MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM

K031980 · Elekta Instrument AB · HAW · Jul 25, 2003 · Neurology

Device Facts

• Record ID: K031980
• Device Name: MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
• Applicant: Elekta Instrument AB
• Product Code: HAW · Neurology
• Decision Date: Jul 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Leksell Stereotactic System with disposable biopsy needle kit Indications for Use is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

Device Story

Leksell Stereotactic System is a mechanical apparatus for intracranial localization and surgical guidance. Used in clinical settings by neurosurgeons for biopsy, surgical intervention, and radiotherapy planning. Device provides a rigid frame and coordinate system to ensure precise targeting of intracranial structures. System includes a disposable biopsy needle kit for tissue sampling. Operates via mechanical alignment and spatial referencing to anatomical targets identified through imaging. Facilitates accurate delivery of therapeutic radiation or surgical instruments to specific intracranial coordinates. Benefits include enhanced precision in targeting intracranial lesions, minimizing damage to surrounding healthy tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical stereotactic frame system; includes disposable biopsy needle kit. Operates as a manual surgical instrument for spatial localization. No electronic, software, or energy-based components described.

Indications for Use

Indicated for localization, diagnosis, and surgical treatment of intracranial disorders, including radiotherapy and stereotactic radiation therapy.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a bird or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2003

Mr. Peter Löwendahl Quality and Regulatory Affairs Manager Elekta Instrument AB P.O. Box 7593 S-103 93 Stockholm SWEDEN

Re: K031980

Trade/Device Name: Leksell Stereotactic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: 84 HAW Dated: May 15, 2003 Received: June 26, 2003

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. Iisting 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); 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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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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ELEKTA LEKSELL STEREOTACTIC SYSTEM® Special Premarket 510(k) Notification: Device Modification

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## Indications for Use Statement

| 510(k) Number | To be assigned by FDA K031980 |
|---------------|-------------------------------------|
| Device Name | Elekta Leksell Stereotactic System© |

The Leksell Stereotactic System with disposable biopsy needle kit Indications for Use is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

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

Daniel A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi

**Prescription Use**
(Per 21 CFR 801.109)

510(k) Number 77031480