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.

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:

1. the WayPoint™ Stereotactic Anchor System:
1. the WayPoint™ Stereotactic Platform Adapter:
1. Device mounting hardware for the Platform; and,
1. 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.

AI/ML Overview

The provided document describes the WayPoint™ Stereotactic System and references performance data to support its substantial equivalence claim. However, it does not explicitly state acceptance criteria or provide a detailed study report that includes all the requested information for acceptance criteria and device performance in a structured format.

The document summarizes performance data rather than presenting it in detail.

Here's an attempt to extract the relevant information based only on the provided text, while also highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly stated in predefined numerical targets (e.g., "accuracy > X mm")	Phantom-based study: Stereotactic Platform Adapter produced by the WPS System is accurate to a submillimetric level.
Not explicitly stated in predefined numerical targets	Intraoperative comparison study: Accuracies comparable to those of conventional frames when comparing intraoperative stereotactic coordinates of an implant to its position in postoperative CT images.
Not explicitly stated in predefined numerical targets	Preoperative target selection/final placement verification study: Error measurements comparable to those for the same procedure as described by other groups using a standard stereotactic frame.

Missing from the table: Specific numerical acceptance criteria (e.g., "Accuracy must be within 0.5 mm") are not provided. The reported performance is qualitative ("submillimetric," "comparable").

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

Sample Size (Test Set): Not specified. The document states "phantom- and imaging-based studies were conducted," but does not give the number of phantoms, images, or cases used in these studies.
Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.
- The 510(k) submission is from FHC, Inc. in Bowdoin, Maine, USA.
- It is not stated whether the studies were prospective or retrospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: Not explicitly stated or described. The document mentions "accuracies comparable to those of conventional frames" and "error measurements were comparable to those for the same procedure as described by other groups using a standard stereotactic frame," which implies a comparison, but it does not detail a formal MRMC study design comparing human readers with and without AI assistance to determine an "effect size." The device itself is a stereotactic system, not an AI for human reader assistance in diagnostic tasks.

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

Standalone Performance: The description of the phantom-based study ("Stereotactic Platform Adapter produced by the WPS System is accurate to a submillimetric level") can be interpreted as a standalone performance assessment of the system's physical and software-driven accuracy in a controlled environment. The "imaging-based studies" comparing coordinates and error measurements also relate to the system's standalone performance in achieving target accuracy.

7. Type of Ground Truth Used

For Phantom-based study: Likely the known physical dimensions and target locations of the phantom, measured with a high-precision reference system. This would be known physical truth.
For Imaging-based studies:
- Comparison of "intraoperative stereotactic coordinates of an implant to its position in postoperative CT images" suggests comparing the device's predicted/achieved coordinates with the actual, visible position on a postoperative imaging modality (CT), which serves as the ground truth for actual placement.
- Comparison of "preoperative target selection and final placement verification based on CT images" also implies using CT images as the basis for both planning and verifying outcomes.

8. Sample Size for the Training Set

Training Set Sample Size: Not specified. The document describes the system's performance but does not provide details on the development or training of any software components within the WPS System, nor does it refer to separate "training" and "test" sets in the context of machine learning model development. This device predates widespread explicit mention of training sets for AI in 510(k) summaries.

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

Ground Truth for Training Set: Not specified, as training set details are absent.

Summary

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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)

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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:

1. the WayPoint™ Stereotactic Anchor System:
1. the WayPoint™ Stereotactic Platform Adapter:
1. Device mounting hardware for the Platform; and,
1. 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.

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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.

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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

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Indications for Use

510(k) Number (if known): K092192

Device Name: WayPoint™ Stercotactic System

Indications for Use:

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

Regulation Number and Section

§ 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).