(100 days)
Not Found
No
The summary describes standard radiation treatment planning software functionalities and does not mention AI, ML, or related concepts.
No
The device is described as "radiation treatment planning software designed to analyze and plan radiation treatments," which provides estimates of dose distributions. It is used to assist in "treating patients with cancer" but does not directly administer treatment or perform a therapeutic function itself. It is a tool for planning, not a device that applies therapy.
No
Explanation: The device is described as "radiation treatment planning software" that "analyzes and plans radiation treatments" and provides "estimates of dose distributions," which are used after review and approval for administering treatments. This indicates it is for planning and treatment, not for diagnosing a condition.
Yes
The device description explicitly states "The Oncentra Treatment Planning (OTP 1.2) system is radiation treatment planning software". It describes various software modules and functionalities and mentions it runs on a Windows XP platform, which is the operating environment, not a component of the medical device itself. There is no mention of any hardware components being part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that OTP is "radiation treatment planning software designed to analyze and plan radiation treatments... for the purpose of treating patients with cancer." It uses "externally acquired medical images" and user input to create treatment plans.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples from the patient. The software operates on medical images and user input, not on in vitro samples.
Therefore, OTP falls under the category of medical device software used for treatment planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
The Oncentra Treatment Planning (OTP 1.2) system is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. OTP 1.2 is uses externally acquired medical images and user input. The OTP software is based on a modular client/server design, with the treatment planning functions divided into "Activities". OTP 1.2 contains the following Activities: Anatomy Module (Structure Definition, Target Definition, Image Registration), Beam Module, Connectivity Module, DICOM Import / Export, Dose Module, Evaluation Module (Plan Evaluation, Volume Rendering). In addition, various system utilities are available. The software runs on a Windows XP platform.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
externally acquired medical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
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.
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
K031349
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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 opposite sides of it. The logo is simple and modern.
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 Fax +31 318 550485
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 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: | 7080 Columbia Gateway Drive |
| Columbia, MD 21046-2133 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | OTP 1.2 |
|---|---|
| Common/Usual Name: | Radiation Therapy Planning System |
| Classification Name: | Accessory to Radiotherapy Device |
| 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 | of a was well of the first and the commend of the bell the may of the county of the count
Device | 510(k)
1 # |
|--------------|-----------------------------------------------------------------------------------------------------|---------------|
| Nucletron BV | TheraPlan Plus
A MARK STATUS CONTRACTORS CONTRACTOR | K970236 |
Description:
The Oncentra Treatment Planning (OTP 1.2) system is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
1
K031349
Payeref2
OTP 1.2 is uses externally acquired medical images and user input. The OTP software is based on a modular client/server design, with the treatment planning functions divided into "Activities".
OTP 1.2 contains the following Activities:
- Anatomy Module: .
- Structure Definition .
- Target Definition .
- Image Registration .
- Beam Module ●
- Connectivity Module: ●
- DICOM Import / Export .
- Dose Module .
- Evaluation Module: .
- Plan Evaluation .
- Volume Rendering ●
In addition, various system utilities are available.
The software runs on a Windows XP platform.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Summary of technological considerations:
OTP is substantially equivalent to the cleared predicate device, TheraPlan Plus, 510(k)#: K970236.
T.J. Bt
April 15, 2003
Date
Name: Tim Bateman Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands
2
Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA'.
radiation therapy system
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2003
Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046
Re: K031349 Trade/Device Name: OTP 1.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle
Regulatory Class: II Product Code: 90 MUJ Dated: July 14, 2003 Received: July 16, 2003
Dear Ms. Dimmick:
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 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.
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.
3
Page 2
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
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 Statement
510(k) Number
Device Name
OTP 1.2
Indications for Use
OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Daniel R. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number