(336 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on traditional dose calculation algorithms.
No.
The device is a treatment planning system, not a device that directly administers therapy or performs a therapeutic function on a patient. It is used to plan radiation doses for treatment, but it does not deliver the radiation itself.
No
Explanation: The device is described as a "radiation dose planning and simulation system" and a "Radiotherapy Treatment Planning System (RTPS)". Its purpose is to plan and simulate radiation treatments, not to diagnose medical conditions. Devices that plan treatments are distinct from diagnostic devices, which identify a disease or condition.
Yes
The device description explicitly states "The system software is designed to be convenient and low cost to the user," and the entire description focuses on the software's function in dose calculation and planning, without mentioning any associated hardware components included with the device itself. While it interacts with hardware (linear accelerators), the device being cleared appears to be the planning software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "radiation dose planning and simulation of patients undergoing external beam treatment in the oncology clinic." This is a treatment planning and simulation tool, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces that it's a "Radiotherapy Treatment Planning System (RTPS)" for planning radiation dose.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
IVDs are devices used in vitro (outside the body) to examine specimens from the human body. This device operates in vivo (on the body) in the sense that it plans treatment for a patient's body, but it doesn't analyze biological samples.
N/A
Intended Use / Indications for Use
The TOPSLANE product ATES is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ATES is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
The ARTP (Anti-Tumor Radiation Treatment Planning System) is a radiation dose planning and simulation of patients undergoing external beam treatment in the oncology clinic. ARTP is used to plan and simulate radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
Product codes
KPQ
Device Description
The TOPSLANE ATES is a Radiotherapy Treatment Planning System (RTPS) for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ATES is using modem photon beam convolution dose calculation algorithm and electron pencil beam dose calculation algorithm. The system software is designed to be convenient and low cost to the user.
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
oncology 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
Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the word "TOPSLANE" in a bold, outlined font. The letters are all uppercase and evenly spaced. The font style gives the word a distinct, almost block-like appearance.
1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS
AUG - 5 1997
| 1. Submitter's Information: | Dated: August 28, 1996
TOPSLANE
824 Ruth Dr., Pleasant Hill, CA 94523 |
|-----------------------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Ann Zeng
VP of Quality Assurance And Regulatory Affairs |
| 2. Common or Usual Name:
Proprietary Name: | RADIATION TREATMENT PLANNING SYSTEM
ATES |
| Classification Name: | System, Simulation, Radiation Therapy
RA (90) KPQ Class 2
21 CFR 892.5050 |
| Version Number: | 2.0 |
| 3. Predicate Device: | Theraplan V05B
Radiation Therapy Treatment Planning System
K940237
Theratronies |
4. Description of Device:
The TOPSLANE ATES is a Radiotherapy Treatment Planning System (RTPS) for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ATES is using modem photon beam convolution dose calculation algorithm and electron pencil beam dose calculation algorithm. The system software is designed to be convenient and low cost to the user.
5. Statement of intended use:
The TOPSLANE product ATES is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ATES is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
The intended use is the same as the predicate device.
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Image /page/1/Picture/0 description: The image shows the word "TOPSLANE" in a bold, outlined font. Each letter is clearly defined with a double outline, giving the word a distinct and somewhat retro appearance. The letters are uniformly sized and spaced, creating a balanced and legible design.
6. Statement of technological characteristics:
The ATES has no significant change in design, materials, energy source or other technological characteristics compared to the predicate device.
The intended use and the technological characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.
7. Differences:
The minor configuration differences between the ATES and the predicate device do not alter the intended use or affect the safety and effectiveness of the ATES when used as labeled.
8. Special Controls:
Although there are no performance standards established by the FDA for these devices. ATES has been designed, and manufactured to meet the following standards:
Medical electrical equipment - General requirements for safety IEC 601-1 IEC 601-1.1 Safety requirements for medical electrical systems Graphical symbols for electrical equipment in medical practice IEC 878
The device and its development process also comply with the FDA, CDRH, ODE, August 29, 1991, Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.
9. Performance Evaluations:
Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device.
THE END
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe. The figure is composed of three curved lines, and the globe is represented by a simple circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Zeng VP of Quality Assurance and Regulatory Affairs TOPSLANE 824 Ruth Drive Pleasant Hill, CA ... 94523 ...
AUG - 5 1997
Re: K963451 Anti-Tumor Radiation Treatment Planning System (ARTP) Dated: June 19, 1997 Received: June 23, 1997 Regulatory Class: II ....................... 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Zeng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 vours.
h.Liau Yu
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
3
510(k) Number (if known): K963451
Device Name: __ Anti-Tumor Radiation Treatment Planning System (ARTP).
Indications For Use:
The ARTP (Anti-Tumor Radiation Treatment Planning System) is a radiation of The AKTF (Allu-Tumor Kammon a radiation dose planning and simulation of patients undergoing external beam treatment in the oncology climic. ARTIF is used pattents midergoning external beath meating with linear accelerators and other similar to plan and summale (amanon treating from 1 to 25MV, as well as Cobalt-60, and electron energies from I to 25 MeV.
CDHOJ CN
(PLEASE DO NOT WRITE BELLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 109) OR
Over_The_Counter Use
(Optional Format 1-2-96)
L. Mccarthy
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963451