LEKSELL SURGIPLAN WITH IMAGEMERGE

K033340 · Elekta Instrument AB · HAW · Feb 12, 2004 · Neurology

Device Facts

• Record ID: K033340
• Device Name: LEKSELL SURGIPLAN WITH IMAGEMERGE
• Applicant: Elekta Instrument AB
• Product Code: HAW · Neurology
• Decision Date: Feb 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Leksell SurgiPlan® with ImageMerge™ accessory is a computer system intended for use in planning invasive intra-cranial stereotactic surgical procedures

Device Story

Leksell SurgiPlan with ImageMerge is a computer-based planning system for invasive intra-cranial stereotactic surgery. It processes medical imaging data to assist clinicians in surgical trajectory planning and target localization. Used in clinical settings by neurosurgeons and specialized staff, the system transforms patient image inputs into visual surgical plans. The output allows providers to visualize anatomical structures and plan surgical approaches, facilitating precise instrument placement during stereotactic procedures. This aids in improving surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based stereotactic planning system. Includes ImageMerge accessory for image processing. Operates as a software-based planning tool for neurosurgical guidance.

Indications for Use

Indicated for planning invasive intra-cranial stereotactic surgical procedures in patients requiring such interventions.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines emanating from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Mr. Peter Löwendahl Elekta Instrument AB Birger Jarlsgatan 53 P.O. Box 7593 Stockholm, Sweden SE-103 93

Rc: K033340

Trade/Device Name: Leksell Elekta SurgiPlan Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Codc: HAW Dated: January 9, 2004 Reccived: January 15, 2004

Dear Mr. Löwendahl:

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 such 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 docs 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); 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. Peter Löwendahl

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of 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 Manufacturers, International 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,

Miriam C. Provost

Colia 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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## Indications for Use

510(k) Number (if known): K033340

Device Name:__________________________________________________________________________________________________________________________________________________________________

The Leksell SurgiPlan® with ImageMerge™ accessory is a computer Indications For Use: system intended for use in planning invasive intra-cranial stereotactic surgical procedures

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam L Provost

(Division Sign-Off Division of General, Restorative, and Neurological Devices

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KO33340 510(k) Number_