(57 days)
No
The summary describes a hardware modification (motion controller upgrade) to a radiation therapy device. There is no mention of AI or ML in the intended use, device description, or any of the other sections.
Yes
The device is described as a "tele-therapy radiation treatment device" intended for "stereotactic irradiation of intracranial structures," indicating its use in treating medical conditions.
No
The device description indicates that it is a tele-therapy radiation treatment device used for stereotactic irradiation, not for diagnosing conditions.
No
The device description clearly details hardware components, specifically a tele-therapy device with Cobalt-60 sources, a source carrier, a secondary collimator, and a motion controller. The submission is for a modification to the motion controller, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "radiation treatment of selected intracranial abnormalities" and "stereotactic irradiation of intracranial structures." This describes a therapeutic device that delivers radiation directly to a patient's body.
- Device Description: The description details a "tele-therapy device" containing Cobalt-60 sources for delivering radiation. This is consistent with a radiation therapy device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) to treat a condition.
N/A
Intended Use / Indications for Use
The Rotating Gamma System, GammaART 6000 is intended to be used by licensed Medical Professionals for radiation treatment of selected intracranial abnormalities. previously cleared for the OUR Rotating Gamma System and the Leksell Gamma Knife.
The Rotating Gamma System, GammaART 6000 is a tele-therapy radiation treatment device intended to be used for stereotactic irradiation of intracranial structures. The device is to be used by licensed medical professionals, having been trained in the use and safety precautions of this device.
Product codes
IWB
Device Description
This 510(k) Special Submission if for a modification to cleared K970647 Rotating Gamma System that has received a motion controller upgrade. The ACS SB214ND 4axis motion controller (P/N: D-000024) has been replaced with the new Galil DMC-2000 5-axis motion controller (P/N: C-000141).
The Rotating Gamma System, GammaART 6000 is a tele-therapy device which contains 30 Cobalt-60 sources distributed on a hemispheric shielded source carrier. Inside the source unit is the "built in" secondary collimator which has four sides of collimators and one block position. When not treating, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter. Treatment starts with aligning the sources to the prescribed collimator size, then both the source unit and the secondary collimator rotate as one unit. By rotating the Cobalt-60 sources, 30 nonoverlapping full 360 degree arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (structures/abnormalities)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed Medical 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 (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)
Not Found
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
6 2006 APR
American Radiosurgery, Inc. Special 510(k) Submission for Rotating Gamma System, GammaART-6000
K06 03/4
| Submitter: | American Radiosurgery, Inc. (ARI) |
|---|---|
| Address: | 16776 Bernardo Center Drive Suite 203 |
| San Diego, CA 92128 | |
| Phone number: | (858) 451-6173 |
| Fax number: | (858) 487-0662 |
| Contact person: | Franz Krispel |
| Date prepared: | 2/6/06 |
| Trade name: | Rotating Gamma System, GammaART 6000 |
| Common name: | Gamma Knife, Gamma-ray Radiosurgery System, Nuclid |
| Radiation Therapy System | |
| Classification name: | Radionuclide Radiation Therapy System |
| Substantial equivalence claimed to: |
Predicate 510(k) Number K970647
Description:
This 510(k) Special Submission if for a modification to cleared K970647 Rotating Gamma System that has received a motion controller upgrade. The ACS SB214ND 4axis motion controller (P/N: D-000024) has been replaced with the new Galil DMC-2000 5-axis motion controller (P/N: C-000141).
Basis for Submission:
The replacement of the RGS 6000 motion controller is a "control mechanism change" as specified by question B1 of the 510(k) Memorandum #K97-1 from the United States Food and Drug Administration, Office of Device Evaluation dated January 10, 1997. As this change can potentially "raise new issues of safety and effectiveness" (question B.8.3 from the FDA Guidance), a Special 510(k) has been submitted.
Intended use:
The Rotating Gamma System, GammaART 6000 is intended to be used by licensed Medical Professionals for radiation treatment of selected intracranial abnormalities. previously cleared for the OUR Rotating Gamma System and the Leksell Gamma Knife.
Summary of technological characteristics:
Special 510(k) Summary
The Rotating Gamma System, GammaART 6000 is a tele-therapy device which contains 30 Cobalt-60 sources distributed on a hemispheric shielded source carrier. Inside the source unit is the "built in" secondary collimator which has four sides of collimators and one block position. When not treating, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter. Treatment starts with aligning the sources to the prescribed collimator size, then both the source unit and the secondary collimator rotate as one unit. By rotating the Cobalt-60 sources, 30 nonoverlapping full 360 degree arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra.
1
Image /page/1/Picture/2 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines that suggest movement or flight. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 6 2006
American Radiosurgery, Inc. c/o Mr. Daniel P. Olivier President Certified Software Solutions, Inc. 16787 Bernardo Center Drive, Suite A-1 SAN DIEGO CA 92128
Re: K060314
Trade/Device Name: Rotating Gamma System, GammaArt 6000 Regulation Number: 21 CFR §892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 6, 2006 Received: March 6, 2006
Dear Mr. Olivier:
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.
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.
2
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
3
American Radiosurgery, Inc. Special 510(k) Submission for Rotating Gamma System, GammaART-6000
Indications for Use
510(k) Number:
Kob 03/4
Device Name: Rotating Gamma System, GammaART 6000
Indications for Use:
The Rotating Gamma System, GammaART 6000 is a tele-therapy radiation treatment device intended to be used for stereotactic irradiation of intracranial structures. The device is to be used by licensed medical professionals, having been trained in the use and safety precautions of this device.
AND/OR Prescription Use (Per 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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David H. Benson
vision Sign-Off vision of Reproduc d Radiological De 510(k) Number