(106 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on the physical delivery of radiation.
Yes.
The device is used for stereotactic irradiation of various pathological conditions in head structures, which is a therapeutic intervention.
No
The device description states it is a "radiosurgery system" that delivers ionizing radiation to treat head structures, indicating a therapeutic rather than a diagnostic function.
No
The device description explicitly states that Leksell Gamma Knife is a "radiosurgery system" and mentions "new hardware" and "biocompatibility testing," indicating it is a physical device that delivers radiation, not solely software.
No, 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 provide information about a person's health. They are used outside the body.
- Leksell Gamma Knife Function: The Leksell Gamma Knife is a teletherapy device used for stereotactic irradiation of head structures. This means it delivers radiation directly to the target within the patient's body to treat various conditions. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes treating conditions like tumors and neurological disorders by delivering radiation, not by analyzing samples.
- Device Description: The description confirms it's a "radiosurgery system" that delivers "ionizing radiation to the exact site of the target."
The Leksell Gamma Knife is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Leksell Gamma Knife® 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, chordomas, 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, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, skull base tumors)
Product codes
IWB
Device Description
Leksell Gamma Knife® (available models Icon™, Perfexion™ and Elekta Esprit) is a radiosurgery system 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
kV X-rays / CBCT
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)
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new control system and the new hardware 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 affected functionality, mainly the user interface of the Control Panel were effective.
Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification, user needs have been met and that the device functions as intended.
Biocompatibility testing has been performed to ensure that all materials are biocompatible in relation to the use of the device.
No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that the Leksell Gamma Knife - Elekta Esprit is as safe and effective and performs as well as the predicate devices Leksell Gamma Knife Icon and Leksell Gamma Knife Perfexion.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Elekta Solutions AB % Helena Skar Regulatory Affairs Engineer Kungstensgatan 18 Box 7593 Stockholm, Stockholm SE-10393 SWEDEN
Re: K222047
Trade/Device Name: Leksell Gamma Knife® Perfexion™, Leksell Gamma Knife® Icon™, Leksell Gamma Knife® - Elekta Esprit Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: Class II Product Code: IWB Dated: September 27, 2022 Received: September 28, 2022
Dear Helena Skar:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K222047
Device Name
Leksell Gamma Knife® Icon™, Leksell Gamma Knife® Perfexion™, and Leksell Gamma Knife® – Elekta Esprit
Indications for Use (Describe)
Leksell Gamma Knife® 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, chordomas, 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, meningioma, 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."
3
Image /page/3/Picture/1 description: The image shows the logo for Elekta, a company that specializes in precision radiation medicine. The logo features a stylized atom symbol to the left of the company name. The atom symbol is a circle with three smaller circles inside, and the company name is written in a sans-serif font.
510(K) SUMMARY (21 CFR § 807.92)
| I. SUBMITTER | Elekta Solutions AB
Kungstensgatan 18 Box 7593
SE-10393 Stockholm, Sweden |
|-------------------------------|------------------------------------------------------------------------------------------------------------|
| Contact: | Helena Skar
Regulatory Affairs Engineer |
| Establishment Registration #: | 3015232217 |
| 510(k) Number: | K222047 |
| Date Prepared: | 19 September 2022 |
| II. DEVICE | |
| Trade Name: | Leksell Gamma Knife® Perfexion,
Leksell Gamma Knife® Icon™, and
Leksell Gamma Knife® – Elekta Esprit |
| Product Classification: | Class II |
| Common Name: | Leksell Gamma Knife® |
| Regulation Number: | 21 CFR § 892.5750 |
| Regulation Description: | Radionuclide radiation therapy system |
| Product Code: | IWB |
| III. PREDICATE DEVICE | K173789 - Leksell Gamma Knife Perfexion & Leksell
Gamma Knife Icon |
IV. INTENDED USE / INDICATIONS FOR USE
Leksell Gamma Knife® 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 .
- Beniqn 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)
4
Image /page/4/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The graphic is a teal circle with three smaller teal circles inside of it. The word "Elekta" is written in teal.
V. DEVICE DESCRIPTION
Leksell Gamma Knife® (available models Icon™, Perfexion™ and Elekta Esprit) is a radiosurgery system 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI.
Leksell Gamma Knife® (available models Icon™, Perfexion™ and Elekta Esprit) 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.
The major changes of technological characteristics of the new model Leksell Gamma Knife® - Elekta Esprit (subject device), as compared the predicate device Leksell Gamma Knife® (K173789) are primarily update enhancements to the hardware user interface in the operator room, which affected both the hardware and software.
| Feature | Perfexion | Icon | Elekta Esprit |
|---|---|---|---|
| # of radiation sources | 192 | 192 | |
| Operating system | Windows 10 | Windows 10 | |
| LGK treatment control | |||
| system | Control system SW 11.5 | Control system SW 11.5 | |
| User Interface | Operator Control (OPC) | Functional KeyPad (FKP) & | |
| Isolation & Patient | |||
| Surveillance Unit (IPSU) | |||
| Patient Positioning | |||
| System (PPS) | The patient couch runs on | ||
| rails installed in the | |||
| framework with an | |||
| adjustable mattress and | |||
| knee support on top. The | |||
| HDMM IR Camera is | |||
| attached to the frame. | • New material in the mattress and | ||
| knee support. | |||
| • Dampening hinges (soft close) on | |||
| side protection | |||
| • New shape, color and material on | |||
| the HDMM IR camera arm | |||
| • New shape of the PPS tray | |||
| assembly | |||
| Patient Surveillance | |||
| System (PSS) | Analog video camera | Digital PSS Camera | |
| Fixation | Frame only | ||
| (G-frame, | |||
| Vantage) | Frame (G- | ||
| frame, | |||
| Vantage) | |||
| & Mask | Frame (G-frame, Vantage) | ||
| & Mask | |||
| Imaging Modality | N/A | kV X-rays / | |
| CBCT | kV X-rays / CBCT | ||
| Patient Movement | |||
| Detection System | N/A | IFMM | IFMM (Intra fraction motion |
| management system) |
The fundamental technical characteristics of the subject device Leksell Gamma Knife® -Elekta Esprit have not changed and are substantially equivalent to its predicate device Leksell Gamma Knife® (K173789).
5
Image /page/5/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation medicine. The logo consists of a circular symbol with three smaller circles inside, followed by the word "Elekta" in a bold, sans-serif font. The color of the logo is a teal blue.
VII. SUMMARY OF PERFORMACE TESTING (NON-CLINICAL)
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new control system and the new hardware 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 affected functionality, mainly the user interface of the Control Panel were effective.
Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification, user needs have been met and that the device functions as intended.
Biocompatibility testing has been performed to ensure that all materials are biocompatible in relation to the use of the device.
VIII. SUMMARY OF PERFORMACE TESTING (CLINICAL)
No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that the Leksell Gamma Knife - Elekta Esprit is as safe and effective and performs as well as the predicate devices Leksell Gamma Knife Icon and Leksell Gamma Knife Perfexion.
IX. SUBSTANTIAL EQUIVALENCE CONCLUSION
Leksell Gamma Knife® – Elekta Esprit is claimed to be substantially equivalent (SE) to the predicate device, Leksell Gamma Knife® (K173789). The intended use and indications for use are identical to the predicate devices and the principles of operation remain unchanged.
New hardware has been introduced for the subject device, to enhance the user interface and to provide a modernized model. A new control system software version has been introduced to support the new hardware in the new model Elekta Esprit. Leksell Gamma Knife® – Elekta Esprit does not introduce any new clinical requirements or functions.
The technological characteristics are substantially equivalent to the predicate device; enhancements to existing functionality do not affect the fundamental scientific technology or raise different questions of safety or effectiveness of the device. The device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria, FDA guidance, and recognized consensus standards.
The results of verification and validation as well as conformance to relevant safety standards demonstrate that the Leksell Gamma Knife® – Elekta Esprit meets the established safety and performance criteria and is substantially equivalent to the predicate device.