(63 days)
No
The summary does not mention AI or ML, and the device description focuses on hardware and established radiosurgery principles.
Yes
The device is intended for stereotactic irradiation of head structures to treat various medical conditions, which is a therapeutic action.
No
This device is a teletherapy device intended for stereotactic irradiation (treatment) of head structures, not for diagnosis.
No
The device description clearly outlines a physical radiosurgery system with hardware components including a radiation unit, patient positioning system, Cobalt 60 sources, Cone Beam CT, and an Intra Fraction Motion Management system. While it includes software for control and planning (Leksell GammaPlan computer), it is not solely software.
Based on the provided information, the Leksell Gamma Knife® Icon™ is not an In Vitro Diagnostic (IVD) device.
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® Icon™ Function: The description clearly states that the Leksell Gamma Knife® Icon™ is a "teletherapy device intended for stereotactic irradiation of head structures." It delivers ionizing radiation directly to the patient's body for treatment purposes.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is to deliver radiation based on pre-operative imaging and planning.
Therefore, the Leksell Gamma Knife® Icon™ is a therapeutic 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 to several centimeters e.g.,
- Metastatic tumors
- . Recurrent glioblastomas
- Trigeminal neuralgia
- Medically refractory essential tremor .
- Orbital tumors
- Ocular tumors .
- . Optic nerve tumors
- Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyn-. gioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas)
- Skull base tumors
- . Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland)
- Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).
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.
- o 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
Pediatric tumors (such as glioma, ependymoma, pituitary tumors, ● hemanqioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).
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)
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new features against requirement specification. Regression 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 have 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 were effective.
Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met and safety and effectiveness have been achieved.
Clinical testing was not required to support substantial equivalence with the predicate devices. The updated technical features of the modified device is equivalent to the predicate device and a specific risk analysis review was performed to check the impact from the new intended use. The conclusion was that the Leksell Gamma Knife® Icon is as safe and as effective as its predicates (Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™) for the new indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 and 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2016
Elekta Instrument AB % Mr. Alf Laurell Regulatory Affairs Engineer Kungstensgatan 18 Stockholm 10393 SWEDEN
Re: K160440
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: February 11, 2016 Received: February 17, 2016
Dear Mr. Laurell:
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.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160440
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 to several centimeters e.g.,
- Metastatic tumors ·
- . Recurrent glioblastomas
- Trigeminal neuralgia ·
- Medically refractory essential tremor .
- Orbital tumors ·
- Ocular tumors .
- . Optic nerve tumors
- Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyn-. gioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas)
- Skull base tumors
- . Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland)
- Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Dokumentnamn/Name of document
Traditional 510(k)
| Utfärdare/Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | 1 |
| Avser/Regarding | Leksell Gamma Knife® Icon™ |
| Directory | -- |
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 Emma Widmark
Date summary prepared: 2016-02-10
2. Trade Name
Leksell Gamma Knife® Icon™
Common Name 3.
Medical charged-particle radiation therapy system
Device Classification 4.
| 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 | K151159 |
| Leksell Gamma Knife® Icon™ | Elekta Instrument AB | K151561 |
6. Other relevant submissions
| Devices | 510(k) # |
|---|---|
| Leksell Stereotactic System | K080355 |
| Leksell GammaPlan® | K151666 |
| Nanor and Efficast/Nanor Hybrid Thermoplastic Materials | K131795 |
| COMPANY CONFIDENTIAL | |
|---|---|
| -- | ---------------------- |
4
Dokumentnamn/Name of document
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Traditional 510(k) |
|---|---|---|---|
| Alf Laurell | 1 | ||
| 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.
- o 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
Traditional 510(k)
| Utfärdare/Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | 1 |
| Avser/Regarding | Leksell Gamma Knife® Icon™ |
| Directory | -- |
Summary of Non Clinical and Performance testing 8.
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new features against requirement specification. Regression 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 have 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 were effective.
Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met and safety and effectiveness have been achieved.
Clinical testing was not required to support substantial equivalence with the predicate devices. The updated technical features of the modified device is equivalent to the predicate device and a specific risk analysis review was performed to check the impact from the new intended use. The conclusion was that the Leksell Gamma Knife® Icon is as safe and as effective as its predicates (Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™) for the new indications.
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.q.
- Metastatic tumors ●
- Recurrent glioblastomas ●
- Trigeminal neuralgia ●
- Medically refractory essential tremor
- Orbital tumors ●
- Ocular tumors ●
- Optic nerve tumors
- Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas,
6
Dokumentnamn/Name of document
Traditional 510(k)
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Alf Laurell | 1 | |
| Avser/Regarding | Directory | |
| Leksell Gamma Knife® Icon™ | -- |
arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas)
- Skull base tumors
- o Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland)
- Pediatric tumors (such as glioma, ependymoma, pituitary tumors, ● hemanqioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).
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® Icon™(K151561), the modified device includes improved Intra Fraction Management (IFMM) functionality.
When the system detects that the patient is out of position the system stops delivering dose. In release 11.0 the system is paused and moved the patient out of the radiation unit while in release 11.1 the system only stop the dose delivery and resumes the dose delivery when the patient is back in position. This is also defined in the device description, Section 5 - IFMM System and IFMM Graphs and settings
The fundamental functionality and technical characteristics of the Gamma Knife unit have not changed and are substantially equivalent to the predicate device Leksell Gamma Knife® Icon™ (K151561) and the predicate device Leksell Gamma Knife® Perfexion™ (K151159).
Substantial Equivalence 11.
The modified device Leksell Gamma Knife® Icon™ is claimed to be substantially equivalent to the predicate devices Leksell Gamma Knife® Icon™ (K151561) and Leksell Gamma Knife® Perfexion™ (K151159).
The devices are substantially equivalent with regards to fundamental functionality, technical characteristics and Intended use.