(57 days)
No
The summary describes a computer-based system for treatment planning in stereotactic radiosurgery, focusing on dosimetry and processing professional inputs. There is no mention of AI, ML, or related concepts in the provided text.
No
The device, Leksell GammaPlan®, is a computer-based system for planning Leksell Gamma Knife® treatments, specifically for dosimetry planning, and does not directly provide therapy itself. It is a planning tool used by professionals to deliver a desired radiation dose via another device (Leksell Gamma Knife).
No
Explanation: The device is described as a "computer-based system designed for Leksell Gamma Knife® treatment planning" and "planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy." Its function is to process inputs to deliver a desired radiation dose, not to diagnose a medical condition.
No
The device description explicitly states it is "designed for use with the Leksell Gamma Knife" and is intended for "planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy," which are hardware-dependent procedures performed by the Gamma Knife device. While Leksell GammaPlan is a computer-based system, its function is intrinsically tied to the operation of the Leksell Gamma Knife hardware.
Based on the provided information, the Leksell GammaPlan® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy." This involves planning radiation delivery to a patient's body, not analyzing samples taken from the body (in vitro).
- Device Description: The description reinforces its role in processing inputs from healthcare professionals to deliver radiation to a defined volume within the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Leksell GammaPlan®'s function is entirely focused on planning a medical treatment procedure performed on the patient.
N/A
Intended Use / Indications for Use
Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
Product codes (comma separated list FDA assigned to the subject device)
IWB, MUJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals (e.g. neurosurgeons, radiation therapists, radiation physicists)
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)
Summary of clinical testing: Clinical testing on patients was not required to demonstrate substantial equivalence to the predicate device.
Summary of Non Clinical and Performance testing: 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.
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.
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
February 9, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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.
1
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.