(76 days)
No
The summary describes a computer-based treatment planning system that processes inputs from healthcare professionals to deliver a desired radiation dose. There is no mention of AI, ML, or related concepts like training/test sets for model development. The testing described focuses on traditional software verification and validation.
No
The device is a computer-based system for treatment planning (dosimetry) for radiosurgery and radiation therapy, not a device that directly provides therapy. It processes inputs to deliver a desired radiation dose via the Leksell Gamma Knife, which is the therapeutic device.
No
Explanation: The device is described as a "computer-based system designed for Leksell Gamma Knife® treatment planning" and "intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy." Its function is to process inputs to ensure the desired radiation dose is delivered, not to diagnose a condition.
Yes
The device description explicitly states "Leksell GammaPlan® is a computer-based system" and describes its function as processing inputs and planning dosimetry, which are software-based tasks. While it is used with the Leksell Gamma Knife (a hardware device), the 510(k) summary focuses solely on the software's function and verification/validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Leksell Gamma Knife® treatment planning" and "planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy." This is a treatment planning system, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on processing inputs from healthcare professionals to deliver a desired radiation dose. This is a function related to treatment delivery planning, not diagnosis.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
The device is a software system used in conjunction with a medical device (Leksell Gamma Knife) for therapeutic purposes (radiosurgery and radiation therapy).
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)
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
Cone Beam CT (CBCT)
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)
Clinical testing on patients was not required to demonstrate substantial equivalence or safety and effectiveness of the device.
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. Regression and re-test of unchanged functionalities in the developed system was done to ensure that the new and updated functionalities did not introduce any undesirable effects.
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 safety & effectiveness have been achieved.
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
Elekta Instrument AB % Ms. Matilda Forsberg Regulatory Affairs Engineer Kungstensgatan 18 Stockholm, 10393 SWEDEN
Re: K151666
Trade/Device Name: Leksell GammaPlan Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 14, 2015 Received: June 19, 2015
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151666
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)
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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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: Ms Louise Wachtmeister
Date summary prepared: 2015-06-10
2. Trade Name
Leksell GammaPlan®
3. Device Classification
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Leksell GammaPlan® | MUJ | II | 21 CFR 892.5050 |
4. Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell GammaPlan® | K103093 |
5. Other relevant submissions
| Devices | 510(k) # |
|---|---|
| Leksell GammaPlan® | K090972 |
6. 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.
4
Summary of Clinical Testing 7.
Clinical testing on patients was not required to demonstrate substantial equivalence or safety and effectiveness of the device.
8. 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. Regression and re-test of unchanged functionalities in the developed system was done to ensure that the new and updated functionalities did not introduce any undesirable effects.
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 safety & effectiveness have been achieved.
9. Intended Use
Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
10. 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 similar to those of the predicate device K103093.
11. Substantial Equivalence
The functionality for Leksell GammaPlan® is equivalent to its predicate device Leksell GammaPlan® (K103093) in safety and effectiveness. The following workflows have been added to the new version:
- Stereotactic reference can be defined from stand-alone Cone Beam CT ● (СВСТ)
- Mask fixation support with automatic patient position correction from CBCT
- Guided treatment delivery evaluation after CBCT with review of delivery dose
5
The indication for use is the same as its predicate device and the fundamental technical characteristics are similar.