(84 days)
Not Found
No
The document describes a traditional Cobalt Teletherapy unit and explicitly states that AI, DNN, or ML were "Not Found" in the description.
Yes
The device delivers gamma radiation for the treatment of cancer, which directly addresses a disease state.
No
The device description clearly states its purpose is for "treatment of cancer" by delivering radiation, not for diagnosing conditions.
No
The device description clearly outlines physical hardware components (source head, collimator, gantry, main frame, base, controls, counterweight) and describes it as a "Cobalt Teletherapy unit," which is a physical radiation delivery system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "delivery of gamma radiation for the treatment of cancer." This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a machine that delivers radiation, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used to treat a condition, not to diagnose or monitor it through sample analysis.
N/A
Intended Use / Indications for Use
The unit is intended to be used in:
- Delivering the intended dose at a specified position; .
- Delivering the radiation in accordance with the selected relationship of the radiation to the patient . (fixed or moving beam therapy, beam modifying device, etc.);
- . Delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.
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 (comma separated list FDA assigned to the subject device)
IWB
Device Description
The Theratron Equinox consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate device Theratron Elite 80 and 100.
Changes include a new:
- · Control System: the system is easy to maintain and diagnosis of problems is automated as much as possible
- · Parameter Display: for displaying all gantry and collimator parameters relevant to treatment setup
- · Control Panel: providing all hardware links to the unit that cannot be software controlled by the User Interface e.g. emergency stop
- . Graphic User Interface: providing for efficient treatment setup and execution
- · Hand Control modified for modern appearance and ergonomic improvement over previous design
- · Covers: The unit has a more modern appearance
- · Collision Detection Device -- stops motion of the gantry when a collision is detected
- · Asymmetric jaws collimator X and Y jaws can move independently
- · Motorized wedge -- a wedge affixed to the inside of the collimator can be moved to the in or out position
- · In-room display monitors
The major components of the Theratron Elite, 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.
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)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo for MDS Nordion. The logo consists of the text "MDS Nordion" in a bold, sans-serif font. Below the text is the tagline "Science Advancing Health" in a smaller, italicized font. There is a curved line above the text.
MAR 9 2006
510(k) SUMMARY
| Date Summary Prepared | December 7, 2005 |
|---|---|
| Submitted by | MDS Nordion |
| 447 March Road | |
| Ottawa, Ontario K2K 1X8 | |
| Canada | |
| Tel. (613) 592-3400 | |
| Fax. (613) 592-2006 | |
| Contact Person | Mr. Ross Kachaniwsky |
| Director, Quality & Regulatory Affairs | |
| Device Name | Theratron Equinox 80 |
| Theratron Equinox 100 | |
| Common Name | Cobalt Teletherapy Device |
| Classification Name | Radionuclide Radiation Therapy System |
| Legally Marketed Predicate Device | Theratron Elite 80 and 100 |
Description of Device
The Theratron Equinox consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate device Theratron Elite 80 and 100. For a more detailed description, please see Section 4.
Intended Use of Device
The unit is intended to be used in:
- Delivering the intended dose at a specified position; .
- Delivering the radiation in accordance with the selected relationship of the radiation to the patient . (fixed or moving beam therapy, beam modifying device, etc.);
- . Delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.
Summary of Technological Characteristics
The Theratron Equinox 80 and 100 is substantially equivalent to the predicate device (K983917).
The design change is to provide a new 'modern' appearance to the previous design using existing major components of the predicate device, and adds some new functionality that allows customers to treat patients with modern radiotherapy techniques while not changing the intended use of the device.
Changes include a new:
- · Control System: the system is easy to maintain and diagnosis of problems is automated as much as possible
- · Parameter Display: for displaying all gantry and collimator parameters relevant to treatment setup
- · Control Panel: providing all hardware links to the unit that cannot be software controlled by the User Interface e.g. emergency stop
- . Graphic User Interface: providing for efficient treatment setup and execution
- · Hand Control modified for modern appearance and ergonomic improvement over previous design
1
- · Covers: The unit has a more modern appearance
- · Collision Detection Device -- stops motion of the gantry when a collision is detected
- · Asymmetric jaws collimator X and Y jaws can move independently
- · Motorized wedge -- a wedge affixed to the inside of the collimator can be moved to the in or out position
- · In-room display monitors
The major components of the Theratron Elite, 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 Theratron Equinox 80 and 100 is equivalent or better than the predicate device.
In terms of safety, the Theratron Equinox 80 and 100 are designed to comply with
- EN 60601-1 (1995), Medical Electrical Equipment. Part 1; General requirements for safety, and .
- EN 60601-1-2 (2004), Medical Electrical Equipment, Part 1;General requirements for safety; . Electromagnetic Compatibility - Requirements for Tests
- EN 60601-1-4 (2001) Medical electrical equipment Part 1-4: General requirements for safety -. Collateral Standard: Programmable electrical medical systems
- EN 60601-2-11 (2004) Medical electrical equipment Part 2: Particular requirements for the safety of . qamma beam therapy equipment
- EN 61217 (2000) 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Heatth Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 9
2000
Mr. Ross Kachaniwsky Director, Quality Assurance MDS Nordion 447 March Road Ottawa, ON K2K 1X8 CANADA
Re: K053485 Trade/Device Name: Theratron Equinox 80 and Theratron Equinox 100 Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 3, 2006 Received: February 7, 2006
Dear Mr. Kachaniwsky:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
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 vours.
Nancy C. Brigeton
Naney C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the logo for MDS Nordion. The logo consists of the text "MDS Nordion" in a bold, sans-serif font. Below the text is the tagline "Science Advancing Health" in a smaller, italicized font. The logo is simple and professional, and it conveys the company's focus on science and health.
INDICATIONS FOR USE
510(k) Number: K053485
Device Name:
Theratron Equinox 80 Theratron Equinox 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.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Nancy C. Broxton
Division Sign-Off
Jivision Sign-Off) / Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number