(88 days)
The Mini Multileaf Collimator is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The Mini Multileaf Collimator is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate 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. The Mini Multileaf Collimator should only be used for fixed field X-ray treatments.
The Mini Multileaf Collimator is a conformal radiosurgery device that is a line to The Mini Multical Oonlinator to erapy linear accelerator (Linac). The Mini Multileaf Collimator mounted to a standard racines 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 Mini Multileaf Collimator consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism.
The control cabinet with the user console serve as the control station for the operator and are I he control cabinet will the user console. The control cabinet contains the PC, an interface board located the power supply. The PC consists of a specified configuration of a CPU, motherboard, and the power supply. The F & consisted interface between the operator and the planning system software 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 is processed and transferred to the micro-controllers (MC) on the control and verification boards.
The operator at the console initiates position adjustment. The PC then starts all the MC's I'm operator at the consore innussion 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 I it conmitte that position the fitted to theaves via a rack and pinion mechanism. A potentioneter is directly connected with each tungsten leaf to retrieve information on the leaf position. Independent potentiometers for verification are also included in the driving units.
The provided document is a 510(k) summary for a medical device called the "Mini Multileaf Collimator," submitted in 2001. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for new safety and effectiveness claims. Therefore, the document does not contain the kind of specific performance data, acceptance criteria, ground truth details, or comparative study results you've requested that would typically be found in a study proving device meets acceptance criteria.
The document states that the new device has "minor differences" from its predicate and that "All tests were executed with all acceptance criteria met." However, it does not provide any specific details about what those acceptance criteria were, what tests were conducted, or the reported performance data from those tests.
Based on the provided text, I cannot complete most of the requested fields. Here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All tests were executed with all acceptance criteria met." (No specific performance metrics are provided) |
2. Sample size used for the test set and data provenance:
- Not specified. The document mentions "Verification, Validation and other testing activities" but does not detail the nature of these tests, their sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a test set with human-established ground truth in the context of device performance. This is typically relevant for AI/diagnostic devices, not for a collimator's mechanical and electronic performance.
4. Adjudication method for the test set:
- Not applicable/Not specified. As above, no such test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI device. It's a mechanical device (multi-leaf collimator) for radiation therapy. An MRMC study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware with control software, not a standalone algorithm in the AI sense. Its function is to be integrated with a linear accelerator and planning software, with a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of the device (a mechanical collimator controlled by software), "ground truth" would likely refer to physical measurements of leaf positions, field shapes, and consistency with treatment plans, validated against engineering specifications. However, these details are not provided.
8. The sample size for the training set:
- Not applicable/Not specified. This is not an AI device that undergoes "training" in the machine learning sense. The software is deterministic and based on treatment planning data.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. See point 8.
In summary: The provided 510(k) pertains to a hardware device (a multileaf collimator) and primarily focuses on demonstrating substantial equivalence to a predicate device based on engineering changes and subsequent testing. It explicitly states that "All tests were executed with all acceptance criteria met," implying successful verification and validation, but it does not provide the specific details of these tests, acceptance criteria, or performance data that you have requested. It is not an AI/diagnostic device, so many of your questions regarding ground truth, expert readers, and AI performance are not applicable to this document.
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Koll 816
510(k) Summary of Safety and Effectiveness VIII.
Date prepared
June 08, 2001
Company Name and Address
MRC Systems GmbH Hans-Bunte-Str. 10 D-69123 Heidelberg Germany
Contact Person:
Dr. Jörg Stein Managing Director ph: +49-6221-13803-00 fax: +49-6221-13803-01
Device Name
Proprietary Name: Common Name:
Mini Multileaf Collimator Therapeutic X-Ray Collimator
Classification
Proposed Regulatory Class: Device Classification:
II 892.5710
Therapeutic X-Ray Collimators have been classified by the Radiology Devices Panel as Class II devices (21 CFR 892.5710, Product Code IXI).
Predicate Device
The Mini Multileaf Collimator is substantially equivalent to the MRC Motorized Micro Multileaf Collimator (K000349).
