(209 days)
Not Found
No
The description focuses on the mechanical function of the applicator as a path for the radioactive source and mentions image processing for treatment planning, but there is no indication of AI/ML being used for image analysis, treatment planning, or any other function.
Yes
The device is described as an applicator that provides a means of delivering a prescribed radiation dose for brachytherapy procedures, which is a form of radiation therapy used to treat cancer and other conditions. It is used to deliver treatment to the skin or organ surface, indicating a therapeutic intent.
No
The device is designed to deliver a prescribed radiation dose for brachytherapy treatment, not to diagnose a condition. While imaging is used to plan the treatment, the device itself is for therapeutic delivery.
No
The device description clearly details a physical applicator (a closed system with treatment catheters) that is placed on the patient and connected to remote afterloading equipment via transfer tubes. This is a hardware device, not software only.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nucletron Freiburg Flap Applicator Set is a device used in vivo (within the body) during brachytherapy procedures. Its purpose is to provide a path for a radioactive source to deliver radiation directly to a treatment area on the skin or organ surface.
- No Specimen Analysis: The device does not analyze any biological specimens. It is a physical tool used to facilitate a medical treatment.
Therefore, the function and intended use of the Nucletron Freiburg Flap Applicator Set clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nucletron Frieburg Flap Applicator Set is intended for skin surface or intraoperative brachytherapy Nocleares involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and procedures inversing the Nichard Neans of delivering the prescribed radiation dose to the m. Dr. The applicator promos a means system to prevent the radioactive source from coming in contact with body fluids.
Product codes (comma separated list FDA assigned to the subject device)
90 JAQ
Device Description
The Nucletron Freiburg Flap Applicator as described in this submission is designed as an accessory to the Nucletron remote aftertoading equipment: mHDR, mHDR-Classic and mPDR, and is intended for skin surface and intraoperative brachytherapy procedures.
The Nucletron Freiburg Flap Applicator Set is placed on the skin or organ surface and immobilized. 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-Classic and mPDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment catheters and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver the prescribed dose of radiation. When the treatment is complete, the treatment catheters are 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
Skin surface, organ surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical staff
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
§ 892.5700 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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4/20/99
Nucletron Freiburg Flap Applicator Set Date : 18, September 1998
Image /page/0/Picture/3 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square containing a black circle with two white circles on either side. The black circle is slightly offset, creating a dynamic and modern look. The overall design is clean and professional.
Image /page/0/Picture/4 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '8', '3', '3', '3', and '8'. The digits are written in a cursive style, with some connections between them. The overall appearance suggests that the sequence was written quickly and informally.
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 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: | Freiburg Flap Applicator Set |
| Common/Usual Name: | Remote Afterloading for skin surface and intraoperative |
| brachytherapy applications |
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 device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Mick Radio-Nuclear Instruments | H.A.M. Applicator | K961601 |
d. Description
b.
The Nucletron Freiburg Flap Applicator as described in this submission is designed as an accessory to the Nucletron remote aftertoading equipment: mHDR, mHDR-Classic and mPDR, and is intended for skin surface and intraoperative brachytherapy procedures.
1
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Nucletron Freiburg Flap Applicator Set Date : 18. September 1998
The Nucletron Freiburg Flap Applicator Set is placed on the skin or organ surface and immobilized. 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-Classic and mPDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment catheters and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver the prescribed dose of radiation. When the treatment is complete, the treatment catheters are 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.
Intended use e.
Nucletron Freiburg Flap Applicator Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for skin surface and intraoperative 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 Freiburg Flap Applicator Set is substantially equivalent to the predicate device. It combines the functionality, components and design of the predicate device while incorporating a new material.
Johnson Product Manager Title Nucletron BV Veenendaal Netherlands
21-Sept-98
Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 1999
Ralph Shuping, Sc.D. Regulatory Affair Manager Nuceltron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046-2133
Re:
K983338 Freiburg Flap Applicator Set Dated: January 18, 1999 Received: January 20, 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 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). 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 (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,
Dan Pettit
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
Page_of_of____________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Freiburg Flap Applicator Set Device Name :_
Indications For Use:
Nucletron Frieburg Flap Applicator Set is intended for skin surface or intraoperative brachytherapy Nocleares involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and procedures inversing the Nichard Neans of delivering the prescribed radiation dose to the m. Dr. The applicator promos a means system to prevent the radioactive source from coming in contact with body fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K983338 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)