(29 days)
Not Found
No
The summary describes a mechanical system for precise positioning of instruments during neurosurgery and does not mention any AI or ML components or functions.
No
The device is described as a system for precise positioning of instruments in the brain or nervous system, not for therapy itself. It facilitates neurosurgical procedures but does not administer therapeutic treatment.
No
Explanation: The device is described as a system for precise positioning of instruments during neurosurgical procedures, not for diagnosing conditions. Its purpose is to guide and place instruments, not to detect or identify diseases.
No
The device description explicitly lists multiple hardware components, including the STar Drive itself, probes, cases, brushes, and various mounting hardware and adapters. This indicates it is a physical device with software potentially playing a role in its function, but it is not solely software.
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 device is for "accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system" during neurosurgical procedures. This is a surgical tool used in vivo (within the living body).
- Device Description: The description details mechanical components used for precise positioning of instruments within the brain. It does not mention any components or processes related to testing samples of biological material in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, assays, or any other typical components or functions of an IVD device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument for precise placement within the body.
N/A
Intended Use / Indications for 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.
Product codes
HAW
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 tube kit and depth stops
- . custom microelectrode depth stops
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain or nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical procedures
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
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.
Key Metrics
Not Found
Predicate Device(s)
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
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:
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.
1
- 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 probes | |
| in the brain or nervous system | Same | |
| Drive mechanism | Manual and/or optional motor drive | Same |
| Biocompatibility | ||
| Drive 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/or | |
| digital readout capable | Same | |
| Stereotactic frame adapters | Radionics, Leksell, Leibinger RM, | |
| Leibinger ZD, M-IGN NeXframe | ||
| FHC 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.
2
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.
:
:
:
3
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.
4
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
5
Indications for Use
510(k) Number (if known): K092562
Device Name: microTargeting™ STar Drive™ System
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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of
(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