TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5

K990475 · Kps & Assoc., Inc. · MUJ · Nov 18, 1999 · Radiology

Device Facts

• Record ID: K990475
• Device Name: TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
• Applicant: Kps & Assoc., Inc.
• Product Code: MUJ · Radiology
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium (192Ir) seeds. TraPIS is intended for clinical as well as research and academic use.

Device Story

TraPIS is a software-based treatment planning and verification system for prostate brachytherapy. It utilizes ultrasound-guided prostate boundary data to determine seed placement for radiation therapy. The software calculates 3D radiation dose distributions, represented as isolines or point-dose values, based on seed strength and distribution patterns. For post-implant verification, the system uses seed locations derived from CT scans or radiographs to recalculate the actual dose distribution delivered. The device is intended for use by clinicians in clinical, research, or academic settings to assist in treatment planning and verification, ultimately aiming to optimize radiation delivery to the prostate while sparing surrounding tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based radiation therapy treatment planning system. Operates on computer hardware. Supports isotope libraries for 103Pd, 125I, and 192Ir seeds. Performs 3D dose distribution calculations and post-implant verification using imaging inputs (ultrasound, CT, radiographs).

Indications for Use

Indicated for planning and post-implant verification of brachytherapy for patients with carcinoma of the prostate gland.

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.

Submission Summary (Full Text)

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Nov | 8 |999

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## KPS & ASSOCIATES, Inc.

Computer Simulation Consultants (Medical Unit)

## Section V - 510(k) Summary {21 CFR §807.87 (h)/807.92 (a)-(b)}

8807.92(a)(1) 1.

Submitter's Name: KPS & ASSOCIATES, Inc.

Address:

851 E. Northcrest Drive Salt Lake City, Utah 84103

K990475

Phone: Fax: E-mail:

[phone] [phone] [e-mail]

Contact Person: Dr. Krishna P. Sinha

Date of Summary Preparation: February 12, 1999

| 2. | §807.92(a)(2) | Trade/Proprietary Name: | Tra PISO (Transperineal Prostate<br>Implant Simulator) |
|----|---------------|-------------------------|--------------------------------------------------------------------------------------------|
| | | Common/Usual Name: | Treatment Planning and<br>Verification Software for<br>Brachytherapy of Prostate<br>Cancer |
| | | Classification Name: | System, Planning, Radiation<br>Therapy Treatment |
| | | Device Class/Panel: | Class II/Radiology |
| | | Product Code: | MUJ |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

Krishna P. Sinha, Ph.D. President KPS & Associates, Inc. Computer Simulation Consultants (Medical Unit) 851 E. Northcrest Dr. Salt Lake City, Utah 84103

Re:

K990475

TRSPIS-Transperineal Prostate Implant Simulator Dated: August 19, 1999 Received: August 20, 1999 Regulatory class: II 21 CFR 892.5730/Procode: 90 MUJ

Dear Dr. Sinha:

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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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K990475 SIO(K) NUMBER (IF KNOWN):

TraPIS DEVICE NAME :

INDICATIONS FOR USE:

TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium TraPIS is intended for clinical as (192Ir) seeds. well as research and academic use.

In summary, the software is designed to provide a threedimensional radiation dose distribution in the form of isolines (contours of equal dose) or point-dose-values for a specified seed pattern. An ultrasound-guided -A treatprostate boundary dictates the seed locations. ment plan consisting of seed strength and distribution can be developed such that the specified radiation dose distribution is achieved within the prostate boundary. Post-implant verification involves relocating the seeds to their actual locations revealed through CT scans and/or radiographs and recalculating the dose distribution.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CORA, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Shmil h. Segm
(Division Sign-Off)

Division of Reproductive, Ab and Radiological I

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Over-The-Counter-Use (Optional Format: 1-2