LEKSELL STEREOTACTIC SYSTEM

K972324 · Elekta Instrument AB · HAW · Mar 2, 1998 · Neurology

Device Facts

• Record ID: K972324
• Device Name: LEKSELL STEREOTACTIC SYSTEM
• Applicant: Elekta Instrument AB
• Product Code: HAW · Neurology
• Decision Date: Mar 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Elekta Leksell Stereotactic System and Accessories is intended for localization (spatial reference) for cranial surgery using X-Ray, or CT and MRI image data.

Device Story

Leksell Stereotactic System functions on center-of-the-arc principle; utilizes Cartesian coordinate frame and semi-circular arc. Modular design includes dedicated components and accessories for stereotactic micro-surgery, functional interventions, target localization, diagnostic/therapeutic procedures, and Gamma Knife surgery. Used in clinical settings for cranial surgery; operated by neurosurgeons/clinicians. Device provides spatial reference for surgical navigation by integrating X-ray, CT, or MRI image data. Output assists surgeons in precise anatomical targeting; facilitates minimally invasive procedures; improves surgical accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Performance data demonstrated system accuracy and repeatability. Compatibility with low-frequency MR scanners was verified.

Technological Characteristics

Modular stereotaxic instrument; Cartesian coordinate frame and semi-circular arc geometry. Operates on center-of-the-arc principle. Compatible with X-ray, CT, and MRI imaging modalities. MR-compatible in low-frequency scanners.

Indications for Use

Indicated for spatial reference/localization during cranial surgery using X-ray, CT, or MRI image data.

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

• Cosman-Robert-Wells Stereotactic System (K934523)
• ZD Neurosurgical Localizing Unit (K892425)

Submission Summary (Full Text)

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Elekta Instruments AB Elexanse to \$10(k) #K972324 Deficiencies February 16, 1998

MAR - 2 1998

K972324

# SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

## SUBMITTER INFORMATION 18.1

| a. | Company Name: | Elekta, AB |
|----|--------------------------------|---------------------------------------------------------------------------------|
| b. | Company Address: | Birger Jarlsgatan 53, S-103, 93<br>Stockholm, Sweden |
| c. | Company Phone:<br>Company Fax: | (011) 46 8402 5400<br>(011) 46 8402 5500 |
| d. | Contact Person: | Sverker Glans<br>Vice President<br>Quality and Regulatory Affairs<br>Elekta, AB |
| e. | Date Summary Prepared: | April 14, 1997 |

# 18.2. DEVICE IDENTIFICATION

| a. | Trade/Proprietary Name: | Leksell Stercotactic System |
|----|-------------------------|----------------------------------------|
| b. | Classification Name: | Stereotaxic Instrument and Accessories |

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Elekta Instruments AB Response to 510(k) #K972324 Deficiencies February 16, 1998

### IDENTIFICATION OF PREDICATE DEVICE 18.3

| Company | Device | 510(k) No. | Date Cleared |
|-----------------------------|--------------------------------------------|------------|------------------|
| Radionics | Cosman-Robert-Wells<br>Stereotactic System | K934523 | February 8, 1995 |
| Leibinger &<br>F.L. Fischer | ZD Neurosurgical<br>Localizing Unit | K892425 | March 23, 1990 |

#### DEVICE DESCRIPTION 18.4

The Leksell Stereotactic System is a stereotaxic instrument and accessories which functions on the center-of-the-arc principle. The basic components of the system are a cartcsian coordinate frame and a semi-circular arc. The system has been developed as a modular design with dedicated components and a range of optional accessories. Accessories are available for stereotactic micro-surgery and functional interventions, target localization, diagnostic and therapeutic procedures, and Gamma Knife surgery.

#### 18.5 SUBSTANTIAL EQUIVALENCE

The Leksell Stereotactic System is substantially equivalent to other stereotactic systems currently in commercial distribution by Radionics and Leibinger & Fischer in terms of intended use for localization (spatial reference) for cranial surgery using X-Ray, or CT and MRI image data.

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Elekta Instruments AB Response to 510(k) #K972324 Deficiencies February 16, 1998

> The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison charts provided in this 510(k) submission.

#### 18.6 INTENDED USE

The Elekta Leksell Stereotactic System and Accessories is intended for localization (spatial reference) for cranial surgery using X-Ray, or CT and MRI image data.

#### 18.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the predicate and legally marketed devices is provided within this submission.

#### 18.8 PERFORMANCE DATA

The Leksell Stereotactic System has been demonstrated to perform as intended with accuracy and repeatability. The system have been shown to be compatibile when used in MR scanners of low frequencies. Complete results of performance testing of the Leksell Stereotactic System have been included the 510(k) submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Patterson Consultant for Elekta Instruments AB Patterson Consulting Group, Inc. 18140 Smokesignal Drive San Diego, California 92127

K972324 Re: Leksell® Stereotactic System Trade Name: Regulatory Class: II Product Code: HAW December 1, 1997 Dated: December 2, 1997 Received:

# Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set...... forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

MAR - 2 1998

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Page 2 - Ms. Patterson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Elekta Instruments AB Response to 510(k) #K972324 Deficiencies February 16, 1998

# INDICATIONS FOR USE

| 510(k) Number: | To Be Assigned By FDA K972324 |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Elckta Leksell® Stereotactic System |
| Indications For Use: | The Leksell Stereotactic System is a system intended for localization (spatial reference) for cranial surgery using X- |

Ray, or CT and MRI image data.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use OR (Per 21 CFR 801.109)