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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Elcam Vital Signs Wireless System's acceptance criteria and studies:

Assessment of the Provided Information:

The document is a 510(k) summary for a medical device (Elcam Vital Signs Wireless System). 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than undergoing extensive de novo clinical trials with established acceptance criteria and detailed performance metrics.

Therefore, much of the requested information (like specific acceptance criteria, detailed study designs, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance with explicit metrics like sensitivity/specificity, or training set ground truth details) is not typically found in a 510(k) summary focused on substantial equivalence.

The document does mention "performance results provided (including test results and clinical data)" but does not provide the specifics of these results or the acceptance criteria for those tests. It highlights a reliance on the equivalence to the predicate device (Hospira. Vital Signs Wireless Monitoring System - K090610).

Based on the provided text, here's what can be extracted and what is missing or explicitly not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, explicit, quantified acceptance criteria and specific numerical performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the device's clinical operation are not detailed in this summary. Instead, the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate device, especially in design, materials, components, intended use, and labeling. The core "performance" reported is its ability to perform wireless transmission of pressure information, similar to existing methods.

Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (as stated in the summary)
Wireless transmission of physiological characteristics from the patient to the receiver monitor units.	The device utilizes Bluetooth® communications Protocol to eliminate multi-conductor cables and sends its output signal to the receiver unit.
Replaces existing cabling between disposable physiological transducers and bedside monitors in hospital settings.	The device eliminates the multi-conductor, fixed length and shielded reusable cables acting as the interface.
Utilization of Bluetooth® Technology for wireless transmission of physiological signals.	The device utilizes the Bluetooth® communications Protocol.
Safe & effective performance equivalent to the predicate device (Hospira Vital Signs Wireless Monitoring System - K090610).	"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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a sample size for any clinical or performance test set with explicit metrics.
Data Provenance: The document mentions "performance results provided (including test results and clinical data)" but does not detail the provenance (e.g., country of origin, retrospective/prospective nature) of this data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not provided in the 510(k) summary. For devices relying on substantial equivalence, ground truth is often established by adherence to existing engineering standards, bench testing, and comparisons to the predicate device's established performance, rather than a reader study with expert adjudication.

4. Adjudication Method for the Test Set

This information is not provided as there is no described reader study or expert-adjudicated test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC study was not described. This device is a wireless transmission system for physiological signals, not an AI-assisted diagnostic or interpretive tool that would involve human readers and AI assistance. Therefore, this question is not applicable to the Elcam Vital Signs Wireless System described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document implies that performance testing was done on the device's ability to transmit signals, which would be a form of "standalone" functional testing. However, specific details of such standalone performance (e.g., latency, signal integrity, transmission range, battery life in various scenarios, and their acceptance criteria) are not provided in this summary. The focus is on demonstrating its functional equivalence to a wired system and the predicate wireless system.

7. The Type of Ground Truth Used

The implicit "ground truth" for this substantial equivalence submission appears to be the established performance and safety of the predicate device (Hospira Vital Signs Wireless Monitoring System - K090610), along with adherence to relevant engineering and performance standards for wireless communication and medical devices (which would be detailed in other sections of the full 510(k) submission, not this summary). Bench testing results and clinical data were stated to be provided, implying functional validation against expected outputs from transducers and acceptable display on monitors.

8. The Sample Size for the Training Set

This information is not applicable as the described device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware device utilizing a communication protocol.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of a stylized graphic to the left of the text "Elcam MEDICAL". Below the text is a tagline that is difficult to read due to the image quality.

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: (972) 4 6988120/1/2, Fax: (972) 4 6980777

Submission contact person:

Ilan Sharon P.O.B. 4414 (A-109), Caesarea 30889, Israel TEL: 972-52-8704904

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

Intended Use of Device

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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.
1. Replaces the existing cabling between disposable physiological transducers and bedside monitors in hospital settings.
1. 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 (800) 638-2041 or (301) 796-7100 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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Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).