(79 days)
Not Found
No
The document describes a traditional radiotherapy device with mechanical and software controls, and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as delivering gamma radiation for the treatment of cancer, specifically for total body irradiation (TBI), which is a therapeutic intervention.
No
Explanation: The device description explicitly states its purpose is to deliver gamma radiation for the treatment of cancer, not for diagnosis.
No
The device description explicitly states it is a "radiotherapy treatment unit with a cobalt-60 radiation delivery system" and lists physical components like a "source head, main frame, base, and controls." It also mentions mechanical testing and hardware verification and validation. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic." This describes a therapeutic device that delivers radiation to a patient's body.
- Device Description: The description details a "radiotherapy treatment unit with a cobalt-60 radiation delivery system" designed for "total body irradiation (TBI)." This further confirms its role in treating a patient directly.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with patient specimens or any diagnostic purpose.
Therefore, the GammaBeam 500 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.
Product codes
IWB
Device Description
The GammaBeam 500 is a radiotherapy treatment unit with a cobalt-60 radiation delivery system that is designed to be a dedicated, standalone device for performing total body irradiation (TBI). The device consists of a source head, main frame, base, and controls. The design of this device is substantially equivalent to the predicate device Theratron Phoenix.
The GammaBeam 500 is aimed to deliver total body irradiation to patients by generating a large fixed radiation treatment field at an extended Source - to - Skin Distance (SSD). This is a common radiotherapy technique performed by many clinics worldwide. A dedicated device improves the safety, effectiveness and clinical workflow of these treatments.
The unit will be operated in a similar manner as the predicate and has the same redundant mechanisms for safety, auxiliary source drawer lock, secondary and manual source return, emergency stop switches on the unit and control console, source position indicator, and operational and inhibit state interlocks.
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
health care professionals in a radiation therapy clinic.
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)
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the GammaBeam 500, consisting of the main unit and patient couch. The system complies with the following standards for safety:
- 0 IEC 60601-1:2013 Edition 3.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007 Edition 3.0 Medical electrical equipment Part 1-2: General requirements 0 for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- 0 EN 60601-2-11:2011 Edition 3.0 Medical electrical equipment -- Part 2: Particular requirements for the safety of gamma beam therapy equipment
- EN 61217 (2014) Radiotherapy equipment Coordinates, movements and scales 0
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in a serious injury or death to the patient or operator.
Mechanical Testing: The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment. This included:
- · Mechanical validation of the main unit and patient couch
- · Physics validation
- · Simulated use testing
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the GammaBeam 500 performs as intended in the specified use conditions. The performance data demonstrates that the GammaBeam 500 is as safe and effective as the predicate device that is currently marketed for the same intended use.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures facing to the right. The figures are connected and appear to be in motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
Best Theratronics Limited % Mr. Mike de van der Schueren Quality & Regulatory Manager 413 March Road Ottawa, Ontario K2K 0E4 CANADA
Re: K150191
Trade/Device Name: GammaBeam 500 Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 18, 2015 Received: February 19, 2015
Dear Mr. de van der Schueren:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
for
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150191
Device Name GammaBeam 500
Indications for Use (Describe)
A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
| Date Summary Prepared | January 23, 2015 |
|---|---|
| Submitted by | Best Theratronics |
| 413 March Road | |
| Ottawa, Ontario K2K 0E4 | |
| Canada | |
| Tel. (613) 591-2100 | |
| Fax. (613) 592-5680 | |
| Contact Person | Mr. Mike de van der Schueren |
| Quality & Regulatory Manager | |
| Trade Name | GammaBeam 500 |
| Common Name | Cobalt Teletherapy Device |
| Classification Name | Radionuclide Radiation Therapy System |
| Legally Marketed Predicate Device | Theratron Phoenix (K863180) |
| Device Classification | Class II, 21 CFR 892.5750 |
| Product Code | IWB |
DESCRIPTION OF DEVICE
The GammaBeam 500 is a radiotherapy treatment unit with a cobalt-60 radiation delivery system that is designed to be a dedicated, standalone device for performing total body irradiation (TBI). The device consists of a source head, main frame, base, and controls. The design of this device is substantially equivalent to the predicate device Theratron Phoenix.
The GammaBeam 500 is aimed to deliver total body irradiation to patients by generating a large fixed radiation treatment field at an extended Source - to - Skin Distance (SSD). This is a common radiotherapy technique performed by many clinics worldwide. A dedicated device improves the safety, effectiveness and clinical workflow of these treatments.
The unit will be operated in a similar manner as the predicate and has the same redundant mechanisms for safety, auxiliary source drawer lock, secondary and manual source return, emergency stop switches on the unit and control console, source position indicator, and operational and inhibit state interlocks.
INTENDED USE OF DEVICE
A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.
4
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The GammaBeam 500 is substantially equivalent to the predicate device (K863180).
This GammaBeam 500 includes several changes to the design of Phoenix teletherapy unit.
| Device Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Control System | Single computer in control room | Separate main controller and graphic user |
| interface that performs same functionality | ||
| with added safety features, improved | ||
| useability and battery backup | ||
| Treatment Mode | Rotational and/or fixed treatments with | |
| a variable field size | Fixed treatments only and fixed field size | |
| reduces complexity and eliminates collision | ||
| hazards and hazards related to treatment | ||
| setup | ||
| Patient Table | Vertical, longitudinal, lateral and | |
| isocentric positioning of the patient | Optional accessory - Vertical motion only for | |
| ease of lowering patient to the treatment | ||
| height from a comfortable seated position |
Usability is being improved by adding functions relevant to contemporary cancer treatment techniques and removing those that are not.
The major components of the Theratron Phoenix, including the head, source mechanism, main frame and base have had minor modifications to accommodate the above changes.
There are no changes to the mechanical structure or radiological shielding of the head.
The irradiation source and radioactivity of the cobalt-60 source remains unchanged as does the source drawer mechanism.
The control system has been designed to meet the same intended use as the current model.
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the GammaBeam 500, consisting of the main unit and patient couch. The system complies with the following standards for safety:
- 0 IEC 60601-1:2013 Edition 3.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007 Edition 3.0 Medical electrical equipment Part 1-2: General requirements 0 for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- 0 EN 60601-2-11:2011 Edition 3.0 Medical electrical equipment -- Part 2: Particular requirements for the safety of gamma beam therapy equipment
- EN 61217 (2014) Radiotherapy equipment Coordinates, movements and scales 0
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in a serious injury or death to the patient or operator.
5
Image /page/5/Picture/0 description: The image contains the words "Best" and "Theratronics" stacked on top of each other. The word "Best" is in a cursive font, while the word "Theratronics" is in a sans-serif font. The text is gray in color and appears to be a logo or brand name.
Mechanical Testing
The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment. This included:
- · Mechanical validation of the main unit and patient couch
- · Physics validation
- · Simulated use testing
CONCLUSIONS
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the GammaBeam 500 performs as intended in the specified use conditions. The performance data demonstrates that the GammaBeam 500 is as safe and effective as the predicate device that is currently marketed for the same intended use.