LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS

K080355 · Elekta Instrument AB · HAW · May 1, 2009 · Neurology

Device Facts

• Record ID: K080355
• Device Name: LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
• Applicant: Elekta Instrument AB
• Product Code: HAW · Neurology
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Leksell Stereotactic System® with Reusable Fixation Screws is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

Device Story

The Leksell Stereotactic System with Reusable Fixation Screws is a neurosurgical instrument used to affix the Leksell Coordinate Frame G to a patient's skull. The system facilitates the localization and diagnosis of intracranial disorders and supports surgical treatments, including radiotherapy and stereotactic radiation therapy. The device is used in clinical settings by neurosurgeons and medical professionals. By providing a stable, fixed reference frame on the skull, the system enables precise targeting for diagnostic and therapeutic procedures, potentially improving clinical outcomes for patients undergoing intracranial interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device consists of reusable fixation screws designed to integrate with the Leksell Stereotactic System and Coordinate Frame G. It is a mechanical stereotaxic instrument used for skull fixation. No software, energy sources, or electronic components are described.

Indications for Use

Indicated for patients requiring 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.

Predicate Devices

• Leksell Stereotactic System® (K031999)

Submission Summary (Full Text)

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### ELEKTA INSTRUMENT AB

Dokumentnamn/Nama of document Traditional 510/k)

| Utfärdare//ssuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva ¡Edition |
|-------------------------------------------------------------------------------|-----------------------------|-----------------|
| Anders Skoglund | -- | -- |
| Avser/Regarding<br>Leksell Stereotactic System® with Reusable Fixation Screws | | 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.

Leksell Stereotactic System® with Reusable Fixation Screws

#### 3. Device Classification

| 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) # |
|----------------------------------------------------------------|----------|
| Leksell Stereotactic System ® | K031999 |

#### 5. Other relevant submissions

| 10.0.000 00<br>10.000 0<br>AVICAS<br>. | 1 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| SUSTEM<br>9000 | VA21000 |
| ---------------------------------------------------------------------------------------------------------------------------<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Company Company Control Concession Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come<br>· AVCAL.<br>AVERTAIN<br>. A . A considered a do . C . C . C . C . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments .<br>Comments of the Research Annual Comments of the callers and consisted annual consistences and the controlled to the controlled to the controlled to the controlled to the cont<br>And Accessories<br>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 - - - - - - - - - - - - - - - - - - - - - - - - - - - | AND AND AND A<br>170500 |

Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel [phone] Fax [phone]

MAY - 1 2009

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K040 355

## S

### ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document

F-Utl-1 (5.12.1)

| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|------------------------------------------------------------|-----------------------------|-----------------|
| Anders Skoglund | -- | -- |
| Avser/Regarding | Directory | |
| Leksell Stereotactic System® with Reusable Fixation Screws | | |

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

The Reusable Fixation Screws are a part of the Leksell Stereotactic System® and are used to affix the Leksell® Coordinate Frame G firmly to the patient's skull with minimal inconvenience to the patient.

#### 7. Intended Use

The Leksell Stereotactic System® with Reusable Fixation Screws is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy.

#### Substantial Equivalence 8

The functionality for the Leksell Stereotactic System® with Reusable Fixation Screws is equivalent to its predicate device the Leksell Stereotactic System® (K031999) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.

· Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel [phone]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elekta Instrument AB % Mr. Anders Skoglung Director Regulatory Affairs P.O. Box 7593. SE-103 93 Stockholm Sweden

MAY - 1 2009

Re: K080355

Trade/Device Name: Leksell Stereotactic System® with Reusable fixation Screws Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 27, 2009 Received: April 29, 2009

Dear Mr. Skoglung:

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.

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 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.

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Page 2 - Mr. Anders Skoglung

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

Mark A Millman

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K.050355

### ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document Traditional 510/k)

| Utfärdare/Issuer | Rel. nr/Dok. nr/Ref. no/Doc. no | Utgåva /Edition |
|------------------------------------------------------------|---------------------------------|-----------------|
| Anders Skoglund | -- | -- |
| Avser/Regarding | Directory | |
| Leksell Stereotactic System® with Reusable Fixation Screws | | |

### Section 7- Indications for Use Statement

| 510(k) Number | To be defined |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Leksell Stereotactic System® with Reusable Fixation Screws |
| Indications for Use | The Leksell Stereotactic System® with Reusable Fixation Screws is<br>a system intended for localization and diagnosis of intracranial<br>disorders and their surgical treatment, including radiotherapy<br>and stereotactic radiaton therapy |

Prescription X 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Oslen forman

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

510(k) Number K040355

Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tei [phone] Fax [phone]