(193 days)
Not Found
No
The description refers to an "optimization algorithm" and "computer-controlled" processes, but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML like training data or performance metrics related to learning.
No
IMFAST is a MLC optimization algorithm that calculates multi-leaf collimator segments, which are then used by other systems to deliver IMRT. It does not directly provide therapy to the patient.
No
The device is described as an MLC optimization algorithm used for creating multi-leaf collimator segments for Intensity Modulated Radiation Therapy (IMRT). It helps in delivering treatment but does not diagnose conditions or diseases.
Yes
The device is described as an "MLC optimization algorithm" that takes input data and outputs a file containing MLC segments. The description focuses entirely on the software's function and data processing, with no mention of accompanying hardware components being part of the device itself. While it interacts with other systems (RTP, V&R, SIMTEC, MLC), the device being cleared appears to be the algorithm/software that generates the MLC segments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- IMFAST's Function: IMFAST is described as a software algorithm that optimizes the movement of a multi-leaf collimator (MLC) for radiotherapy treatment. It takes an intensity map or compensator thickness data and calculates MLC segments for delivering radiation therapy.
- No Biological Samples: The description clearly states that IMFAST processes data from a radiotherapy treatment planning system and outputs data for a delivery system. There is no mention of processing biological samples from a patient.
- Purpose: Its purpose is to facilitate the delivery of radiation therapy, not to diagnose or monitor a condition based on biological samples.
Therefore, IMFAST falls under the category of a medical device used in the delivery of treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IMFAST product is intended to calculate a sequence of multi-leaf collimator (MLC) segments. These resulting segments are then written to a file, allowing the V&R system or the RTP system to pick it up for further processing. In the case of SIEMENS' LANTIS and PRIMEVIEW, the file can be imported and the segments can be grouped into intensity modulation groups. The treatment can then be delivered in sequence using SIMTEC and an MLC, thus providing the patient with automated, computer-controlled intensity modulation radiotherapy (IMRT).
Product codes
RA 90 IXI, 90 LHN
Device Description
IMFAST is a MLC optimization algorithm that sets the MLC jaws for modulated intensity profiles, thereby eliminating the need for BeamShaper like products or compensator blocks.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter's Information: | Dated: August 21, 1998
Siemens Medical Systems
Oncology Care Systems Group
4040 Nelson Avenue
Concord, CA 94520 |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathryn B. Dodd
Vice President Regulatory Affairs and Quality Assurance |
| Common or Usual Name:
Proprietary Name:
Classification Name: | Radiation therapy beam shaping block
IMFAST
Radiation therapy beam shaping block
21 CFR § 892.5710
Class II, Product Code: RA 90 IXI |
Predicate Device: BeamShaper, 510(k) No. K961902
Description of Device: IMFAST is a MLC optimization algorithm that sets the MLC jaws for modulated intensity profiles, thereby eliminating the need for BeamShaper like products or compensator blocks.
Statement of intended use: The intended use of the IMFAST is to take from the radiotherapy Treatment planning (RTP) system an intensity map or a matrix of compensator thicknesses and calculate a sequence of multi-leaf collimator (MLC) segments.
Statement of technological characteristics: IMFAST takes from the radiotherapy treatment planning (RTP) system an intensity map or a matrix of compensator thickness and calculates a sequence of multi-leaf collimator (MLC) segments. The plan can be reviewed for accuracy and treatment time. These resulting segments are then written to a file, allowing the V&R system or the RTP system to pick it up for further processing. In the case of SIEMENS' LANTIS and PRIMEVIEW, the file can be imported and the segments can be grouped into intensity modulation groups. The treatment can then be delivered in sequence using SIMTEC and an MLC, thus providing the patient with automated, computer-controlled intensity modulation radiotherapy (IMRT).
Differences: The configuration and specification differences between the Siemens BeamShaper and the IMFAST MLC algorithm does not alter the intended use of either products for setting the MLC jaws which eliminates the need for blocks; nor do they introduce new safety issues.
Performance Standards: No applicable performance standards have been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Siemens considers the BeamShaper and IMFAST to be equivalent.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird, indicating the department's name and national affiliation. The logo is simple and recognizable, conveying a sense of authority and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1999
Kathryn B. Dodd Vice President, Regulatory Affairs and Quality Assurance Siemens Medical Systems, Inc. Oncology Care Systems 404 Nelson Avenue Concord, California 94520
K982952 RE:
Siemens IMFAST Dated: December 8, 1998 Received: December 10, 1998 Regulatory Class: II 21 CFR 892.5050/Procode: 90 LHN
Dear Ms. Dodd:
This letter corrects our substantially equivalent letter of March 5, 1999, which neglected to have the correct classification and procode for the Siemens IMFAST device. Please note the correct classification for this above.
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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action.
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Page -2 - Ms. Dodd
In addition, the Food and Drug Administration (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 continue 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 that 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 their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
CAPT Daniel 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
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INDICATIONS FOR USE:
The IMFAST product is intended to calculate a sequence of multi-leaf collimator (MLC) segments. These resulting segments are then written to a file, allowing the V&R system or the RTP system to pick it up for further processing. In the case of SIEMENS' LANTIS and PRIMEVIEW, the file can be imported and the segments can be grouped into intensity modulation groups. The treatment can then be delivered in sequence using SIMTEC and an MLC, thus providing the patient with automated, computer-controlled intensity modulation radiotherapy (IMRT).
David G. Bergman
Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)