WINDSURFER

K050561 · Medcon , Ltd. · DQK · May 4, 2005 · Cardiovascular

Device Facts

• Record ID: K050561
• Device Name: WINDSURFER
• Applicant: Medcon , Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Windsurfer is a system for acquiring, digitizing, storing, displaying and reviewing hemodynamic data (vital signs). The Windsurfer is intended for use in hospital cardiac catheterization laboratories.

Device Story

Windsurfer is a hemodynamic monitoring system for cardiac catheterization labs. It acquires vital sign data via ECG leads, invasive blood pressure transducers, SpO2 finger clips, and NIBP cuffs. The system digitizes, displays, stores, and processes these signals alongside patient information imported from hospital systems. It provides tools for manual entry of measurements, calculations, and procedure notes. Operated by a certified technician using a touch screen, keyboard, and mouse, the system presents waveforms and numeric values to the performing physician. The physician uses this real-time data to monitor patient status during procedures, facilitating clinical decision-making and documentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hemodynamic monitoring system; inputs include ECG, invasive blood pressure, SpO2, and NIBP. Features touch screen, keyboard, and mouse interface. Connectivity includes integration with hospital information systems. Software-based processing for data acquisition, display, and storage.

Indications for Use

Indicated for patients undergoing cardiac catheterization procedures in hospital settings requiring hemodynamic monitoring of vital signs.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• VERICIS Physiolog (K013032)

Submission Summary (Full Text)

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510(k) Notification for Windsurfe

#### Summary of Safety and Effectiveness 4.

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## Submitter:

Medcon Ltd. 3 Tevuot Ha'aretz Street, Tel Aviv 69546. Israel Tel: [phone] Fax: [phone]

## Predicate Device(s)

Windsurfer is substantially equivalent to the VERICIS Physiolog (K013032).

## Name of the Device:

Windsurfer

#### Description of the Device:

Windsurfer is a standard hemodynamic monitoring system for monitoring vital signs before, during and after catheterization procedures. Windsurfer is intended to acquire, display, store, analyze and process vital signs and log all cath lab activity. There are tools for entering measurements, calculations and procedure notes. Windsurfer also acquires patient information from other hospital information systems and makes hemodynamic information available to them.

Windsurfer is connected to a patient in the cath lab via:

- ECG leads .
- Invasive Blood Pressure transducers .
- . SpO2 finger clip
- NIBP cuff .

Windsurfer uses an intuitive interface that clearly displays patient data, procedure data, waveforms and numeric values. The performing physician views the monitor in the cath lab and conveys instructions and procedure notes to the certified technician, who operates the application using a touch screen, keyboard and mouse, for maximum convenience.

3 " ( ) = Angers, che and

February 27, 2005

Date

Uzi Blumensohn Chief Executive Officer, Medcon Ltd.

Image /page/0/Picture/25 description: The image shows the logo for Medcon Telemedicine Technology. The word "Medcon" is written in large, bold, black letters. Below the word "Medcon" is the phrase "Telemedicine Technology" written in a smaller font size.

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Public Health Service

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MAY - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medcon, Ltd. c/o Dr. Eli M. Orbach International Regulatory Consultants POB 6718 Efrat 90435 ISRAEL

Re: K050561

K050501
Trade Name: Windsurfer Hemodynamic Monitoring System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: February 27, 2005 Received: March 3, 2005

Dear Dr. Orbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section > ro(t) presidentially equivalent (for the indications felerenced above and nave december of a legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manent date of the Medical Device American be of Drys. commerce proof to May 20, 1976, the enational with the provisions of the Federal Food. Drug, devices that have occh recalison in accera approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosmelle Act (Act) that do not require approvise the general controls provisions of the Act. The You may, therefore, market the devices, books of the works for annual registration, listing of general controls provisions of the rest 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 If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Feach Regaring your device in the Federal Register.

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Page 2 – Dr. Eli M. Orbach

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oe advised that I Dri 3 issuantes vour device complies with other requirements of the Act mat IDA has made a determinations administered by other Federal agencies. You must of ally I cuclar statutes and regulations, including, but not limited to: registration and listing (21 Comply will an the rive orequirements)01); good manufacturing practice requirements as set CTN in the quality systems (21 OFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section ) our device as described in your Section 510(k) I ins letter will anow you to begin maticoling of substantial equivalence of your device to a legally premarket notincation. The PDF mismig of casification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific aurice for your avoil 2001 276-0120. Also, please note the regulation entitled, contact the Office of Company of Set notification" (21CFR Part 807.97) you may obtain. IMisoranding of reference to presses in the Act may be obtained from the Outler general information on your respectional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dvina R. Vachner

Image /page/2/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a combination of curved and angular lines. The symbol is dark and stands out against a white background, suggesting it was written with a pen or marker.

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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510(k) Notification for Windsurfer

5-2

# Indications for Use

510(k) Number (if known): KΩ گان کان

Device Name: Windsurfer

Indications For Use:

The Windsurfer is a system for acquiring, digitizing, storing, displaying and reviewing hemodynamic data (vital signs). The Windsurfer is intended for use in hospital cardiac catheterization laboratories.

Prescription Use

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(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)

Nuna R. Holmes
(Division Sign-Off)

Division Ci Čardiovascular Devices

Image /page/3/Picture/16 description: The image shows the logo for Medcon Telemedicine Technology. The word "Medcon" is in large, bold, black letters. Below the word "Medcon" is the phrase "Telemedicine Technology" in smaller, white letters on a black background.

510(k) Number K 65