(256 days)
Not Found
No
The summary describes image processing and planning tools but does not mention AI, ML, or related terms, nor does it describe features typically associated with AI/ML like automated analysis or prediction based on learned patterns.
No
The device is planning system software for brain stereotactic surgery, assisting in procedures like biopsies and treatment of Parkinson's disease. It does not directly perform a therapeutic action on the patient.
No
The device is described as "planning system software for brain Stereotactic Surgery" and helps the surgeon avoid critical structures, not diagnose diseases.
Yes
The device description explicitly states "WIN-NEUS ™ is planning system software" and details its functions as software-based image processing and planning tools. While it is intended to be used with hardware (Leksell Coordinate G Frame and Leksell Multi Purpose Stereotactic Arc systems), the device itself, as described, is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "planning system software for brain Stereotactic surgery such as biopsies and treatment of Parkinson disease." This describes a tool used during a surgical procedure to guide the surgeon, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces this by detailing image processing, registration, fusion, and planning tools for surgical guidance. It doesn't mention analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or other biological samples. The focus is entirely on image processing and surgical planning.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is clearly related to surgical planning and execution, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
WIN-NEUS is planning system software for brain Stereotactic surgery such as biopsies and treatment of Parkinson disease. The WIN-NEUS is intended to be used with Leksell Coordinate G Frame and Leksell Multi Purpose Stereotactic Arc systems.
Product codes
HAW
Device Description
WIN-NEUS is planning system software for brain Stereotactic Surgery. The user can load image patient studies from different image modalities (CT, MRI, etc) with or without fiducials, register them and define a variety of image fusions among them. A brain Atlas and tools for image segmentation are also available. Image reconstructions in axial, coronal and sagital planes can be used along with image reconstruction in planes along and orthogonal to the proposed track to avoid probe intersection with critical structures or vessels. Win-NEUS is a powerful tool for Stereotactic Surgery such as biopsies and treatment of Parkinson disease.
Stereotactic system definition (stereotactic frame and arc) is input information for the software. Other input information is images studies from the patient of different modalities. At least the reference image study has to be taken with the stereotactic frame in place and with fiducials. Fiducials are used to register the image study against the virtual space defined by the stereotactic frame already inputted at the system. Additional or auxiliary image studies can be registered either with fiducials or co-registered against previously registered image studies without using fiducials.
Once image studies have been registered, a correspondence between coordinates defined on the esterotactic frame in the real patient and points in images displayed by the software are established.
After registering images against the stereotactic frame the user can proceed to plan the stereotactic surgical procedure. He can use images to identify anatomical structures and determine the target, which is the point where the surgeon wants to take the biopsy or wants to locate the tip of a catheter for example. Afterwards the user has to decide the track, which is the intersection of the needle or catheter with the patient in order to avoid critical structures. The software will display image reconstructions with the position of the proposed track superimposed, so that the user can choose the better track.
The Output of the software are the target coordinates to be set on the stereotactic frame and angles to be set on the stereotactic arc for the surgeon to reach the chosen target with the chosen track.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
The proposed device's performance was compared to the predicate device's performance as described in section 10 of this submission. All of the items contained in the tables of section 10 have been found to be substantially equivalent.
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Ko90190
Nuclemed S.A. V. Arredondo 2684-2ª Piso ♦ 1426 Buenos Aires ♦ Argentina Tel: (54) 114896-0989
510(K) SUMMARY
OCT - 9 2009
WIN-NEUS TM
| Date: | July 14th, 2009 |
|---|---|
| ------- | ----------------- |
- Nuclemed S.A. Submitter: V. Arredondo 2684 - 2ª Piso 1426 Buenos Aires - Argentina Phone: (54) 11 4896-0989
- Contact Person: Raymond J Kelly IV Arazy Group 56B Shadowbrook, Dr Hudson, NH 03051 Phone: (603) 595-0095 Fax: (603) 595-0095 E-mail: ray@arazygroup.com
Device Names:
Trade Name: WIN-NEUS TM Stereotactic Surgery Treatment Planning System Common Name: Stereotaxic Instrument Classification Name: Instrument, Stereotaxic
Legally Marketed Device to Which Substantial Equivalence is Claimed:
The WIN-NEUS TM unit is *substantially equivalent (SE) to Leksell SurgiPlan (K033340) cleared in 2004.
*Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infrination [42 Fed. Reg. 42,520 et seq. (1977)].
