MICROTARGETING XL STAR DRIVE SYSTEM

K121950 · FHC, Inc. · HAW · Jul 26, 2012 · Neurology

Device Facts

• Record ID: K121950
• Device Name: MICROTARGETING XL STAR DRIVE SYSTEM
• Applicant: FHC, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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 Story

The microTargeting™ XL STar™ Drive System is a stereotaxic instrument used by neurosurgeons to precisely position intracranial electrodes and instruments during functional neurosurgery. It interfaces with commercially available stereotactic frames via specialized mounting hardware. The system consists of a drive unit, insertion tubes, a verification probe, and cleaning/sterilization accessories. It utilizes a manual or optional motor-driven mechanism to advance instruments into the brain or nervous system. The device provides a position indicator (mechanical or digital) to assist the surgeon in achieving accurate placement. By enabling precise electrode positioning, the system facilitates functional neurosurgical interventions. It is designed for use in clinical settings where stereotactic procedures are performed.

Clinical Evidence

Bench testing only. Performance testing documented in design control verification phases demonstrated equivalence or improvement over the predicate system in mechanical and electrical quietness, ease of use, repeatability, accuracy, rigidity, and adaptability.

Technological Characteristics

Materials: 304 stainless steel (insertion tubes), hardcoated aluminum, stainless steel. Drive mechanism: Manual or optional motor. Travel: 125mm maximum. Connectivity: Interfaces with stereotactic frames (Radionics, Leksell). Sterilization: Steam. Position indicator: Manual, mechanical, or digital readout.

Indications for Use

Indicated for neurosurgical procedures requiring accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Regulatory Classification

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.

Predicate Devices

• FHC, Inc. microTargeting™ STar Drive™ System (K092562)

Submission Summary (Full Text)

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Microelectrodes and Instrumentation for Neuroscience
Research and Clinical microTargeting®

FHC Corporate & Manufacturing
1201 Main Street
Bowdoin, ME 04287-7302 USA
Tel: [phone]
US & Can: 800-326-2905
Fax: [phone]
E-mail: [e-mail]
www.fh-co.com

# SPECIAL 510(k) SUMMARY

FHC, Inc., 1201 Main Street, Bowdoin, Maine 04287 Submitter: Tel: [phone]; Fax: [phone]

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

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.

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#### Intended Use:

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

# Technological Characteristics:

# Comparison Table

| Parameter | microTargeting™ Star<br>Drive™ | microTargeting™ XL Star™<br>Drive |
|--------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------|
| Indications for Use | Accurate positioning of probes in<br>the brain or nervous system | Same |
| Drive mechanism | Manual and/or optional motor<br>drive | Same |
| Biocompatibility | | |
| Drive system &<br>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 digital<br>readout capable | Same |
| Stereotactic frame<br>adapters | Radionics, Leksell, Leibinger<br>RM, Leibinger ZD, M-IGN<br>NeXframe and FHC<br>microTargeting™ Platform | Radionics and Leksell |
| Materials | Hardcoated Aluminum, Stainless<br>Steel | 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

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

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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.

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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 [phone] or [phone] 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

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Page 1 of 1

KI21950 510(k) Number (if known):

Device Name: microTargeting™ XL STar™ Drive System

Indications for Use:

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.

(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)