(84 days)
Not Found
No
The description focuses on optimization algorithms based on user-defined parameters and dose objectives, without mentioning AI or ML techniques. The process is described as a calculation based on input data and user settings, not a learning or adaptive system.
No
This device is a treatment planning package used to optimize radiation therapy plans, not to directly deliver or provide therapy. It generates data for delivery equipment but does not activate it or perform treatment itself.
No
KonRad is a treatment planning system that optimizes MLC positions or block shapes for radiation therapy. It calculates and displays dose distributions and DVH curves but does not diagnose medical conditions.
Yes
The device is described as a "radiation therapy treatment planning package" that is a "PC based system" and "software uses defined anatomical structures for the optimization and treatment planning process." The description focuses entirely on the software's functionality and its interaction with imported data and external hardware (Linear Accelerator or Record and Verify system) for export, without mentioning any proprietary hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- KonRad's Function: KonRad is a radiation therapy treatment planning software. Its purpose is to optimize the delivery of radiation therapy based on medical images and user-defined parameters. It does not analyze biological samples from the patient.
- Input Data: The input data for KonRad is primarily medical imaging (tomographic images like CT) and user-defined treatment parameters, not biological samples.
- Output: The output of KonRad is a treatment plan, not a diagnostic result based on the analysis of a biological sample.
Therefore, KonRad falls under the category of medical devices used for treatment planning and delivery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
KonRad is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate. After approval the results are exported to the delivery equipment, Lincar Accelerator or Record and Verify system, for final verification before treatment delivery.
Product codes
90 MUJ
Device Description
KonRad as described in this submission is a radiation therapy treatment planning package designed to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). KonRad is a PC based system.
KonRad software uses defined anatomical structures for the optimization and treatment planning process. The images or contours are based on tomographic images imported via Dicom and Dicom RT protocols from various sources, e.g. CT. Virtual Simulation software etc. The users treatment machine beam data is utilized for plan calculation.
The user defines the desired dose to be delivered to the target and the surrounding structures. Values are entered to weight the optimizations according to the importance of reaching the dose objectives for the target and other structures. After the user starts the optimization, the software calculates the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This is done for each beam simultaneously and the resulting dose distribution and DVH are displayed. Once the optimization is complete, the dose distribution and DVH are displayed for the user to evaluate. If the user is not satisfied with the results of the optimization, the input parameters can be modified and the optimization repeated until the desired results are met. When the user is statisfied, the final treatment plan can be stored and is ready for export.
The resulting treatment plan can be exported, to the appropriate delivery equipment. Linear Accelerator or Record and Verify system (R&V) via defined protocols, e.g. Dicom RT. The export of the treatment plan does not activate the delivery equipment, all information must be verified by the user prior to treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
tomographic images imported via Dicom and Dicom RT protocols from various sources, e.g. CT. Virtual Simulation software etc.
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)
Not Found
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
Premarket Notification MRC Systems: KonRad Date : 1 July 2002
Kozz307
MRC Systems GMBH
Hans-Bunte-Str. 10 D-69123 Heidelberg Germany Phone: (+49) 6221-13803-00 (+49) 6221-13803-01 Fax:
Date: July 1, 2002
Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by section 807.92(c)
Submitter of 510(k) a.
| Company name: | MRC Systems |
|---|---|
| Registration # | 9040319 |
| Address: | Hans-Bunte-Str.10 |
| D-69123 Heidelberg | |
| Germany | |
| Contact Person: | Mark-Aleksi Keller-Reichenbecher Ph.D |
| Manager Quality Assurance and Regulatory Affairs | |
| Phone: | (+49) 6221-13803-00 |
| Fax: | (+49) 6221-13803-01 |
Device Name: b.
| Trade/Proprietary Name: | KonRad |
|---|---|
| Common/Usual Name: | Radiation Therapy Planning System |
| Classification Name: | Accelerator, Linear, Medical, Accessory |
| 21 CFR 892.5050 Class II. |
Legally Marketed Predicate Device(s) C.
Our device is substantially equivalent to the legally marketed predicate device cited in the table below.
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron | PLATO ITP | K992434 |
1
Premarket Notification MRC Systems: KonRad Date : 1 July 2002
Description d.
KonRad as described in this submission is a radiation therapy treatment planning package designed to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). KonRad is a PC based system.
KonRad software uses defined anatomical structures for the optimization and treatment planning process. The images or contours are based on tomographic images imported via Dicom and Dicom RT protocols from various sources, e.g. CT. Virtual Simulation software etc. The users treatment machine beam data is utilized for plan calculation.
The user defines the desired dose to be delivered to the target and the surrounding structures. Values are entered to weight the optimizations according to the importance of reaching the dose objectives for the target and other structures. After the user starts the optimization, the software calculates the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This is done for each beam simultaneously and the resulting dose distribution and DVH are displayed. Once the optimization is complete, the dose distribution and DVH are displayed for the user to evaluate. If the user is not satisfied with the results of the optimization, the input parameters can be modified and the optimization repeated until the desired results are met. When the user is statisfied, the final treatment plan can be stored and is ready for export.
The resulting treatment plan can be exported, to the appropriate delivery equipment. Linear Accelerator or Record and Verify system (R&V) via defined protocols, e.g. Dicom RT. The export of the treatment plan does not activate the delivery equipment, all information must be verified by the user prior to treatment.
Intended use e.
KonRad is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate.
After approval the results are exported to the delivery equipment, Linear Accelerator or Record and Verify system, for final verification before treatment delivery.
f. Summary of technological considerations
The KonRad software is substantially equivalent to the predicate device. It enhances the functionality of the defined predicate device by providing the ability to finalize the dose
calculation.
Name: Mark Aleksi Keller-Reichenbecher Ph.D Title: Manager
Quality Assurance & Regulatory Affairs
MRC Systems GMBH
Heidelberg, Germany
$\frac{02/07/01}{Date}$
Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image of an eagle. The eagle is depicted with three curved lines representing its body and wings. The text is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 0 Corporate Boulevard Rockville MD 20850
Re: K022307
Jörg Stein, Ph.D. Managing Director MRCSystems GmbH Hans-Bunte-Strasse 10 69123 Heidelberg . GERMANY
Trade/Device Name: KonRad Treatment Planning System v2.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ
Dated: July 1, 2002 Received: July 16, 2002
Dear Dr. Stein:
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 (sec 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); 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.
3
Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Hodgdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page I of I
| 510(k) Number (if known): | K022307 |
|---|---|
| --------------------------- | --------- |
Device Name:
KonRad
Indications For Use:
KonRad is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate. After approval the results are exported to the delivery equipment, Lincar Accelerator or Record and Verify system, for final verification before treatment delivery.
(Please Do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
David C. Seager
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 2230 510(k) Number __
(Optional Format 1-2-96)