(90 days)
K 914698
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a calculation program for quality assurance, not on learning or adaptive algorithms.
No
The device is described as a "quality assurance tool only and not as a treatment planning device" and "does not connect to or control any radiation hardware device," indicating it is not directly involved in treating patients.
No
The device is described as a "quality assurance tool only and not as a treatment planning device." Its purpose is to validate monitor unit or timer settings previously calculated, not to diagnose a patient's condition or disease.
Yes
The device description explicitly states it is a "software program" designed to operate on a personal computer and does not connect to or control any radiation hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "calculate a monitor unit or timer setting for the purpose of validating a monitor unit or timer setting previously calculated by a primary radiation treatment planning system or hand calculation." This is a quality assurance tool for radiation therapy, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The device is a software program operating on a personal computer. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment of a disease based on biological sample analysis.
The device's function is related to the planning and quality assurance of radiation therapy, which falls under the category of medical devices used in treatment delivery and planning, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The muCheck Monitor Unit Validation Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to operate on a stand alone mode independent of any radiation treatment planning system. It does not connect to or control any radiation hardware device.
The intended use for the muCheck Monitor Unit Validation Program is the same as for the predicate device: to calculate a monitor unit or timer setting for the purpose of validating a monitor unit or timer setting previously calculated by a primary radiation treatment planning system or hand calculation. The intended use is as a quality assurance tool only and not as a treatment planning device.
In a radiation therapy department a course of patient treatment is prescribed by a written directive from the radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the beam therapy. As part of the planning process, a monitor unit setting will be calculated which determines the machine duration of beam exposure. The primary radiation treatment planning software may or may not calculate the monitor unit setting. Regardless, the dosimetrist or physicist will either perform a manual calculation or perhaps use an in-house developed spreadsheet or program to calculate the monitor unit setting.
A manual calculation will involve the dosimetrist looking up beam data factors from a booklet of measured beam data provided by the physicist. These beam data factors are unique to each machine and must be measured by the physicist. The beam data booklet can contain 50 or more pages for a typical machine consisting of 2 photon beams and 5 electron beams. These factors are plugged into a standardized worksheet and a calculator is used to compute the monitor unit setting. This can be a tedious, time consuming process as well as error prone. The dosimetrist may have to search through multiple pages of data to find the correct factors to use. They will then have to be written down on the worksheet to be used for the final monitor unit calculation. Ideally they should be double checked for accuracy.
The muCheck Monitor Unit Validation Program (the device under review) makes this process much faster and more accurate. Initially, all of the beam data factors for each beam energy are entered into the system one time and stored in a database as part of the pre-installation process. After entry these factors are then plotted on a graph and printed along with tables of actual values entered to verify accuracy of data entry. To use the program, the dosimetrist simply enters the key data parameters as prompted by the program. As the parameters are entered into the system, beam factors are looked up and are automatically used by the program to calculate the correct monitor unit setting. All of the pertinent calculation data is displayed on the screen in worksheet form. This worksheet can be printed out and stored in the patients chart for permanent documentation. There are many user imput edits incorporated into the system during the pre-installation process to insure the accuracy of the calculation. It must be stressed that this program does not provide the primary treatment calculation. It merely serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
The muCheck Monitor Unit Validation Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to operate on a stand alone mode independent of any radiation treatment planning system. It does not connect to or control any radiation hardware device.
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
medical dosimetrist and/or medical physicist
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)
Non-clinical tests: The non-clinical tests were conducted using both the predicate device and muCheck. In addition each test was further validated using a treatment plan which provide a monitor unit or hand calculation. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary.
Beta Clinical Testing: The results received and summarized from the beta testing conducted in St. John Hospital support the claim of substantial equivalence. See Figure 6.1 in section 6 for comparison summary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 914698
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.
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
Medical Dosimetry Services, Inc.
FAX (405) 745-3233 12401 S. Riverview Rd. Oklahoma City, Ok. 73173 Tel. (405) 745-2188
いましたが、そして、この日は、2008年には、日本
(405) 743-5233
JUN - 8 1998
510(k) Safety and Effectiveness Summary
| Submitter: | Medical Dosimetry Services, Inc.
12401 Riverview Rd.
Oklahoma City, Ok. 73173
tel. (405) 745-2188
fax (405) 745-3233 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Gregory G. Miller, Vice-President |
| Date: | March 6, 1998 |
| Trade Name: | muCheck - Monitor Unit Validation Program |
| Common Name: | Monitor Unit Validation Program |
| Classification Panel: | Radiology |
| Classification Name: | Medical Charged Particle Radiation Therapy
System(Accessory)
21 CFR 892.5050 (class II) |
| Performance Standards: | none established under section 514 |
| Substantial Equivalence: | K & S Associates, PC Setup Program
510(k) K 914698 |
Description:
The muCheck Monitor Unit Validation Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to operate on a stand alone mode independent of any radiation treatment planning system. It does not connect to or control any radiation hardware device.
