ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)

K120253 · Elcam Medical Acal · DRG · Jul 16, 2012 · Cardiovascular

Device Facts

• Record ID: K120253
• Device Name: ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
• Applicant: Elcam Medical Acal
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

Elcam Vital Signs Wireless System is indicated for use on patients requiring pressure monitoring. Elcam Vital Signs Wireless System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

Device Story

The Elcam Vital Signs Wireless System replaces physical cables between disposable pressure transducers and bedside patient monitors. The system consists of a remote transmitter unit that connects to a disposable transducer and a receiver unit that attaches to the bedside monitor. It utilizes Bluetooth® communication protocol to transmit physiological pressure signals wirelessly. Used in hospital settings such as operating rooms, critical care units, emergency rooms, and catheterization labs, the system allows for cable-free monitoring. Healthcare providers receive pressure data on the existing bedside monitor, facilitating clinical decision-making by maintaining continuous pressure monitoring without the constraints of fixed-length, multi-conductor cables.

Clinical Evidence

The submission includes performance results and clinical data to support substantial equivalence. Specific metrics, sample sizes, or study designs are not detailed in the provided text.

Technological Characteristics

The system utilizes Bluetooth® wireless communication to transmit physiological pressure signals. It consists of a remote transmitter unit and a receiver unit designed to interface with disposable pressure transducers and bedside monitors. The device is intended for use in hospital environments. No specific materials, ASTM standards, or software algorithm classes are detailed in the provided documentation.

Indications for Use

Indicated for patients requiring pressure monitoring. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• Hospira Vital Signs Wireless Monitoring System (K090610)

Submission Summary (Full Text)

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JUL 16 2012

# 510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92

#### Submitter Information

Elcam Medical A.C.A.L. Kibbuts BarAm, M.P. Merom HaGalil, 13860, Israel Tel: [phone], Fax: [phone]

## Submission contact person:

Ilan Sharon P.O.B. 4414 (A-109), Caesarea 30889, Israel TEL: [phone]

# Device Classification

| Proprietary Device Name: | Elcam Vital Signs Wireless System |
|----------------------------|------------------------------------------------------------------|
| Common name: | Radiofrequency physiological signal transmitter and receiver |
| Product Code: | DRG |
| Classification Name: | Transmitters and receivers, physiological signal, radiofrequency |
| Classification Regulation: | 21 CFR § 870.2910 |
| Regulatory Class: | II |

#### Identification of Legally Marketed Predicate Devices

Hospira. Vital Signs Wireless Monitoring System - K090610

#### Device Description

Elcam Vital Signs Wireless System utilizes the Bluetooth® communications Protocol in order to eliminate the multi-conductor, fixed length and shielded reusable cables that typically acts as the interface between the patient's bedside monitor and disposable transducer. The disposable transducer will simply plugs into the system's remote transmitter unit, which sends its output signal to the system's receiver unit affixed to the bedside monitor.

The wireless system is intended to operate at varying distances to accommodate typical layouts that exist within hospital operating rooms, critical care units, emergency rooms and catheterization lab suites.

## Intended Use of Device

Elcam Vital Signs Wireless System is indicated for use on patients requiring pressure monitoring. Elcam Vital Signs Wireless System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

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## Safety & Effectiveness

The proposed and predicate devices are similar in design, materials of construction, components, intended use and labeling.

Based on the performance results provided (including test results and clinical data) and the analysis of similarities and differences presented above, Elcam Medical believes that the proposed device safe & effectiveness is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues.

#### Rational for Substantial Equivalency

Elcam Vital Signs Wireless System is substantially equivalent to the predicate device with respect to the following characteristics:

- I . Wireless transmission of physiological characteristics from the patient to the receiver monitor units.
- 2. Replaces the existing cabling between disposable physiological transducers and bedside monitors in hospital settings.
- 3. Utilization of the Bluetooth® Technology for wireless transmission of physiological signals.

The claim for substantial equivalence is supported by the information provided in the 510(k) submission

# Substantial Equivalence Statement

Based on the above, it is Elcam Medical's opinion that the proposed Vital Signs Wireless System is substantially equivalent in terms design principles, performance features and of safety & effectiveness to the legally cleared predicate device (K090610) referred to in chapter 4 of this 510(K) submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

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

JUL 16 2012

Elcam Medical A.C.A.L. c/o Ilan Sharon Submission Correspondent P.O.Box 4262 Zichron Yaacov Israel, 30900

Re: K120253

Trade/Device Name: Elcam Vital Signs Wireless System™ (VSWS) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: June 14, 2012 Received: June 19, 2012

Dear Mr. Sharon:

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.

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 - Mr. Ilan Sharon

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 (OS) 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,

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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# Indications for Use

510(k) Number (if known): Κλώρ. Σ. 3

Device Name: Elcam Vital Signals Wireless System

Indications for Use:

Elcam Vital Signs Wireless System is indicated for use on patients requiring pressure monitoring.

Elcam Vital Signs Wireless System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) Division of Cardiovascular Devices |
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| 510(k) Number | K120253 |
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