Device Description:
WIN-NEUS ™ is planning system software for brain Stereotactic Surgery. The user can load image patient studies from different image modalities (CT, MRI, etc) with or without fiducials, register them and define a variety of image fusions among them. A brain Atlas and tools for image segmentation are also available. Image reconstructions in axial, coronal and sagital planes can be used along with image reconstruction in planes along and orthogonal to the proposed track to avoid probe intersection with critical structures or vessels. Win-NEUS is a powerful tool for Stereotactic Surgery such as biopsies and treatment of Parkinson disease.
Traditional Premarket Notification for WIN-NEUS, Nuclemed S.A.
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1
510(K) SUMMARY (CONTINUED)
WIN-NEUS TM
Stereotactic system definition (stereotactic frame and arc) is input information for the software. Other input information is images studies from the patient of different modalities. At least the reference image study has to be taken with the stereotactic frame in place and with fiducials. Fiducials are used to register the image study against the virtual space defined by the stereotactic frame already inputted at the system. Additional or auxiliary image studies can be registered either with fiducials or co-registered against previously registered image studies without using fiducials.
Once image studies have been registered, a correspondence between coordinates defined on the esterotactic frame in the real patient and points in images displayed by the software are established.
After registering images against the stereotactic frame the user can proceed to plan the stereotactic surgical procedure. He can use images to identify anatomical structures and determine the target, which is the point where the surgeon wants to take the biopsy or wants to locate the tip of a catheter for example. Afterwards the user has to decide the track, which is the intersection of the needle or catheter with the patient in order to avoid critical structures. The software will display image reconstructions with the position of the proposed track superimposed, so that the user can choose the better track.
The Output of the software are the target coordinates to be set on the stereotactic frame and angles to be set on the stereotactic arc for the surgeon to reach the chosen target with the chosen track.
Indications For Use:
WIN-NEUS ™ is planning system software for brain Stereotactic surgery such as biopsies and treatment of Parkinson disease. The WIN-NEUS ™ is intended to be used with Leksell Coordinate G Frame and Leksell Multi Purpose Stereotactic Arc systems.
Technological Characteristics Comparison to Predicate Device:
The proposed device was compared to the predicate devices as described in section 9 of this submission. All of the items contained in the tables of section 9 have been found to be substantially equivalent.
Performance Data:
The proposed device's performance was compared to the predicate device's performance as described in section 10 of this submission. All of the items contained in the tables of section 10 have been found to be substantially equivalent.
FOIA: The submission associated with this summary contains FOIA exempt voluntary information concerning the applicant's commercial and/or financial goals and trade secrets. This information is privileged and confidential and is exempt from public disclosure in accordance to FOIA Exemption 4, 21 CFR 20.61, and the "Trade Secrets Act" of Exemption 3. Applicant requests the "Right to Reverse" any FOIA action regarding the submission and a chance to redact the submission's contents as appropriate. Applicant requests a consultation prior to any FOIA release under the provisions in 21 CFR 20 and sections affording similar rights. This 510(k) summary is suitable for public disclosure.
Traditional Premarket Notification for WIN-NEUS, Nuclemed S.A.
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2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)". The caduceus is depicted with a staff and a snake winding around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Nuclemed S.A. c/o Mr. Raymond Kelly, Arazy Group 56B Shadowbrook Dr. Hudson, New Hampshire 03051
OCT - 9 2009
Re: K090190
Trade/Device Name: WIN-NEUS Stereotactic Surgery Treatment Planning System Regulation Number: 21 CFR 882.4560 Regulation Name: Instrument, Stereotaxic Regulatory Class: Class II Product Code: HAW Dated: August 11, 2009 Received: August 11, 2009
Dear Mr. Kelly:
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 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 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.
3
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ohm
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
090190
Nuclemed S.A. V. Arredondo 2684-2ª Piso ♦ 1426 Buenos Aires ♦ Argentina Tel: (54) 114896-0989
INDICATIONS FOR USE
510(k) Number (if known): K090190
WIN-NEUSTM Device Name:
Indications For Use:
NUK
WIN-NEUS ™ is planning system software for brain Stereotactic surgery such as biopsies and treatment of Parkinson disease. The WN-NEUS ™ is intended to be used with Leksell Coordinate G Frame and Leksell Multi Purpose Stereotactic Arc systems.
Prescription Use ﮩ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K090190 510(k) Number
Traditional Premarket Notification for WIN-NEUS, Nuclemed S.A.
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