(69 days)
No
The description focuses on the hardware and basic control systems for delivering radiation, with no mention of AI or ML for planning, targeting, or other functions.
Yes.
The device is used for stereotactic irradiation to treat conditions like metastatic tumors, arteriovenous malformations, trigeminal neuralgia, meningiomas, and vestibular schwannomas.
No
The Leksell Gamma Knife® Perfexion is explicitly described as a teletherapy device for stereotactic irradiation, which is a treatment modality, not a diagnostic one. It uses preoperative radiological examinations (diagnostic tools) to guide its therapeutic function.
No
The device description explicitly states it is a "radiosurgery system" containing "192 sealed sources of Cobalt 60" and a "radiation unit with a patient positioning system," indicating it is a hardware-based device that delivers ionizing radiation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Leksell Gamma Knife Perfexion Function: The description clearly states that the Leksell Gamma Knife Perfexion is a teletherapy device that uses ionizing radiation to treat intra-cranial structures directly within the patient's body. It is a form of external radiation therapy.
The device's function is to deliver treatment, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / 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 turnors, arteriovenous malformations, trigeminal neuralgia, meningiomas and vestibular schwannomas.
Product codes (comma separated list FDA assigned to the subject device)
IWB
Device Description
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.
Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.
Each unit contains 192 sealed sources of Cobalt 60.
Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.
- . The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
- The office side consists of the operator console with control panel and office computer. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5750 Radionuclide radiation therapy system.
(a)
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.(b)
Classification. Class II.
0
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document 13 Traditional 510(k)
| Utfärdare//ssuer | Viveka Wretman |
|---|---|
| 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
1. Subscribers Name & Address
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 Official Correspondent: Mr Anders Skoglund
MAY 2 4 2012
Trade Name 2.
Leksell Gamma Knife® Perfexion™
3. Device Classification
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Leksell Gamma Knife® Perfexion™ | 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™ | K063512 |
5. Other relevant submissions
| Devices | 510(k) # |
|---|---|
| Leksell Steretocatic System | K080355 |
| Leksell GammaPlan® PFX | K103093 |
1
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document Traditional 510(k)
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Viveka Wretman | -- | -- |
| Avser/Regarding | ||
| Leksell Gamma Knife Perfexion | -- | Directory |
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.
Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.
Each unit contains 192 sealed sources of Cobalt 60.
Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.
- . The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
- The office side consists of the operator console with control panel and office computer. .
7. 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 turnors, arteriovenous malformations, trigeminal neuralgia, meningiomas and vestibular schwannomas.
8 Substantial Equivalence
The functionality for the Leksell Gamma Knife Perfexion is equivalent to its predicate device K063512 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.
14
2
Image /page/2/Picture/0 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 a stylized symbol resembling an abstract human figure or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Viveka Wretman Regulatory Affairs Engineer Elekta Instrument AB Kungstensgatan 18 STOCKHOLM 10393 SWEDEN
2 4 2012 MAY
Re: K120811
Trade/Device Name: Leksell Gamma Knife Perfexion Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: March 14, 2012 Received: March 16, 2012
Dear Ms. Wretman:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document
ELEKTA INSTRUMENT AB
Traditional 510(k) K1205118
| Utfärdare/Issuer | Viveka Wretman |
|---|---|
| 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 | To be defined |
|---|---|
| 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, arteriovenous | |
| malformations, trigeminal neuralgia, meningiomas and | |
| vestibular schwannomas. |
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)
(Division Sign Off)
Division of Radiological Devices Diagnostic Device Evaluation and Safety Office of In Vitro
Kla0811
510K