(105 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 intended for stereotactic irradiation of head structures" and a "radiosurgery system for use in the stereotactic irradiation of intra-cranial structures," indicating its use in treating medical conditions.
No
The document describes a teletherapy device for stereotactic irradiation, which is a treatment modality, not a diagnostic one.
No
The device description explicitly states the system 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:
- IVD devices are used to examine specimens from the human body. The description clearly states that the Leksell Gamma Knife® PERFEXION ™ is a "teletherapy device intended for stereotactic irradiation of head structures" and a "radiosurgery system for use in the stereotactic irradiation of intra-cranial structures." This involves treating the patient directly, not analyzing samples taken from the patient.
- The intended use is therapeutic. The device delivers radiation to treat conditions within the head. IVD devices are used for diagnosis, monitoring, or screening, not for direct treatment.
Therefore, the Leksell Gamma Knife® PERFEXION ™ falls under the category of a therapeutic medical device, specifically a radiosurgery system.
N/A
Intended Use / Indications for Use
Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors.
Product codes
IWB
Device Description
Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial structures. Surgery 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
head structures, intra-cranial 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)
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
Ka6351/2
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of docume Traditional 510/k)
Traditional 510(k)
| Utfärdare/Issuer | Anders Skoglund |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | - |
| Avser/Regarding | Leksell Gamma Knife® PERFEXION ™ |
| Directory |
Section 4- 510(k) Summary
As Required by 21 CFR 807.87(k)510 (k) Summary
MAR 0 5 2007
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 ™
Device Classification 3.
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Radionuclide radiation therapy system. | IWB | II | 21 CFR 892.5750 |
Predicate Device Identification 4.
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Leksell Gamma Knife® PERFEXION TM | K061941 |
Other relevant submissions 5.
| Devices | 510(k) # |
|---|---|
| Leksell Stereotactic System | K972324 |
| Leksell GammaPlan® PFX | K061540 |
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 255 00
1
Page2f2
Dokumentnamn/Nome of doe
Traditional 51016
ELEKTA INSTRUMENT AB
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Anders Skoglund | - | - |
| Avser/Regarding | ||
| Leksell Gamma Knife® PERFEXION TM | Directory |
Device Description (for detailed description see Section "Device Description") 6.
Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial structures. Surgery 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).
Intended Use 7.
Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors.
Substantial Equivalence 8
The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device the Leksell Gamma Knife® PERFEXION ™ (K061941) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.
2
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Anders Skoglund Regulatory Affairs Elekta Instrument AB Kungstensgatan 18, P.O. Box 7593 SE-103 93 Stockholm SWEDEN
MAR C 5 2007
Re: K063512
Rooss12
Trade/Device Name: Leksell Gamma Knife® PERFEXION™ System Regulation Number: 21 CFR §892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 15, 2007 Received: February 20, 2007
Dear Mr. Skoglund:
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.
Image /page/2/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. Three stars are below the word "Centennial". The text "Growth & Innovation in Consumer Protection" is around the top of the circle, and the text "In the Service of Food" is around the bottom of the circle.
3
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of 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 807.97). 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-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. Brogdon
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 | Anders Skoglund |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | - |
| Avser/Regarding | Leksell Gamma Knife® PERFEXION ™ |
| Directory |
Section 7- Indications for Use Statement
| 510(k) Number | K063512 |
|---|---|
| Device Name | Leksell Gamma Knife® PERFEXION ™ |
| Indications for Use | Leksell Gamma Knife® PERFEXION ™ is a teletherapy device |
| intended for stereotactic irradiation of head structures ranging | |
| from very small target sizes of a few millimeters to several | |
| centimeters e.g. metastatic tumors. |
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) T
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _