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)

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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria as it relates to a specific performance metric (like diagnostic accuracy). Instead, it focuses on the substantial equivalence of a new device model (Leksell Gamma Knife® - Elekta Esprit) to a predicate device (Leksell Gamma Knife® K173789) through non-clinical performance testing.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Overall Conclusion from the Text: The document claims the new device is substantially equivalent to the predicate device because its fundamental technical characteristics are unchanged despite hardware and software updates to the user interface. Therefore, the performance is assumed to be equivalent, and no new clinical studies were conducted for this 510(k) submission.

Missing Information (per the request, but not available in the provided text):

A table of acceptance criteria and reported device performance for a specific performance characteristic (e.g., diagnostic accuracy, sensitivity, specificity).
Sample size used for a "test set" in the context of diagnostic performance.
Data provenance (country of origin, retrospective/prospective).
Number of experts, their qualifications, and adjudication methods for establishing ground truth.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone (algorithm only) performance.
Specific type of ground truth used (pathology, outcomes data, etc.) for performance evaluation.
Sample size for a "training set" for an algorithm.
How ground truth for a "training set" was established.

Information Available from the Text (interpreted in the context of "acceptance criteria" as general device functionality and safety):

The "acceptance criteria" here are implicitly related to ensuring the device performs as intended and is as safe and effective as its predicate, primarily through non-clinical testing of hardware and software updates.

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical performance testing to ensure the new model functions as intended and meets requirements.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Conformance to technical requirement specification	"Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification, user needs have been met..." (Page 5)
Functionality and Performance as intended	"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." (Page 5) "Results from verification and validation testing demonstrate... that the device functions as intended." (Page 5)
No undesirable effects from new/updated functionalities	"Regression test of unchanged functionalities in the developed system was done to ensure that new and updated functionalities did not introduce any undesirable effects." (Page 5)
Usability and design validation (meets intended use/user needs)	"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." (Page 5)
Effectiveness of risk control measures related to safety (FRS)	"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." (Page 5)
Biocompatibility	"Biocompatibility testing has been performed to ensure that all materials are biocompatible in relation to the use of the device." (Page 5)
Safety and Effectiveness Equivalence to Predicate	"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." (Page 5) "The device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria, FDA guidance, and recognized consensus standards." (Page 5) "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." (Page 5)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in terms of patient cases or images, as the testing was non-clinical and focused on system functionality. It refers to "module, integration and system level verification testing."
Data Provenance: Not applicable in the context of patient data. The testing was conducted internally by Elekta Solutions AB (Sweden).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable to this 510(k) submission, as no clinical performance study involving diagnostic accuracy with expert-established ground truth was performed for substantial equivalence. "Design and usability validation... performed by competent and professionally qualified personnel" (Page 5) speaks to the expertise in verifying engineering and human factors aspects, not medical image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." (Page 5). This device is a radiation therapy system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of an algorithm's diagnostic performance. The device itself is a treatment system, and its standalone performance refers to its ability to deliver radiation as specified, validated through non-clinical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical testing, the "ground truth" was the device's technical specifications and intended functionality. Verification and validation ensured the device met these engineering and design requirements. There was no medical "ground truth" (e.g., pathology, clinical outcomes) established for diagnostic or treatment efficacy in a clinical setting in this submission.

8. The sample size for the training set:

Not applicable, as this device is not an AI/ML algorithm trained on a dataset in the sense of image recognition or diagnostic prediction.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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

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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

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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)

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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 ABKungstensgatan 18 Box 7593SE-10393 Stockholm, Sweden
Contact:	Helena SkarRegulatory 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™, andLeksell 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 & LeksellGamma 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)

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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

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 controlsystem	Control system SW 11.5		Control system SW 11.5
User Interface	Operator Control (OPC)		Functional KeyPad (FKP) &Isolation & PatientSurveillance Unit (IPSU)
Patient PositioningSystem (PPS)	The patient couch runs onrails installed in theframework with anadjustable mattress andknee support on top. TheHDMM IR Camera isattached to the frame.		• New material in the mattress andknee support.• Dampening hinges (soft close) onside protection• New shape, color and material onthe HDMM IR camera arm• New shape of the PPS trayassembly
Patient SurveillanceSystem (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 MovementDetection System	N/A	IFMM	IFMM (Intra fraction motionmanagement 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).

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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.

Regulation Number and Section

§ 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.