(191 days)
Not Found
No
The device description focuses on a physical applicator used in brachytherapy and does not mention any software or algorithms that would incorporate AI/ML. The image processing and AI/ML sections are explicitly marked as "Not Found".
No.
The device is an accessory that helps deliver radiation, but it does not directly treat the condition.
No
This device is described as an applicator for delivering radiation dose during brachytherapy procedures, which is a form of treatment, not diagnosis. While it uses imaging for planning, its primary function is therapeutic.
No
The device description clearly details a physical applicator (mould set) made of materials that are inserted into the patient's body. It is described as an "accessory" to hardware afterloading equipment and provides a "treatment path" for a radioactive source. This is a physical medical device, not software.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nucletron Rotterdam Nasopharynx Mould Set is a medical device used in brachytherapy procedures. Its primary function is to provide a physical path for a radioactive source to deliver radiation directly to a tumor in the nasopharynx. It is an applicator, not a diagnostic test.
- Intended Use: The intended use clearly states it's for "intracavitary nasopharynx brachytherapy procedures" and "delivering the prescribed radiation dose." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details how the device is inserted and used to guide a radioactive source. It does not mention any analysis of biological samples.
While the device uses imaging (radiographic images, CT, MR) for planning, this imaging is used to determine the physical location of the applicator for treatment delivery, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Nucletron Rotterdam Nasopharynx Mould Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.
Product codes
90 JAQ
Device Description
The Nucletron Rotterdam Nasopharynx Mould as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures.
The Nucletron Rotterdam Nasopharynx Mould Set is inserted into the mouth and positioned within the nasopharynx cavity with the assistance of guidance tubes. Once in position, it is immobilized and treatment catheters are inserted. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic and mPDR, by the Nucletron transfer tubes. The transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there is no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete. the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient.
The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit: it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic images, planar films or transverse slices, i.e. CT, MR
Anatomical Site
nasopharynx cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Nucletron Rotterdam Nasopharynx Mould Set 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
4/2/99
Premarket Notification Nucletron Rotterdam Nasopharynx Mould Set Date : 18. September 1998
Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font next to a square graphic. The graphic contains a black shape with two white circles inside of it. The black shape is in the center of the square and the white circles are on opposite sides of the shape.
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 Device 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 |
Device Name:
| Trade/Proprietary Name: | Rotterdam Nasopharynx Mould Set |
|---|---|
| Common/Usual Name: | Remote Afterloading Intracavitary Nasopharynx |
Classification Name:
Accessory to remote afterloader 21 CFR 892.5700, Class II.
Brachytherapy Applicator
Legally Marketed Predicate Device(s) C.
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron BV | Standard Nasopharyngeal Applicator Set | K953946 |
Description d.
b.
The Nucletron Rotterdam Nasopharynx Mould as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures.
1
Premarket Notification
Nucletron Rotterdam Nasopharynx Mould Set
Date : 18. September 1998
The Nucletron Rotterdam Nasopharynx Mould Set is inserted into the mouth and positioned within the nasopharynx cavity with the assistance of guidance tubes. Once in position, it is immobilized and treatment catheters are inserted. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic and mPDR, by the Nucletron transfer tubes. The transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there is no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete. the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient.
The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit: it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment.
e. Intended use
Nucletron Rotterdam Nasopharynx Mould Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.
f. Summary of technological considerations
The Nucletron Rotterdam Nasopharynx Mould Set is substantially equivalent to the predicate device. It combines the functionality, components and design of the predicate device while incorporating a new material.
Name: L. A. Johnson Title Product Manager Nucletron BV Veenendaal Netherlands
21-Sept-98
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes above a wavy base. The logo is rendered in black and white.
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 Dr. Columbia, MD 21046
Re:
K983337 Nucletron Rotterdam Nasopharynx Mould Set Dated: January 18, 1999 Received: January 19, 1999 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAQ
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 pror 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 III (Special Controls) or dass 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 Requlations. 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 Requlation (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,
CART Daniel O. Schultz, M.D.
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
3
Premarket Notification Nucletron Rotterdam Nasopharynx Mouid Set Date : 18, September 1998
Image /page/3/Picture/1 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black circle with two white circles on either side. The square is outlined in black. The text is aligned to the right of the square.
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenen« P.O.Box 930 3900 AX Veenenc The Netherlands Phone +31 318 557133 +31 318 550485 Fax
Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Pre-Market Notification section
Statement of intended use
Device Name:
Rotterdam Nasopharynx Mould Set
Intended use
Nucletron Rotterdam Nasopharynx Mould Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.
Prescription use
The Nucletron Rotterdam Nasopharynx Mould Set is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
Signature:
2/-Sept-98
Date
Name L. A. Johnson Product Manager Title Nucletron BV Veenendaal Netherlands
Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Dev
510(k) Number K983337
Prescription Use Fer 21 CFR 801.109)