ONCENTRA GYN

K080929 · Nucletron Corporation · MUJ · Apr 16, 2008 · Radiology

Device Facts

• Record ID: K080929
• Device Name: ONCENTRA GYN
• Applicant: Nucletron Corporation
• Product Code: MUJ · Radiology
• Decision Date: Apr 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, 3rd-Party Reviewed

Intended Use

Oncentra GYN is a software application intended for Brachytherapy Treatment Planning, for the treatment of cancer, ie. intercavitary, interstitial, intraluminal, involving radioactive sources.

Device Story

Oncentra GYN is a real-time brachytherapy treatment planning system for gynecological cancers. It imports 3D MRI, CT, and ultrasound images of the patient's treatment area. Physicians use the software to determine optimal positioning and loading of radioactive sources within target volumes. The system provides plan evaluation tools, including dose volume histograms, dose verification points, and dose profiles, to assist in generating optimal dose distributions. It supports multiple target volumes and various applicators and needles. The software acts as an accessory to a brachytherapy afterloader, running on a Windows XP platform. By providing anatomical and dosimetric information, it enables physicians to update source dwell positions in real-time, facilitating precise radiation delivery and potentially improving treatment outcomes for gynecological cancer patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based treatment planning system; Windows XP platform; supports 3D MRI, CT, and ultrasound image import; includes treatment planning software and Smoothbase database; accessory to brachytherapy afterloader; utilizes optimization algorithms for gynecological dose distribution.

Indications for Use

Indicated for brachytherapy treatment planning for patients with gynecological cancers requiring intercavitary, interstitial, or intraluminal radiation therapy using 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

• SWIFT 2.0 (K031158)

Submission Summary (Full Text)

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K0809 29

APR 1 6 2008

TITER TELETTER

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Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black shape with two white circles. The black shape appears to be a stylized representation of an atom or molecule. The overall design is simple and clean, with a focus on the company name and a visual element that suggests science or technology.

#### 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 Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)

### Submitter of 510(k):

| Company name: | Nucletron Corporation |
|----------------------|---------------------------------------------------------|
| Registration number: | 1121753 |
| Address: | 8671 Robert Fulton Drive<br>Columbia, MD 21046 |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick<br>Director Assurance & Regulatory Affairs |

#### New Device Name:

| Trade/Proprietary Name: | Oncentra GYN |
|-------------------------|---------------------------------------------|
| Common/Usual Name: | Treatment Planning System |
| Classification Name: | System,Planning,Radiation Therapy Treatment |
| Classification: | 21Cfr892.5050 Class II |

#### Legally Marketed Device(s)

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

| <br>Manufacturer | Device | 510(k) # |
|------------------|-----------|----------|
| Nucletron BV | SWIFT 2.0 | K031158 |

## Description:

Oncentra GYN is a "real time" treatment planning system for brachytherapy especially meant for the treatment of gynaecological cancers. Direct 3D imaging of the treatment area gives the

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physician the possibility to update the planning of the dwell positions of the radioactive source in the target volume of the patient.

The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, e.g. dose volume histograms, dose verification points and dose profiles. The software program provides the physician with anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment,

The software is an adaptation of the software of the predicate device to make the software more suitable for the use with gynaecological cancers. The following features have been added for this:

- . Support for applicators and needles (instead of only needles)
- 3D MRI, CT and ultra sound image import (instead of only ultra sound) .
- Support of multiple target volumes (instead of only one) .
- Optimisation algorithms more suitable for gynaecological treatments .

The modified device is an accessory to a brachytherapy afterloader. The program consists of two modules:

- Treatment planning Software: Oncentra GYN .
- Database: Smoothbase .

The software runs on a Windows XP platform on the same hardware as Swift 2.0

#### Intended use:

The modified device has the same intended use as the legally marketed device cited:

Oncentra GYN is a software application intended for Brachytherapy Treatment Planning, for the treatment of cancer, ie. intercavitary, interstitial, intraluminal, involving radioactive sources.

#### Summary of technological considerations:

Oncentra GYN is substantially equivalent to the cleared predicate device, Swift 2.0, k031158.

Name: Paul van den Biggelaar
Title: Director, New Product Development
Nucletron B.V.
Veenendaal, The Netherlands

13-March 2008
Date

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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 consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nucletron Corporation % Mr. Jav Y. Kogoma Technical Reviewer and Primary Contact Intertek Testing Services NA, Inc. 2307 E Aurora Rd., Unit B7 TWINSBURG OH 44087

APR 1 6 2008

Re: K080929

Trade/Device Name: Oncentra GYN 1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: March 31, 2008 Received: April 1, 2008

Dear Mr. Kogoma:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Burgdon

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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# Indications for Use

510(k) Number (if known)

K080929

Oncentra GYN 1.0

Device Name

Indications for Use

Oncentra GYN 1.0 is a software application intended for Brachytherapy Treatment Planning, for the treatment of cancer, ie. intercavitary, interstitial, intraluminal, involving radioactive sources.

Prescription Use _ X (Part 21 CFR 801 subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 subpart C)

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

Concurtence of CDRH, Office of Device Evaluation (ODE)

Torque M. Wran

Division of Reproductive. Abdominal and Radiological Devi 510(k) Number

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