltd.

# EverOn Central Display System (CDS)

7.1.1 Applicant's Name:

EarlySense Ltd. 12 Tzvi st. Ramat Gan 52504, Israel Tel: [phone] Fax: [phone]

#### 7.1.2 Contact Person:

Dalia Argaman EarlySense Ltd. 12 Tzvi Street. Ramat Gan 52504, Israel Tel: [phone] Fax: [phone] Mail: [e-mail]

#### 7.1.3 Date Prepared:

Feb. 15, 2011

#### 7.1.4 Trade Name:

#### EverOn Central Display Station

#### 7.1.5 Classification Name:

System Network and communication, physiological monitors Medical Specialty / Panel: Cardiovascular Product Code: MSX Class: II Regulation Number: 870.2300

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## 7.1.7 Predicate Devices

The EverOn Central Display Station (CDS) is substantially equivalent to the following:

- 1. Masimo Safety Net Patient (PSN) system, K071047 (Masimo Corporation), Regulation number: 21 CFR 870.2300, System Network and communication, Physiological Monitors; Product code: MSX
- 2. EverOn Central Display Station (CDS) K100376 (EarlySense Ltd) Regulation number: 21 CFR 870.2300, System Network and communication, Physiological Monitors; Product code: MSX

## 7.1.8 Device Description:

The EverOn Central Display Station (CDS) is intended to communicate with multiple EverOn bed-side monitoring devices and remotely display the information as displayed on multiple individual bed side monitoring units, on a central screen. The communication can be performed either via standard wired or via wireless LAN communication.

The transmitted information from Bed-side to CDS includes alert information and physiological parameters. The CDS can also format the alert information as obtained from bed-side units into a message that can be transmitted to external devices that can communicated with the CDS via standard TCP/IP port. Data and report files (.CSV and .PDF) generated at the bed-side units can be retrieved via the CDS by the user and can be downloaded and / or sent for printing from the CDS. The CDS includes standard hardware (PC, communication and IT hardware). EarlySense develops the application software which is used on the system's PC computer (Central Display Station).

## 7.1.9 Intended Use:

The EverOn Central Display Station (CDS) is intended to provide secondary display of the information as displayed on multiple individual bed side monitoring units, on a central remote screen. The EverOn CDS is not intended to replace any part of the bed-side patient monitoring procedures. The system can be used in hospitals or hospital type and clinic environment.

## 7.1.10 Performance Standards:

The EverOn Central Display Station follows and complies with the following standards:

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- Programmable electrical medical system Requirements for safety. EN/IEC 60601-1-4 (2000)
- 트 ANSI / AAMI/ ISO - Application of risk management to medical devices. ISO 14971-1 (2007)
- General Principles of Software Validation; Final Guidance for 트 Industry and FDA Staff, FDA, CDRH, 11/1/02
- 해 IEC 62304:2006 Software Development Life Cycle for medical devices.
- IEC 60812 Ed.2:2006. Analysis technique for system reliability - ■ Procedure for failure modes and effects analysis (FMEA)

## 7.1.12 Performance Data & Substantial Equivalence

The EverOn CDS with wireless communication capability is substantially equivalent in all aspects e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the Masimo Patient Safety Net (PSN) (K071047) and is identical in all aspects to the EverOn Central Display Station (K100376).

#### The modification:

The CDS software was modified to include the capability of wireless communication. The modified System was subjected to the following:

- 제 Hazard analysis was performed, including risk analysis, level and solutions performed for the entire system and software.
- The modified software went through comprehensive software verification and validation testing.
- Full load bench testing was performed to establish the correct . communication between bed-side and CDS and establish the correct performance of the system with wireless communication.

Based on the design verification and validation processes performed as a result of risk assessment and results of the testing performed, EarlySense Ltd. believes that the CDS with wireless communication capability is substantially equivalent to the cleared EverOn CDS where communication utilized only standard wired LAN, without raising new safety and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.

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

EarlySense Ltd. c/o Ms. Dalia Argaman 12 Tzvi Street. Ramat Gan 52504, Israel

APR 1 9 2011

Re: K110521

Device Name: EverOn Central Display Station (CDS) with Wireless Communication Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological monitors network and communication system Regulatory Class: Class II (Two) Product Codes: MSX Dated: March 22, 2011 Received: March 30, 2011

Dear Ms. Argaman:

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.

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

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Page 2 – Ms. Dalia Argaman

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/CDRH/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Cor Bram D. Zuckerman, M.D. C Director Division of Cardiovascular 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):_____________________________________________________________________________________________________________________________________________________

Device Name: EverOn Central Display Station

Indications for Use:

The EverOn Central Display Station (CDS) is intended to provide secondary display of the information as displayed on multiple individual bed side monitoring units, on a central remote screen. The EverOn CDS is not intended to replace any part of the bed-side patient monitoring procedures. The system can be used in hospitals or hospital type and clinic environment.

Prescription Use _ V (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE) Wision Sign-Off)

ivision of Čardiovascular Devices

**510(k) Number** k//0a52/