(210 days)
No
The description focuses on software and hardware for controlling a brachytherapy unit, managing treatment data, and generating reports. There is no mention of AI or ML algorithms for tasks like treatment planning optimization, image analysis, or predictive modeling.
Yes
The device is described as a "Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments," indicating its direct function in delivering therapeutic radiation.
No
Explanation: The device is described as a "Remote Afterloading Brachytherapy Unit" that programs and monitors treatment. It does not perform any diagnostic functions like analyzing patient data to identify conditions or diseases.
No
The device description explicitly states it is a "software and hardware package" and includes a "Treatment Control Panel" which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for remote afterloading brachytherapy treatments. This is a therapeutic procedure involving the delivery of radiation to a patient's body.
- Device Description: The description details a system for controlling and monitoring a brachytherapy unit, including software for programming treatments and hardware for control and monitoring. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is designed to deliver treatment.
N/A
Intended Use / Indications for Use
Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.
Product codes
90 JAQ
Device Description
The Treatment Control Station (TCS) described in this submission is a software and hardware package which replaces the current Treatment Control Unit (TCU) for the microSelectron-HDR classic.
The TCS is windows based software and runs on a PC based computer system. TCS will allow the user to program a treatment and monitor a treatment in progress. TCS will come together with a Treatment Control Panel, which takes care of the secondary timing and providing hardware independent "Start", "Interrupt" button and source location indicators.
The TCS user obtains authorization for parts of the functionality depending on the user name and password.
Treatment data can either be entered manually, based on a standard plan, based on a previously fraction or Imported from the Nucletron Treatment Planning System (PLATO). Prlor and after treatment completion an extensive report is generated providing full details of how the patient will be and is treated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interstitial, intracavitary, intraluminal, including bronchial, endovascular, intraoperative and surface applicator treatments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Treatment Control Station - microSelectron-HDR classic Upgrade is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
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
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
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4/2/99
Premarket Notification Nucletron mlcroSelectron-HDR classic with TCS Date : 31 August, 1998
Image /page/0/Picture/5 description: The image shows the word "Nucletron" in bold, black font, next to a square logo. The logo contains a black circle with two white circles on either side, all within a black square border. The word "Nucletron" is positioned to the right of the logo.
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 Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section
PKG MKT mHDR 510k
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by section 807.92(c)
Submitter of 510(k) a.
Company name: Registration # Address:
Nucletron Corporation 1121753 7080 Columbia Gateway Drive Columbia, MD 21046-2133
Contact Person:
Ralph E. Shuping Regulatory Affairs Manager 410-312-4100 Phone: Fax: 410-312-4197
b. Device Name:
| Trade/Proprietary Name: | Treatment Control Station - microSelectron-HDR classic
Upgrade, Remote Afterloading System |
|-------------------------|-----------------------------------------------------------------------------------------------|
| Classification Name: | Remote Control Radionuclide Applicator System |
| | 21 CFR 892.5700 Class II. |
Legally Marketed Predicate Device(s) C.
Our Device is substantially equivalent to the legally marketed prodicate devices cited in the table below.
Appendix 5, page 2
1
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Premarket Notification Nucletron microSelectron-HDR classic with TCS Date : 31 August, 1998
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron | microSelectron-HDR classic | K864210 |
| Nucletron | microSelectron-HDR | K953946 |
DescriptIon d.
The Treatment Control Station (TCS) described in this submission is a software and hardware package which replaces the current Treatment Control Unit (TCU) for the microSelectron-HDR classic.
The TCS is windows based software and runs on a PC based computer system. TCS will allow the user to program a treatment and monitor a treatment in progress. TCS will come together with a Treatment Control Panel, which takes care of the secondary timing and providing hardware independent "Start", "Interrupt" button and source location indicators.
The TCS user obtains authorization for parts of the functionality depending on the user name and password.
Treatment data can either be entered manually, based on a standard plan, based on a previously fraction or Imported from the Nucletron Treatment Planning System (PLATO). Prlor and after treatment completion an extensive report is generated providing full details of how the patient will be and is treated.
A detailed description including principles of operation and other information necessary to understand the device is provided in Section 3.
Intended use e.
The indications for use for the Treatment Control Station - microSelectron-HDR classic Upgrade are:
Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.
Summary of technological considerations f.
The Treatment Control Station - microSelectron-HDR classic Upgrade Is substantially equivalent to the predicate devices. It allows the use of an enhanced user interface to program a treatment and monitor a treatment in progress.
g
31-08-98
Date
Name: P.Krechting Title Product Manager Nucletron bv Veenendaal Netherlands
Appendix 5, page 3
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1995
Ralph E. Shuping, Sc.D. Regulatory Affairs Manger Nucletron Corporation 7080 Columbia Gateway Drive Columbia, Maryland 21046
Re: K983115
Treatment Control Station (TCS) MicroSelectron HDR Classic Upgrade Dated: January 14, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 892.5700/Procode: 90 JAQ
Dear Dr. Schuping:
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 controis 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 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 (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,
CART Daniel O. Schultz, M.D.
CAPT 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
3
G
Premarket Notification Nucletron microSelectron-HDR classic with TCS Date : 31 August, 1998
Image /page/3/Picture/4 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black shape with two white circles inside.
Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section
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
PKG MKT mHDR 510k
Statement of intended use
Device Name: Treatment Control Station - microSelectron-HDR classic Upgrade, remote afterloading system
Intended use
The indications for use for the Treatment Control Station - microSelectron-HDR classic Upgrade are:
Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.
Prescription use
The Treatment Control Station - microSelectron-HDR classic Upgrade is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
Name
P. Krechting
31-08-98
Date
Title
Product Manager Nucletron BV
Veenendaal
Netherlands
David b. Stypman
Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological 510(k) Number
Appendix 5, page 4