(24 days)
No
The description focuses on electromechanical control and data processing based on pre-generated treatment plans, with no mention of adaptive learning, pattern recognition, or other AI/ML characteristics.
Yes
The device is described as a "conformal radiation therapy and radiosurgery device" that "delivers a shaped X-ray beam" for treatment, directly indicating its therapeutic purpose.
No
The device is described as a "conformal radiation therapy and radiosurgery device" that "delivers 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 (containing a PC, interface board, and power supply), and a collimator mechanism with driving units and potentiometers. While software is involved in processing data and controlling the hardware, the device itself is a physical system with significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to deliver a shaped X-ray beam for radiation therapy and radiosurgery. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a mechanical device that shapes a radiation beam based on a treatment plan. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- 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 or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.
The device is a component used in a radiation therapy system, which is a treatment modality, not a diagnostic one.
N/A
Intended Use / Indications for Use
The microMLC is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The microMLC 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 assist the clinician in the delivery of well-defined target volumes of radiation while sparing the surrounding tissues and organs.
Product codes
IXI
Device Description
The microMLC is a conformal radiation therapy and radiosurgery device that is mounted to a standard radiation therapy linear accelerator (Linac). The microMLC receives input from planning system software that determines the collimator aperture shapes at different gantry positions along the target area. Radiation is delivered at a constant rate.
The microMLC consists of three parts: (1) the user console, (2) the control cabinet and (3) the collinator mechanism.
The control cabinet with the user console serves as the control station for the operator and is located near the Linac operator console. If the system fails or the patient is endangered, the operator can push the emergency stop button that immediately cuts the power supply to all motors. 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 tungsten leaves. Eighty independent potentiometers for the verification system are included that serve as feedback for the verification system and 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
The Siemens Medical Solutions Oncology Care Systems, microMLC, is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
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)
Motorized Micro Multileaf Collimator (K000349)
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
OCT = 2 2003
Exhibit A 510(k) Summarv
| Submitter: | Siemens Medical Solutions USA, Inc.
Oncology Care Systems Group
4040 Nelson Avenue
Concord, CA 94520 | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------|--|
| Contact: | Ken Nehmer
Manager of Regulatory Affairs | |
| Phone: | (925)602-8011 | |
| Fax: | (925)602-8008 | |
| Email: | ken.nehmer@siemens.com | |
| Establishment Registration: | 2910081 | |
| Proprietary Name: | microMLC | |
| Common Name: | Accelerator, Linear, Medical | |
| Classification: | 892.5710
Class II device | |
| Product Code: | IXI | |
| Substantial Equivalence Claimed To: | Motorized Micro Multileaf Collimator (K000349) | |
Description:
The microMLC is a conformal radiation therapy and radiosurgery device that is mounted to a standard radiation therapy linear accelerator (Linac). The microMLC receives input from planning system software that determines the collimator aperture shapes at different gantry positions along the target area. Radiation is delivered at a constant rate.
The microMLC consists of three parts: (1) the user console, (2) the control cabinet and (3) the collinator mechanism.
The control cabinet with the user console serves as the control station for the operator and is located near the Linac operator console. If the system fails or the patient is endangered, the operator can push the emergency stop button that immediately cuts the power supply to all motors. 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.
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K032790
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The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 driving units that position the tungsten leaves. Eighty independent potentiometers for the verification system are included that serve as feedback for the verification system and checks the correct positioning of the leaves.
Intended use:
The microMLC is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The microMLC 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 assist the clinician in the delivery of well-defined target volumes of radiation while sparing the surrounding tissues and organs.
Summary of technological considerations:
The Siemens Medical Solutions Oncology Care Systems, microMLC, is substantially equivalent to the cleared predicate device, Motorized Micro Multileaf Collimator K000349.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Mr. Ken Nehmer Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. Oncology Care Systems Group 4040 Nelson Avenue CONCORD CA 94520
Re: K032790
Trade/Device Name: microMLC Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: 90 IXI Dated: September 5, 2003 Received: September 8, 2003
Dear Mr. Nehmer:
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 adultcration.
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); 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 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
Enclosure
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4
510(k) Number (if known):
032790
Device Name: microMLC
Indications for Use:
The microMLC is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The microMLC 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 assist the clinician in the delivery of well-defined target volumes of radiation while sparing the surrounding tissues and organs.
Prescription use:
The Siemens Medical Solutions Oncology Care Systems, microMLC, is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
(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) ✓
ાવ
Over-the-Counter Use_________
David R. Lynn
Division Sign-Off)
Reproductive, Ahdomin and Radiological De 510(k) Number
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