(184 days)
Not Found
No
The description focuses on deterministic calculations and comparisons to manual methods and predicate devices, with no mention of learning or adaptive algorithms.
No
The device is a quality assurance tool for verifying monitor unit calculations in radiation oncology. It does not treat, prevent, or diagnose disease, nor does it affect the structure or function of the body.
No
Explanation: The device is described as "a quality assurance tool for monitor unit calculations" and "a verification of treatment planning derived monitor unit settings." It does not diagnose medical conditions but rather verifies calculations for existing treatment plans.
Yes
The device description explicitly states it is a program designed to operate on a personal computer and does not connect to or control any radiation hardware device. Its function is solely calculation and verification based on user input.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to verify monitor unit calculations for radiation therapy, which is a treatment process, not a diagnostic process performed on in vitro samples.
- Device Description: The device operates on a computer and performs calculations based on clinical data. It does not interact with biological samples or perform tests on them.
- 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 analytes, or providing diagnostic information about a patient's health status.
The device is clearly described as a quality assurance tool for radiation oncology, focused on verifying calculations related to treatment delivery.
N/A
Intended Use / Indications for Use
The intended use of the MU Plus! monitor unit calculation verification program is the same as for the predicate devices: to calculate monitor unit or timer settings for the purpose of validating a monitor unit or timer setting previously calculated by a radiation treatment planning system or hand calculation. MU Plus! also calculates an expected diode reading which is used to verify proper delivery of radiation therapy treatment.
MU Plus! is a quality assurance tool for monitor unit calculations performed in radiation oncology clinics. MU Plus! is designed to be used as a verification of treatment planning derived monitor unit settings or hand generated monitor unit settings. Monitor unit calculations for linear accelerators are performed by various staff of radiation oncology clinics, including medical physicists, dosimetrists, and radiation therapists. MU Plus! also contains a diode measurement verification program which predicts an expected diode reading based on a formalism similar to the monitor unit calculations.
Product codes
90 IYE
Device Description
The MU Plus! monitor unit calculation verification program is designed to operate on an IBM compatible personal computer using Windows 95. Windows NT 4.0, or higher operating system. It is designed to operate independently of any radiation treatment planning system. It does not connect to or control any radiation hardware device. It is designed to verify monitor unit calculations for accelerator produced photons and electrons. It also calculates expected diode readings based on clinical data entered by the user.
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
radiation oncology clinics, including medical physicists, dosimetrists, and radiation therapists.
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
Non-clinical tests were conducted using the predicate devices and MU Plus!. Standard test cases were used on both systems. The test results matched very closely which supports the claim of substantial equivalence. See Appendixes A and B for a comparison summary.
In addition monitor unit settings calculated by MU Plus! were compared against those performed by manual lookup to verify that the program was performing monitor unit calculations correctly. All tests matched very closely. See Appendixes C and D for a comparison summary.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted using the predicate devices and MU Plus!. Standard test cases were used on both systems. The test results matched very closely which supports the claim of substantial equivalence. See Appendixes A and B for a comparison summary.
In addition monitor unit settings calculated by MU Plus! were compared against those performed by manual lookup to verify that the program was performing monitor unit calculations correctly. All tests matched very closely. See Appendixes C and D for a comparison summary.
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 0 2000
K992689
Page 1 of 3
510(k) Summary
| Submitter: | Rad Therapy Solutions, Inc.
738 Alden Drive
Ormond Beach, FL 32176
Tel. (904) 441-7400
Email: muplus1@aol.com |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact:
Date: | Steve Gruse, President
August 7. 1999 |
| Trade Name: | MU Plus! |
| Common Name: | Monitor Unit Calculation Verification Program |
| Classification Panel: | Radiology |
| Classification Name: | Medical Charged Particle Radiation Therapy
System (Accessory)
21 CFR 892.5050 (class II) |
| Substantial Equivalence: | K&S Associates, PC Setup Program
510(k) K914698
SSGI, Prowess Pro-Sim
510(k) K980379 |
Description:
The MU Plus! monitor unit calculation verification program is designed to operate on an IBM compatible personal computer using Windows 95. Windows NT 4.0, or higher operating system. It is designed to operate independently of any radiation treatment planning system. It does not connect to or control any radiation hardware device. It is designed to verify monitor unit calculations for accelerator produced photons and electrons. It also calculates expected diode readings based on clinical data entered by the user.
Intended Use:
The intended use of the MU Plus! monitor unit calculation verification program is the same as for the predicate devices: to calculate monitor unit or timer settings for the purpose of validating a monitor unit or timer setting previously calculated by a radiation treatment planning system or hand calculation. MU Plus! also calculates an expected diode reading which is used to verify proper delivery of radiation therapy treatment.
1
K 9926089
Page 2 of 3
Technological Characteristics:
MU Plus! calculates monitor unit settings in a fashion similar to Prowess for photon calculations. MU Plus! calculates monitor unit settings for photons using the following formalism:
Calculated Dose MU = TMR * Sp * Sc * WF * TF * OAFx * OAFy * ISF * Output (cGy/MU)
Prowess calculates monitor settings for photons using the following formalism:
Calculated Dose MU = TMR * OF * (PSF'/PSF) * WF * TF * ISF * Output (cGy/MU)
where: OF * (PSF'/PSF) = Sp * Sc
MU Plus! calculates monitor unit settings in a fashion similar to PC Setup Program for electrons. MU Plus! calculates monitor unit settings for photons using the following formalisms:
Calculated Dose MU = Cone Output Factor * SSD Output Factor * Isodose Prescription
OR
MU = Calculated Dose Calibration Factor * Isodose Prescription
PC Setup Program calculates monitor unit settings for electrons using the following formalism:
Calculated Dose MU = Cone Output Factor * Modifier Factor * Isodose Prescription
Although terms in these formalism may differ slightly, the formalism is essentially the same for both MU Plus! and PC Setup Program.
Non-clinical tests:
Non-clinical tests were conducted using the predicate devices and MU Plus!. Standard test cases were used on both systems. The test results matched very closely which supports the claim of substantial equivalence. See Appendixes A and B for a comparison summary.
2
K992689
page 3 of 3
In addition monitor unit settings calculated by MU Plus! were compared against those performed by manual lookup to verify that the program was performing monitor unit calculations correctly. All tests matched very closely. See Appendixes C and D for a comparison summary.
Conclusions:
Based on the technological characteristics, intended use, non-clinical tests, as well as clinical tests, MU Plus! is substantially equivalent to the predicate device. The documentation submitted for review supports this claim.
3
Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2000
Steve Gruse, M.S., DABR President Rad Therapy Solutions, Inc. 738 Alden Drive Ormond Beach, Florida 32176 Re:
MU Plus ! Dated: November 12, 1999 Received: November 18, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Gruse:
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 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). 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 III (Special Controls) or dass 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications of Use
Applicant: Rad Therapy Solutions. Inc.
15992689 510(k) Number: N/A
Device Name: MU Plus!
Indications For Use:
MU Plus! is a quality assurance tool for monitor unit calculations performed in radiation oncology clinics. MU Plus! is designed to be used as a verification of treatment planning derived monitor unit settings or hand generated monitor unit settings. Monitor unit calculations for linear accelerators are performed by various staff of radiation oncology clinics, including medical physicists, dosimetrists, and radiation therapists. MU Plus! also contains a diode measurement verification program which predicts an expected diode reading based on a formalism similar to the monitor unit calculations.
Prescription Use (Per 21 CFR 801.109)
David A. Segerson
(Division Sign Off)
vision Sign-Off vision of Reproductive, Abdomi d Radiological De 510(k) Number