(106 days)
Not Found
No
The summary does not mention AI or ML, and the device description focuses on the physical delivery of radiation based on preoperative imaging.
Yes
The device is intended for "stereotactic irradiation of head structures" for various medical conditions, including tumors and benign diseases, which falls under the definition of therapeutic treatment.
No
The device is a teletherapy device intended for stereotactic irradiation, which is a treatment modality, not a diagnostic one. It uses preoperative radiological examinations (which are diagnostic) for planning, but the device itself delivers radiation for treatment.
No
The device description explicitly states that the Leksell Gamma Knife systems are "radiosurgery systems" and "teletherapy devices" that deliver "ionizing radiation" using "collimated beams." This indicates the presence of significant hardware components for radiation delivery, making it a hardware-based medical device, not software-only.
Based on the provided information, the Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that these devices are "teletherapy devices intended for stereotactic irradiation of head structures." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces this by stating they are "radiosurgery systems for use in the stereotactic irradiation of head structures." They deliver radiation to treat conditions.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Using reagents or assays
In summary, these devices are therapeutic medical devices used for radiation treatment, not diagnostic devices used for testing samples.
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, craniopharyngioma, 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, oropharynx, 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).
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
• 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, cramopharyngiona, hemangioblastomas, schwannomas, ateriovenous malformations, cavemous malformations, chordomas, glomus tumors, hemangiomas) - • Skull base tumors
• Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharyix, nasopharynx, sinonasal, salivary gland)
• Pediatic tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, cramopharyagioma, memmzioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, skull base tumors).
Product codes (comma separated list FDA assigned to the subject device)
IWB
Device Description
Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ are radiosurgery systems for use in the stereotactic irradiation of head 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 unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
preoperative radiological examinations
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing was not required to support substantial equivalence with the predicate devices.
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new control system against requirement specification.
Regression test of unchanged functionalities in the developed system was done to ensure that 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.
Biocompatibility testing has been performed to ensure that all materials are biocompatible in relation to the use of the device.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 30, 2018
Elekta Instrument AB % Mr. Alf Laurell Regulatory Affairs Engineer Kungstensgatan 18, P.O. Box 7593 SE 103 93 Stockholm SWEDEN
Re: K173789
Trade/Device Name: Leksell Gamma Knife® Icon™ Leksell Gamma Knife® Perfexion™ Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 22, 2018 Received: March 1, 2018
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 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);
1
Page 2 - Mr. Alf Laurell
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document
ELEKTA INSTRUMENT AB
Traditional 510(k)
| Utfärdare/Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | 1 |
| Avser/Regarding | Leksell Gamma Knife® |
| Directory | -- |
| | Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(k) Number ( if known ) | K173789 | |
| 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, craniopharyngioma, 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, oropharynx, 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) | | |
| | [X] 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
PRAStaff@fda.hhs.gov | |
| | "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." | |
| | | |
3
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document
ELEKTA INSTRUMENT AB
| Utfärdare/Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | - |
| Avser/Regarding | Leksell Gamma Knife® |
Traditional 510(k)
| Utgåva /Edition | 1 |
|---|---|
| Directory | -- |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)
Device Name
Leksell Gamma Knife® Perfexion™
Indications for Use (Describe)
Leksell Gamma Kuife® 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
· 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, cramopharyngiona, hemangioblastomas, schwannomas, ateriovenous malformations, cavemous malformations, chordomas, glomus tumors, hemangiomas)
- · Skull base tumors
· Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharyix, nasopharynx, sinonasal, salivary gland)
· Pediatic tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, cramopharyagioma, memmzioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous 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)
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 PRAStaff@fda.hhs.gov
"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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (101) 443-6700 EF
4
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: Mats Premfors, QA Manager
Date summary prepared: 2018-02-12
2. Trade Name
Leksell Gamma Knife® Icon™ Leksell Gamma Knife® Perfexion™
Device Classification 3.
| Trade Name | Product Code | Panel | Class | Regulation Number |
|---|---|---|---|---|
| Leksell Gamma Knife® Icon™ | IWB | Radiology | II | 21 CFR 892.5750 |
| Leksell Gamma Knife® Perfexion™ | IWB | Radiology | II | 21 CFR 892.5750 |
4. Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | Manufacturer | 510(k) # |
|---|---|---|
| Leksell Gamma Knife® Icon™ | Elekta Instrument AB | K160440 |
| Leksell Gamma Knife® Perfexion™ | Elekta Instrument AB | K151159 |
Other relevant submissions 5.
| Devices | 510(k) # |
|---|---|
| Leksell GammaPlan® v. 11.1 | Pending 510(k) |
5
6. Device Description
Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ are radiosurgery systems for use in the stereotactic irradiation of head 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 unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.
7. Summary Clinical testinq
Clinical testing was not required to support substantial equivalence with the predicate devices.
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 control system against requirement specification.
Regression test of unchanged functionalities in the developed system was done to ensure that 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.
Biocompatibility testing has been performed to ensure that all materials are biocompatible in relation to the use of the device.
9. Intended Use
Intended Use (Leksell Gamma Knife® Icon™):
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
6
- 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, 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, oropharynx, 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).
Intended Use (Leksell Gamma Knife® Perfexion™):
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
- 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, 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, oropharynx, 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).
10. Indications for use
Indications for use (Leksell Gamma Knife® Icon™):
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.
7
- 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, 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, oropharynx, 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).
Indications for use (Leksell Gamma Knife® Perfexion™):
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
- 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, 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, oropharynx, 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).
8
11. Technological Characteristics
Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ are radiosurgery systems 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 fundamental technical characteristics of the Gamma Knife unit have not changed and are substantially equivalent to their predicate devices Leksell Gamma Knife® Icon™ (K160440) and Leksell Gamma Knife® Perfexion™ (K151159).
12. Substantial Equivalence
A new control system software version has been introduced to support Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™.
The modified device Leksell Gamma Knife® Icon™ is claimed to be substantially equivalent to the predicate device Leksell Gamma Knife® Icon™ (K160440).
The modified device Leksell Gamma Knife® Perfexion™ is claimed to be substantially equivalent to the predicate device Leksell Gamma Knife® Perfexion™ (K151159).
The devices are substantially equivalent with regards to fundamental functionality, technical characteristics and Intended use.