(16 days)
No
The summary describes a computer-based dose planning system with image co-registration and atlas support, but it does not mention AI, ML, deep learning, or any related concepts. The processing described is standard for medical imaging and planning software.
No
The device is a computer-based dose planning system used for treatment planning in radiosurgery and radiotherapy, not for directly delivering therapeutic treatment.
No
The device is described as a "computer-based dose planning system" for "planning the dosimetry of treatments." It helps healthcare professionals determine the radiation dose for a defined target area, rather than identifying or diagnosing a disease or condition itself.
No
The device is described as a "computer-based dose planning system" that is "specifically designed for use with the Leksell Gamma Knife®". While it is software, its function is intrinsically tied to the hardware of the Gamma Knife, indicating it is part of a larger system, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Leksell GammaPlan 4C with MultiView is a treatment planning system used in conjunction with a radiation delivery device (Leksell Gamma Knife). It processes medical images and other inputs to plan the delivery of radiation to a target area within the cranium.
- Lack of Biological Sample Analysis: The device does not analyze biological samples from the patient. Its function is focused on image processing and dose calculation for radiation therapy.
Therefore, the Leksell GammaPlan 4C with MultiView 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 4C with MultiView is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan 4C with MultiView is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgey and stereotactic radio therapy. It processes the inputs from the healt care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife® to a precisely defined target area within the cranium.
Product codes
IWB, MUJ
Device Description
The Leksell GammaPlan 4C with MultiView adds support for frameless images by means of co-registration of image series. This simplifies stereotactic radiosurgery procedures as only one image series needs to be acquired with the Leksell stereotactic frame. Leksell GammaPlan 4C with MultiView also adds support for brain altas structures and visualization of color mapped PET images for use in preoperative planning.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healt care professionals
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
§ 892.5050 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
ELEKTA INSTRUMENT AB
Dokumentnamn/Nome of document Special 510(k)
12
| Utfärdare/Issuer
| Anders Skoglund | Ref nr/Dok nr/Ref no/Doc no | Utgava / Edition | |
|---|---|---|---|
| Avser/Regarding | |||
| Leksell GammaPlan 4C with MultiView | Directory |
GammaPlan 4C with MultiView
Kø4 2269
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: Mr Anders Skoglund Official Correspondent: Mr Peter Löwendahl
Trade Name 2.
Leksell GammaPlan 4C with MultiView
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) # |
|---|---|
| Leksell GammaPlan | K973441 |
5. Other relevant submissions
| Devices | 510(K) # |
|---|---|
| Leksell Surgiplan with Atlaspace | K013861 |
| Leksell Surgiplan with Imagemerge | K033340 |
1
| ELEKTA INSTRUMENT AB | Ky4 2264 | Dokumentnamn/Name of document | 13 |
|---|---|---|---|
| Special 510(k) | |||
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | |
| Anders Skoglund | - | 1 |
Avser/Regarding Leksell GammaPlan 4C with MultiView
Device Description (for detailed description see Section "Device Description") 6.
The Leksell GammaPlan 4C with MultiView adds support for frameless images by means of co-registration of image series. This simplifies stereotactic radiosurgery procedures as only one image series needs to be acquired with the Leksell stereotactic frame. Leksell GammaPlan 4C with MultiView also adds support for brain altas structures and visualization of color mapped PET images for use in preoperative planning.
Intended Use 7.
The Leksell GammaPlan 4C with MultiView is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan 4C with MultiView is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgey and stereotactic radio therapy. It processes the inputs from the healt care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife® to a precisely defined target area within the cranium.
Substantial Equivalence 8
The functionality for the Lekscll GammaPlan 4C with MultiView is equivalent to its predicate device Leksell GammaPlan (K973441) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Mr. Peter Löwendahl Quality and Regulatory Affairs Manager Elekta Instrument AB P.O. Box 7593 SE-103 93 Stockholm SWEDEN
Re: K042269 Trade/Device Name: Leksell GammaPlan 4C with MultiView Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II
Product Code: 90 MUJ Dated: August 20, 2004 Received: August 23, 2004
Dear Mr. Löwendahl:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roviewed your coreemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 9776, the enactment date of the Medical Device Amendments, or to eoniner of process that have been recordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Oosmotion For (100) the ) the device, subject to the general controls provisions of the Act. The r ou may, the crowisions 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 such additional controls. Existing major regulations affecting your device can may or subject to Sateral 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 that I Dr. I has had 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) This letter will anow you to oght hands.org of substantial equivalence of your device to a legally premarket notification. The PDA maily gour 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 desire specific advice for your de to the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on and personation entitled, "Miso, please note the regulation entitled, "Misbranding Other of Complanos at (201) 22ation" (21CFR Part 807.97) you may obtain. Other general by relection on your responsibilities under the Act may be obtained from the Division of Small mornation on your responsionities 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
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
16
ELEKTA INSTRUMENT AB
Special 510(k)
| Utfärdare/Issuer | Anders Skoglund | Utgåva /Edition | 1 |
|---|---|---|---|
| Ref nr/Dok nr/Ref no/Doc no | - | Directory | |
| Avser/Regarding | Leksell GammaPlan 4C with MultiView |
Section 7- Indications for Use Statement
| 510(k) Number | To be defined
K$\phi$42269 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Leksell GammaPlan 4C with MultiView |
| Indications for Use | The Leksell GammaPlan 4C with MultiView is a computer-based dose
planning system specifically designed for use with the Leksell Gamma
Knife®. The Leksell GammaPlan 4C with MultiView is intended to be
used for planning the dosimetry of treatments in stereotactic
radiosurgey and stereotactic radio therapy. It processes the inputs
from the healt care professionals such that the desired radiation dose
is provided by the Leksell Gamma Knife® to a precisely defined target
area within the cranium. |
X Prescription Use (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)
David A. Layman
(Division Sign-Off)
Division of Reproductive, Abdomis and Radiological Devices 510(k) Number J