(90 days)
K8426151
Not Found
No
The description details a physical manufacturing process for lead beam blocks and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to shape radiation beams, not to deliver therapy directly. It is a tool for radiation therapy, making it an accessory or a supporting device rather than a therapeutic device itself.
No
The device is described as an electron beam block used in radiation therapy to create irregularly shaped treatment fields, not to diagnose a condition.
No
The device description clearly states it is a physical electron beam block made of lead alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The described device is a lead beam block used in radiation therapy to shape the radiation beam. It is a physical shield that interacts with the radiation, not with biological specimens.
- Intended Use: The intended use is clearly stated as being for "creating irregularly shaped treatment fields in electron beam therapy," which is a therapeutic procedure, not a diagnostic one.
- No Contact with Patient: The description explicitly states the device "is not in contact with the patient at any time when in use." IVDs typically involve analyzing samples taken from the patient.
Therefore, this device falls under the category of a therapeutic medical device used in radiation oncology, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to be used in Radiation Therapy for creating irregularly shaped treatment fields in electron beam therapy.
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the desired treatment shape. Irregular shaped fields for electron beam cases can be achieved by supplementing the shaping ability of the treatment machine's electron collimation system with tertiary beam blocks. These Beam Blocks are inserted into the ends of the electron cones. The electron beam blocks are created from low melting point lead alloy that is poured in a molten state into a pre-cut Styrofoam form. When the molten lead alloy cools it creates a hard, lead shield custom shaped for the desired form.
Product codes
IXI
Device Description
The electron beam block is mounted in the end of an electron cone and is not in contact with the patient at any time when in use. Therefore, no biocompatibility studies were undertaken for the device. Only the optional accessory, the Polycarbonate Inserts, used to transfer an outline of the area that requires beam blocking from the patients skin to the Styrofoam that must be cut with the hot wire cutter to produce a cerrobend mask, come in contact with the patient.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K8426151
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ﺮ
JAN 1 4 1998
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
October 10, 1997
General Provisions 1.
Trade Name: Electron Beam Field Shaping 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
Clark Research and Development, Clark Precision Block Cutter K8426151
Classification 3.
This device is classified as a class II device according to 21 CFR 870.5710.
Performance Standards 4.
The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Beam Shaping Blocks.
Intended Use and Device Description ડ.
This device is intended to be used in Radiation Therapy for creating irregularly shaped treatment fields in electron beam therapy.
Biocompatibility 6.
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
The electron beam block is mounted in the end of an electron cone and is not in contact with the patient at any time when in use. Therefore, no biocompatibility studies were undertaken for the device. Only the optional accessory, the Polycarbonate Inserts, used to transfer an outline of the area that requires beam blocking from the patients skin to the Styrofoam that must be cut with the hot wire cutter to produce a cerrobend mask, come in contact with the patient. The extent of patient contact is very short in duration (less than 2 minutes per use). As clearly stated in section 11 of the Material Data Safety Sheet supplied by the manufacturer of the Polycarbonate material, there are no adverse eye, skin or inhalation effects observed in toxicological testing .
7. Summary of Substantial Equivalence
This device is similar in design, construction, materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its feathers.
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:
K973953 Akinta Medical Physics Corporation Electron Beam Shaping System Dated: October 10, 1997 Received: October 16, 1997 Regulatory class: II 21 CFR 892.5710/Procode: 90 IXI
1 4 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, 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 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 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 Yri
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:
Device Name: Electron Beam Field Shaping System
Indications for Use:
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the desired treatment shape. Irregular shaped fields for electron beam cases can be achieved by supplementing the shaping ability of the treatment machine's electron collimation system with tertiary beam blocks. These Beam Blocks are inserted into the ends of the electron cones. The electron beam blocks are created from low melting point lead alloy that is poured in a molten state into a pre-cut Styrofoam form. When the molten lead alloy cools it creates a hard, lead shield custom shaped for the desired form.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:_ 801.109)
or
Over-The Counter Use: __
(Per 21 CFR
David C. Stegner
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number