(30 days)
No
The summary describes a computer-based dose planning system and does not mention AI, ML, or related terms.
No
The device is described as a "computer-based dose planning system" for use with a therapeutic device (Leksell Gamma Knife®), but it is not the therapeutic device itself. It plans the therapy, rather than delivering it.
No
Explanation: The device is described as a "computer-based dose planning system" for radiosurgery and radiotherapy, which is a treatment planning function, not a diagnostic one.
Yes
The device is described as a "computer-based dose planning system" and is specifically designed for use with a separate hardware device (Leksell Gamma Knife®). The description focuses solely on the software's function in planning, without mentioning any associated hardware components included with the submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Leksell GammaPlan® is a "computer-based dose planning system specifically designed for use with Leksell Gamma Knife®." This describes a system used for planning radiation treatment, which is an in-vivo procedure (performed on a living organism).
- Device Description: The description reinforces its use in "stereotactic radiosurgery and stereotactic radiotherapy," both of which are treatment modalities applied directly to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis, which are hallmarks of IVD devices.
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®.
Product codes
IWB
Device Description
Leksell GammaPlan® is a computer-based dose planning system specifically designed for Eeksell Gamma Knife®. Leksell Gamma Plan® is intended to be used for alse with the Losiments, 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)
Reference Device(s)
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
§ 892.5750 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
| ELEKTA INSTRUMENT AB | K061540 | Dokumentnamn/Name of document |
|---|---|---|
| Special 510(k) | ||
| Utfärdare/Issuer | Louise Lindblad | Utgåva /Edition |
| Ref nr/Dok nr/Ref no/Doc no | . | 1 |
| Avser/Regarding | Leksell GammaPlan® | Directory |
Section 4 - 510(k) Summary
As Required by 21 CFR 807.87(k)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 Contact Person for this submission: Ms Louise Lindblad Official Correspondent: Mr Peter Löwendahl
Trade Name 2.
Leksell GammaPlan®
Device Classification 3.
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Radionuclide radiation therapy system | IWB | II | 892.5750 |
Regulatory History (Unmodified Predicate Device) 4.
| Devices | 510(k) # |
|---|---|
| GammaPlan® | K051022 |
Other relevant submissions 5.
| Devices | 510(k) # |
|---|---|
| Leksell GammaPlan® | K973441 |
1
ELEKTA INSTRUMENT AB
1061540
| Dokumentnamn/Name of document | Special 510(k) |
|---|---|
| Utfärdare/Issuer | Louise Lindblad |
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva / Edition | 1 |
| Avser/Regarding | Leksell GammaPlan® |
| Directory |
Device Description (for detailed description see Section "Device Description") 6.
Leksell GammaPlan® is a computer-based dose planning system specifically designed for Eeksell Gamma Knife®. Leksell Gamma Plan® is intended to be used for alse with the Losiments, 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
o - - - Substainful Equivalent is equivalent to its predicate devices The ranchanel (K051022) and Leksell GammaPlan® (K973441) in safety and effectiveness. Gammal lan- (18051022) and issuesistics are similar to those of the predicate devices.
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL - 5 2006
Ms. Louise Lindblad Elekta Instrument AB Kungstensgatan18 P.O. Box 7593 Stockholm SWEDEN SE-103 93
Re: K061540
Trade/Device Name: Leksell GammaPlan® Regulation Number: 21 CFR §892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: May 30, 2006 Received: June 5, 2006
Dear Ms. Lindblad:
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 (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 898. In addition, FDAD may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a stylized font, with the word "Centennial" underneath. Above the letters "FDA" are the numbers "1906 - 2006". The text around the circle reads "A Century of Consumer Protection". There are also three stars below the word "Centennial".
Protecting and Promoting Public Health
3
Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/edrh/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ELEKTA INSTRUMENT AB
| Dokumentnamn/Name of document |
|---|
| Special 510lkl |
| Utfärdare/Issuer | Louise Lindblad |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgava / Edition | 1 |
| Avser/Regarding | Leksell GammaPlan® |
| Directory |
Section 7- Indications for Use Statement
To be defined
| 510(k) Number | K061540 |
|---|---|
| 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 Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
. –
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
==============================================================================================================================================================================
Nancy C Hoadon
(Division Sign-Off)
Division of Reproductive, Abo and Radiological Devices 510(k) Number _