(40 days)
No
The summary describes a computer-based dose planning system for Gamma Knife treatment, but there is no mention of AI, ML, or related concepts in the provided text.
No
GammaPlan® is a treatment planning system, not a device that directly delivers therapy or has a therapeutic effect on the patient. Its role is in planning the dosimetry for Gamma Knife® treatments, which is a precursor to therapy but not the therapy itself.
No
GammaPlan® is described as a treatment planning system for dosimetry in stereotactic radiosurgery and radiotherapy, not a device used to diagnose a medical condition.
Yes
The device description explicitly states "GammaPlan® is a computer-based dose planning system" and "computer-based system". While it is designed for use with the Gamma Knife® (a hardware device), the 510(k) summary describes the planning system itself as software running on a computer, not the Gamma Knife hardware. The predicate devices are also described as "GammaPlan®", reinforcing the focus on the software planning component.
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 GammaPlan® is a computer-based system for Gamma Knife® treatment planning. This involves planning the dosimetry for radiosurgery and radiotherapy.
- Device Description: The description reinforces its role in dose planning for use with the Gamma Knife®.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are specifically designed to perform tests on biological samples to provide diagnostic or other health-related information. GammaPlan®'s function is to plan a medical treatment based on imaging and other patient data, not to analyze biological samples.
N/A
Intended Use / Indications for Use
GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning.
Product codes
IWB, MUJ
Device Description
GammaPlan® is a computer-based dose planning system specifically designed for use with the Gamma Knife®. 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
ELEKTA INSTRUMENT AB
JUN 1 - 2005
Dokumentnamn/Name of document Traditional 510(k)
| Utfärdare/Issuer | Louise Lindblad |
|---|---|
| Avser/Regarding | GammaPlan® |
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | 1 |
| Directory |
Section 4- 510(k) Summary
Kosiolzz
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.
GammaPlan®
Device Classification 3.
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Radionuclide radiation therapy system | IWB | II | 892.5750 |
Regulatory History (Unmodificd Predicate Device) 4.
| Devices | 510(k) # |
|---|---|
| Leksell GammaPlan® | K973441 |
| Leksell GammaPlan® 4C with MultiView | K042269 |
5. Other relevant submissions
| Devices | 510(k) # |
|---|---|
| Leksell Gamma Knife® Target System, Model 24001 | K984328 |
1
ELEKTA INSTRUMENT AB
Kos 1022
Dokumentnamn/Name of document Traditional 510(k)
| Utfärdare/Issuer | Louise Lindblad |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | 1 |
| Avser/Regarding | GammaPlan® |
| Directory |
Device Description (for detailed description see Section "Device Description") 6.
GammaPlan® is a computer-based dose planning system specifically designed for use with the Gamma Knife®. Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.
Intended Use 7.
GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning.
Substantial Equivalence 8
The functionality for the GammaPlan® is equivalent to its predicate device Leksell GammaPlan® (K973441) and Leksell GammaPlan® 4C with MultiView (K042269) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device.
2
JUN 1 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Löwendahl Manager Quality & Regulatory Affairs Elekta Instrument AB Kunsgstensgatan 18, P.O. Box 7593 Stockholm, SE-10393 SWEDEN
Re: K051022 Trade/Device Name: GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB and MUJ Dated: April 13, 2005 Received: April 22, 2005
Dear Mr. Löwendahl:
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, 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w Jourse organ inding of substantial equivalence of your device to a legally prematice notification: - The PDF maces
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 If you done sportive at no af the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 601:57). I ou may orders, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hodgdon
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 Traditional 510(k)
| Utfärdare/Issuer | Louise Lindblad |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | 1 |
| Avser/Regarding | GammaPlan® |
| Directory |
Section 7- Indications for Use Statement
| 510(k) Number | KOSIDZZ
To be defined |
|---------------------|----------------------------------------------------------------------------------------|
| Device Name | GammaPlan® |
| Indications for Use | GammaPlan® is a computer-based system designed for Gamma Knife®
treatment planning. |
| | |
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ra-E. Phillips
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00