LEKSELL GAMMA KNIFE PERFEXION

K063512 · Elekta Instrument AB · IWB · Mar 5, 2007 · Radiology

Device Facts

• Record ID: K063512
• Device Name: LEKSELL GAMMA KNIFE PERFEXION
• Applicant: Elekta Instrument AB
• Product Code: IWB · Radiology
• Decision Date: Mar 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors.

Device Story

Leksell Gamma Knife® PERFEXION™ is a teletherapy radiosurgery system for stereotactic irradiation of intracranial structures. System components include a radiation unit, patient positioning system, and operator console with control panel and computer. The device delivers prescribed doses of ionizing radiation as one or more shots to precise target sites. Used in clinical settings by trained medical professionals to treat conditions such as metastatic tumors. Output consists of targeted radiation delivery; healthcare providers use this to perform non-invasive intracranial surgery, potentially benefiting patients by providing precise treatment of lesions while sparing surrounding healthy tissue.

Technological Characteristics

Teletherapy radionuclide radiation therapy system. Consists of radiation unit, patient positioning system, and operator console with system computer. Designed for stereotactic irradiation of intracranial structures.

Indications for Use

Indicated for stereotactic irradiation of intracranial head structures, including small targets and metastatic tumors, in patients requiring radiosurgery.

Regulatory Classification

Identification

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

Predicate Devices

• Leksell Gamma Knife® PERFEXION TM (K061941)

Reference Devices

• Leksell Stereotactic System (K972324)
• Leksell GammaPlan® PFX (K061540)

Submission Summary (Full Text)

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Ka6351/2

# ELEKTA INSTRUMENT AB

Dokumentnamn/Name of docume Traditional 510/k)

Traditional 510(k)

| Utfärdare/Issuer | Anders Skoglund |
|-----------------------------|----------------------------------|
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | - |
| Avser/Regarding | Leksell Gamma Knife® PERFEXION ™ |
| Directory | |

### Section 4- 510(k) Summary

As Required by 21 CFR 807.87(k)510 (k) Summary

MAR 0 5 2007

#### 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 Gamma Knife® PERFEXION ™

#### Device Classification 3.

| Common Name | Product Code | Class | Regulation Number |
|----------------------------------------|--------------|-------|-------------------|
| Radionuclide radiation therapy system. | IWB | II | 21 CFR 892.5750 |

#### Predicate Device Identification 4.

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Leksell Gamma Knife® PERFEXION TM | K061941 |

#### Other relevant submissions 5.

| Devices | 510(k) # |
|-----------------------------|----------|
| Leksell Stereotactic System | K972324 |
| Leksell GammaPlan® PFX | K061540 |

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

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K063512

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Dokumentnamn/Nome of doe

Traditional 51016

## ELEKTA INSTRUMENT AB

| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|------------------------------------------------------|-----------------------------|-----------------|
| Anders Skoglund | - | - |
| Avser/Regarding<br>Leksell Gamma Knife® PERFEXION TM | | Directory |

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

Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).

#### Intended Use 7.

Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors.

#### Substantial Equivalence 8

The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device the Leksell Gamma Knife® PERFEXION ™ (K061941) 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.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Anders Skoglund Regulatory Affairs Elekta Instrument AB Kungstensgatan 18, P.O. Box 7593 SE-103 93 Stockholm SWEDEN

MAR C 5 2007

Re: K063512

Rooss12
Trade/Device Name: Leksell Gamma Knife® PERFEXION™ System Regulation Number: 21 CFR §892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 15, 2007 Received: February 20, 2007

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. Three stars are below the word "Centennial". The text "Growth & Innovation in Consumer Protection" is around the top of the circle, and the text "In the Service of Food" is around the bottom of the circle.

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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.

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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.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 INSTRUMENT AB

Dokumentnamn/Name of document Traditional 510(k)

| Utfärdare/Issuer | Anders Skoglund |
|-----------------------------|----------------------------------|
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | - |
| Avser/Regarding | Leksell Gamma Knife® PERFEXION ™ |
| Directory | |

# Section 7- Indications for Use Statement

| 510(k) Number | K063512 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Leksell Gamma Knife® PERFEXION ™ |
| Indications for Use | Leksell Gamma Knife® PERFEXION ™ is a teletherapy device<br>intended for stereotactic irradiation of head structures ranging<br>from very small target sizes of a few millimeters to several<br>centimeters e.g. metastatic tumors. |

Prescription Use X (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) T

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _