SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0

K992303 · Nucletron Corp. · MUJ · Mar 27, 2000 · Radiology

Device Facts

• Record ID: K992303
• Device Name: SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
• Applicant: Nucletron Corp.
• Product Code: MUJ · Radiology
• Decision Date: Mar 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Brachytherapy planning, utilizing a 3D ultrasound imaging cube, with Sonoaraphic Planning of Oncology Treatments (SPOT) is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, 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.

Device Story

SPOT is a software-based brachytherapy planning system running on a Windows NT workstation. It acquires 2D ultrasound images to generate 3D reconstructions of target volumes. Physicians use the system to define treatment volumes, plan needle placement, identify anatomical/dose points, and calculate dose distributions and treatment times. The system allows pre-insertion evaluation of implants to optimize dose distribution. Once approved, treatment data is exported to remote afterloading equipment or used for manual loading. The device does not control treatment units; it provides data for clinical verification. Benefits include improved treatment planning accuracy and optimized radiation delivery for oncology patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based planning system; runs on Windows NT workstation. Utilizes 3D ultrasound imaging for target volume reconstruction. Features include dose volume histograms, dose verification points, and dose profiles. Connectivity via network for data export to remote afterloading systems and PLATO planning modules.

Indications for Use

Indicated for patients undergoing brachytherapy procedures (intercavitary, interstitial, intraluminal) requiring manual or remote afterloading of radioactive sources. Used by physicians to determine source positioning, loading, and treatment planning.

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)
• LIS 6000A (K961403)

Submission Summary (Full Text)

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VA- L 1

Premarket Notification Nucletron Sonographic Planning of Oncology Treatments (SPOT) Date: July 1, 1999

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. Inside the square is a black circle with two white circles on either side of it. The logo and the word "Nucletron" are both black.

K992303

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

# 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 |
| Name: | |

### b. Device Name:

Trade/Proprietary Name: Common/Usual Name: Classification Name:

Sonographic Planning of Oncology Treatments (SPOT) Brachytherapy planning system Accessory to remote afterloader 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 |
| LIS, Inc | LIS 6000A | K961403 |

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Premarket Notification Nucletron Sonographic Planning of Oncology Treatments (SPOT) Date: July 1, 1999

## d. Description

Sonographic Planning of Oncology Treatments (SPOT) as described in this submission is a software package which utilizes the acquisition of 2D ultrasound images and 3D reconstruction of the ultrasound images for treatment planning of brachytherapy procedures. This software runs on a Windows NT workstation.

Nucletron Sonographic Planning of Oncology Treatments (SPOT) software initially acquires 2D ultrasound images and generates 3D ultrasound image processing for definition of the treatment volume. These images are utilized for reconstructing the target volume of the brachytherapy implant, needles placement, defining the location of the radioactive sources within the implant, identifying a reference point, i.e. dose points. anatomical points. Once the treatment volume is identified and the implant is reconstructed 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 Sonographic Planning of Oncology Treatments (SPOT) software can export the treatment data to the Nucletron remote afterloading system and the PLATO Brachytherapy Planning System via a network. The Sonographic Planning of Oncology Treatments (SPOT) 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.

Nucletron' Sonographic Planning of Oncology Treatments (SPOT) 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, utilizing a 3D ultrasound imaging cube, with Sonoaraphic Planning of Oncology Treatments (SPOT) is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, 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.

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Premarket Notification Nucletron Sonographic Planning of Oncology Treatments (SPOT) Date: July 1, 1999

With remote afterloading brachytherapy treatment planning the Sonographic Planning of Oncology Treatments (SPOT) program exports the treatment data, i.e. treatment times to the remote afterloader. With manual brachytherapy treatment planning the program exports treatment data regarding, source loading, 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 treatment planning software modules.

#### Summary of technological considerations f.

The Sonographic Planning of Oncology Treatments (SPOT) 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.

J. Kimble-

Name J. Kindlein Title Product Manager Nucletron BV Veenendaal The Netherlands

July 1, 1999
Date

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized human profiles incorporated into the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2000

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

Re:

K992303 Sonographic Planning or Oncology Treatments (SPOT) Dated: January 18, 2000 Received: January 18, 2000 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 pror 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Aproval), it may be subject to such additional controls. Existing major requirecting vour device can be found in the Code of Federal Requirations. Title 21. Parts 800 to 895. A substantially equivation 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 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 question 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" (21CFR 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/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

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(s)

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# Statement of indications for use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Brachytherapy planning, utilizing 3D Ultrasound Imaging, Sonographic Planning of Oncology Treatments (SPOT) is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, 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. From this information the patient can be treated with radioactive sources.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | |
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|---------------------------------------|--|

OR

| Over the Counter Use | |
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(Optional Format 1-2-96)David A. Segner
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number