(193 days)
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).
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. 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).
The provided text describes the Siemens IMFAST device, an MLC optimization algorithm for radiation therapy. However, the document is a 510(k) submission summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with explicit acceptance criteria.
Therefore, the requested information regarding acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment is not available within the provided text. The document states that "No applicable performance standards have been established by the FDA under section 514 of the Food, Drug and Cosmetic Act," and Siemens considers IMFAST to be "substantially equivalent" to the predicate device, BeamShaper.
Based on the provided text, I cannot complete the table or answer the specific questions about the device's performance study and acceptance criteria as they are not detailed.
The document primarily focuses on:
- Device Description: IMFAST is an MLC optimization algorithm that calculates sequences of multi-leaf collimator segments for Intensity Modulated Radiation Therapy (IMRT).
- Intended Use: To generate MLC segments from intensity maps or compensator thickness matrices from a radiotherapy Treatment Planning (RTP) system.
- Technological Characteristics: Outputting MLC segments to a file for further processing by V&R or RTP systems, and for grouped intensity modulation with Siemens' LANTIS and PRIMEVIEW, delivered via SIMTEC and MLC for automated IMRT.
- Predicate Device: BeamShaper, 510(k) No. K961902.
- Substantial Equivalence Argument: The configuration and specification differences do not alter the intended use or introduce new safety issues compared to the predicate.
- FDA Clearance: A 510(k) clearance based on substantial equivalence, with a correction to the classification and procode.
In summary, the provided text does not contain the specific performance study details, acceptance criteria, or experimental results you are asking for.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter's Information: | Dated: August 21, 1998Siemens Medical SystemsOncology Care Systems Group4040 Nelson AvenueConcord, CA 94520 |
|---|---|
| Contact Person: | Kathryn B. DoddVice President Regulatory Affairs and Quality Assurance |
| Common or Usual Name:Proprietary Name:Classification Name: | Radiation therapy beam shaping blockIMFASTRadiation therapy beam shaping block21 CFR § 892.5710Class 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)
§ 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.