(15 days)
Not Found
No
The description focuses on traditional treatment planning software features, image import, and optimization algorithms without mentioning AI or ML. The added features are related to image modalities, applicator support, and multiple target volumes, which are standard functionalities in medical imaging and treatment planning.
No.
This device is a software application for brachytherapy treatment planning, which assists physicians in determining the positioning and loading of radioactive sources. It is not directly involved in the treatment delivery but rather in the planning and optimization process.
No
The device is a treatment planning system for brachytherapy, which assists in determining the positioning and loading of radioactive sources for cancer treatment. It does not diagnose conditions.
No
The device is described as software that runs on a Windows XP platform on the same hardware as the predicate device (Swift 2.0). While the core function is software-based treatment planning, it explicitly mentions running on specific hardware, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Brachytherapy Treatment Planning, for the treatment of cancer... involving radioactive sources." This describes a therapeutic planning tool used in the treatment of a disease, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a software application that uses medical imaging (MRI, CT, ultrasound) to plan the placement of radioactive sources for cancer treatment. It provides tools for dose distribution analysis and optimization. This is consistent with a treatment planning system, not a diagnostic device.
- Lack of IVD Characteristics: An IVD device typically involves testing biological samples (blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions. This device does not mention any interaction with biological samples or diagnostic testing.
Therefore, Oncentra GYN 1.0 is a medical device used for treatment planning, not an in vitro diagnostic device.
N/A
# Intended Use / 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.
# Product codes (comma separated list FDA assigned to the subject device)
MUJ
# Device 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 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
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
3D MRI, CT and ultra sound image import
# Anatomical Site
gynaecological cancers (treatment of cancer, ie. intercavitary, interstitial, intraluminal)
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
Not Found
# Description of the training set, sample size, data source, and annotation protocol
Not Found
# Description of the test set, sample size, data source, and annotation protocol
Not Found
# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K031158](https://510k.innolitics.com/search/K031158)
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K0809 29
APR 1 6 2008
TITER TELETTER
r
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 +31 318 557133 +31 318 550485 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 |
| Columbia, MD 21046 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| 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:
|
| 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
1
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
2
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.
3
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 (800) 638-2041 or (240) 276-3150 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
4
Indications for Use
510(k) Number (if known)
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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