(75 days)
Not Found
No
The summary describes a teletherapy device and its fixation system with new software functions, but there is no mention of AI or ML in the provided text.
Yes
The device is a teletherapy device intended for stereotactic irradiation of head structures, which is a therapeutic purpose.
No
The device is described as a "teletherapy device intended for stereotactic irradiation," which indicates it is used for treatment (therapy) rather than diagnosis. It focuses on delivering radiation to head structures, not on identifying diseases or conditions.
No
The device description explicitly states it consists of a "patient fixation system" in addition to new software functions. This indicates a hardware component is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is a "teletherapy device intended for stereotactic irradiation of head structures." This describes a therapeutic device that delivers radiation to treat conditions, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on patient fixation and software for geometric coordinates for treatment delivery. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring biomarkers or other indicators of disease
Therefore, the Leksell Gamma Knife Perfexion™ with Extend™ Frame System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Leksell Gamma Knife Perfexion™ with Extend™ Frame System is a teletherapy device intended for stereotactic irradiation of head structures.
Product codes
IWB
Device Description
The Extend™ system is an extension to Leksell Gamma Knife Perfexion™. It consists of a patient fixation system and new software functions in the system application. The patient fixation system is used to provide target localization and fixation of the patient's head at prescribed geometric coordinates.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K09 2083.
SEP 2 2 2009
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™ with Extend™ Frame System |
| 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
2. Trade Name
Leksell Gamma Knife Perfexion™ with Extend™ Frame System
3. Device Classification
| 1 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - 1 - -
. Standar and and on the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the maili
A 10-12 1-1 15-12-20 1-32-11
ommon Name
いつけているときになることです。ここではないということです。
and the comments of the first of the first of the first of
Carlos Station College Company Comparent
Section Amar 2017 - 11:
| Product Code Class
Section of the station de 2000 - 30
| 1.17 30 1.0 2014 12:20 12 12 12 12 12 12 12 | Regulation
1991 1991 1991
Number |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------|
| Radionuclide radiation therapy system | VA/F | | 1 5/5/ |
4. Predicate Device Identification
| 32 4 1 1 1 0 - 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
| The Press of the Research of September of the September 1992 and Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child C |
|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| - STEXION IN |
| K 1917 B |
| עומארים |
| ------------------------------------------------------------------------------------------------------------------------ |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Other relevant submissions 5.
| | Status Sunday of Street States of Children Company of
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------|
| | | | |
| | | | |
| | | | |
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| | | | |
| | | | |
| A Books | | 1000 1000 | |
| | | | |
Elekta Instrument AB, P.O. Box 7593, SE-103 83 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00
1
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of documen al CAAIL
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Anders Skoglund | -- | -- |
| Avser/Regarding | Directory | |
| Leksell Gamma Knife Perfexion™ with Extend™ Frame System | -- | -- |
Device Description (for detailed description see Section "Device Description") 6.
The Extend™ system is an extension to Leksell Gamma Knife Perfexion™. It consists of a patient fixation system and new software functions in the system application.
The patient fixation system is used to provide target localization and fixation of the patient's head at prescribed geometric coordinates.
7. Intended Use
Leksell Gamma Knife Perfexion™ with Extend™ Frame System is a teletherapy device intended for stereotactic irradiation of head structures.
8 Substantial Equivalence
The functionality for the Leksell Gamma Knife Perfexion™ with Extend™ Frame System is equivalent to its predicate device the Leksell Gamma Knife Perfexion™ (K063512) and Headfix(K030439) 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.
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 255 00
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and two curved lines representing its legs. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
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
SEP 2 2 2009
Mr. Anders Skoglund Director Regulatory Affairs Elekta Instrument AB Kungstensgatan 18 P.O. Box 7593 STOCKHOLM SWEDEN SE-103 93
Re: K092083
Trade/Device Name: Leksell Gamma Knife Perfexion™ with Extend™ Frame System Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: July 7, 2009 Received: July 9, 2009
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 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); medical device reporting (reporting of medical
3
Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janina M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
ELEKTA INSTRUMENT AB
Traditional 510(k)
| Utfärdare/Issuer | Anders Skoglund |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Utgåva /Edition | -- |
| Avser/Regarding | Leksell Gamma Knife Perfexion™ with Extend™ Frame System |
| Directory | -- |
Section 7- Indications for Use Statement
| 510(k) Number | To be defined K092083 |
|---|---|
| Device Name | Leksell Gamma Knife Perfexion™ with Extend™ Frame System |
| Indications for Use | Leksell Gamma Knife Perfexion™ with Extend™ Frame System |
| is a teletherapy device intended for stereotactic irradiation of | |
| head structures. |
Prescription
. , ﺮ
Use × (Part 21 CFR 801 Subpart D) AND/OR . )
Over-The-Counter Use (21 CFR 801 Subpart C)
Dokumentnamn/Name of document
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hozu'thwhs
(Division Sign-Off) (Division Sign-Ont)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 255 00