TRIMED PLAN, VERSION 2.2

K031088 · Trimed Systems, Inc. · MUJ · Jul 23, 2004 · Radiology

Device Facts

• Record ID: K031088
• Device Name: TRIMED PLAN, VERSION 2.2
• Applicant: Trimed Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

TriMed Plan is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with X-ray energy from 1 MV to 24 MV, as well as Cobalt-60, and electron energy from 4 MeV to 50 MeV. TriMed Plan uses 3D radiotherapy treatment approaches to combine modality plans, asymmetric and non-coplanar fields, total body irradiation, multi-leaf collimators, hand blocking, customized blocking, and wedges.

Device Story

TriMed Plan is a 3D radiation treatment planning system (TPS) software; operates on Windows-based personal workstations. Inputs include patient-specific anatomical data and treatment parameters; system models dose distribution for photon (1-24 MV) and electron (4-50 MeV) therapy. Supports complex planning including asymmetric/non-coplanar fields, total body irradiation, multi-leaf collimators, hand/customized blocks, and wedges. Output is a calculated radiation treatment plan; reviewed, modified, and approved by qualified medical personnel (radiation oncologists/physicists) before delivery. Facilitates precise dose modeling to optimize therapeutic radiation delivery; improves clinical decision-making by enabling visualization and quantification of dose distribution prior to treatment.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, software verification, and validation documentation, including engineering diagrams and fault tree analyses.

Technological Characteristics

Software-based radiation treatment planning system; runs on Windows NT/2000/XP workstations. Supports 3D dose calculation for photon (1-24 MV) and electron (4-50 MeV) beams. Features 2D/3D GUI for plan modeling. Integrates beam modifiers (MLC, wedges, blocks). Connectivity via standard PC hardware. No specific hardware materials or energy sources; software-only device.

Indications for Use

Indicated for patients requiring radiation therapy planning for photon or electron external beam sources. Intended for use by qualified medical personnel to satisfy radiation oncology prescriptions.

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

• CadPlan Version 2.62 (K962950)

Submission Summary (Full Text)

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JUL 2 3 2004

TriMed Systems, Inc.

KOSTOR

# SUMMARY OF SAFETY AND EFFECTIVENCESS

| 1. Submitter's Information: | Dated: March 28, 2003<br>TriMed Systems, Inc.<br>1804 Loehr Estates Ct.<br>Ballwin, MO 63021 |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact:<br>Sherry Zhang<br>VP of Quality Assurance And Regulatory Affairs |
| 2. Common or Usual Name:<br>Product Name:<br>Classification Name: | Radiation Treatment Planing System<br>TriMed TPS<br>System, Simulation, Radiation Therapy<br>RA(90)KPQ Class 2<br>21 CFR 892.5050 |
| Version Number: | 2.2 |
| 3. Predicate Device: | CadPlan Version 2.62<br>Radiation Therapy Treatment Planning System<br>K962950<br>Varian Cadplan |
| 4. Description: | TriMed Plan is a comprehensive 3D radiation treatment<br>planning system for modeling dose distribution of radiation<br>of patient undergoing photon or electron therapy based on<br>modern personal workstation running Windows NT,<br>Windows 2000 and Windows XP. External beam dose<br>calculations for both photon and electron machines are all<br>in 3-dimensional volume that support coplanar and non-<br>coplanar fields. Beam modifiers include hand block,<br>customized block, multi-leaf collimators, and wedge.<br>Different energies and modalities can be combined into the<br>same plan. State-of-the-art 2D/3D graphics user interface<br>makes the system very user friendly. |
| 5. Intended Use: | TriMed Plan is used to plan radiation therapy treatments<br>employing linear accelerators and other similar teletherapy<br>devices with X-ray energy from 1 MV to 24 MV, as well as<br>Cobalt-60, and electron energy from 4 MeV to 50 MeV.<br>TriMed Plan uses 3D radiotherapy treatment approaches to<br>combine modality plans, asymmetric and non-coplanar<br>fields, total body irradiation, multi-leaf collimators, hand<br>blocking, customized blocking, and wedges. |

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#### 6. Technological Considerations:

TriMed Plan has no significant differences in design, materials, energy source or other technological characteristics compared to the predicate device.

#### 7. Software Development and Verification:

Software development, validation and verification of the TriMed Plan has been conducted according to the policies and procedures discussed in the 510(k), which includes engineering diagrams, fault tree analyses, the Verification and Validation documentation, and all pertinent reference articles.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUL 2 3 2004

Ms. Sherry Zhang VP of Quality Assurance and Regulatory Affairs TriMed Systems, Inc. 1804 Loehr Estates Ct., BALLWIN MO 63021

Re: K031088

Trade/Device Name: TriMed Plan 2.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: June 24, 2004

Received: June 25, 2004

Dear Ms. Zhang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosers) vo ttgms.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to may 20, 2017) in accordance with the provisions of the Federal Food, Drug, devices that have occh roomstred in aquire approval of a premarket approval application (PMA). and Costlictic Act (110) that to not required to the general controls provisions of the Act. The I ou may, therefore, marries include requirements for annual registration, listing of general controls provisions or ractice, 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 If your device is classinod (500 a0070) cols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to satin additions, 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 i loast be advised that I Dr over device complies with other requirements of the Act that I DX has made a cerefits and regulations administered by other Federal agencies. You must comply or any I cacares and reguirements, including, but not limited to: registration and listing (21 CFR Part with an the Free Prequirement 801); good manufacturing practice requirements as set forth in the our ; idocimig (21 CFR Part 820); and if applicable, the electronic product quality by control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to organization of substantial equivalence of your device to a legally premarket notication: "The Privation 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 If you desire spoolite at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for quebellers of [phone]. Also, please note the regulation entitled, "Misbranding Other of Othphallos av (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on Jour responder Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indication for Use

#### 510(k) Number:

Device Name: TriMed Plan - Radiation Treatment Planning System

Indication for User: TriMed Plan is a radiation treatment planning software developed by TriMed Systems, Inc, running on IBM compatible personal computers with Microsoft Windows operating systems.

TriMed Plan provides radiation treatment planning capability, for both photon and electron external beam sources, to satisfy the prescription of the radiation oncology. Tribed Plan uses 3D conformal therapy treatment approaches to combine modality plans, I rimed I har asso on-coplanar fields, total body irradiation, multi-leaf collimators, hand blocking, customized blocking, and wedges. The resulting treatment plan from this system is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.

*Prescription Use*

Nancyc bridon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031088