(12 days)
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.
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).
The provided document is a 510(k) Premarket Notification Summary for "The Edge™ - Scanning Diode Detector." It describes the device, its intended use, similarities and differences with marketed predicate devices, and a safety summary. However, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies typically associated with AI/ML-based medical devices.
The document is a regulatory submission demonstrating substantial equivalence to predicate devices, focusing on safety and effectiveness for its intended use, rather than a performance study report for predefined acceptance criteria.
Therefore, I cannot provide the requested information in the format specified because the document does not contain it. The content is primarily a descriptive submission for regulatory clearance.
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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 (< 10 uV) required for the Edge detector and the Dosimetry Diode.
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- Dosimetry Diode uses p-type diode, while Edge detector uses a special radiation hardened n-type diode.
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- Dosimetry Diode and PinPoint chamber are in cylindrical shape, while Edge detector is rectangular.
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Safety and Effectiveness Summary for Edge detector
Edge detector is only used by the radiation therapy professionals, it is not used with the patient. The Edge detector is designed to be used with zero bias voltage when with the pation: "The Dage access thus should not generate electrical shock hazard to the operator.
Sun Nuclear has deemed the devices safe and effective for their intended uses as long as they are used in accordance with all of the accompanying labeling and instructions. When used properly, Edge detector can collect the useful dosimetry modeling data for radiation therapy treatment planning. Sun Nuclear believes that modeling data for radiations of actives were followed during the development and manufacture of Edge detector (Model 1118000-0).
Safety features of Edge detector
| Feature | Effect |
|---|---|
| 1. No bias voltage applied | Eliminate electrical shock hazard and excessiveleakage current |
| 2. Low noise cable | Provide stable measurement and low leakage |
| 3. Shielded housing | Provide stable measurement |
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Image /page/3/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Noel M. Downey Project Manager Sun Nuclear Corporation 425-A Pineda Court MELBOURNE FL 32940 Re: K051921
Trade/Device Name: The Edge™ Detector Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE
Dated: July 14, 2005 Received: July 15, 2005
Dear Mr. Downey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
JUL 2 7 2005
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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11051921 510(k) Number (if known):___
Device Name: _ _ The Edge™ Detector
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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use
OR
Over-The-Counter Use_
Nancyi Gordon
12-1
§ 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.