The FHC microTargeting™ XL STar™ Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Device Description

When used in conjunction with commonly available stereotactic systems, the microTargeting "M XL STar™ Drive System allows a neurosurgeon to precisely position intracranial microelectrodes, stimulating electrodes, lesion electrodes and other instruments during functional neurosurgical procedures.

microTargeting™ XL STar™ Drive System Components

microTargeting™ XL STarTM Drive .
insertion tubes
verification probe ●
sterilization case ●
cleaning brushes .

Device Mounting Hardware and other Components
Additional components for device mounting include hardware specifically designed to interface between the microTargeting™ XL STar™ Drive system and other stereotactic frames or instruments, and also include optional components to increase utility.

Adapters to fit Radionics and Leksell stereotactic systems .
microTargeting controller firmware based on user specifications of drive travel.

AI/ML Overview

This document is a 510(k) summary for the FHC microTargeting™ XL STar™ Drive System, a medical device. The purpose of this summary is to demonstrate substantial equivalence to a predicate device, not to present a comprehensive study proving the device meets specific acceptance criteria in the context of a typical AI/software performance study.

Therefore, many of the requested items (e.g., sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, specific acceptance criteria for a clinical study) are not applicable or not provided in this type of regulatory submission. The submission focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device to establish substantial equivalence.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" in the format typically seen for algorithm performance studies with numerical metrics like sensitivity, specificity, or accuracy. Instead, it uses a "Comparison Table" to demonstrate substantial equivalence based on technological characteristics and states that performance testing documented in verification phases shows "equivalence or improvement" over the predicate.

Parameter	Acceptance Criteria (Implied: Equivalent or Improved vs. Predicate)	Reported Device Performance (microTargeting™ XL Star™ Drive)
Indications for Use	Same as predicate	Same
Drive mechanism	Same as predicate	Same
Biocompatibility (Drive system & Accessories)	No contact with tissue (same as predicate)	No contact with tissue (same)
Biocompatibility (Insertion Tubes)	304 stainless steel (same as predicate)	304 stainless steel (same)
Travel	Equivalent or improved, specifically, increased from 50mm	Maximum of 125mm (Improved, larger travel)
Sterilization	Steam (same as predicate)	Steam (same)
Position Indicator	Manual, mechanical and/or digital readout capable (same as predicate)	Same
Stereotactic frame adapters	Equivalent or improved, specifically, compatible with Radionics and Leksell	Radionics and Leksell (Note: The predicate lists more adapters; the XL version appears to have a more focused compatibility initially, but this is assessed as "equivalent" overall).
Materials	Hardcoated Aluminum, Stainless Steel (same as predicate)	Same
General Performance	Equivalent or improved over predicate	Documented in verification phases to be equivalent or improved in ease of manufacturing, mechanical and electrical quietness, ease of use, repeatability, accuracy, rigidity, and adaptability.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As a 510(k) for a hardware device, the "performance testing" refers to engineering and design verification/validation directly on the device, not clinical data or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable to this type of device submission. There is no clinical "ground truth" to establish in the context of this 510(k) summary, as it describes a mechanical stereotaxic instrument.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not done and is not applicable. This is not an AI-assisted device for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. The "performance testing" for this device likely involved engineering measurements and tests (e.g., measuring travel distance, repeatability, accuracy of positioning) against design specifications, rather than clinical ground truth from patient data.

8. The sample size for the training set

This is not applicable. This is a hardware device; there is no "training set" in the machine learning sense.

9. How the ground truth for the training set was established

This is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the letters "FHC" in a bold, textured font. The letters are arranged horizontally, with "F" on the left, "H" in the middle, and "C" on the right. The texture of the letters gives them a slightly rough or patterned appearance.

Microelectrodes and Instrumentation for Neuroscience
Research and Clinical microTargeting®

FHC Corporate & Manufacturing
1201 Main Street
Bowdoin, ME 04287-7302 USA
Tel: 207-666-8190
US & Can: 800-326-2905
Fax: 207-666-8292
E-mail: fhciric@ih-co.com
www.fh-co.com

SPECIAL 510(k) SUMMARY

FHC, Inc., 1201 Main Street, Bowdoin, Maine 04287 Submitter: Tel: 207-666-5651; Fax: 207-666-8539

Contact Person: Keri Seitz

Date of Summary Preparation: June 28, 2012

Trade Name: microTargeting™ XL STar™ Drive System

Common Name: Stereotaxic instrument

Classification Name: Stereotaxic instrument (21 CFR 882.4560, Product Code HAW)

Substantially Equivalent To: FHC, Inc. microTargeting™ STar Drive™ System K092562, September 18, 2009

Description:

1.121950

microTargeting™ XL STar™ Drive System Components

microTargeting™ XL STarTM Drive .
insertion tubes
verification probe ●
sterilization case ●
cleaning brushes .

Device Mounting Hardware and other Components

Additional components for device mounting include hardware specifically designed to interface between the microTargeting™ XL STar™ Drive system and other stereotactic frames or instruments, and also include optional components to increase utility.

Adapters to fit Radionics and Leksell stereotactic systems .
microTargeting controller firmware based on user specifications of drive travel.

{1}------------------------------------------------

Intended Use:

Technological Characteristics:

Comparison Table

Parameter	microTargeting™ StarDrive™	microTargeting™ XL Star™Drive
Indications for Use	Accurate positioning of probes inthe brain or nervous system	Same
Drive mechanism	Manual and/or optional motordrive	Same
Biocompatibility
Drive system &Accessories	No contact with tissue	Same
Insertion Tubes	304 stainless steel	Same
Travel	50 mm	Maximum of 125mm
Sterilization	Steam	Steam
Position Indicator	Manual, mechanical and/or digitalreadout capable	Same
Stereotactic frameadapters	Radionics, Leksell, LeibingerRM, Leibinger ZD, M-IGNNeXframe and FHCmicroTargeting™ Platform	Radionics and Leksell
Materials	Hardcoated Aluminum, StainlessSteel	Same

Performance testing

Performance testing of the microTargeting™ XL STar™ Drive System documented in the verification phases of design control (See Section 10 and APPENDIX C of this document) show the system to be equivalent or improved over the predicate system in ease of manufacturing, mechanical and electrical quietness, ease of use, repeatability, accuracy, rigidity, and adaptability.

Substantial Equivalence statement:

The microTargeting™ XL STar™ Drive System is substantially equivalent in design, construction, materials, intended use and performance characteristics to its predicate

{2}------------------------------------------------

4121950
P. 3 of 3

device, the FHC microTargeting™ STar Drive™ System, which was cleared under 510(k) K092562, September 18, 2009.

. . . .

く

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 26 2012

FHC. Incorporated % Ms. Keri Seitz President and CEO 1201 Main Street Bowdoin, Maine 04287

Re: K121950

Trade/Device Name: microTargeting™ XL STar Drive™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 28, 2012 Received: July 3, 2012

Dear Ms. Seitz:

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). and Coometer for (110) in 10. (110) in the general controls provisions of the Act. The r ou may, alere, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and advileerstion. 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.

{4}------------------------------------------------

Page 2 - Ms. Keri Seitz

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/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/MedicalDevices/Safety/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Eula A. Rumm, MD, of

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

KI21950 510(k) Number (if known):

Device Name: microTargeting™ XL STar™ Drive System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121950

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

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).