(202 days)
Not Found
No
The summary describes a computer-based dose planning system that processes imported images and user inputs for treatment planning, but it does not mention or describe any AI or ML capabilities.
No
The device is a planning system for dosimetry and does not deliver therapy itself. It is used in conjunction with a therapeutic device (Leksell Gamma Knife).
No
Explanation: The device is described as a "computer based dose planning system" for radiation therapy. Its purpose is to plan the dosimetry of treatments, not to diagnose a disease or condition. It processes images for treatment planning, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "computer based dose planning system specifically designed for use with the Leksell Gamma Knife," which is a hardware device. While the GammaPlan is software, its function is intrinsically tied to controlling and planning treatments delivered by the Gamma Knife hardware.
Based on the provided information, the Leksell GammaPlan is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Leksell GammaPlan's Function: The Leksell GammaPlan is a software system used for planning the dosimetry of radiation treatments for patients undergoing stereotactic radiosurgery or radiation therapy using the Leksell Gamma Knife. It processes medical images (CT, MR, angiograms) to determine how radiation should be delivered to a target area within the cranium.
- No Specimen Examination: The Leksell GammaPlan does not involve the collection, preparation, or examination of any specimens taken from the human body. Its function is entirely focused on treatment planning based on imaging data.
Therefore, the Leksell GammaPlan falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Leksell GammaPlan (LGP) is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument, AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professionals (Neurosurgeons, Radiation Therapists, Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
Product codes
90 IWB
Device Description
The Leksell GammaPlan® is a computer based dose planning system specifically designed for use with the Leksell Gamma Knife. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Digital images from CT or MR scanners, or angiograms are imported and processed for treatment planning. Patient treatment protocols are based on single or multiple targets and alternative treatment plans can be generated by the GammaPlan.
Mentions image processing
Digital images from CT or MR scanners, or angiograms are imported and processed for treatment planning.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, and AI modalities (angiograms inferred from AI)
Anatomical Site
cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals (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
Testing of the software includes Module, Integration and System testing. All test results have been included in Section 14 of this notification.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Leksell GammaPlan® has been demonstrated to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 19:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
APR - 1 1998
SUBMITTER INFORMATION 19.1
rau v
| a. Company Name: | Elekta Instrument, AB |
|---|---|
| b. Company Address: | Birger Jarlsgatan 53 |
| Stockholm, Sweden | |
| c. Company Phone: | |
| Company Facsimile: | (011) 46 8 587 254 00 |
| (011) 46 8 587 255 00 | |
| d. Contact Person: | Sverker Glans |
| Vice President | |
| Quality/Regulatory Affairs | |
| Elekta Instrument, AB |
September 2, 1997 e. Date Summary Prepared:
DEVICE IDENTIFICATION 19.2.
| a. Trade/Proprietary Name: | Leksell GammaPlan® | |
|---|---|---|
| -- | ---------------------------- | -------------------- |
b. Classification Name:
Radionuclide radiation therapy system. CFR 892.5750
IDENTIFICATION OF PREDICATE DEVICE 19.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Elekta Instrument, AB | Leksell GammaPlan® | K914808 | January 23, 1992 |
1
19.4 DEVICE DESCRIPTION
The Leksell GammaPlan® is a computer based dose planning system specifically designed for use with the Leksell Gamma Knife. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Digital images from CT or MR scanners, or angiograms are imported and processed for treatment planning. Patient treatment protocols are based on single or multiple targets and alternative treatment plans can be generated by the GammaPlan.
19.5 SUBSTANTIAL EQUIVALENCE
The Leksell GammaPlan® is substantially equivalent to the previous version of the Leksell GammaPlan currently in commercial distribution by Elekta Instrument, AB, in terms of achieving a safe and accurate simulation or plan of stereotactic Leksell Gamma Knife radiosurgery/radiation therapy.
The fundamental algorithm principle of calculation and other technical characteristics are the same as that of the predicate device.
19.6 INTENDED USE
The Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan® is intended to beused for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs from the health care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
2
TECHNOLOGICAL CHARACTERISTICS 19.7
A comparison of the technological characteristics of the predicate and legally marketed devices has been completed. Both the original and upgraded versions of the Leksell GammaPlan® use the same algorithm principle. Calculation of the radiation dose for the treatment plan and overlay of the isodose curve is the same in the new version, as in the predicate device. The computer workstation has remained the same in the upgraded version. Image input from CT, MR and AI, modalities have remained the same.
19.8 PERFORMANCE DATA
The Leksell GammaPlan® has been demonstrated to perform as intended. Testing of the software includes Module, Integration and System testing. All test results have been included in Section 14 of this notification.
510(K) CHECKLIST 19.9
This notification contains all information required by 21 CFR 807 87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract shapes resembling birds or waves, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10008 APR - I
Sverker Glans Elekta Instrument. AB c/o Carol Patterson Consultant for Elekta Instrument, AB 18140 Smokesignal Drive San Diego, CA 92127
Re:
K973441 Leksell GammPlan (Radionuclide Radiation Therapy Planning System) Dated: January 8, 1998 Received: January 12, 1998 Regulatory class: II 21 CFR 892.5750/Procode: 90 IWB
Dear Ms. Glans:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act increde requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrhdsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number:
To Be Assigned By FDA K 9734 4 |
Device Name:
Leksell GammaPlan®
Indications For Use: The Leksell GammaPlan (LGP) is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument, AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professionals (Neurosurgeons, Radiation Therapists, Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Kand H. Kymm
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number.