(55 days)
No
The summary does not mention AI, ML, or related concepts, and the description focuses on the hardware and control systems of a traditional radiosurgery device.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "stereotactic irradiation of head structures" to treat conditions like "metastatic tumors, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, postsurgical pituitary adenomas and recurrent glioblastomas," which are all therapeutic applications.
No
The device is described as a "teletherapy device" and a "radiosurgery system" intended for "stereotactic irradiation". It delivers a "prescribed dose" using "ionizing radiation" to treat medical conditions. This indicates a therapeutic function, not a diagnostic one. While it uses preoperative radiological examinations and includes a Cone Beam CT, these are for guiding the treatment, not for diagnosing conditions.
No
The device description clearly outlines a complex hardware system including a radiation unit with Cobalt 60 sources, a patient positioning system, a Cone Beam CT, and an Intra Fraction Motion Management system, in addition to software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The Leksell Gamma Knife® Icon™ is a teletherapy device that uses ionizing radiation to treat structures within the head. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "stereotactic irradiation of head structures" for various conditions. This is a treatment modality.
- Device Description: The description details a radiosurgery system that delivers radiation doses. It does not mention any analysis of biological samples.
Therefore, the Leksell Gamma Knife® Icon™ falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Leksell Gamma Knife® Icon™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters, e.g. metastatic tumors, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, post-surgical pituitary adenomas and recurrent glioblastomas.
Product codes
IWB
Device Description
Leksell Gamma Knife® Icon™ 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® Icon™ 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.
The Leksell Gamma Knife Icon system consists of several parts, physically separated into a control room and a treatment room.
- The control room contains an operator console and an office cabinet. The . treatment session is controlled and monitored by the operator from the control room. The control room also contains a Leksell GammaPlan computer.
- . The treatment room contains the Leksell Gamma Knife unit. A Leksell Gamma Knife unit consists of the radiation unit, the patient positioning system, and a set of covers. A Leksell Gamma Knife Icon unit also includes a Cone Beam CT and an Intra Fraction Motion Management (IFMM) system. The treatment room also contains a camera, patient speakers, a microphone, a treatment room monitor, and a radiation warning lamp.
The system is electrically separated into an office side and a medical side.
- . The office side consists of the equipment in the control room, as well as the following equipment in the treatment room: a camera, patient speakers, a microphone, a treatment room monitor and the radiation warning lamp. The office side is powered and controlled by the office cabinet in the control room.
- . The medical side consists of the Leksell Gamma Knife unit in the treatment room, and is electrically isolated from the office side. The medical side is powered and controlled by a medical cabinet, placed inside the rear cover of the radiation unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone Beam CT
Anatomical Site
head structures, intra-cranial 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
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features aqainst requirement specification. Regression and re-test of unchanged functionalities in the developed system was done to ensure that the new and updated functionalities did not introduce any undesirable effects.
Design and usability validation of the system has been performed by competent and professionally qualified personnel to ensure that the product fulfils the intended use and user needs. The design and usability validation was also made to ensure that the risk control measures associated with functions related to safety (FRS) for the new functionality was effective.
The system has been subjected to compliance testing to voluntary consensus safety standards, e.g. IEC 60601-1 Ed 3, IEC 60601-1-2 Ed 3, IEC 60601-1-3 Ed 2 and IEC 60601-2-11 Ed 3.
Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met and safety & effectiveness have been achieved.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2015
Elekta Instruments AB % Ms. Matilda Forsberg Regulatory Affairs Engineer Kungstensgatan 18 Stockholm 10393 SWEDEN
Re: K151561
Trade/Device Name: Leksell Gamma Knife® Icon™ Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: June 5, 2015 Received: June 10, 2015
Dear Ms. Forsberg:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Leksell Gamma Knife Icon
Indications for Use (Describe)
Leksell Gamma Knife® Icon™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters, e.g. metastatic tumors, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, post-surgical pituitary adenomas and recurrent glioblastomas.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
Dokumentnamn/Name of document
| Utfärdare/Issuer | Matilda Forsberg |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | Q2015-043 |
| Utgåva /Edition | -- |
| Avser/Regarding | Leksell Gamma Knife Icon |
| Directory | -- |
Traditional 510(k)
Section 4- 510(k) Summary
As Required by 21 CFR 807.92(c) 510 (k) Summary
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 Official Correspondent: Ms Louise Wachtmeister
Date summary prepared: 2015-06-05
=
2. Trade Name
Leksell Gamma Knife® Icon™
3. Common Name
Medical charged-particle radiation therapy system
4. Device Classification
| Trade Name | Product Code | Class | Regulation
Number |
|----------------------------|--------------|-------|----------------------|
| Leksell Gamma Knife® Icon™ | IWB | II | 21 CFR 892.5750 |
5. Predicate Device Identification
| Legally marketed devices to which
| equivalence is being claimed | Manufacturer | 510(k) # |
|---|---|---|
| Leksell Gamma Knife® Perfexion™ | Elekta Instrument AB | K133565 |
| XVI R5.0 | Elekta LTD. | K131965 |
6. Other relevant submissions
| Devices | 510(k) # |
|---|---|
| Leksell Stereotactic System | K080355 |
| Leksell GammaPlan® | K103093 |
| Nanor and Efficast/Nanor Hybrid Thermoplastic Materials | K131795 |
4
Dokumentnamn/Name of document
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Matilda Forsberg | Q2015-043 | -- |
| Avser/Regarding | Directory | |
| Leksell Gamma Knife Icon | -- |
Device Description 7.
