IMFAST

K982952 · Siemens Medical Solutions USA, Inc. · LHN · Mar 5, 1999 · Radiology

Device Facts

• Record ID: K982952
• Device Name: IMFAST
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LHN · Radiology
• Decision Date: Mar 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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).

Device Story

IMFAST is a software-based MLC optimization algorithm; inputs include intensity maps or compensator thickness matrices from radiotherapy treatment planning (RTP) systems. Algorithm calculates sequence of MLC segments to achieve modulated intensity profiles; eliminates need for physical compensator blocks. Output is a data file containing segment sequences; imported by V&R or RTP systems (e.g., LANTIS, PRIMEVIEW) for grouping into intensity modulation groups. Delivered via SIMTEC and MLC hardware. Used in clinical radiotherapy settings by oncology staff; enables automated, computer-controlled IMRT delivery. Benefits include improved efficiency in treatment planning and delivery by replacing manual block fabrication.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based MLC optimization algorithm. Operates as a module within radiotherapy treatment planning workflows. Connectivity via file export/import to V&R and RTP systems (LANTIS, PRIMEVIEW).

Indications for Use

Indicated for patients undergoing intensity modulation radiotherapy (IMRT) requiring automated, computer-controlled multi-leaf collimator (MLC) segment sequencing.

Regulatory Classification

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.

Predicate Devices

• BeamShaper (K961902)

Reference Devices

• LANTIS
• PRIMEVIEW
• SIMTEC

Submission Summary (Full Text)

{0}------------------------------------------------

K982952

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter's Information: | Dated: August 21, 1998<br>Siemens Medical Systems<br>Oncology Care Systems Group<br>4040 Nelson Avenue<br>Concord, CA 94520 |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathryn B. Dodd<br>Vice President Regulatory Affairs and Quality Assurance |
| Common or Usual Name:<br>Proprietary Name:<br>Classification Name: | Radiation therapy beam shaping block<br>IMFAST<br>Radiation therapy beam shaping block<br>21 CFR § 892.5710<br>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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

{3}------------------------------------------------

## 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)