(90 days)
K853671A
Not Found
No
The description details a system for scanning radiation and light fields using physical detectors and a stepper motor. The data is presented for quality control and analysis of beam characteristics. There is no mention of algorithms that learn from data or perform complex pattern recognition, which are hallmarks of AI/ML. The processing appears to be based on direct measurement and comparison.
No
The device is used for quality control of radiation therapy machines, not for treating patients.
No
The device is used for quality control of radiation therapy machines, not for diagnosing medical conditions in patients. While it provides data for determining machine performance, this is distinct from diagnosing a patient's health status.
No
The device description clearly outlines hardware components including a readout module with LCD, microprocessor, memory, and interfaces, and a scanner module with a stepper motor, transport mechanism, and detecting diodes. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Model 37-185 is used to scan and measure the light and radiation fields generated by radiation therapy machines. It analyzes the physical characteristics of the radiation beam itself, not biological samples from a patient.
- Intended Use: The intended use clearly states it's for "quality control purposes only" of radiation therapy machines and aids in determining the "therapy machine's performance characteristics."
- Device Description: The description details components for measuring light and radiation, a stepper motor for movement, and a reference detector for beam fluctuations. These are all related to the physical properties of the radiation beam, not biological analysis.
Therefore, the Model 37-185 is a quality control device for radiation therapy equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model 37-185 provides a means of scanning the light field and radiation (Function): field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics. The Model 37-185 is intended for use by persons responsible for the proper interpretation of its readings and observing the appropriate safety procedures in the presence of radiation.
As a quality control tool the use of this product does not involve patient contact nor is it used to evaluate patient treatment planning. The patient is not in the room while this product is in use.
Model 37-185 is used to provide a means of scanning the light field and radiation field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics.
Product codes
90 LHN, 90 LHN
Device Description
The product consists of two main parts; the readout module, and the scanner (data acquisition) module. The readout module is located outside the treatment room while the scanner is positioned on the treatment couch in such a manner as to allow the detectors to transverse the radiation beam as determined by the operator. The readout and the scanner are connected via a single 25 meter (75 foot) shielded cable.
The readout contains a LCD (Liquid Crystal Display) and 8 softkeys providing the operator interface. The readout also includes the microprocessor system, memory, printer interface and computer interface. Connections are provided for the power supply, parallel printer, computer RS-232 interface and the scanner cable.
The scanner module contains a stepper motor and a transport mechanism that moves a light detecting diode and a radiation detecting diode 50 cm, in a straight line to obtain a beam or light field profile during a measurement cycle. There is a fixed radiation detecting diode located in the center of the scanner which acts as a reference to null out any fluctuations in the amplitude of the radiation beam (as a function of time). The stepper motor controller and detector pre-amplifiers are also housed in the scanner assembly. The product includes a separate leveling mechanism to level the scanner module and rotate it 90 degrees.
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
"The Model 37-185 is intended for use by persons responsible for the proper interpretation of its readings and observing the appropriate safety procedures in the presence of radiation." The device is used in a setting with radiation therapy machines.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Beam Scan, Model 37-201, 510(k) #K853671A
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
EXHIBIT A
Victoreen, Inc.
Image /page/0/Picture/3 description: The image shows a logo with three horizontal bars. The top bar is black, the middle bar is white, and the bottom bar is white with the word "VICTOREEN" in black, bold, sans-serif font. The logo is simple and clean, with a focus on the text.
Premarket Notification [510k] Summary as required by section 807.92(c)
IAN I 4 1998
Date Summary was prepared:
September 30, 1997
Submitter's Name
Victoreen, Inc. 6000 Cochran Road Cleveland, Ohio 44139-3395
Contact Person:
Linda S. Nash Director of Regulatory Affairs and Quality Assurance Phone: 440-248-9300 440-248-9301 Fax:
Device Name:
Model 37-185
Classification Name:
Medical charged - particle radiation therapy system
Predicate Device:
Beam Scan, Model 37-201, 510(k) #K853671A
Product Description:
The product consists of two main parts; the readout module, and the scanner (data acquisition) module. The readout module is located outside the treatment room while the scanner is positioned on the treatment couch in such a manner as to allow the detectors to transverse the radiation beam as determined by the operator. The readout and the scanner are connected via a single 25 meter (75 foot) shielded cable.
The readout contains a LCD (Liquid Crystal Display) and 8 softkeys providing the operator interface. The readout also includes the microprocessor system, memory, printer interface and computer interface. Connections are provided for the power supply, parallel printer, computer RS-232 interface and the scanner cable.
6000 Cochran Road Cleveland, Ohio 44139-3395 (216) 248-9300 FAX (216) 248-9301 DATA (216) 248-9043
1
The scanner module contains a stepper motor and a transport mechanism that moves a light detecting diode and a radiation detecting diode 50 cm, in a straight line to obtain a beam or light field profile during a measurement cycle. There is a fixed radiation detecting diode located in the center of the scanner which acts as a reference to null out any fluctuations in the amplitude of the radiation beam (as a function of time). The stepper motor controller and detector pre-amplifiers are also housed in the scanner assembly. The product includes a separate leveling mechanism to level the scanner module and rotate it 90 degrees.
Intended Use:
The Model 37-185 provides a means of scanning the light field and radiation (Function): field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics. The Model 37-185 is intended for use by persons responsible for the proper interpretation of its readings and observing the appropriate safety procedures in the presence of radiation.
As a quality control tool the use of this product does not involve patient contact nor is it used to evaluate patient treatment planning. The patient is not in the room while this product is in use.
2
Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing people or services provided by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Linda S.Nash Director of Regulatory Affairs & Quality Assurance Victoreen, Inc. 6000 Cochran Road Cleveland, OH 44139-3395
Dear Ms. Nash:
Re: K973960
Beam Scan Model 37-185 Dated: October 14, 1997 Received: October 16, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN 1481 / 1000
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 ise 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 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 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 OS 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 vitry 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/cdrl/dsmamain.html", ............................................................................................
Sincerely yours,
h. Tiau 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
3
510(k) Number: K973960
Device Name: Model 37-185
Indications for Use:
Model 37-185 is used to provide a means of scanning the light field and radiation field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Leyman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Or
Over-The Counter Use