(12 days)
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No
The device description focuses on the physical characteristics and function of a silicon diode detector for measuring radiation distribution, with no mention of AI or ML technologies.
No.
The device is used to measure radiation distribution for dose modeling in treatment planning, not to directly treat a patient.
No
The device is described as a radiation scanning detector for measuring beam data in radiotherapy departments for dose modeling in treatment planning. It helps characterize the radiation beam, not diagnose a patient's condition.
No
The device description clearly states it is a "radiation hardened silicon diode" encapsulated in a "rectangular housing made of thin brass sheet," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure radiation beam data in a water tank scanning system for dose modeling in radiotherapy treatment planning. This is a measurement of a physical parameter (radiation dose distribution) in a phantom (water tank), not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The device is a radiation detector designed to measure radiation in a water phantom. It does not interact with or analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring analytes in biological samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, the Edge™ Detector is a medical device used in the field of radiation therapy for quality assurance and treatment planning, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Edge™ Detector is a device that is designed for use as a radiation scanning detector in any water tank scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Edge™ detector is a radiation hardened silicon diode. The diode is encapsulated in a rectangular housing made of thin brass sheet. The active dimension of The Edge™ detector is 0.8 x 0.8 mm2. The diode die plane is parallel with the long axis of the detector housing with the center of the die marked by the cross on the top surface. The detector is mounted such that its top surface is parallel to the water surface and perpendicular to the incident radiation beam axis. The Edge™ detector is water-proof.
The Edge™ detector is designed to measure the radiation distribution in a water phantom. Because of its very small active dimension, The Edge™ detector can measure small field beam parameters, such as penumbra and flatness, more accurately than the conventional ionization chamber with larger active dimensions. Therefore, The Edge™ detector is especially useful for beam modeling in radiation therapy techniques involving small field sizes, such as IMRT (Intensity Modulation Radiation Therapy).
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
radiation therapy professionals
Description of the training set, sample size, data source, and annotation protocol
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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.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a stylized sun symbol on the left, followed by the words "SUN NUCLEAR" in a bold, sans-serif font on the top line. Below that, the word "corporation" is written in a smaller, sans-serif font.
K05 1921
JUL 2 7 2005
510(k) Premarket Notification Summary
Contact: Date: Trade Name: Common Name: Substantial Equivalence: Noel Downey April 1, 2005 The Edge™ - Scanning Diode Detector Scanning Diode Detector PTW Dosimetry Diode and the PTW Pinpoint Type Ionization Chamber
Description and Use:
The Edge™ detector is a radiation hardened silicon diode. The diode is encapsulated in a rectangular housing made of thin brass sheet. The active dimension of The Edge™ detector is 0.8 x 0.8 mm2. The diode die plane is parallel with the long axis of the detector housing with the center of the die marked by the cross on the top surface. The detector is mounted such that its top surface is parallel to the water surface and perpendicular to the incident radiation beam axis. The Edge™ detector is water-proof.
The Edge™ detector is designed to measure the radiation distribution in a water phantom. Because of its very small active dimension, The Edge™ detector can measure small field beam parameters, such as penumbra and flatness, more accurately than the conventional ionization chamber with larger active dimensions. Therefore, The Edge™ detector is especially useful for beam modeling in radiation therapy techniques involving small field sizes, such as IMRT (Intensity Modulation Radiation Therapy).
Similarities and differences between SNC The Edge™ Scanning Diode Detector and PTW Diode and PTW Chamber:
The Edge Detector, PTW Dosimetry Diode and PinPoint Ionization Chamber can be used to measure the radiation beam data in water phantoms for treatment planning in a radiation department. Their similarities are:
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Similarities with Marketed Devices:
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- Their intended use is essentially the same.
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- They all connect to electrometers with a water phantom system.
- They are all Water-proof. 3.
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- They all measure the same beam energies.
Differences with Marketed Devices
There are no fundamental differences among these detectors in terms of their overall functionality. Their design and operation are somewhat different:
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- The active dimension is 0.8 mm for the Edge detector, 1 mm for the Dosimetry Diode, and 2 mm for the PinPoint chamber.
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- With respect to the beam axis, the axis of the Edge detector and the PinPoint chamber is perpendicular, the axis of the Dosimetry Diode is parallel.
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- There is a high voltage (~ 300 V) required for the PinPoint ionization chamber, while there is a "zero" voltage (