ELEKTA MICRODRIVE, MODEL 916716

K040979 · Elekta Instrument AB · HAW · Jul 23, 2004 · Neurology

Device Facts

• Record ID: K040979
• Device Name: ELEKTA MICRODRIVE, MODEL 916716
• Applicant: Elekta Instrument AB
• Product Code: HAW · Neurology
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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

Device Story

The ELEKTA Microdrive is a stereotactic instrument used in neurosurgery. It consists of a drive unit, a MicroGun for holding guide tubes, and an electrode holder. The device attaches to a stereotactic system's instrument holder. Guide tubes are inserted into the MicroGun and positioned near the target point in the brain. A sledge mechanism, operated by a fine-pitch screw, advances up to five electrodes simultaneously through the guide tubes to the target. The device is operated by a neurosurgeon in a clinical setting to facilitate precise electrode placement, aiding in stereotactic neurosurgical procedures.

Clinical Evidence

No clinical data provided; the submission relies on a comparison of technical characteristics and intended use to the predicate device.

Technological Characteristics

Mechanical stereotaxic instrument. Components include a drive unit, MicroGun, and electrode holder. Features a sledge mechanism with a fine-pitch screw for manual advancement of up to five electrodes. Guide tubes available in 11 mm or 21 mm lengths. Device is a non-powered, manual surgical instrument.

Indications for Use

Indicated for accurate positioning of electrodes or other devices during stereotactic neurosurgery in patients undergoing such procedures.

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® Drive System (K011775)

Submission Summary (Full Text)

{0}------------------------------------------------

| 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: [phone] Fax: [phone] 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 .

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>AA A - A 400 AM A<br>19.95<br>------------------<br>Property of Children<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>i<br>1<br>DULCAS<br> | - A Box A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A<br>(1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1<br>t<br>i<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------ |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <br>.<br>AND TYPE<br>------------------------------------<br><br>----------------------------------------------------------------------<br>- LED CARDA<br><br>i<br>Access All All All<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A MONTH LAND OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMN OF COLUMNITY<br>4-4-4-4-4<br> | ------<br>i<br>Amaza Automotive At Alle<br>-<br>Acres College |

{1}------------------------------------------------

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.

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.

### 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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

| 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