(106 days)
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, 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® 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.
This submission describes the Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ devices, which are teletherapy systems for stereotactic irradiation of head structures. The submission focuses on a new control system software version for these devices.
Here's an analysis of the provided text in relation to your request:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria in a numerical form typically associated with AI/ML device performance (e.g., sensitivity, specificity, AUC, Dice score). Instead, the acceptance criteria are implicitly linked to the successful completion of various engineering and design validation tests. The reported device performance is described qualitatively.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performance and functionality meets requirement specification. | Testing in the form of module, integration and system level verification was performed. |
| New and updated functionalities do not introduce undesirable effects. | Regression test of unchanged functionalities in the developed system was done to ensure this. |
| Product fulfills intended use and user needs. | Design and usability validation of the system have been performed by competent and professionally qualified personnel to ensure that the product fulfills the intended use and user needs. |
| Risk control measures for safety-related functions are effective. | 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. |
| Conformance to applicable technical requirement specification and user needs. | Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met. |
| All materials are biocompatible for the device's use. | Biocompatibility testing has been performed to ensure that all materials are biocompatible in relation to the use of the device. |
| Substantial Equivalence to predicate devices. | The modified devices (Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ with the new software version) are claimed to be substantially equivalent to their predicate devices (Leksell Gamma Knife® Icon™ (K160440) and Leksell Gamma Knife® Perfexion™ (K151159)) with regards to fundamental functionality, technical characteristics, and Intended use. The fundamental technical characteristics of the Gamma Knife unit have not changed. This effectively means meeting the predicate device's performance, which is not quantified in this document. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data for performance evaluation. The testing described is primarily non-clinical, focusing on system verification, integration, and design validation. There's no mention of a clinical test set size or data provenance specifically for evaluating the performance of the software upgrade or the device's clinical efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No information is provided regarding the number or qualifications of experts used to establish a ground truth for a test set, as no clinical test set is described in the provided sections. The "competent and professionally qualified personnel" mentioned for design and usability validation are not further defined.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information on an adjudication method is provided, as no clinical test set evaluation is described.
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 MRMC comparative effectiveness study is mentioned. The device is a radiation therapy system, not an AI-assisted diagnostic or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a medical device, the Leksell Gamma Knife, which is a teletherapy device for stereotactic irradiation. The "new control system software version" is an integral part of this device. It is not an "algorithm only" device in a standalone AI sense, but rather a software component controlling a physical device. Its performance is evaluated through system-level verification and validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since clinical testing for device performance is stated as "not required to support substantial equivalence," the concept of a clinical ground truth (like pathology or outcomes data) for evaluation is not relevant to this submission. The "ground truth" for the engineering and design validation tests would be the established technical requirements and user needs.
8. The sample size for the training set
This document does not describe an AI/ML component in the sense of a machine learning model that requires a "training set." The software upgrade is a new control system software version, not a learning algorithm trained on data. Therefore, no training set size is applicable or mentioned.
9. How the ground truth for the training set was established
As there is no mention of a training set for an AI/ML model, the establishment of ground truth for such a set is not applicable.
{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. 0910-0120Expiration Date: 06/30/2020See 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) StaffPRAStaff@fda.hhs.gov | ||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation 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.
§ 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.