The ELEKTA Microdrive consists of a drive which is connected to the instrument holder of the stereotactic system, the MicroGun that holds the guide tubes and the Electrode holder where the electrodes are fixed. The guide tubes are inserted into the MicroGun and fixed with the lower end of the guidetubes 11 or 21 mm (two different lengths of guide tubes exist) in front of the target point. By moving a sledge with a fine-pitch screw the electrodes are advanced through the guide tubes into the brain. It is possible to position up to five electrodes simultaneously.

AI/ML Overview

I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for the ELEKTA Microdrive, which is a stereotaxic instrument. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, study data, sample sizes, expert involvement, or ground truth establishment. It is a regulatory filing, not a scientific study report.

Summary

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JUL	2
3	2004

K040979

ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document Traditional 5101k1

Utfärdare/Issuer	Anders Skoglund
Ref nr/Dok nr/Ref no/Doc no	Pd106 OEM MER MICRODRIVE FDA
Utgåva /Edition	1
Avser/Regarding	ELEKTA Microdrive
Directory

Section 4- 510(k) Summary

As Required by 21 CFR 807.87(k)510 (k) Summary

Subscribers Name & Address 1.

Elekta Instrument AB Kungstensgatan 18, P:O Box 7593 SE-103 93 Stockholm, Sweden Tel: (011) 46 8 587 254 00 Fax: (011) 46 8 587 255 00 Contact Person for this submission: Mr Anders Skoglund Official Correspondent: Mr Peter Löwendahl

Trade Name 2.

ELEKTA Microdrive

Device Classification 3.

Common Name	Product Code	Class	Regulation Number
Stereotaxic instrument	HAW	II	21 CFR 882.4560

Predicate Device Identification 4.

Legally marketed devices to which equivalence is being claimed	510(k) #
FHC Inc, MicroTargeting® Drive System	K011775
--	--

Other relevant submissions ર .

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------iAmaza Automotive At Alle-Acres College

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K0409/9

ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document Traditional 510lk)

Utfärdare/Issuer	Anders Skoglund
Avser/Regarding	ELEKTA Microdrive
Ref nr/Dok nr/Ref no/Doc no	Pd106 OEM MER MICRODRIVE FDA
Utgåva /Edition	1
	Directory

Device Description (for detailed description see Section "Device Description") 6.

Intended Use 7.

The ELEKTA Microdrive is intended to be used for accurate positioning of electrodes or other devices during stereotactic neurosurgery.

Substantial Equivalence 8

The functionality for the ELEKTA Microdrive is equivalent to its predicate device the FHC Inc, MicroTargeting® Drive System (K011775) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above two wavy lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Mr. Anders Skoglund Regulatory Affairs Engineer Elekta Instrument AB Kungstensgatan 18 P.O. Box 7593 SE-103 93 Stockholm Sweden

Re: K040979

Trade/Device Name: ELEKTA Microdrive Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 24, 2004 Received: June 30, 2004

Dear Mr. Skoglund:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been i that do not require approval of a premarket approval application (PMA). and Cosmetter For (110) that the device, subject to the general controls provisions of the Act. The r ou may, merelore, marrov of the Act include requirements for annual registration, listing of general obtitled provision 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 rr your device is classified to corrols. Existing major regulations affecting your device can may oe subject to Sach additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any i with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 - Mr. Anders Skoglund

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and in Journe FDA finding of substantial equivalence of your device to a legally premarket notification: " results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you deem's specific as Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Economic and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark H. Millican

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Utfärdare/Issuer	Anders Skoglund
Ref nr/Dok nr/Ref no/Doc no	Pd106 OEM MER MICRODRIVE FDA
Avser/Regarding	ELEKTA Microdrive

Dokumentnamn/Name of document
Traditional 510(k)

Utgåva / Edition
1

Directory
-----------

ELEKTA INSTRUMENT AB

Section 7- Indications for Use Statement

510(k) Number	To be defined K040979
Device Name	ELEKTA Microdrive
Indications for Use	The ELEKTA Microdrive is intended to be used for accurate positioning of electrodes or other devices during stereotactic neurosurgery.

X Prescription Use (Part 21 CFR 801 Subpart D)

. .

AND/OR

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

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

Mark A. Milburn

Division of General, Restorative, and Neurological Devices

510(k) Number K040974

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).