(206 days)
Not Found
No
The summary describes a stereotactic system that uses software to create patient-customized fixtures from scanned images for accurate instrument positioning. While it involves image processing and planning, there is no mention of AI, ML, or related concepts like training or test sets for algorithmic performance evaluation. The focus is on mechanical accuracy and software-assisted planning based on anatomical structures.
No.
The device is described as a "Stereotactic System" intended for "accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system" and to "facilitate microelectrode recording, stimulation, data collection, device implantation and other surgical procedures." It does not directly provide therapy but rather assists in procedures that might involve therapeutic interventions.
No
The device is described as a "Stereotactic System" intended for accurately positioning instruments during neurosurgical procedures. Its primary function is to facilitate precise targeting and instrument placement, not to diagnose conditions or diseases. While it uses "scanned patient images" and "planning software" to create a "Stereotactic Platform Adapter," this information is used for procedural guidance, not for diagnostic interpretation of the images themselves.
No
The device description clearly states that the WayPoint™ Stereotactic System consists of multiple hardware components (Anchor System, Platform Adapter, mounting hardware) in addition to the software. While the software is a crucial part of the system, it is not the sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system." This describes a surgical guidance and positioning system used during a surgical procedure on a patient.
- Device Description: The description details components like anchors, platform adapters, and mounting hardware designed to be secured to the skull and hold surgical instruments. This is consistent with a surgical device, not a device used to examine specimens in vitro (outside the body).
- Anatomical Site: The device is used on the "brain or nervous system," which is an anatomical site within the living patient. IVDs analyze specimens taken from the body (like blood, urine, tissue samples) but not the body itself.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory tests.
The device is a surgical stereotactic system used for precise instrument placement during neurosurgery. This falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The WayPoint™ Stereotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, implantable electrodes or other instruments in the brain or nervous system.
Product codes
84 HAW, HAW
Device Description
The WayPoint™ Stereotactic System (WPS System) accurately locates and rigidly supports neurosurgical or other surgical instruments relative to specific anatomical structures or targets, thus facilitating microelectrode recording, stimulation, data collection, device implantation and other surgical procedures. The WPS System provides patient-customized stereotactic fixtures designed to be secured on skull-based anchor mounting sets to hold and align surgical instruments with patient anatomy and to allow selected targets to be reached with sub-millimeter accuracy. The WPS System consists of several components that work together to become a stereotactic system. These components are:
-
- the WayPoint™ Stereotactic Anchor System:
-
- the WayPoint™ Stereotactic Platform Adapter:
-
- Device mounting hardware for the Platform; and,
-
- WayPoint™ compatible Planning software such as:
- a. WayPoint™ Planner; or,
- b. VoXim®Planning software.
The WayPoint™ Stereotactic Anchor/Locator System provides tools and components for the temporary implantation of anchors to be used as reference points and mounting sets for the surgical procedure. The WPS System software designs a Stereotactic Platform Adapter that will mount to the WayPoint™ Stereotactic Anchor System. For each surgical instrument or device to be mounted to the Stereotactic Platform Adapter, suitable hardware is provided to act as a secure interface and allow flexibility in targeting, if required. The two existing software components of the WPS System (WayPoint™ Planner and VoXim® microTargeting™ Planning software) provide tools to create a Stereotactic Platform Adapter from scanned patient images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanned patient images (implied CT images based on performance studies)
Anatomical Site
Brain or nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Both phantom- and imaging-based studies were conducted in order to evaluate the accuracy of the WPS System. Results from the phantom-based study showed that the Stereotactic Platform Adapter produced by the WPS System is accurate to a submillimetric level. Using the WPS System, a comparison of intraoperative stereotactic coordinates of an implant to its position in postoperative CT images demonstrated accuracies comparable to those of conventional frames. Finally, in a study that compared preoperative target selection and final placement verification based on CT images, error measurements were comparable to those for the same procedure as described by other groups using a standard stereotactic frame.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003776, K961120, K080250, K972324
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
K0921.92
Image /page/0/Picture/1 description: The image shows the letters FHC in a bold, sans-serif font. The letters are black, and the background is white. The letters appear to be slightly distorted, as if they have been copied or scanned. The letters are arranged horizontally, with the F on the left, the H in the middle, and the C on the right.
