(191 days)
K894165/B
Not Found
No
The summary describes a traditional Cobalt Teletherapy unit with mechanical components and improved shielding, with no mention of AI, ML, or image processing.
Yes
The device delivers gamma radiation for the treatment of cancer, which directly addresses a disease state.
No
Explanation: The device is described as a teletherapy unit that delivers gamma radiation for the treatment of cancer, indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical hardware components such as a source head, collimator, gantry, main frame, base, controls, and a 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.
- Device Description: The description details a machine that delivers radiation, not a test that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is a therapeutic device, specifically a radiation therapy unit.
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)
90 IWD
Device Description
The Theratron 1000E consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is similar as the predicate device Theratron 1000 with improved safety features and radiation shielding in the collimator area of the unit head assembly.
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 Theratron 1000E development and validation is in compliance with Theratronics product development procedures. The validation demontrates that the device meets its published specifications, performs as well or better than the predicate device to which it is substantially equivalent, and is safe and effective for its intended use.
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.
K894165/B
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
MAY 2 8 1997
Appendix 2
510(k) Summary
| Submitter: | Theratronics International Limited
413 March Road, P.O. Box 13140
Kanata, Ontario
Canada K2K 2B7 |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| Phone: | 613-591-2100 |
| Fax: | 613-592-3816 |
| Contact person: | E. S. Martell, Vice President Quality Assurance & Regulatory
Affairs |
| Date: | October 21, 1996 |
| Trade name: | Theratron 1000E |
| Common name: | Cobalt Teletherapy device |
| Classification name: | Radionuclide Radiation Therapy System |
| Equivalent device: | Theratron 1000, 510(k) number K894165/B |
Description of device:
The Theratron 1000E consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is similar as the predicate device Theratron 1000 with improved safety features and radiation shielding in the collimator area of the unit head assembly.
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 comparison to predicate device.
See Appendix 5.
Summary of conclusions drawn from nonclinical tests
The Theratron 1000E development and validation is in compliance with Theratronics product development procedures. The validation demontrates that the device meets its published specifications, performs as well or better than the predicate device to which it is substantially equivalent, and is safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three heads.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.MAY 28 1997
E. S. Martell Vice President Quality Assurance and Regulatory Affairs THERATRONICS International Limited 413 March Road P.O. Box 13140 Ontario, Canada K2K 2B7
Re: K964607
THERATRON T 1000E Cobalt Teletherapy Unit Dated: February 27, 1997 Received: March 3, 1997 Regulatory Class: II 21 CFR 892.5750/Procode: 90 IWD
Dear Mr. Martell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decembed the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 sgainst misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device san be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Foderal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 (2) CFR Part 801 and additionally 809.10 for in viter diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of _1
Number (if known): K964607
Device Name: THERATRON 1000E
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.
1000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Hegemann
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiclogical Devices
510(k) Number K96 4607
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)