PLATO BRACHYTHERAPHY, MODEL V. 14.0

K983343 · Nucletron Corp. · MUJ · Apr 2, 1999 · Radiology

Device Facts

• Record ID: K983343
• Device Name: PLATO BRACHYTHERAPHY, MODEL V. 14.0
• Applicant: Nucletron Corp.
• Product Code: MUJ · Radiology
• Decision Date: Apr 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Brachytherapy planning with PLATO Brachytherapy is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal (including bronchial) and surface applicator treatments, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information (i.e. radiographs, transverse slices, or 3D coordinates) to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specified loading. From this information the patient can be treated with radioactive sources. With remote afterloading brachytherapy treatment planning the PLATO Brachytherapy program exports the treatment data, i.e. treatment times to the remote afterloader. With manual brachytherapy treatment planning the program exports treatment data regarding insertion/removal time, total dose in permanent implantation and dose distributions for patient records. With both types of software the dose grid is exported and can be evaluated in conjunction with the Nucletron PLATO External Beam treatment planning software. The PLATO Brachytherapy (BPS v.14.0) 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

PLATO Brachytherapy (BPS v.14.0) is a software-based treatment planning system for brachytherapy. Input data includes patient anatomical information via radiographs, transverse slices, or 3D coordinates. The system processes this data to define radioactive source locations, reference points, and prescription doses; it calculates dose distributions and treatment times. The software provides evaluation tools like dose-volume histograms, verification points, and dose profiles. Used in clinical settings by trained medical professionals, the system outputs treatment data (times, loading parameters) for export to remote afterloading units via floppy disk, program card, or network, or for manual record-keeping. The software does not control the treatment unit; clinical staff verify all exported data. The system assists physicians in optimizing dose distribution prior to source insertion, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based treatment planning system; runs on a dedicated workstation. Features include 3D reconstruction of implants, dose calculation algorithms, and data export capabilities for remote afterloaders. Connectivity via network, floppy, or program card. No specific hardware materials or sterilization methods applicable as it is a software-only accessory.

Indications for Use

Indicated for patients undergoing brachytherapy procedures, including intercavitary, interstitial, intraluminal (e.g., bronchial), and surface applicator treatments, requiring manual or remote afterloading of radioactive sources.

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

• PLATO Brachytherapy Planning System (K915562)
• Nucletron Planning System (K911612)

Reference Devices

• Nucletron PLATO External Beam treatment planning software

Submission Summary (Full Text)

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4/2/99

: :

Premarket Notification Nucletron PLATO Brachytherapy Date : 20 September 1998

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square logo. The logo contains a black circle with two white circles on either side. The logo and the word "Nucletron" are aligned horizontally.

# CONFIDENTIAL

K983343

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

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<br>Columbia, MD 21046-2133 |
| Contact Person: | Ralph E. Shuping<br>Regulatory Affairs Manager |
| Phone:. | 410-312-4100 |
| Fax: | 410-312-4197 |

#### b. Device Name:

| Trade/Proprietary Name: | PLATO Brachytherapy (BPS v. 14.0) |
|-------------------------|--------------------------------------------------------------|
| Common/Usual Name: | PLATO Brachytherapy planning system |
| Classification Name: | Accessory to remote afterloader<br>21 CFR 892.5700 Class II. |

#### 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) # |
|--------------|-------------------------------------|----------|
| Nucletron BV | PLATO Brachytherapy Planning System | K915562 |
| Nucletron BV | Nucletron Planning System | K911612 |

Appendix 5, page 2

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Premarket Notification Nucletron PLATO Brachytherapy Date : 20 September 1998

# CONFIDENTIAL

#### Description d.

PLATO Brachytherapy as described in this submission is a software package designed for treatment planning of brachytherapy procedures. This software runs on a PLATO radiation therapy treatment planning system workstation

Nucletron PLATO Brachytherapy software is capable of reconstructing the brachytherapy implant (i.e. radiographs, transverse slices, or 3D coordinates), defining the location of the radioactive sources within the implant, identifying a reference point, i.e. dose points, anatomical points. Once this data is entered the prescription dose is defined and the software program calculates treatment data, including dose distributions and treatment/implantation time.

The brachytherapy treatment planning session allows the physician to evaluate the implant prior to insertion of the radioactive sources in order to determine the most optimal dose distribution within the treatment volume. Once the physician approves the treatment plan the implant is loaded with radioactive sources manually or via the Nucletron remote afterloading equipment. The PLATO Brachytherapy software exports the treatment data to the Nucletron remote afterloading system via a floppy, program card or network. The PLATO Brachytherapy software does not control the treatment unit; it strictly exports treatment times and related information. The Nucletron remote afterloading system and the clinical staff verify this data input prior to treatment.

Nucletrons' PLATO Brachytherapy software includes remote afterloading radioactive source brachytherapy treatment planning and manual loaded radioactive source brachytherapy treatment planning. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution. i.e. dose volume histograms, dose verification points, dose profiles, etc.

#### Intended use e.

Brachytherapy planning with PLATO Brachytherapy is intended for use with brachytherapy procedures involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specified loading. From this information the patient can be treated with radioactive sources.

With remote afterloading brachytherapy treatment planning the PLATO Brachytherapy program exports the treatment data, i.e. treatment times to the remote afterloader. With manual brachytherapy treatment planning the program exports treatment data regarding insertion/removal time, total dose in permanent implantation and dose distributions for patient records. With both types of software the dose grid is exported and can be evaluated in conjunction with the Nucletron PLATO External Beam treatment planning software.

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CONFIDENTIAL

Premarket Notification Nucletron PLATO Brachytherapy Date : 20 September 1998

#### Summary of technological considerations f.

The PLATO Brachytherapy software is substantially equivalent to the predicate devices. It combines the functionality of the defined predicate devices into one user interface for brachytherapy treatment planning.

Signature

18- Sept-98

Date

Name: L. A. Johnson Product Manager Title Nucletron BV Veenendaal Netherlands

ﯩﺖ.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Re:

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1999

Ralph E. Shuping, Sc.D. Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046-2133

K983343 PLATO Brachytherapy (BPS v14.0) Dated: January 7, 1999 Received: January 11, 1999 Regulatory class: II 21 CFR 892.5700/Procode: 90 MUJ

Dear Dr. Shuping:

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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 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,

APT 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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## CONFIDENTIAL

Premarket Notification Nucletron PLATO Brachytherapy Date : 20 September 1998

Image /page/4/Picture/2 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square logo. The logo contains a black circle with two white circles on either side of it.

### NUCLETRON B.V.

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

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 Brachytherapy

## Intended use

Brachytherapy planning with PLATO Brachytherapy is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal (including bronchial) and surface applicator treatments, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information (i.e. radiographs, transverse slices, or 3D coordinates) to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specified loading. From this information the patient can be treated with radioactive sources.

With remote afterloading brachytherapy treatment planning the PLATO Brachytherapy program exports the treatment data, i.e. treatment times to the remote afterloader. With manual brachytherapy treatment planning the program exports treatment data regarding insertion/removal time, total dose in permanent implantation and dose distributions for patient records. With both types of software the dose grid is exported and can be evaluated in conjunction with the Nucletron PLATO External Beam treatment planning software.

### Prescription use

The PLATO Brachytherapy (BPS v.14.0) is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical

professional.
Name L. A. Johnson

Product Manager Title Nucletron BV Veenendaal Netherlands

18-Sept.-98

Date

Yhmil h. Slym
(Division Sign-Off)

Division of Reproductive, Abdominal, El

510(k) Number K983342

Appendix 5, page 5

Prescription Use . (Per 21 CFR 801.109)