Substantial Equivalence Summary:
Intended Use:
The intended use for the muCheck Monitor Unit Validation Program is the same as for the predicate device: to calculate a monitor unit or timer setting for the purpose of validating a monitor unit or timer setting previously calculated by a primary radiation treatment planning system or hand calculation. The intended use is as a quality assurance tool only and not as a treatment planning device.
1
In a radiation therapy department quality assurance is an important part of patient care. The ability to provide a secondary check for the primary monitor unit calculation is part of good treatment protocol as well being a recommendation by Task Group 40. Mucheck provides this verv important quality assurance function.
Safety and Effectiveness:
The staff at Medical Dosimetry Services includes a certified medical dosimetrist with over 20 years of experience. The computer programming and design has been provided by a systems analyst with over 20 years of experience in the design and development of systems. The combined expertise as well as conformance to the GMP regulations helped to insure that the finished product is safe and effective to use.
A comprehensive users manual available as a hard copy as well as on-line, provides extensive documentation and tutorial for the user. Initial system startup and training is provided on-site as part of the service provided by Medical Dosimetry Services.
Technological Characteristics:
The technological characteristics are mostly the same as for the predicate device with the main exception being that the predicate device was designed to operate in a DOS environment as a character based menu driven system. MuCheck was designed to operate in a windows environment using both mouse and keyboard.
Non-clinical tests:
The non-clinical tests were conducted using both the predicate device and muCheck. In addition each test was further validated using a treatment plan which provide a monitor unit or hand calculation. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary.
Beta Clinical Testing:
The results received and summarized from the beta testing conducted in St. John Hospital support the claim of substantial equivalence. See Figure 6.1 in section 6 for comparison summary.
Conclusions:
Based upon the technological characteristics, intended use, non-clinical tests, as well as clinical tests, muCheck is substantially equivalent to the predicate device. The documentation submitted for review supports this claim.
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features an eagle with three human profiles within its body. Below the logo, the date "JUN - 8 1998" is printed.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gregorv Miller Medical Dosimetry Services, Inc. 12401 Riverview Road Oklahoma City, OK 73173
Re:
muCheck - Monitor Unit Validation Program Dated: March 6, 1998 Received: March 10, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Miller:
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 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). 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 (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 (OS) 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification submission does not affect any obligation you might have under sections 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/dsmaldsmam.html",
Sincerely yours,
Lillian Yiu, Ph.D.
Lillian Yin. Ph.D. Director, Division of Reproductiv Abdominal, Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications For Use
In a radiation therapy department a course of patient treatment is prescribed by a written directive from the radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the beam therapy. As part of the planning process, a monitor unit setting will be calculated which determines the machine duration of beam exposure. The primary radiation treatment planning software may or may not calculate the monitor unit setting. Regardless, the dosimetrist or physicist will either perform a manual calculation or perhaps use an in-house developed spreadsheet or program to calculate the monitor unit setting.
A manual calculation will involve the dosimetrist looking up beam data factors from a booklet of measured beam data provided by the physicist. These beam data factors are unique to each machine and must be measured by the physicist. The beam data booklet can contain 50 or more pages for a typical machine consisting of 2 photon beams and 5 electron beams. These factors are plugged into a standardized worksheet and a calculator is used to compute the monitor unit setting. This can be a tedious, time consuming process as well as error prone. The dosimetrist may have to search through multiple pages of data to find the correct factors to use. They will then have to be written down on the worksheet to be used for the final monitor unit calculation. Ideally they should be double checked for accuracy.
The muCheck Monitor Unit Validation Program (the device under review) makes this process much faster and more accurate. Initially, all of the beam data factors for each beam energy are entered into the system one time and stored in a database as part of the pre-installation process. After entry these factors are then plotted on a graph and printed along with tables of actual values entered to verify accuracy of data entry. To use the program, the dosimetrist simply enters the key data parameters as prompted by the program. As the parameters are entered into the system, beam factors are looked up and are automatically used by the program to calculate the correct monitor unit setting. All of the pertinent calculation data is displayed on the screen in worksheet form. This worksheet can be printed out and stored in the patients chart for permanent documentation. There are many user imput edits incorporated into the system during the pre-installation process to insure the accuracy of the calculation. It must be stressed that this program does not provide the primary treatment calculation. It merely serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.
Prescription Use
(Per 21 CFR 801.109)
Ginist G. Sejrom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number