← Product Code [IWB](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB) · K063512 # LEKSELL GAMMA KNIFE PERFEXION (K063512) _Elekta Instrument AB · IWB · Mar 5, 2007 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K063512 ## Device Facts - **Applicant:** Elekta Instrument AB - **Product Code:** [IWB](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB.md) - **Decision Date:** Mar 5, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5750 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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](/device/K061941.md)) ## Reference Devices - Leksell Stereotactic System ([K972324](/device/K972324.md)) - Leksell GammaPlan® PFX ([K061540](/device/K061540.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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: (011) 46 8 587 254 00 Fax: (011) 46 8 587 255 00 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) # | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 +46 8 587 255 00 {1}------------------------------------------------ K063512 Page2f2 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
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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 (800) 638-2041 or (301) 443-6597 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 {4}------------------------------------------------ # 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
intended for stereotactic irradiation of head structures ranging
from very small target sizes of a few millimeters to several
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 _ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K063512](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K063512) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com