(62 days)
Not Found
No
The summary describes a standard hemodynamic monitoring system with data acquisition, display, storage, and basic analysis capabilities. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
No
A therapeutic device is used to treat a disease or condition. The Windsurfer is a monitoring system that acquires, displays, and stores vital signs; it does not provide any treatment.
Yes
The device "acquires, displays, stores, analyzes and processes vital signs" in a hospital cardiac catheterization laboratory setting. While it doesn't make a diagnosis directly, the analysis and processing of vital signs for patient monitoring during a medical procedure are part of a diagnostic and treatment pathway, providing critical information to the physician for diagnostic and clinical decisions. Its intended use in a "hospital cardiac catheterization laboratory" for monitoring vital signs "before, during and after catheterization procedures" further supports its role in aiding diagnosis and procedure management.
No
The device description explicitly states that the Windsurfer system is connected to a patient via hardware components such as ECG leads, invasive blood pressure transducers, SpO2 finger clip, and NIBP cuff. This indicates it is a hardware-software system, not software-only.
Based on the provided information, the Windsurfer device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Windsurfer's Function: The Windsurfer system acquires, digitizes, stores, displays, and reviews hemodynamic data (vital signs) directly from the patient through external sensors (ECG leads, blood pressure transducers, SpO2 clip, NIBP cuff). It is monitoring physiological signals in vivo (within the living body), not analyzing samples in vitro (in a test tube or lab setting).
The Windsurfer is a patient monitoring system used in a clinical setting to observe and record vital signs during cardiac catheterization procedures. This falls under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
DQK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital cardiac catheterization laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: +972 3 648 7702 Fax: +972 3 647 8593
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.
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1
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.
2
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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dvina R. Vachner
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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
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510(k) Number K 65