(64 days)
The product is to be used by radiation oncologist, dosimetrist, and radiation therapy physicist to check the correctness of the x-ray treatment fields from high energy treatment machines that are planned to be or have been applied to a patient. This product is to be used in addition to the treatment planning system to provide a means for additional and redundant verification that the plan is in fact successfully accomplished. This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.
Dosimetry Check with Exit Dose is a software program intended to provide a means for testing the dosimetry of radiation therapy treatments applied to a patient using high energy x-rays. This test is performed from measurements made during treatment of the patient by measuring the radiation fields after they have passed through the patient with a suitable imaging device such as an electronic portal imaging device or other measuring devices or media. The following software functions are then performed:
- The patient's CT scan treatment plan image set is traced to provide the water equivalent path to points on the measured exit dose plane.
- A deconvolution process is performed with a kernel that is a function of radius and the thickness transversed to convert the exit images back to x-ray intensity in air fluence prior to patient entry. The kernel is derived prior from phantom measurements with the same imaging device or media.
- The derived in air fluence is now the same starting point as when the radiation fields are measured directly prior to patient entry.
- The existing Dosimetry Check (FDA 510(k) K010225) software functions are then used to compute the dose to the patient using the in air fluence for each treatment beam and to evaluate the correctness of the dose to the patient.
I am sorry, but the provided text does not contain the information required to populate the requested table and answer the questions regarding acceptance criteria, study details, and performance metrics. The document is a 510(k) summary and FDA clearance letter for a device called "Dosimetry Check with Exit Dose". It describes the device's function and indications for use but does not include:
- Specific acceptance criteria for device performance.
- Details of a study conducted to prove the device meets acceptance criteria (e.g., sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets).
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- 510(k) Summary, page 1 of 1
File: dcexit510ksummary.doc Date: 29 April 2010
5. 510(k) Summary
AUG 04 2010
Dosimetry Check with Exit Dose is a software program intended to provide a means for testing the dosimetry of radiation therapy treatments applied to a patient using high energy x-rays. This test is performed from measurements made during treatment of the patient by measuring the radiation fields after they have passed through the patient with a suitable imaging device such as an electronic portal imaging device or other measuring devices or media. The following software functions are then performed:
-
The patient's CT scan treatment plan image set is traced to provide the water equivalent path to points on the measured exit dose plane.
-
A deconvolution process is performed with a kernel that is a function of radius and the thickness transversed to convert the exit images back to x-ray intensity in air fluence prior to patient entry. The kernel is derived prior from phantom measurements with the same imaging device or media.
-
The derived in air fluence is now the same starting point as when the radiation fields are measured directly prior to patient entry.
-
The existing Dosimetry Check (FDA 510(k) K010225) software functions are then used to compute the dose to the patient using the in air fluence for each treatment beam and to evaluate the correctness of the dose to the patient.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Wendel Dean Renner President Math Resolutions, LLC 5975 Gales Lane COLUMBIA MD 21045
AUG 0 4 2010
Re: K101503
Trade/Device Name: Dosimetry Check with Exit Dose Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 27, 2010 Received: June 1, 2010
Dear Mr. Renner:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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Enclosure
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Donald J. Heyer
Donald J. St Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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- Indications for Use page 1 of 1
File: dcexitinduse.doc Date: 29 April 2010
4. Indications for Use
K101503 510(k) Number
AUG 04 2010
Device Name: Dosimetry Check with Exit Dose
Indications for Use:
The product is to be used by radiation oncologist, dosimetrist, and radiation therapy physicist to check the correctness of the x-ray treatment fields from high energy treatment machines that are planned to be or have been applied to a patient. This product is to be used in addition to the treatment planning system to provide a means for additional and redundant verification that the plan is in fact successfully accomplished. This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.
Document approved by: Wendel Dean Renner Title: President
Date: 29 April 2010
Wendel Dean Ke
(Division Sign-Off)
Division of Radiological Devices
Office In Vitro Diagnostic Device Evaluation and Safety
§ 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.