The FHC microTargeting™ STar Drive™ System is intended to be used with commercially available positioning 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™ STar Drive™ System allows a neurosurgeon to precisely position intracranial microelectrodes, stimulating electrodes, lesion electrodes and other instruments during functional neurosurgical procedures.

microTargeting™ STar Drive™ System Components

microTargeting™ STar Drive™ .
optional lower guide .
lead holder with lead /lesion stop .
. 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 TM STar Drive™ system and other stereotactic frames or instruments, and also include optional components to increase utility.

Adapters to fit Radionics, Leksell, Leibinger RM, Leibinger ZD. . FHC MicroTargeting™ Platform and Medtronic-IGN NeXframe stereotactic systems
♥ single electrode insertion tube set
. array electrode insertion tube set
. lesion insertion kit and depth stops
. custom microelectrode depth stops

AI/ML Overview

The provided document, K092562, is a Special 510(k) Summary for the FHC microTargeting™ STar Drive™ System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed acceptance criteria and standalone algorithm performance.

Here's an analysis based on the provided text, addressing your questions to the best of its ability:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or a dedicated table for device performance in the way a de novo device might. Instead, it relies on demonstrating equivalence to a predicate device and states that performance testing documented in "verification and validation phases of design control" shows the device is "equivalent or improved" over the predicate.

The table in the document is a "Comparison Table" highlighting technological characteristics similarities, not acceptance criteria for performance.

Parameter	Predicate Device Performance (microTargeting™ Drive)	Proposed Device Performance (microTargeting™ STar Drive™)
Indications for Use	Accurate positioning of probes in the brain or nervous system	Same (Accurate positioning of probes in the brain or nervous system)
Drive mechanism	Manual and/or optional motor drive	Same (Manual and/or optional motor drive)
BiocompatibilityDrive system & Accessories	No contact with tissue	Same (No contact with tissue)
Insertion Tubes	304 stainless steel	Same (304 stainless steel)
Travel	50 mm	Same (50 mm)
Sterilization	Steam; ethylene oxide	Steam
Position Indicator	Mechanical and/or digital readout capable	Same (Mechanical and/or digital readout capable)
Stereotactic frame adapters	Radionics, Leksell, Leibinger RM, Leibinger ZD, M-IGN NeXframe, FHC microTargeting™ Platform	Same (Radionics, Leksell, Leibinger RM, Leibinger ZD, M-IGN NeXframe, FHC microTargeting™ Platform)
Materials	Hardcoated Aluminum, Stainless Steel	Same (Hardcoated Aluminum, Stainless Steel)
Other Performance (General Statement)	Implied satisfactory performance as a legally marketed device.	"equivalent or improved over the predicate system 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 Data Provenance

The document does not specify a "test set" in the context of clinical or performance data for the purpose of establishing a new device's efficacy through primary studies. This is a 510(k) submission, specifically a Special 510(k), which streamlines the process for certain device modifications. The focus is on demonstrating equivalence to the predicate device (FHC microTargeting™ Drive System K003776).

The "Performance testing" mentioned refers to "verification and validation phases of design control" which would typically involve engineering tests, bench tests, and possibly simulated use, rather than a clinical human test set. Therefore, there is no mention of country of origin or whether data was retrospective or prospective in detail.

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

Not applicable. This type of submission for a mechanical stereotaxic instrument does not involve establishing ground truth through expert consensus on medical images or diagnoses, as would be the case for an AI/algorithm-based diagnostic device. The performance evaluation is based on engineering principles and comparison to a predicate.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" in the sense of clinical cases requiring expert adjudication, no adjudication method is described.

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

Not applicable. The device is a mechanical stereotaxic instrument, not an AI or imaging diagnostic algorithm. Therefore, an MRMC study related to interpretation or AI assistance is not relevant to this submission.

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

Not applicable. The device is a mechanical system and does not involve a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be established through engineering specifications, measurements, and validation against known standards for mechanical accuracy, repeatability, and rigidity. For example, accuracy could be validated against a known target in a phantom. The document implies that such testing was performed during design control ("verification and validation phases"), but it does not detail the specific methodology or "ground truth" used for each aspect (e.g., "accuracy").

