LEKSELL SURGIPLAN, MODEL 1006947

K080250 · Elekta Instrument AB · HAW · May 13, 2008 · Neurology

Device Facts

• Record ID: K080250
• Device Name: LEKSELL SURGIPLAN, MODEL 1006947
• Applicant: Elekta Instrument AB
• Product Code: HAW · Neurology
• Decision Date: May 13, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Leksell SurgiPlan® is intended for use in planning invasive intracranial stereotactic surgical procedures.

Device Story

Leksell SurgiPlan® is image-based neurosurgical planning software designed for use with Leksell Stereotactic System®. It processes medical imaging data to assist clinicians in planning invasive intracranial stereotactic surgical procedures. The software provides tools for surgical trajectory and target visualization, enabling surgeons to define surgical plans. It is used in clinical settings by neurosurgeons to improve surgical precision and patient outcomes during stereotactic interventions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Image-based neurosurgical planning software; designed for integration with Leksell Stereotactic System. Operates as a software application for surgical planning. No specific hardware materials or sterilization methods are applicable as this is a software-only submission.

Indications for Use

Indicated for planning invasive intracranial 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.

Predicate Devices

• Leksell SurgiPlan® (K033340)

Reference Devices

• Leksell Stereotactic System (K031980)

Submission Summary (Full Text)

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

### ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document

Special 510(k)

| Utfärdare/Issuer | Anders Skoglund |
|-----------------------------|--------------------|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Utgåva /Edition | -- |
| Avser/Regarding | Leksell SurgiPlan® |
| Directory | |

# K080250

## Section 4- 510(k) Summary

MAY 1 3 2008

2

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 SurgiPlan®

#### 3. Device Classification

| Common Name | Product Code | Class | Regulation Number |
|------------------------|--------------|-------|-------------------|
| Stereotaxic instrument | HAW | II | 21 CFR 882.4560 |

#### 4. Predicate Device Identification

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| Leksell SurgiPlan® | K033340 |

1. 1. 2

#### 5. Other relevant submissions

| Devices | And Archive of the state of the state of the comments of the comments of the comments of the with the with the with the with and the with the with and the world to the with a<br>510(k) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 100<br>PICAL<br>1118111 | ---------------<br>KO1286 |
| eksel<br>Stereotactic System | K031980<br>ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤ |

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

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

Dokumentnamn/Name of document Conciol E10/L)

### ELEKTA INSTRUMENT AB

| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|--------------------|-----------------------------|-----------------|
| Anders Skoglund | -- | -- |
| Avser/Regarding | Directory | |
| Leksell SurgiPlan® | | |

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

Leksell SurgiPlan® is an advanced image-based neurosurgical planning software, specifically designed for Leksell Stereotactic System®.

#### 7. Intended Use

100 100 100

Leksell SurgiPlan® is intended for use in planning invasive intracranial stereotactic surgical procedures.

### Substantial Equivalence 8

The functionality for the Leksell SurgiPlan® is equivalent to its predicate device the Leksell SurgiPlan® (K033340) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device.

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

{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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized stripes forming its wing.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 13 2008

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

Re: K080250

Trade/Device Name: Leksell SurgiPlan® Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 24, 2008 Received: April 28, 2008

Dear Mr. Skoglund:

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 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.

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

Page 2 - Mr. Anders Skoglund

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 M Millerson

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

Enclosure

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

### ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document

| Utfärdare/issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Special 510(k) |
|--------------------|-----------------------------|-----------------|----------------|
| Anders Skoglund | -- | -- | |
| Avser/Regarding | | Directory | |
| Leksell SurgiPlan® | | | |

### Section 7- Indications for Use Statement

| 510(k) Number | To be defined K080250 |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name | Leksell SurgiPlan® |
| Indications for Use | Leksell SurgiPlan® is intended for use in planning invasive intra-<br>cranial stereotactic surgical procedures. |

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)

Nil Re dgl formxm

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

510(k) Number K 080250

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