(162 days)
No
The description focuses on the mechanical function of the multi-leaf collimator and its control by a standard computer, without mentioning any AI or ML algorithms for treatment planning or device control.
No.
Explanation: The device is a component that shapes the radiation field of a LINAC and is used by the radiation oncologist team. It assists in delivering radiation, but it does not directly perform a therapeutic action on the patient.
No
The MMLC is described as a device that shapes the x-ray field for radiation therapy, functioning similarly to customized beam shaping blocks. Its purpose is to assist in the delivery of radiation and spare normal tissue, not to diagnose a condition.
No
The device description explicitly states that the MMLC is a physical device mounted to a LINAC, controlled by a computer, and contains motors and electronics. This indicates it is a hardware device with associated software, not a software-only medical device.
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 "assist the radiation oncologist team in the delivery of radiation" and "shaping the x-ray field." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a device mounted to a LINAC for shaping radiation beams. This is consistent with radiation therapy equipment, not IVD equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions in vitro, or providing diagnostic information based on such analysis.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used to deliver treatment.
N/A
Intended Use / Indications for Use
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. This is accomplished through 31 pairs of opposing tungsten leaves, which allow the MMLC to shape the xray beam according to a treatment plan generated by a planning system such as the RSA XPlan software. XPlan is a stereotactic LINAC-based radiation treatment planning software and was previously cleared under 510(k) K972905. In this application, the MMLC performs the same function as customized beam shaping blocks or stereotactic collimators, which have been used for many years.
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics XPlan Conformal Treatment Planning Software on any treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.
Product codes
IYE
Device Description
The MMLC is a conformal radiation therapy and radiosurgery device. The MMLC is mounted to a standard radiation therapy LINAC and is capable of shaping the x-ray field (maximum field treatment of 10 cm x 12 cm). A stand-alone computer controls the MMLC unit. The computer communicates with the MMLC to position the leaves according to the treatment plan. An individual motor controls each leaf. Power to the motors and electronics is provided by a switching power supply.
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
radiation oncologist team
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)
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
General Device Summary Section I:
Proprietary Name:
. .
Model MMLC Radionics Mini Multi-Leaf Collimator
Common Name:
Radiotherapy beam shaping block
Product Code/Classification Panel:IYE / Radiology
Classification:
Class II $892.5710
Summary of Safety and Effectiveness
The 510(k) Summary of Safety and Effectiveness is provided in Appendix A.
Performance Standards
No applicable performance standards have been issued under section 514 of the Food, Drug, and Cosmetic Act.
Voluntary Standards
- EN55011: Electromagnetic Disturbances . Class A, Group 1, ISM
- EN 60601-1-2: Collateral Standard . Electromagnetic Compatibility Medical Electrical Equipment
- . EN 60601-1: Medical Electrical Equipment
- UL 2601: Medical Electrical Equipment . Part 1: Requirements for Safety
1
General Device Summary (Continued) Section I:
Establishment Registration
Manufacturing Facility Address:
Radionics, Inc. 22 Terry Avenue Burlington, MA 01803
FDA Establishment Registration No.: 1219140
Sterilization Site:
No part of this device is supplied sterile.
Predicate Devices
Brainlab Micro Multi-Leaf Collimator (K970586) manufactured by Brainlab Medical Computersysteme GmbH (hereafter referred to as "Brainlab MLC")
2
General Device Summary (Continued) Section I:
1.0 Indications for Use
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. This is accomplished through 31 pairs of opposing tungsten leaves, which allow the MMLC to shape the xray beam according to a treatment plan generated by a planning system such as the RSA XPlan software. XPlan is a stereotactic LINAC-based radiation treatment planning software and was previously cleared under 510(k) K972905. In this application, the MMLC performs the same function as customized beam shaping blocks or stereotactic collimators, which have been used for many years.
1.1 Device Characteristics
The MMLC is a conformal radiation therapy and radiosurgery device. The MMLC is mounted to a standard radiation therapy LINAC and is capable of shaping the x-ray field (maximum field treatment of 10 cm x 12 cm). A stand-alone computer controls the MMLC unit. The computer communicates with the MMLC to position the leaves according to the treatment plan. An individual motor controls each leaf. Power to the motors and electronics is provided by a switching power supply.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 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 a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the wings and body of the bird.
DEC 30 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Cromwick Director of Regulatory Affairs and Quality Assurance Radionics® Inc. 22 Terry Avenue Burlington, MA 01803-2516
Re:
K982549 Mini Multileaf Collimator Dated: October 23, 1998 Received: October 26, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Cromwick:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 dass 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. Fallure 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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,
Capt, Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Section II:
2.0 Indications for Use:
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics XPlan Conformal Treatment Planning Software on any treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.
(División Sign-Off) ( Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)