(74 days)
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No
The summary describes a physical device for supporting radiation therapy blocks and explicitly states it is similar to predicate devices without mentioning any software, image processing, or AI/ML terms.
No.
The device is described as a support for beam shaping or beam defining blocks, not as a device that delivers or performs therapy itself.
No
The "Intended Use / Indications for Use" states that the device is a support for beam shaping or defining blocks in radiation therapy, which is a treatment delivery function, not a diagnostic one.
No
The device description explicitly states it is "similar in design and construction, utilizes the identical intended and performance materials, and has the same use characteristics to the predicate devices." The predicate device (K944315) is described as "Beam Blocking Trays," which are physical hardware components used in radiation therapy. This strongly indicates the subject device is also a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy." This is a therapeutic application, not a diagnostic one.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not interact with patient samples in this way.
- Device Description: The description focuses on the physical characteristics and use in radiation therapy, not on analyzing biological samples.
Therefore, this device falls under the category of a medical device used in radiation therapy, not an in vitro diagnostic device.
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.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
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
FEB 1 1 1997
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
October 16, 1996
General Provisions 1.
Common/Usual Name: Beam Block Trays or Shadow Trays
Proprietary Name: Beam Block Trays
Applicant Name and Address:
Aktina Medical Physics Corporation 360 North Route 9W Congers, NY 10920
Name of Predicate Devices: 2.
(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 sheath introducers 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.
Biocompatibility 6.
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 identical intended and performance materials, and has the same use
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
characteristics to the predicate devices. No new issues of safety or
effectiveness are introduced by using this device.
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