(191 days)
No
The description focuses on standard brachytherapy planning functionalities like reconstruction, source localization, dose calculation, and data export. There is no mention of AI/ML terms or capabilities like learning, prediction, or automated optimization beyond standard dose calculation algorithms.
No
The device is a software package for brachytherapy treatment planning, calculating dose distributions and treatment times. It does not directly administer therapy but rather aids in the planning process.
No
The device is a treatment planning software that provides dosimetric and anatomical information for brachytherapy procedures. It calculates treatment data and dose distributions, but it does not diagnose a disease or condition. Its purpose is to plan the treatment, not to identify or characterize medical conditions.
Yes
The device is described as a "software package" that "runs on a PLATO radiation therapy treatment planning system workstation." While it interacts with hardware (the workstation and remote afterloading system), the submission focuses solely on the software's functionality for planning and data export, without describing any hardware components of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PLATO Brachytherapy software is a treatment planning system. It uses imaging data (radiographs, transverse slices, 3D coordinates) to plan the delivery of radiation therapy (brachytherapy) to a patient. It calculates treatment parameters like source positioning, loading, treatment time, and dose distribution.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its input is imaging data, not biological samples.
Therefore, the function and intended use of the PLATO Brachytherapy software clearly fall outside the scope of an In Vitro Diagnostic device. It is a medical device used for treatment planning in radiation oncology.
N/A
Intended Use / Indications for 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.
Product codes
90 MUJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, transverse slices, or 3D coordinates
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional / 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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 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 |
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 |
| 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
1
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.
2
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.
3
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 (301) 594-4613. 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"(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 (800) 638-2041 or (301) 443-6597, 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
4
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 +31 318 557133 +31 318 550485 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)