(19 days)
No
The description focuses on hardware components, control systems, and data processing for positioning leaves based on pre-generated treatment plans. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
No
The device is described as a 'conformal radiation therapy and radiosurgery device' that 'delivers a shaped X-ray beam from a radiation therapy source' used to 'help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs.' However, it's an accessory to a linear accelerator (Linac) and its function is to shape the radiation beam, not to generate or apply the therapy itself. Therefore, it's a component that aids in therapeutic delivery but is not a standalone therapeutic device.
No
The device is described as a radiation therapy and radiosurgery device used to deliver a shaped X-ray beam for treatment, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a user console, control cabinet with PC, interface board, power supply, and a collimator mechanism with driving units and potentiometers. While software is involved in processing data and control, the device is fundamentally a hardware system with integrated software.
Based on the provided text, the ModuLeaf device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- ModuLeaf Function: The ModuLeaf is a radiation therapy device used to shape and deliver radiation directly to a target area within the patient's body. It is an external device that interacts with a linear accelerator to treat disease, not to analyze biological samples.
The description clearly states its purpose is to "deliver a shaped X-ray beam from a radiation therapy source" and "collimates the radiation delivery to a target based on a treatment plan." This is a therapeutic function, not a diagnostic one involving in vitro analysis.
N/A
Intended Use / Indications for Use
The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs.
Product codes
90 IXI
Device Description
The ModuLeaf is a conformal radiation therapy and radiosurgery device that is mounted to a standard radiation therapy linear accelerator (Linac). The ModuLeaf receives input from planning system software that determines the collimator aperture shapes at different gantry positions along the arc around the target area. Radiation is delivered at a constant rate.
The ModuLeaf consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism.
The control cabinet with the user console serves as the control station for the operator and is located near the Linac operator console. The control cabinet contains the PC, an interface board and the power supply. The PC consists of a specified configuration of a CPU, motherboard. RAM, VGA board and HDD. It is used as the communication interface between the operator and the planning system software or the record and verify (R&V) system that contains the treatment positioning data. The PC also serves as the master for the control and verification system. The data received from the planning system software or the record and verify (R&V) system is processed and transferred to the micro-controllers on the control and verification boards.
The operator initiates position adjustment at the console or at the record and verify (R&V) system depending on the configuration. When an R&V system is involved the leaf positions are downloaded to the PC. The PC then starts all the micro-controllers simultaneously and retrieves the position of the leaves, comparing the values of the control system with those of the verification system.
The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 driving units that position the tunqsten leaves via a rack and pinion mechanism. Two independent potentiometers are directly connected with each tungsten leaf to retrieve information on the leaf position, i.e. there are 80 potentiometers for leaf positioning and an additional 80 potentiometers for independent leaf position verification. They serve as feedback for the verification system that checks the correct positioning of the leaves.
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
Used to help the clinician.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.
0
Special 510(k) MRC Systems: ModuLeaf February 21, 2003
MAR 1 7 2003
MRC
KU30609
MRC Systems GMBH Hans-Bunte-Str. 10 D-69123 Heidelberg Germany Phone: (+49) 6221-13803-00 (+49) 6221-13803-01 Fax:
Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Special 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)
Submitter of 510(k):
| Company name: | MRC Systems GmbH |
|---|---|
| Registration number: | 9040319 |
| Address: | Hans-Bunte-Str. 10 |
| 69123 Heidelberg | |
| Germany | |
| Phone: | (+49) 6221-13803-00 |
| Fax: | (+49) 6221-13803-01 |
| Correspondent: | Mark-Aleksi Keller-Reichenbecher Ph.D. |
| Manager Quality Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | ModuLeaf |
|---|---|
| Common/Usual Name: | Multileaf Collimator |
| Classification Name: | Block, Beam Shaping, Radiation Therapy |
| Classification | 21 CFR 892.5710, Class II |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| MRC Systems GmbH | ||
| Not of Callery of Children Commended Call and Call Associated of Call Associated of Call Associated of Call Associated of Call Associated of Call Associated of Call Associate | Mini Multileaf Collimator | K011816 |
Description:
The ModuLeaf is a conformal radiation therapy and radiosurgery device that is mounted to a standard radiation therapy linear accelerator (Linac). The ModuLeaf receives input from
1
Special 510(k) MRC Systems: ModuLeaf February 21, 2003
Ku30609
planning system software that determines the collimator aperture shapes at different gantry positions along the arc around the target area. Radiation is delivered at a constant rate.
The ModuLeaf consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism.
The control cabinet with the user console serves as the control station for the operator and is located near the Linac operator console. The control cabinet contains the PC, an interface board and the power supply. The PC consists of a specified configuration of a CPU, motherboard. RAM, VGA board and HDD. It is used as the communication interface between the operator and the planning system software or the record and verify (R&V) system that contains the treatment positioning data. The PC also serves as the master for the control and verification system. The data received from the planning system software or the record and verify (R&V) system is processed and transferred to the micro-controllers on the control and verification boards.
The operator initiates position adjustment at the console or at the record and verify (R&V) system depending on the configuration. When an R&V system is involved the leaf positions are downloaded to the PC. The PC then starts all the micro-controllers simultaneously and retrieves the position of the leaves, comparing the values of the control system with those of the verification system.
The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 driving units that position the tunqsten leaves via a rack and pinion mechanism. Two independent potentiometers are directly connected with each tungsten leaf to retrieve information on the leaf position, i.e. there are 80 potentiometers for leaf positioning and an additional 80 potentiometers for independent leaf position verification. They serve as feedback for the verification system that checks the correct positioning of the leaves.
Intended use:
The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs.
Summary of technological considerations:
The MRC Systems, ModuLeaf, is substantially equivalent to the cleared predicate device, Mini Multileaf Collimator, K011816.
Um Vala
Mark-Aleksi Keller-Reichenbecher Ph.D. Namel Title: Manager Quality Assurance & Requlatory Affairs MRC Systems GMBH
Heidelberg, Germany
02 Feb 21
Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Joerg Stein, Ph.D. Managing Director MRC Systems GMBH Hans-Bunte-Straße 10 69123 Heidelberg GERMANY
Re: K030609
MAR 1 7 2003
Trade/Device Name: Moduleaf Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: 90 IXI Dated: February 21, 2003 Received: February 26, 2003
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 vour 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); 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
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MRC Systems Applicant: (030609 510(k) Number (if known): Device Name: ModuLeaf
Indications For Use:
The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109) (Optional Format 1-2-96)
Prescription Use
David A. Segner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number