(80 days)
Not Found
No
The description focuses on the mechanical and control aspects of the device for shaping radiation fields, with no mention of AI or ML for tasks like treatment planning, image analysis, or adaptive therapy.
Yes
The device description explicitly states, "The m3 is a therapeutic X-ray Collimator." Additionally, its intended use is to assist in the delivery of radiation for "static conformal treatments," "step and shoot IMRT," "dynamic arc," and "dynamic IMRT" treatments, which are all forms of therapy.
No
The document describes a therapeutic device used for shaping radiation fields during cancer treatment, not a device used for diagnosing medical conditions.
No
The device description explicitly states that the m3 "comprises multiple motorised tungsten leafs," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for assisting the radiation oncologist in the delivery of radiation to a patient. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as a "therapeutic X-ray Collimator" that shapes X-ray fields for treatment. This further reinforces its therapeutic purpose.
- Lack of Diagnostic Activities: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.), detect diseases, or provide diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) during radiation therapy.
N/A
Intended Use / Indications for Use
The m3 is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In conjunction with Elekta and GE Linacs, the m3 performs the same function as customized shadow blocks or stereotactic collimators. This standard configuration is suitable for static conformal treatments and "step and shoot IMRT". The advanced m3 Siemens Integration feature available for Siemens Linacs allows additionally to perform "dynamic arc" and automated "step and shoot IMRT" treatments with the m3.
The advanced Varian integration feature available for Varian Linacs allows to perform "dynamic arc" and "dynamic IMRT" treatments with the m3.
Product codes
90 IYE
Device Description
The m3 is a therapeutic X-ray Collimator. It comprises multiple motorised tungsten leafs, which are suited to shaping specific therapeutic X-ray fields, both in a static fashion as well as dynamically via leaf-movement during treatment.
The subject of this submission is the use of the m3 together with Siemens Linear Accelerators for advanced treatment modalities such as Dynamic Arc and automated Step and Shoot Treatments. The correct m3 setup is controlled by the "LANTIS" Verify and Record System with PRIMEVIEW front end. In case the m3 is not correctly set-up according to the Linac settings, treatment will be aborted or not permitted.
The verification and validation procedures have shown the safety and effectiveness of the m3 (micro-Multileaf Collimator) and the device can be utilized within its intended use.
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
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
6 2002 Jun
510(k) Summary of Safety and Effectiveness for m3 (micro-Multileaf Collimator)
1. Company
| Address: | BrainLAB AG
Ammerthalstrasse 8
85551 Heimstetten
Germany |
|-----------------|-------------------------------------------------------------------|
| Contact Person: | Stefan Vilsmeier, President- |
| Telephone: | +49 (89) 991568-0 |
| Fax: | +49 (89) 991568-33 |
2. Device Name
| Trade name: | m3 (micro-Multileaf Collimator) |
|---|---|
| Common name: | micro-Multi-Leaf Collimator |
| Device Classification name: | Accelerator, Linear, Medical |
3. Predicate Devices:
micro-Multi-Leaf Collimator (K004022)
Device Classification Name: Accelerator, Linear, Medical Regulatory Class: Class II
4. Device Description
The m3 is a therapeutic X-ray Collimator. It comprises multiple motorised tungsten leafs, which are suited to shaping specific therapeutic X-ray fields, both in a static fashion as well as dynamically via leaf-movement during treatment.
The subject of this submission is the use of the m3 together with Siemens Linear Accelerators for advanced treatment modalities such as Dynamic Arc and automated Step and Shoot Treatments. The correct m3 setup is controlled by the "LANTIS" Verify and Record System with PRIMEVIEW front end. In case the m3 is not correctly set-up according to the Linac settings, treatment will be aborted or not permitted.
The verification and validation procedures have shown the safety and effectiveness of the m3 (micro-Multileaf Collimator) and the device can be utilized within its intended use.
1
Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text includes 'KO 20860' on the first line and '2 of 2' on the second line. The handwriting is somewhat rough, giving the impression that it was written quickly or with a writing instrument that produced a thick line.
5. Intended Use
The m3 is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In conjunction with Elekta and GE Linacs, the m3 performs the same function as customized shadow blocks or stereotactic collimators. This standard configuration is suitable for static conformal treatments and "step and shoot IMRT".
The advanced m3 Siemens Integration feature available for Siemens Linacs allows additionally to perform "dynamic arc" and automated "step and shoot IMRT" treatments with the m3. The advanced Varian integration feature available for Varian Linacs allows to perform "dynamic arc" and "dynamic IMRT" treatments with the m3.
Performance Standards: 6.
No applicable standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stefan Vilsmeier President and CEO BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten GERMANY
Re: K020860
JUN - 6 2002
Trade/Device Name: m3 Mocro-Multileaf Collimator Accelerator, Linear, Medical Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II
Product Code: 90 IYE Dated: March 14, 2002 Received: March 18, 2002
Dear Mr. Vilsmeier:
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 (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 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. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known):
Device Name:
m3 (micro-Multileaf Collimator)
Indications For Use:
The m3 is intended to assist the radiation oncologist in the delivery of radiation to welldefined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In conjunction with Elekta and GE Linacs, the m3 performs the same function as customized shadow blocks or stereotactic collimators. This standard configuration is suitable for static conformal treatments and "step and shoot IMRT". The advanced m3 Siemens Integration feature available for Siemens Linacs allows additionally to perform "dynamic arc" and automated "step and shoot IMRT" treatments with the m3.
The advanced Varian integration feature available for Varian Linacs allows to perform "dynamic arc" and "dynamic IMRT" treatments with the m3.
(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 __
(Optional Format I-2-96)
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number _