(176 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on physical measurements and remote control, not data analysis or learning algorithms.
No
The device is described as a "Constancy Check Device" for daily quality assurance of radiation therapy machines, not for direct therapeutic application to a patient. Its purpose is to verify machine output, not to deliver therapy itself.
No
This device is a quality assurance tool used for daily checks of machine output in external beam radiation therapy, not for diagnosing a medical condition in a patient. It ensures the proper functioning of the therapy machine rather than providing a diagnosis for a patient's health.
No
The device description explicitly states it is "designed to operate by either: being mounted on standard beamblock trays or, placed on a table". This indicates the device includes physical hardware components for mounting and placement, not just software.
Based on the provided information, the AKTINA "Velos" Constancy Check Device, model 55-145, is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "daily, morning checks of machine output" in external beam radiation therapy. This is a quality assurance step for the radiation therapy machine itself, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is described as a means of "verifying machine output." It measures the performance of the radiation therapy equipment.
- Lack of Biological Sample Interaction: There is no mention of the device interacting with or analyzing any biological samples (blood, tissue, urine, etc.) from a patient. IVD devices are specifically designed to examine such samples to provide diagnostic information.
- Comparison to Predicate: The predicate device (K874893) is described as a "Therapy Beam Evaluation System," which further supports the idea that these devices are for evaluating the performance of the therapy equipment, not for diagnosing a patient's condition.
Therefore, the AKTINA "Velos" Constancy Check Device falls under the category of a quality assurance or performance monitoring device for medical equipment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AKTINA "Velos" Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893.
More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist. Not intended as a substitute for machine calibrations or validations of machine beam energy, these checks are quality assurance steps to safeguard accepted standards of good practice in Radiation Oncology.
"Velos" is designed to operate by either:
being mounted on standard beamblock trays or,
placed on a table, when measurements are needed from various SID's
and functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
This device is intended to be used as a means of verifying machine output on a daily basis in the delivery of external beam radiation therapy.
"Velos" is designed to operate by either:
being mounted on standard beamblock trays or,
placed on a table, when measurements are needed from various SID's
and functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.
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
daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist.
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)
Not Found
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
§ 892.5050 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/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1937
George Zacharopoulos Certified Radiological Physicist Aktina Medical Physics Corp: . ............................................................................................................................................... 360 North Route 9W Congers, NY 10920
Re: K970384
Velos Constancy Check Device (CCD), -Model 55-145 Dated: June 2, 1997 Received: June 5, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Zacharopoulos:
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 Medica! 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, 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 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 question 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.
h.T) 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
1
x970384
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
January 1, 1997
JUL 2 9 1997
1. General Provisions
Common/Usual Name: Constancy Check Device
Velos Constancy Check Device, model 55-145 Proprietary Name:
Applicant Name and Address:
Aktina Medical Physics Corporation 360 North Route 9W Congers, N.Y. 10920
Name of Predicate Devices: 2.
(1) Keithly Instruments, Inc., Tracker Therapy Beam Evaluation system (K874893)
3. Classification
This device is classified as a class II device according to 21 CFR 892.5050
Performance Standards 4.
Performance standards for these devices have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
5. Intended Use and Device Description
This device is intended to be used as a means of verifying machine output on a daily basis in the delivery of external beam radiation therapy.
6. Biocompatibility
1
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).
2
No issues of biocompatability are raised with regard to this device.
Summary of Substantial Equivalence 7.
This device is similar in design and construction, utilizes the same This device is simmal in access the same intended use and performance materials, and has the Same intended and issues of safety or characteristics to the produced by using this device.
3
P. 02
CDRH DRAERD
Page I of l
510(k) Number if known: | K970384 |
---|---|
Device Name: | "Velos" Constancy Check Device |
Indications for Use:
The AKTINA "Velos" Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893.
More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist. Not intended as a substitute for machine calibrations or validations of machine beam energy, these checks are quality assurance steps to safeguard accepted standards of good practice in Radiation Oncology.
"Velos" is designed to operate by either:
being mounted on standard beamblock trays or, ਕ.
placed on a table, when measurements are needed from various SID's b.
and functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.
Concurrence of CDRH, Office of Device Evaluation(ODE) |
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------------------------------------------------------- |
Prescription Use (Per21 CFR 801.109 | |
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OR | |
Over-The-Counter Use ______ |
(Division Sign-Off) | |
---|---|
(Optional Format 1-2-96) | |
LLY | |
Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
510(k) Number | K970384 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NECDED)