(93 days)
No
The summary describes a traditional cobalt teletherapy unit and does not mention any AI/ML components or functionalities.
Yes
The device is described as delivering gamma radiation for the treatment of cancer, which directly indicates a therapeutic purpose.
No
The device description states it is a "radiotherapy treatment unit" and is used for "treatment of cancer," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical hardware components like a source head, collimator, gantry, main frame, base, controls, and counterweight, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of cancer by delivering gamma radiation. IVDs are used for the diagnosis of diseases or conditions by examining samples from the human body (like blood, urine, tissue).
- Device Description: The description details a radiotherapy treatment unit, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting specific analytes (like proteins, DNA, etc.).
- Providing diagnostic information.
This device is clearly a therapeutic device used for treating cancer, not a diagnostic device used for identifying it.
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 100 is a radiotherapy treatment unit with a cobalt-60 radiation delivery system. The device consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is substantially equivalent to predicate device Theratron Phoenix.
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
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. Validation testing demonstrated that the device is as safe and effective as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Theratron Phoenix (K863180)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Best Theratronics Limited % Mr. Mike de van der Schueren Quality and Regulary Manager 413 March Road Ottawa, Ontario K2K 0E4 CANADA
Re: K142219
Trade/Device Name: Gammabeam 100 Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: October 15, 2014 Received: October 15, 2014
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.
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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. 'O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K142219 510(k) Number:
Device Name: GammaBeam 100
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.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Date Summary Prepared | October 14, 2014 |
|---|---|
| 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 100 |
| 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 100 is a radiotherapy treatment unit with a cobalt-60 radiation delivery system. The device consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is substantially equivalent to predicate device Theratron Phoenix.
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.
The indications/intended use of the modified device, as described in the labeling, has not changed as a result of the modifications.
Summary of Technological Characteristics
The GammaBeam 100 is substantially equivalent to the predicate device (K863180).
This GammaBeam 100 includes several changes to the design of Phoenix teletherapy unit.
- . an updated control system
- new independent jaws collimator
- . new covers
Changes are made due to obsolescence of many components in the existing Phoenix control system as well as to achieve compliance with current regulatory standards.
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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, gantry, main frame, base, and pendulum/beam stopper counterweight 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.
Safety & Effectiveness
The safety of the GammaBeam 100 is equivalent or better than the predicate device.
In terms of safety, the GammaBeam 100 is designed to comply with
- IEC 60601-1-2: Edition 3.0 2007-03 Medical electrical equipment Part 1-2: General . requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (Appendix Q)
- IEC 60601-1: Edition 3.0 2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Appendix R)
- EN 60601-2-11 (2004) Medical electrical equipment Part 2: Particular requirements for the . safety of gamma beam therapy equipment
- EN 61217 (2011) Radiotherapy equipment Coordinates, movements and scales .
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. Validation testing demonstrated that the device is as safe and effective as the predicate device.