(42 days)
No
The summary describes a traditional radiosurgery system and does not mention any AI or ML components or capabilities.
Yes
The device is described as a "teletherapy device" and a "radiosurgery system" that delivers "ionizing radiation" to "intra-cranial structures" for treatment, which clearly indicates a therapeutic function.
No
The device description states it is a "teletherapy device" and a "radiosurgery system" for "stereotactic irradiation," which are therapeutic functions, not diagnostic.
No
The device description explicitly states it consists of a "radiation unit with patient positioning system and the operator console (with control panel and system computer)," indicating significant hardware components beyond just software.
Based on the provided information, the Leksell Gamma Knife® PERFEXION ™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures." This describes a therapeutic device that delivers radiation to treat conditions within the body.
- Device Description: The description reinforces this by calling it a "radiosurgery system" that delivers "ionizing radiation" to a target site.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The Leksell Gamma Knife does not perform such tests.
Therefore, the Leksell Gamma Knife® PERFEXION ™ is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.
Product codes
FWB
Device Description
Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic Lessen Gamilia Nime Fire - Fire Erivery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-cranial
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)
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
Image /page/0/Picture/0 description: The image shows a series of handwritten numbers and letters. The characters appear to be 'K061941'. The writing is in black ink and the background is white.
13
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document
AUG 2 1 2006
Traditional 510(k)
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Anders Skoglund | - | - |
| Avser/Regarding | - | Directory |
| Leksell Gamma Knife® PERFEXION ™ | - |
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 Gamma Knife® PERFEXION тм
Device Classification 3.
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Radionuclide radiation therapy system. | FWB | II | 21 CFR 892.5750 |
Predicate Device Identification 4.
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell Gamma Knife Target System, Model 24001 | K984328 |
Other relevant submissions 5.
| Devices | 510(k) # |
|---|---|
| Leksell Stereotactic System | K972324 |
1
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of docur Traditional 510(k)
14
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Anders Skoglund | - | - |
| Avser/Regarding | Directory | |
| Leksell Gamma Knife® PERFEXION ™ | - | - |
Device Description (for detailed description see Section "Device Description") 6.
Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic Lessen Gamilia Nime Fire - Fire Erivery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).
7. Intended Use
Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.
Substantial Equivalence 8
The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its Fire Tanetionality for the Lettorma Knife Target System, Model 24001 (K984328) in predicate deffectiveness. The fundamental technical characteristics are similar to those of sates) and enversion and are listed on the comparison charts provided in this 510(k) submission.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 1 2006
Mr. Peter Löwendahl Director Group Regulatory Affairs Elekta Instrument AB P.O. Box 7593 SE-103 93 Stockholm SWEDEN
Re: K061941
K001941
Trade/Device Name: Leksell Gamma Knife® PERFEXION™ Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: July 6, 2006 Received: July 10, 2006
Dear Mr. Löwendahl:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass sunce in the encready to regain date of the Medical Device Amendments, or to devices that proof to May 26, 1770, and marked 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 ancerors, mailier and abrilor, salejove excirements for annual registration, listing of devices, good controls provisions or alsocing, 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 Apploval), It thay be subject to back aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located 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 Please be advised that FDA s issualies of a sudential requirements of the Act
that FDA has made a determination that your device of a Force onerains. You must that FDA has made a delechniation that Jour St. Co., St. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. L. or any Federal statutes and regulations daminents but not limited to: registration and listing (21 comply with all the Act Stequirements, monamal manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing the dectronic CFR Part 807); labeling (21 CFR Part 601); good fixed 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicabl forth in the quality systems (Sections (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) I his letter will anow you to ocgin makemig your antial equivalence of your device to a legally premarket notification. The PDA midning of basination 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 desire specific advice for your decided on 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" Also, please note the regulation chittics, "Thistanation on your responsibilities under (21CFR Part 807.97). 100 may obtain other general and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C Hodgon
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
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Anders Skoglund | - | - |
| Avser/Regarding | Directory | |
| Leksell Gamma Knife® PERFEXION ™ | - | - |
Section 7- Indications for Use Statement
| 510(k) Number | To be defined K061941 |
|---|---|
| Device Name | Leksell Gamma Knife® PERFEXION TM |
| Indications for Use | Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures. |
Prescription X Use (Part 21 CFR 801 Subpart D)
ADDIOR
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 R. Lynn
(Division Sign-Off Division of Reprodu and Radiological De 510(k) Number