(89 days)
Not Found
No
The summary describes a physical device (beam blocking trays) used to support radiation therapy blocks. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The description focuses on the device's physical properties and intended use as a support system.
No
The device is described as a support for beam shaping or defining blocks, aiding in the proper definition of the treatment field in radiation therapy. It does not directly provide therapy but rather supports components used in the delivery of radiation therapy.
No
Explanation: The device is described as a support for beam shaping or beam defining blocks in radiation therapy, not for diagnosing medical conditions.
No
The device description clearly states it is a physical support for beam shaping blocks, made of materials and having a design similar to predicate devices which are also physical trays. There is no mention of software components.
No, 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, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states the device is a "support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy." It's a physical accessory used during a radiation treatment procedure, not for analyzing biological samples.
- Intended Use: The intended use is to hold beam blocks in place to shape the radiation field, which is a part of the treatment delivery process, not a diagnostic test.
The device is a component used in radiation therapy equipment, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
This device is intended to be used as a support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy.
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the desired shape of the treatment volume. Irregular shapes can be achieved by supplementing the shaping ability of the treatment machines collimation system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field and are often custom formed from low metling alloys containing lead and other high density metals. In order to be used, beam blocks must be supported in the path of the incident beam so that the resultant treatment field is properly defined at the patient Shadow Trays provide a simple system for holding the blocks in surface. position for treatment with pre-defined geometry.
Product codes
90 IYE
Device Description
This device is intended to be used as a support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy. This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices.
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)
Reference Device(s)
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
JUN 2 9 1999
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
March 15, 1999
1. General Provisions
Common/Usual Name: Beam Block Trays or Shadow Trays
Shadow Trays Proprietary Name:
Applicant Name and Address: Mick Radio-Nuclear Instruments, Inc. 1470 Outlook Avenue Bronx, New York 10465
2. Name of Predicate Devices:
(1) MED-TEC, Inc. Beam Blocking Trays (K944315)
3. Classification
This device is classified as a class II device according to 21 CFR 892.5050
4. Performance Standards
Performance standards for shadow (beam block) trays have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description 5.
This device is intended to be used as a support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy.
6. Biocompatibility
I
No issues of biocompatability are raised with regard to this device.
Summary of Substantial Equivalence 7.
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
This device is similar in design and construction, utilizes the identical materials, and has the same 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 1999
Felix Mick President Mick Radio-Nuclear Instruments, Inc. P.O. Box 99 Bronx, New York 10465
Re:
K991107 Mick Radio-Nuclear Shadow Trays Dated: March 15, 1999 Received: April 1, 1999 Regulatory Class: II 21 CFR 892.5050/procode: 90 IYE
Dear Mr. Mick:
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 legally marketed predicate 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. 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 requirements, 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 requlatory 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 the Electronic Product 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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Indications for Use
510(k) Number: K991107
Device Name: Shadow Trays
Indications for Use:
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the desired shape of the treatment volume. Irregular shapes can be achieved by supplementing the shaping ability of the treatment machines collimation system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field and are often custom formed from low metling alloys containing lead and other high density metals. In order to be used, beam blocks must be supported in the path of the incident beam so that the resultant treatment field is properly defined at the patient Shadow Trays provide a simple system for holding the blocks in surface. position for treatment with pre-defined geometry.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:_Y (Per 21 CFR 801.109)
Over-The Counter Use: _
Urind A. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, B and Radiological Devic 510(k) Number