(105 days)
Not Found
No
The summary describes a computer-based dose planning system for radiosurgery, which is a standard function in this field. There are no mentions of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development. The predicate devices are also earlier versions of the same software, suggesting a traditional software update rather than the introduction of a new AI/ML capability.
No
Leksell GammaPlan® is a dose planning system, a tool used for planning medical treatments, not a device that directly administers therapy or performs a therapeutic function on a patient. It assists in the therapeutic process but is not a therapeutic device itself.
No
Explanation: The device is described as a "computer-based dose planning system" for treatments, specifically for "planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy," which indicates a therapeutic planning function rather than a diagnostic one.
No
The device is described as a "computer-based dose planning system specifically designed for use with Leksell Gamma Knife®". While it is software, its function is intrinsically tied to the Leksell Gamma Knife® hardware, implying it is not a standalone software-only medical device but rather a component or accessory to a larger hardware system.
Based on the provided information, the Leksell GammaPlan® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Leksell GammaPlan® Function: The description clearly states that Leksell GammaPlan® is a computer-based dose planning system for use with the Leksell Gamma Knife®. Its purpose is to plan the dosimetry of treatments in stereotactic radiosurgery and radiotherapy. This involves planning radiation delivery to the body, not analyzing samples from the body.
Therefore, 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
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®. Leksell Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.
Product codes (comma separated list FDA assigned to the subject device)
IWB, MUJ
Device Description
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife". Leksell Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.
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
Not Found
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)
Not Found
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.
K061540, K051022, K042269, K973441, K914808
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.
Not Found
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.
0
510(k) Summary
JUL 2 0 2009
As Required by 21 CFR 807.87(k)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 Contact Person for this submission: Mrs Anna Keck Official Correspondent: Mr Anders Skoglund
2. Trade Name
Leksell GammaPlan®
3. . Device Classification
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Radionuclide radiation therapy system | IWB | II | 892.5750 |
Predicate Device Identification 4.
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell GammaPlan® | K061540 |
| Leksell GammaPlan® | K051022 |
| Leksell GammaPlan® 4C with Multiview | K042269 |
| Leksell Gamma Plan® | K973441 |
| Leksell GammaPlan® | K914808 |
5. Other relevant submissions
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Device Description (for detailed description see Section "Device Description") 6. Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife". Leksell Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.
Intended Use 7.
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.
Substantial Equivalence 8
The functionality for Leksell GammaPlan® is equivalent to its predicate devices Leksell GammaPlan® (K061540) and Leksell GammaPlan® (K051022) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2009
Mr. Anders Skoglund Director Regulatory Affairs Elekta Instrument AB Kungstensgatan 18. P.O. Box 7593 SE-103 93 Stockholm SWEDEN
Re: K090972
Trade/Device Name: Leksell GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 2, 2009 Received: June 4, 2009
Dear Mr. Skoglund:
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.
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
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number | K0909072 |
|---|---|
| Device Name | Leksell GammaPlan® |
| Indications for Use | Leksell GammaPlan® is a computer-based dose planning system |
| specifically designed for use with Leksell Gamma Knife®. |
Prescription X Over-The-Counter Use Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
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Heidi Reimer
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 09/972 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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