(15 days)
Not Found
No
The document describes a software program for dose calculation verification and does not mention AI, ML, or related concepts.
No
The device is described as a software program that independently verifies the dose calculated by a primary radiation treatment planning system, rather than directly delivering or influencing treatment.
No
Explanation: This device is described as a software program that performs dose calculations to verify the dose calculated by a primary radiation treatment planning system. It is used for quality assurance of treatment plans, not for diagnosing a medical condition in a patient.
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. Its function is solely dose calculation verification.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that MuCheck and its Gamma-Knife QA Check module are software programs used for independent verification of dose calculations performed by radiation treatment planning systems. They do not interact with or analyze biological specimens from a patient.
- Intended Use: The intended use is to verify calculations related to radiation therapy, not to diagnose or monitor a patient's condition through the analysis of biological samples.
Therefore, this device falls under the category of medical software used in the planning and quality assurance of radiation therapy, not as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for the Gamma-Knife QA Check program is the same as for the predicate devices: to calculate a dose for the purpose of validating a dose previously calculated by a the primary GammaKnife treatment planning system The intended use is as a quality assurance tool only and not as a treatment planning device.
In a radiation therapy department quality assurance is an important part of patient care. The ability to provide a secondary check for the primary dose calculation is part of good treatment protocol as well being a recommendation by Task Group 40. Gamma Knife QA Check provides this very important quality assurance function.
MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system.
The intended use of the MuCheck software has been extended to include an optional module, Gamma-Knife QA Check to independently verify the dose for single or multiple points that have been previously calculated by the Gamma Knife treatment planning system or other points as determined by the physicist.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Gamma-Knife QA Check 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 onerate either in a stand alone mode independent of the Gammaknife treatment planning grown or to import plans from the GammaKnife treatment planning system. It does not connect to a control any radiation hardware device. Gamma Knife QA Check performs dose calculations to verify the dose calculated by the primary GammaKnife radiation treatment planning system.
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
Not Found
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: Verification and validation test plans were completed in accordance with Oncology Data Systems procedures and GMP guidelines. A Hazard Analysis was completed and hazards were resolved as appropriate. All system specifications were met and testing performed to demonstrate substantial equivalence. The non-clinical tests were conducted using the GammaKnife treatment planning system and Gamma-Knife QA Check. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary.
Summary of Clinical Testing: Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness.
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.
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
1-2
JUN 18 2009
510(k) Safety and Effectiveness Summary
| Submitter: | Oncology Data Systems, Inc.
1601 S.W 89th, Ste. E-100
Oklahoma City, Ok. 73159
tel. (405) 680-5222
fax (405) 680-5444 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact:
Date: | Vince Ruminer
May 18, 2009 |
| Trade Name: | Mucheck Gamma-Knife QA Check |
| Common Name: | Dose Validation Software |
| 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:
| Device Name | 510(K) Number |
|---|---|
| MuCheck Monitor Unit Validation (V4 for IMRT) | K012227 |
| MuCheck Monitor Unit Validation (V7 for Brachy) | K061152 |
| Leksell GammaPlan | K061540 |
Description:
The Gamma-Knife QA Check 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 onerate either in a stand alone mode independent of the Gammaknife treatment planning grown or to import plans from the GammaKnife treatment planning system. It does not connect to a control any radiation hardware device. Gamma Knife QA Check performs dose calculations to verify the dose calculated by the primary GammaKnife radiation treatment planning system.
Substantial Equivalence Summary:
Intended Use:
The intended use for the Gamma-Knife QA Check program is the same as for the predicate devices: to calculate a dose for the purpose of validating a dose previously calculated by a the
1
K09/602
1-3
primary GammaKnife treatment planning system The intended use is as a quality assurance tool only and not as a treatment planning device.
In a radiation therapy department quality assurance is an important part of patient care. The ability to provide a secondary check for the primary dose calculation is part of good treatment protocol as well being a recommendation by Task Group 40. Gamma Knife QA Check provides this very important quality assurance function.
Technological Characteristics:
The technological characteristics are the same as for the predicate devices. Gamma-Knife OA Check was designed to operate in a windows environment using both mouse and keyboard.
Non-clinical tests:
Verification and validation test plans were completed in accordance with Oncology Data Systems procedures and GMP guidelines. A Hazard Analysis was completed and hazards were resolved as appropriate. All system specifications were met and testing performed to demonstrate substantial equivalence. The non-clinical tests were conducted using the GammaKnife treatment planning system and Gamma-Knife QA Check. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary.
Summary of Clinical Testing:
Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness.
Conclusions:
Based upon the technological characteristics, intended use, and non-clinical tests, Gamma Knife QA Check is substantially equivalent to the predicate device. The documentation submitted for review supports this claim.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ﻳﻤﻜﻨ
JUN 18 2009
Oncology Data Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313
Re: K091602
Trade/Device Name: MuCheck V8 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 1, 2009 Received: June 3, 2009
Dear Mr. Job:
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. Insting 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 (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Larry Morris
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
99/607 510(k) Number (if known):
Device Name: MuCheck V8
Indications For Use:
MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system.
The intended use of the MuCheck software has been extended to include an optional module, Gamma-Knife QA Check to independently verify the dose for single or multiple points that have been previously calculated by the Gamma Knife treatment planning system or other points as determined by the physicist.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Camufo Rorxes
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number