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical instrument and does not involve a "training set" for an algorithm.

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

Not applicable. As there is no training set for an algorithm, the concept of establishing its ground truth is not relevant to this submission.

Summary of the K092562 document regarding acceptance criteria and studies:

The document primarily demonstrates substantial equivalence to an existing predicate device (K003776) by showing that the new device has the same intended use and similar technological characteristics, materials, and performance. The performance section broadly states that internal "verification and validation phases of design control" showed the device to be "equivalent or improved" in several mechanical and usability aspects (ease of manufacturing, mechanical and electrical quietness, ease of use, repeatability, accuracy, rigidity, and adaptability).

However, it does not provide:

Specific, quantifiable acceptance criteria.
Detailed reports of specific performance studies (e.g., a clinical trial, a detailed bench study with a specified number of samples).
Any information regarding human-in-the-loop studies, multi-reader studies, AI performance, or data provenance in the context of clinical evaluation.

This is typical for a 510(k) submission for a non-AI, mechanical device that is substantially equivalent to a predicate, where the focus is on engineering verification/validation and comparison rather than new clinical efficacy trials or AI performance metrics.

Summary

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K092562

SEP 1 8 2009

Microelectrodes and Instrumentation for Neuroscience
Research and Clinical microTargeting

FHC Corporate & Manufacturing
1201 Main Stree!
Bowdom, ME 04287-7302 USA
Tel. 207-666-8190
US & Can 800-326-2905
Fax 207-656-8292
E-mail fhcinc@fh.co.com
www.th-co.com

SPECIAL 510(k) SUMMARY

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

Contact Person: Lee D. Margolin, MS, PhD.

Date of Summary Preparation: August 19, 2009

Trade Name: microTargeting™ STar Drive™ System

Common Name: Stereotaxic instrument

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

Substantially Equivalent To: FHC, Inc. microTargeting™ Drive System K003776, February 23, 2001

Description:

microTargeting™ STar Drive™ System Components

microTargeting™ STar Drive™ .
optional lower guide .
lead holder with lead /lesion stop .
. 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 TM STar Drive™ system and other stereotactic frames or instruments, and also include optional components to increase utility.

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Adapters to fit Radionics, Leksell, Leibinger RM, Leibinger ZD. . FHC MicroTargeting™ Platform and Medtronic-IGN NeXframe stereotactic systems
♥ single electrode insertion tube set
. array electrode insertion tube set
. lesion insertion tube kit and depth stops
. custom microelectrode depth stops

Intended Use:

The FHC microTargeting™ 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

Technological Characteristics:

Comparison Table

Parameter	microTargeting™ Drive	microTargeting™ STar Drive™
Indications for Use	Accurate positioning of probesin the brain or nervous system	Same
Drive mechanism	Manual and/or optional motor drive	Same
BiocompatibilityDrive system & Accessories	No contact with tissue	Same
Insertion Tubes	304 stainless steel	Same
Travel	50 mm	Same
Sterilization	Steam; ethylene oxide	Steam
Position Indicator	Mechanical and/ordigital readout capable	Same
Stereotactic frame adapters	Radionics, Leksell, Leibinger RM,Leibinger ZD, M-IGN NeXframeFHC microTargeting™ Platform	Same
Materials	Hardcoated Aluminum, Stainless Steel	Same

Performance testing

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

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Substantial Equivalence statement:

. .

The microTargeting™ STar Drive™ System is substantially equivalent in design, construction, materials, intended use and performance characteristics to its predicate device, the FHC microTargeting™ Drive System, which was cleared under 510(k) K003776, February 23, 2001.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines.

SEP 1 8 2009

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

FHC, Inc c/o Lee Margolin, MS, PhD Senior Associate Director of Research & Development Quality System Officer 1201 Main Street Bowdoin, Maine 04287

Re: K092562

Trade/Device Name: microTargeting™ STar Drive™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 19, 2009 Received: August 20, 2009

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, 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 (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.

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Page 2 - Dr. Lee Margolin

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,

Kesia Alexander for

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

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Indications for Use

510(k) Number (if known): K092562

Device Name: microTargeting™ STar Drive™ System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nath Kohm

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

510(k) Number K092562

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).