ITP, MODEL 1.0

K992434 · Nucletron Corp. · MUJ · Jan 13, 2000 · Radiology

Device Facts

• Record ID: K992434
• Device Name: ITP, MODEL 1.0
• Applicant: Nucletron Corp.
• Product Code: MUJ · Radiology
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

PLATO ITP is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT) prior to final dosimetry planning on PLATO RTS external beam planning. Once the optimization is complete, the dose distribution and dose-volume histogram curves are displayed for the user to evaluate. The optimized plan can be saved for final dose calculation and plan output using PLATO RTS. The PLATO ITP is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

Device Story

Software package for IMRT treatment planning; runs on PLATO workstation. Inputs: CT-based 3D patient model, anatomical structures, beam data from PLATO database, user-defined dose objectives, and priority weighting factors. Operation: software calculates optimal MLC or partial attenuation block shapes to meet dose objectives; simultaneous calculation for all beams; real-time display of dose distribution and dose-volume histograms (DVH). Output: optimized plan saved for final dosimetry calculation in PLATO RTS. Used by radiation oncology professionals in clinical settings. Benefits: enables automated optimization of complex radiation delivery parameters to improve dose distribution accuracy; allows iterative refinement of plans based on user evaluation of DVH and dose distribution.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based treatment planning system; runs on PLATO workstation. Utilizes 3D patient models derived from CT imaging. Integrates with PLATO RTS database for beam data and final dosimetry. Connectivity: supports export to DICOM RT Plan compatible systems. No specific hardware materials or energy sources defined as it is a software-only module.

Indications for Use

Indicated for patients undergoing intensity modulated external beam radiation therapy (IMRT) requiring optimization of multi-leaf collimator (MLC) positions or partial attenuation block shapes.

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

• Peacock Plan (K940663)
• Target Series 2 (K841997)
• PLATO RTS (K964206)

Submission Summary (Full Text)

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K99 2434

Premarket Notification Nucletron Inverse Treatment Planning (ITP) Date: July 7, 1999

JAN 1 3 2000

Image /page/0/Picture/3 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black circle with two white circles inside.

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone [phone] Fax [phone]

Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by section 807.92(c)

#### Submitter of 510(k) a.

| Company name: | Nucletron Corporation |
|-----------------|-----------------------------|
| Registration # | 1121753 |
| Address: | 7080 Columbia Gateway Drive |
| | Columbia, MD 21046-2133 |
| Contact Person: | Ralph E. Shuping |
| | Regulatory Affairs Manager |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |

#### Device Name: b.

| Trade/Proprietary Name: | PLATO ITP |
|-------------------------|---------------------------------------------------|
| Common/Usual Name: | Radiation therapy treatment planning system |
| Classification Name: | Radiation Therapy Simulation System, accessory to |

#### Legally Marketed Predicate Device(s) C.

Our device is substantially equivalent to the legally marketed predicate devices cited in the table below.

| Manufacturer | Device | 510(k) # |
|------------------|-----------------|----------|
| NOMOS Corp. | Peacock Plan | K940663 |
| General Electric | Target Series 2 | K841997 |
| Nucletron | PLATO RTS | K964206 |

Appendix 5, page 2

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Premarket Notification Nucletron Inverse Treatment Planning (ITP) Date: July 7, 1999

K992434

#### d. Description

PLATO ITP as described in this submission is a software package which is used to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). ITP is installed and runs on a PLATO radiation therapy planning system workstation.

Nucletron's PLATO ITP software uses previously defined anatomical structures and beams from the PLATO database to construct a 3D patient model used in the optimization process. The 3D patient model is based on CT images and is displayed in single or multiple image windows. The software also uses the treatment machine beam data from the PLATO radiation therapy planning system database.

The user defines the desired dose to be delivered to the target and the maximum dose to be delivered to the surrounding structures. Priority values are entered to weight the optimization calculations according to the importance of reaching the dose objectives for the target and other structures. After the user starts the optimization, the software calculates the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This is done for each beam simultaneously and the resulting dose distribution and DVH are displayed in real-time. Once the optimization is complete, the dose distribution and DVH curves are displayed for the user to evaluate. If the user is not satisfied with the results of the optimization, the input parameters can be modified (dose constraints and priority values) and the optimization repeated.

The optimized plan can be saved for final dose calculation using PLATO RTS. Plans that have not been recalculated using PLATO radiation therapy planning system cannot be used for patient treatment. After final dose calculation thereforming system cannot be exported to a DICOM RT Plan compatible system for treatment delivery.

#### Intended use e.

PLATO ITP is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT) prior to final dosimetry planning on PLATO RTS external beam planning.

Once the optimization is complete, the dose distribution and dose-volume histogram curves are displayed for the user to evaluate. The optimized plan can be saved for final dose calculation and plan output using PLATO RTS.

#### f. Summary of technological considerations

The PLATO ITP software is substantially equivalent to the predicate devices. It allows optimization of beam intensity for muli-leaf collimators and partial attenuation blocks.

.J. RZ

Name: T. J. Bateman Title: Product Manager Nucletron BV Veenendaal, The Netherlands

7/7/99
Date

Date

Appendix 5, page 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 17 2000

Ralph Shuping, Sc.D. Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046

Re: K992434 PLATO ITP (Inverse Treatment Planning) Regulatory Class: II /21 CFR 82.5700 Product Code: 90 MUJ Dated: October 14, 1999 Received: October 15, 1999

Dear Dr. Shuping:

This letter corrects our substantially equivalent letter of January 13, 2000 regarding the PLATO ITB (Inverse Treatment Planning).

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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic OS inspections. FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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) promarket 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.

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Page 2 - Ralph Shuping, Sc.D.

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]. 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,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Nucletron Inverse Treatment Planning (ITP) Date: July 7, 1999

Image /page/4/Picture/1 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black circle with two white circles inside. The white circles are positioned on opposite sides of the black circle.

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone [phone] Fax [phone]

Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section

# Statement of intended use

Device Name: PLATO ITP

### Intended use

PLATO ITP is intended to optimize multi-leaf collimator (MLC) positions or partial r attenuation block shapes for intensity modulated external beam redialion or partial
prior to final dosimetry planning on PLATO DISCOLL bear radiation therapy (IMRT) prior to final dosimetry planning on PLATO RTS external beam radiation.
Ones the sating on PLATO RTS external beam planning.

Once the optimization is complete, the dose distribution and dose-volume histogram curves and the user to evaluate. The optimized plan can be saved for final dose-volume histogram o
calculation and plan outsut using PLATO Dian can be saved for final dose calculation and plan output using PLATO RTS.

### Prescription use

The PLATO ITP is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

.J. Btz

Name: T. J. Bateman Title: Product Manager Nucletron BV Veenendaal, The Netherlands

7/7/99

Date

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K992434

Prescription Use . (Per 21 CFR 801.109)

Appendix 5, page 4