(169 days)
No
The summary describes a teletherapy device for stereotactic irradiation and mentions a computerized control system, but there is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
Yes
The device is described as a "teletherapy device indicated for use in the stereotactic irradiation of intracranial structures," which is a therapeutic function.
No
The device is described as a "teletherapy device indicated for use in the stereotactic irradiation of intracranial structures," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly lists multiple hardware components (Computerized Control System, Automatic Positioning System, Couch, Radiation Unit, Patient Surveillance System, Stereotactic Coordinate Frame) and mentions testing of both software and hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "teletherapy device indicated for use in the stereotactic irradiation of intracranial structures." This describes a therapeutic device that delivers radiation to a patient's body.
- Device Description: The description details components like a Radiation Unit, Couch, and Patient Surveillance System, all consistent with a radiation therapy device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, based on the provided information, the Leksell® Gamma Knife Target System Model 24001 is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Elekta Instruments Leksell® Gamma Knife Target System Model 24001 is intended for the stereotactic irradiation of intracranial structures.
The Leksell® Gamma Knife Target System Model 24001 is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
Product codes
90 IWB
Device Description
The Leksell® Gamma Knife Target System is an upgraded version of the currently available Leksell® Gamma Knife device. The device is intended for the stereotactic irradiation of intracranial structures and is composed of seven basic components. The Leksell® Gamma Knife Target System receives data from the Leksell Gamma Plan software. The Target System is composed of a Computerized Control System, Automatic Positioning System, Couch, Radiation Unit and Patient Surveillance System. The patient's head is fixated by the Leksell Stereotactic Coordinate Frame.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial structures
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)
The Leksell® Gamma Knife Target System has been demonstrated to perform as intended with accuracy and repeatability. The Leksell® Gamma Knife Target System has been tested on the system and subsystem level. Through testing of the software and hardware components of the device have also been completed. Integration testing and complete system testing have also been performed. Results of performance testing, software and hardware testing of the Leksell® Gamma Knife Target System have been included in Sections 13, 15, and 16 of this submission.
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
MAY 2 1 1999
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 19:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 19.1
| a. | Company Name: | Elekta Instruments, AB |
|---|---|---|
| b. | Company Address: | Birger Jarlsgatan 53, S-103, 97 |
| Stockholm, Sweden | ||
| c. | Company Phone: | |
| Company Fax: | (011) 46 8 5872 54 00 | |
| (011) 46 8 5872 55 00 | ||
| d. | Contact Person: | Sverker Glans |
| Vice President | ||
| Quality and Regulatory Affairs | ||
| Elekta Instruments, AB | ||
| e. | Date Summary Prepared: | November 20, 1998 |
19.2. DEVICE IDENTIFICATION
| a. | Trade/Proprietary Name: | Leksell® Gamma Knife Target System
Model 24001 |
|----|-------------------------|----------------------------------------------------------|
| b. | Classification Name: | Radionuclide Radiation Therapy Device
21 CFR 892.5750 |
IDENTIFICATION OF PREDICATE DEVICE 19.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Elekta Instruments | Leksell Gamma Unit | ||
| Model 23004, Type B | K924849 | November 20, 1995 |
1
19.4 DEVICE DESCRIPTION
The Leksell® Gamma Knife Target System is an upgraded version of the currently available Leksell® Gamma Knife device. The device is intended for the stereotactic irradiation of intracranial structures and is composed of seven basic components. The Leksell® Gamma Knife Target System receives data from the Leksell Gamma Plan software. The Target System is composed of a Computerized Control System, Automatic Positioning System, Couch, Radiation Unit and Patient Surveillance System. The patient's head is fixated by the Leksell Stereotactic Coordinate Frame.
19.5 SUBSTANTIAL EQUIVALENCE
The Leksell® Gamma Knife Target System Model 24001 is substantially equivalent to previous version of the Leksell® Gamma Knife Model 23004 currently in commercial distribution by Elekta Instruments. The Leksell® Gamma Knife Target System and the predicate device are both indicated for the stereotactic irradiation of intracranial structures.
The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison charts provided in this 510(k) submission.
19.6 INTENDED USE
The Elekta Instruments Leksell® Gamma Knife Target System Model 24001 is intended for the stereotactic irradiation of intracranial structures.
2
19.7 TECHNOLOGICAL CHARACTERISTICS
A complete comparison of the technological characteristics of the predicate is provided within this submission. Both the predicate and Target System are composed of the same radiation unit using Cobalt 60 through 201 collimator sources. The Target System and the predicate receive treatment planning data from the Leksell® Gamma Plan software program. In both devices, the patient's head is fixated by the Leksell® Stereotactic Coordinate Frame.
19.8 PERFORMANCE DATA
The Leksell® Gamma Knife Target System has been demonstrated to perform as intended with accuracy and repeatability. The Leksell® Gamma Knife Target System has been tested on the system and subsystem level. Through testing of the software and hardware components of the device have also been completed. Integration testing and complete system testing have also been performed. Results of performance testing, software and hardware testing of the Leksell® Gamma Knife Target System have been included in Sections 13, 15, and 16 of this submission.
19.9 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
3
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
MAY 2 1 1999
Elektra Instruments AB C/O Carol Patterson Consultant 18140 Smokesignal Drive San Diego, California 92127 RE:
K984328 Gamma Knife: Dated: May 17, 1999 Received: May 18, 1999 Regulatory Class: II 21 CFR 892.5750/Procode: 90 IWB
Dear Ms. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any oblication you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
| 510(k) Number: | K984328
|
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Elekta Leksell® Gamma Knife Target System Model 24001 |
| Indications for Use: | The Leksell® Gamma Knife Target System Model 24001 is
a teletherapy device indicated for use in the stereotactic
irradiation of intracranial structures |
| To Be Assigned By FDA | |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Segerson
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Deyig 510(k) Number
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)