Leksell Gamma Knife® Icon™ 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® Icon™ 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.
The Leksell Gamma Knife Icon system consists of several parts, physically separated into a control room and a treatment room.
- The control room contains an operator console and an office cabinet. The . treatment session is controlled and monitored by the operator from the control room. The control room also contains a Leksell GammaPlan computer.
- . The treatment room contains the Leksell Gamma Knife unit. A Leksell Gamma Knife unit consists of the radiation unit, the patient positioning system, and a set of covers. A Leksell Gamma Knife Icon unit also includes a Cone Beam CT and an Intra Fraction Motion Management (IFMM) system. The treatment room also contains a camera, patient speakers, a microphone, a treatment room monitor, and a radiation warning lamp.
The system is electrically separated into an office side and a medical side.
- . The office side consists of the equipment in the control room, as well as the following equipment in the treatment room: a camera, patient speakers, a microphone, a treatment room monitor and the radiation warning lamp. The office side is powered and controlled by the office cabinet in the control room.
- . The medical side consists of the Leksell Gamma Knife unit in the treatment room, and is electrically isolated from the office side. The medical side is powered and controlled by a medical cabinet, placed inside the rear cover of the radiation unit.
5
Dokumentnamn/Name of document
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Matilda Forsberg | Q2015-043 | -- |
| Avser/Regarding | Directory | |
| Leksell Gamma Knife Icon | -- |
8. Summary of Non Clinical and Performance testing
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features aqainst requirement specification. Regression and re-test of unchanged functionalities in the developed system was done to ensure that the new and updated functionalities did not introduce any undesirable effects.
Design and usability validation of the system has been performed by competent and professionally qualified personnel to ensure that the product fulfils the intended use and user needs. The design and usability validation was also made to ensure that the risk control measures associated with functions related to safety (FRS) for the new functionality was effective.
The system has been subjected to compliance testing to voluntary consensus safety standards, e.g. IEC 60601-1 Ed 3, IEC 60601-1-2 Ed 3, IEC 60601-1-3 Ed 2 and IEC 60601-2-11 Ed 3.
Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met and safety & effectiveness have been achieved.
9. Intended Use
Leksell Gamma Knife® Icon™ 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, medically refractory essential tremor, meningiomas, vestibular schwannomas, postsurgical pituitary adenomas and recurrent glioblastomas.
10. Technological Characteristics
Leksell Gamma Knife Icon 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.
Compared to the previously cleared Leksell Gamma Knife Perfexion (K133565). the Leksell Gamma Knife Icon contains new fixation option of the patient with a mask. including a Cone Beam Computerized Tomography (CBCT) and an Intra Fraction Motion Management (IFMM) system. These additional features will give an option to patients to receive treatment without the need for the attachment of an invasive stereotactic frame.
6
okumentnamn/Name of document aditional E40/L)
Traditional 510(k)
| Utfärdare/Issuer | Matilda Forsberg |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | Q2015-043 |
| Utgåva /Edition | -- |
| Avser/Regarding | Leksell Gamma Knife Icon |
| Directory | -- |
The fundamental functionality and technical characteristics of the Gamma Knife unit have not changed and are substantially equivalent to the predicate device K133565.
11. Substantial Equivalence
Compared to the previously cleared Leksell Gamma Knife Perfexion (K133565), the Leksell Gamma Knife Icon contains new fixation option of the patient with a mask. including a Cone Beam Computerized Tomography (CBCT) and an Intra Fraction Motion Management (IFMM) system. The CBCT part is substantially equivalent to the predicate device XVI R5.0 (K131965) and the fundamental functionality and technical characteristics of the Gamma Knife unit have not changed and is substantially equivalent to the previously cleared Leksell Gamma Knife Perfexion (K133565).
The conclusion is that the differences in technological characteristics between Leksell Gamma Knife Icon and the predicate devices do not raise questions of safety and effectiveness.