(57 days)
Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
Leksell GammaPlan® is designed for use with the Leksell Gamma Knife and is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of health care professionals (e.g. neurosurgeons, radiation therapists, radiation physicists) such that the desired radiation dose is delivered by the Leksell Gamma Knife to a precisely defined volume.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
The FDA 510(k) summary for Leksell GammaPlan® (K173791) explicitly states that clinical testing on patients was NOT required to demonstrate substantial equivalence to the predicate device (K151666). This means the submission does not contain information about studies designed to prove clinical performance against specific acceptance criteria in a patient population.
Instead, the submission focuses on non-clinical testing to demonstrate that the new version of the device maintains the same fundamental functionality and technical characteristics as the predicate.
Therefore, many of the requested elements for describing a study that proves the device meets acceptance criteria (especially those related to clinical performance, sample sizes, expert involvement, and ground truth in a clinical context) are not applicable to this particular 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present specific, measurable acceptance criteria in a table format that would typically be used for clinical performance. Instead, it refers to internal verification and validation against "requirement specification" and "user needs."
| Acceptance Criteria (Inferred from non-clinical testing) | Reported Device Performance (Summary of Non-Clinical and Performance testing) |
|---|---|
| Conformance to applicable technical requirement specifications | "Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification...have been met." |
| Conformance to user needs | "...and user needs have been met." |
| Functionality and performance of new and existing features | "Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features against requirement specification." |
| Effective risk control measures for safety-related functions | "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 was effective." |
| Device is "confident and stable" | "...and that the system is confident and stable." |
| Maintains fundamental functionality and technical characteristics of the predicate | "The fundamental functionality and technical characteristics of the device are the same as the predicate device, K151666." |
| Supports Leksell Gamma Knife® Icon and Perfexion | New Feature: Added support for both Leksell Gamma Knife® Icon and Leksell Gamma Knife Perfexion. |
| Supports non-square images for pre-planning and follow-up | New Feature: Possible to import and co-register non-square images. |
| Volumetric margin expansion tool functions as intended | New Feature: A new margin tool allows for performing volumetric expansion of delineated volumes. |
| DICOM import improvements (layout, identification, USB, attribute viewing) | New Features: Improved DICOM import dialog with image preview, easier navigation, series description display and assignment, USB import, and viewing of DICOM attributes for imported series. |
| Upgrade to CentOS 7.1 with from CentOS 5.8 | New Feature: Upgraded Operating System to CentOS 7.1. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable (no patient-based clinical test set or data described).
- Data provenance: Not applicable (no patient-based clinical data described).
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)
- Number of experts: Not applicable (no clinical test set requiring expert ground truth).
- Qualifications of experts: The document mentions "competent and professionally qualified personnel" performed design and usability validation, but provides no further details on their specific qualifications or their role in establishing ground truth for a test set. This likely refers to internal development and quality assurance personnel rather than external clinical experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable (no clinical test set 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
- MRMC study: No, an MRMC comparative effectiveness study was not done. The device is a treatment planning system, not an AI-assisted diagnostic tool for human readers.
- Effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: The non-clinical testing included "module, integration and system level verification" against requirements. This can be interpreted as evaluating the algorithm's (software's) performance in a standalone context, ensuring its internal logic and functions work as specified. However, this is not a diagnostic algorithm's standalone performance, but rather a planning system's functional performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: For the non-clinical testing, the "ground truth" would be the software requirements specifications and design documents. The validation sought to prove the system performed according to these pre-defined specifications. There is no mention of clinical ground truth (expert consensus, pathology, outcomes data) as part of this submission.
8. The sample size for the training set
- Sample size for training set: Not applicable. This device is a treatment planning system and not an AI/ML device that requires a training set in the conventional sense for a diagnostic algorithm. Its development would involve software engineering and testing principles, not machine learning model training.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable. As with the previous point, there's no mention of a training set or associated ground truth establishment methods for an AI/ML model.
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February 9, 2018
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Elekta Instrument AB % Ms. Matilda Forsberg Regulatory Affairs Engineer Kungstensgatan 18 Stockholm. 10393 SWEDEN
Re: K173791
Trade/Device Name: Leksell GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB, MUJ Dated: December 12, 2017 Received: December 14, 2017
Dear Ms. Forsberg:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Matilda Forsberg
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Leksell GammaPlan
Indications for Use (Describe)
Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
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)
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Section 4- 510(k) Summary
As Required by 21 CFR 807.92(c) 510 (k) Summary
1. Subscribers Name & Address
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: Pia Lindberg
Date summary prepared: 2017-12-01
2. Trade Name
Leksell GammaPlan®
3. Common Name
Treatment planning system
4. Device Classification
| Trade Name | Product Code | Regulation Number | Device Class | Classification Panel |
|---|---|---|---|---|
| Leksell GammaPlan® | IWB, MUJ | 21 CFR 892.5750 | II | Radiology |
5. Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell GammaPlan® | K151666 |
6. Other relevant submissions
| Device | 510(k) # |
|---|---|
| Leksell Gamma Knife Icon | K160440 |
| Leksell Gamma Knife Perfexion | K151159 |
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7. Device Description
Leksell GammaPlan® is designed for use with the Leksell Gamma Knife and is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of health care professionals (e.g. neurosurgeons, radiation therapists, radiation physicists) such that the desired radiation dose is delivered by the Leksell Gamma Knife to a precisely defined volume.
Summary of clinical testing 8.
Clinical testing on patients was not required to demonstrate substantial equivalence to the predicate device.
Summary of Non Clinical and Performance testing 9.
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features against requirement specification.
Design and usability validation of the system has 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 was effective.
Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met and that the system is confident and stable.
10. Intended Use
Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
11. Technological Characteristics
Leksell GammaPlan® is designed for use with the Leksell Gamma Knife and is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. The fundamental functionality and technical characteristics of the device are the same as the predicate device, K151666.
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12. Substantial Equivalence
The Leksell GammaPlan® has the following similarities to the previous cleared Leksell GammaPlan® (K151666):
- Same indication for use
- Use the same operating principle
- Build on the same software platform
Compared to the previously cleared Leksell GammaPlan (K151666) this new version includes support for both Leksell Gamma Knife® Icon and Leksell Gamma Knife Perfexion. In addition, the following changes have been made:
. Support for non-square images for the purpose of pre-planning and follow up.
lt is now possible to import and co-register non-square images for the purpose of pre-planning and follow-up
. Volumetric margin expansion tool.
A new margin tool that allows for performing volumetric expansion of delineated volumes has been added.
. DICOM import improvements
- The DICOM import dialog has an improved layout that includes image preview and o easier navigation of DICOM attributes.
- For easier identification of image series, the series description is now both o displayed upon selection, and assigned as the default name for imported image series upon DICOM import.
- DICOM import from USB storage device has been added. o
- o Possible to view DICOM attributes for an already imported image series
● New Operating System
- o Upgrade to CentOS 7.1 with from CentOS 5.8
Summary:
The fundamental technical characteristics and indication for use is the same as the previously cleared device, only new support is added. The conclusion is that Leksell GammaPlan® is substantial equivalent to its predicate device.
§ 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.