Device Description
The Mini Multileaf Collimator is a conformal radiosurgery device that is a line to The Mini Multical Oonlinator to erapy linear accelerator (Linac). The Mini Multileaf Collimator mounted to a standard racines 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 Mini Multileaf Collimator consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism.
The control cabinet with the user console serve as the control station for the operator and are I he control cabinet will the user console. The control cabinet contains the PC, an interface board located the power supply. The PC consists of a specified configuration of a CPU, motherboard, and the power supply. The F & consisted interface between the operator and the planning system software 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
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software is processed and transferred to the micro-controllers (MC) on the control and verification boards.
The operator at the console initiates position adjustment. The PC then starts all the MC's I'm operator at the consore innussion 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 I it conmitte that position the fitted to theaves via a rack and pinion mechanism. A potentioneter is directly connected with each tungsten leaf to retrieve information on the leaf position. Independent potentiometers for verification are also included in the driving units.
Intended Use
The Mini Multileaf Collimator is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The Mini Multileaf Collimator is attached to a linear accelerator and consists of a series of tungsten leaves that collimate andiation 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. The Mini Multileaf Collimator should only be used for fixed field X-ray treatments.
Summary of Technological Characteristics Compared to Predicate Device
Similarities
The intended use and the indications for use are the same. Both the cleared unmodified and the modified device are conformal radiation therapy and radiosurgery devices that are attached to a standard radiation therapy linear accelerator (Linac) capable of shaping an X-ray beam.
Both devices consist of a series of pairs of motorized parallel tungsten leaves that collimate the radiation delivery to a target according to a treatment plan generated by treatment planning software.
Minor Differences
To achieve a larger maximum field size a somewhat different electromechanical design had to be employed, including
- different design of drive mechanism .
- focused instead of non-focused leaves •
- different type of leaf bearings .
The above described changes in the electromechanical design required/enabled minor changes to the electronic design:
- Control boards could be integrated in the Mini Multileaf Collimator enclosure enabling easier handling for the operator
- Independent real time operating system PC integrated in Windows-PC driving Micro -Controllers (rather the Windows-PC itself)
The hardware changes required some minor software changes, which did not raise any new safety/effectiveness questions and did not change the "level of concern".
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The results of the Risk Management, Verification, Validation and other testing activities indicate that the differences between the modified and the unmodified device do not raise new questions about safety and effectiveness. All tests were executed with all acceptance criteria met.
The modified device (Mini Multileaf Collimator) is substantially equivalent to the unmodified device (Motorized Micro Multileaf Collimator).
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and in a bold, serif font. The text is black and the background is white.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Jörg Stein Managing Director MRC Systems GMBH Hans-Bunte-Strasse 10 D-69123 Heidelberg GERMANY
SEP - 7 2001
Re: K011816
Mini Multileaf Collimator Model KMI, Version 1.2 Dated: June 8, 2001 Received: June 11, 2001 Regulatory Class: II 21 CFR 892.5710/Procode: 90 IXI
Dear Dr. Stein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed in interstate commerce prior to May 28, 1976, the enactnent date of the Medical Device 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 (Special Controls) or class 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
(301) 594-4591 8xx.1xxx 876.2xxx, 3xxx, 4xxx, 5xxx (301) 594-4616 (301) 594-4616 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx (301) 594-4654 892.2xxx, 3xxx, 4,xxx, 5xxx 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 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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for use enclosure
510(k) number (if known):
Device name:
Mini Multileaf Collimator
Indications for Use:
The Mini Multileaf Collimator is a conformal radiation therapy and-radiosurgery device that I he Mini Multilear Collimator is a voltation therapy source. The Mini Multileaf Collimator is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate 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. The Mini Multileaf Collimator should only be used for fixed field X-ray treatments.
(Please Do not write below this line -- continue on another page if needed)
Concurrence of CDRH, Office of device evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-counter-use__________________________________________________________________________________________________________________________________________________________
Nancy Snowden
terminator
(optional format 1-2-96)
§ 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.