FEB 1 2 2010
Microelectrodes and Instrumentation for Neuroscience
Research and Clinical microTargetingTM
FHC Corporate & Manufacturing
1201 Main Street
Bowdoin, ME 04287-7302 USA
Tel: 207-666-8190
US & Can.: 800-326-2905
Fax: 207-666-8539
E-mail: fhcinc@fh-co.com
www.fh-co.com
510(k) SUMMARY
(Per 807.92 510(k) content instructions)
A. Summarv
(1) Submitter's name, address, telephone number, a confact person and date summary was prepared:
FHC, Inc. 1201 Main Street Bowdoin, Maine 04287 · Tel: 207-666-5651 Fax: 207-666-8539 Contact: Lee D. Margolin, MS, PhD. January 12, 2010
. (2) Name(s) of device:
Proprietary/Trade Name: WavPoint™ Stereotactic System Common Name: Stereotaxic instrument Classification Name: Stereotaxic instrument (21 CFR 882.4560) Product Code (84 HAW)
Legally Marketed Predicate Devices to which submitter claims (3) substantial equivalence:
The WayPoint™ Stereotactic System functionality is claimed to be substantially equivalent to the following:
-
FHC, Inc. microTargeting 100 Drive System (K003776; decision date: February 23, 2001; product code HAW).
-
Howmedica Leibinger, Inc. Ost-Reg Marker System (K961120; decision date: May 10. 1996; product code HAW).
-
Elekta Instruments AB Leksell SurgiPlan (K080250; decision date: May 13, 2008; product code HAW).
-
Elekta Instruments AB Leksell Stereotactic System (K972324; decision date: March 2. 1998; product code HAW).
Description of device: (4)
The WayPoint™ Stereotactic System. (WPS System) accurately locates and rigidly supports neurosurgical or other surgical instruments relative to specific anatomical structures or targets, thus facilitating microelectrode recording, stimulation, data collection, device implantation and other surgical procedures. The WPS System provides patient-customized stereotactic fixtures designed to be secured on skull-based anchor mounting sets to hold and
1
align surgical instruments with patient anatomy and to allow selected targets to be reached with sub-millimeter accuracy. The WPS System consists of several components that work together to become a stereotactic system. These components are:
-
- the WayPoint™ Stereotactic Anchor System:
-
- the WayPoint™ Stereotactic Platform Adapter:
-
- Device mounting hardware for the Platform; and,
-
- WayPoint™ compatible Planning software such as:
- a. WayPoint™ Planner; or,
- b. VoXim®Planning software.
The WayPoint™ Stereotactic Anchor/Locator System provides tools and components for the temporary implantation of anchors to be used as reference points and mounting sets for the surgical procedure. The WPS System software designs a Stereotactic Platform Adapter that will mount to the WayPoint™ Stereotactic Anchor System. For each surgical instrument or device to be mounted to the Stereotactic Platform Adapter, suitable hardware is provided to act as a secure interface and allow flexibility in targeting, if required. The two existing software components of the WPS System (WayPoint™ Planner and VoXim® microTargeting™ Planning software) provide tools to create a Stereotactic Platform Adapter from scanned patient images.
Statement of intended use: (5)
The WayPoint™ Stereotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, implantable electrodes or other instruments in the brain or nervous system.
(6) Comparison of Technological Characteristics to Predicate Devices:
The WayPoint™ Stereotactic System is substantially equivalent to the predicate devices in design, construction, materials, intended use and performance characteristics. No new issues of safety or effectiveness are introduced in the use of this device.
B. Performance data
Both phantom- and imaging-based studies were conducted in order to evaluate the accuracy of the WPS System. Results from the phantom-based study showed that the Stereotactic Platform Adapter produced by the WPS System is accurate to a submillimetric level. Using the WPS System, a comparison of intraoperative stereotactic coordinates of an implant to its position in postoperative CT images demonstrated accuracies comparable to those of conventional frames. Finally, in a study that compared preoperative target selection and final placement verification based on CT images, error measurements were comparable to those for the same procedure as described by other groups using a standard stereotactic frame.
2
Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The logo is black and white and appears to be a scan of a document.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 1 2 2010 -
FHC, Inc. c/o Lee D. Margolin, M.S., Ph.D. Director of Research and Compliance Quality System Officer 1201 Main Street Bowdoin, ME 04287-7302
Re: K092192
Trade/Device Name: WayPoint™ Stercotactic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 15, 2010 Received: January 19, 2010
Dear Dr. Margolin:
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, Or ve 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Lee D. Margolin, M.S., Ph.D.
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 (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.
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/CDRHQffices/ucm11.5809.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/ReportuProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erik Finholt
Malvina B. Eydelman, N Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K092192
Device Name: WayPoint™ Stercotactic System
Indications for Use:
The WayPoint™ Stercotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microclectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
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)
R.J. Hrom
Page _________________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092192