(23 days)
Not Found
No
The description focuses on mechanical and electrical components for precise positioning, with no mention of AI or ML capabilities. The firmware mentioned is likely for controlling the drive travel based on user input, not for learning or adaptive functions.
No
The device is a system that aids in the accurate positioning of instruments during neurosurgical procedures, rather than directly providing a therapeutic effect itself.
No
This device is used for precise positioning of instruments in the brain during neurosurgical procedures, not for identifying a medical condition.
No
The device description explicitly lists multiple hardware components including the drive itself, insertion tubes, verification probe, sterilization case, cleaning brushes, and mounting hardware. While it mentions controller firmware, the core of the device is clearly hardware-based.
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 describes a surgical tool used in vivo (within a living organism).
- Device Description: The description reinforces its use in positioning instruments during functional neurosurgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be used within the body for surgical manipulation or positioning.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HAW
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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.
1
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
Drive™ | microTargeting™ XL 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 | Maximum of 125mm |
| Sterilization | Steam | Steam |
| Position Indicator | Manual, mechanical and/or digital
readout capable | Same |
| Stereotactic frame
adapters | Radionics, Leksell, Leibinger
RM, Leibinger ZD, M-IGN
NeXframe and FHC
microTargeting™ Platform | Radionics and Leksell |
| Materials | Hardcoated Aluminum, Stainless
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.
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:
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)