(63 days)
Not Found
No
The summary describes a computer-based dose planning system for radiosurgery, which is a standard function of such systems. There is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development.
No
The device is a dose planning system; it does not directly treat the patient but rather assists in planning the treatment.
No
Explanation: The device is described as a "dose planning system" used for "planning the dosimetry of treatments" in radiosurgery and radiotherapy. This indicates it is a treatment planning device, not a diagnostic device.
No
The device is described as a "computer-based dose planning system specifically designed for use with Leksell Gamma Knife®". While it is computer-based (implying software), its function is intrinsically tied to the Leksell Gamma Knife® hardware for treatment delivery, making it a system that includes both software and hardware components for its intended use.
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®" for "planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy." This describes a system used for planning medical treatments on a patient, not for testing samples from a patient in vitro.
- Device Description: The description reinforces the intended use as a dose planning system for a medical device (Leksell Gamma Knife®).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis based on sample analysis
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Leksell GammaPlan® is a treatment planning tool, not a diagnostic testing tool.
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)
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.
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
DEC 2 1 2010
ELEKTA INSTRUMENT AB
| Dokumentnamn/Name of document |
|---|
| Special 510(k) |
| Utfärdare/Issuer | Viveka Wretman |
|---|---|
| Avser/Regarding | Leksell GammaPlan® |
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | - |
| 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: Mrs Viveka Wretman Official Correspondent: Mr Anders Skoglund
Trade Name 2.
Leksell GammaPlan®
3. Device Classification
| Common Name
| Comments of the programments of the All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All Al | Product Code Class | Regulation Number |
|---|---|---|
| Radionuclide radiation therapy system | 892.5750 |
Predicate Device Identification 4.
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell GammaPlan® | K090972 |
| XiO RTP | K092132 |
5. Other relevant submissions
| ----------
1
Carrely of Canadian Career of
10111000
1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
And Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of
----------------- | Property of Children
No. of Cattle
PAGI |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Amore of the property of | Michael Address Marcel
And Antiques of Concession of Concession of Children Andrew And | -
Character of Children of Children Company of Children Company Company Comments of Children |
COMPANY CONFIDENTIAL
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00
13
1
ELEKTA INSTRUMENT AB
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Special 510(k) |
|---|---|---|---|
| Viveka Wretman | - | - | |
| Avser/Regarding | Directory | ||
| Leksell GammaPlan® | - | - |
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.
7. Intended Use
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.
8 Substantial Equivalence
The functionality for Leksell GammaPlan® is equivalent to its predicate devices Leksell GammaPlan® (K090972) and XiO RTP System (K092132) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices. .
COMPANY CONFIDENTIAL
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00
14
Dokumentnamn/Name of document
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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Bo Nilsson Director Quality & Regulatory Affairs Elekta Instrument AB, Box 7593 SE-103 93 Stockholm SWEDEN
Re: K103093
BEE 2 1 2019
Trade/Device Name: Leksell GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 30, 2010 Received: December 2, 2010
Dear Mr. Nilsson:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5 000). This recei notification. The FDA finding of substantial equivalence of your device to a legally ronalteted 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 fre number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dan
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure.
4
Dokumentnamn/Name of docume
ELEKTA INSTRUMENT AB
| Utfärdare/Issuer | Viveka Wretman |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | - |
| Special 510(k) | |
| Avser/Regarding | Leksell GammaPlan® |
| Directory |
Section 7- Indications for Use Statement
| 510(k) Number | To be defined |
|---|---|
| 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)
0 (Division Sign-Off)
Concurrence of CDRH, Office
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103093
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00