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.

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.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any statistical measures.

The document is a 510(k) premarket notification letter from the FDA to Best Theratronics Limited regarding their "Gammabeam 100" device (a Radionuclide radiation therapy system). It primarily states that the device has been found substantially equivalent to a legally marketed predicate device (Theratron Phoenix).

The document mentions:

Safety & Effectiveness: It states that "The safety of the GammaBeam 100 is equivalent or better than the predicate device" and that "Validation testing demonstrated that the device is as safe and effective as the predicate device."
Compliance with Standards: It lists several IEC and EN standards that the device is designed to comply with (e.g., IEC 60601-1-2, IEC 60601-1, EN 60601-2-11, EN 61217).
Functional Specifications: It vaguely mentions "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."

However, it does not provide:

A table of acceptance criteria and reported device performance (with specific metrics).
Sample sizes or data provenance for a test set.
Information about experts, ground truth establishment, or adjudication methods for a test set.
Details on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
Details on a standalone algorithm performance study.
The type of ground truth used (beyond implying functionality and safety against standards).
Sample size for a training set or how its ground truth was established.

This document is a regulatory approval letter based on substantial equivalence, not a detailed study report providing performance metrics against quantitative acceptance criteria.

Summary

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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 Theratronics413 March RoadOttawa, Ontario K2K 0E4CanadaTel. (613) 591-2100Fax. (613) 592-5680
Contact Person	Mr. Mike de van der SchuerenQuality & 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

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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Image /page/4/Picture/1 description: The image contains the logo for "Best Theratronics". The word "Best" is written in a stylized, cursive font in blue. Below "Best", the word "Theratronics" is written in a sans-serif font in green. There is a registered trademark symbol next to the word "Best".

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.

Regulation Number and Section

§ 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.