(90 days)
K9417191
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on physical beam blocks.
No
The device is used to shape radiation fields, which is a supportive function in radiation therapy, not a direct therapeutic action itself for a disease or condition. Its purpose is to physically manipulate the radiation beam.
No
This device is described as being used in Radiation Therapy for creating irregularly shaped treatment fields, which points to a therapeutic or treatment-related function, not a diagnostic one.
No
The summary describes a device used for creating irregularly shaped treatment fields in Radiation Therapy, specifically mentioning "tertiary beam blocks" which are physical components used to collimate and contour the treatment field. This indicates a hardware component is involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as being used in Radiation Therapy to shape treatment fields. This is a therapeutic application, not a diagnostic one.
- Device Description: The description reinforces its role in shaping radiation beams for treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
- Predicate Device: The predicate device is a "Half Beam Block," which is a component used in radiation therapy equipment, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the delivery of radiation therapy.
N/A
Intended Use / Indications for Use
This device is intended to be used in Radiation Therapy for creating irregularly shaping treatment fields. In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the charing the shaping In Nation Therapy, It is often nobsoad fields can be achieved by supplementing the shaping the shaping desired treatment shape. Integral shaped that system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field.
Product codes (comma separated list FDA assigned to the subject device)
90 IXI
Device Description
This device is intended to be used in Radiation Therapy for creating irregularly shaping treatment fields.
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
Not Found
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.
K9417191
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
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.
0
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
November 8, 1997
1. General Provisions
FEB 1 0 1998
Trade Name: Photon Beam Blocking System Common Name: Blocks, beam Shaping
Applicant Name and Address:
Aktina Medical Physics Corporation 360 North Route 9 W Congers, New York, 10920 Phone: 914-268-0101 FAX: 914-268-1700 Registration Number: 2436865
2. Name of Predicate Devices
Med-Tec, Inc., 360 degree, Half Beam Block, K9417191
3. Classification
This device is classified as a class II device according to 21 CFR 870.5710 .
Performance Standards 4.
Performance standards for Beam Shaping Blocks not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
న్. Intended Use and Device Description
This device is intended to be used in Radiation Therapy for creating irregularly shaping treatment fields.
6. Biocompatibility
l
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).
1
No Biocompatability issues are raised with design or use of this device. Biocompatability testing was not performed.
Summary of Substantial Equivalence 7.
::い
This device is similar in design, construction, materials, intended use and performance characteristics to the predicate device. No new issues of safety or effectiveness are introduced by using this device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Joan Zacharopoulos Vice-President Aktina Medical Physics Corporation 360 North Route 9W Congers, NY 10920
Re:
K974239 Photon Beam Blocking System Dated: November 6, 1997 Received: November 12, 1997 Regulatory class: II 21 CFR 892.5710/Procode: 90 IXI FEB 1 0 1998
Dear Ms. 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 Medical 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 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 (OS) 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 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/dsmamam.html":
Sincerely yours,
W.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
Indications for Use
510(k) Number: K974293
Device Name: Photon Beam Blocking System
Indications for Use:
・
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the charing In Nation Therapy, It is often nobsoad fields can be achieved by supplementing the shaping the shaping desired treatment shape. Integral shaped that system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ✓
801.109)
or
Over-The Counter Use: _
(Per 21 CFR
Edward M. Kopmann
(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological Devices 510(k) Number