(69 days)
Not Found
No
The description focuses on the mechanical components and process of using the applicator for brachytherapy, with no mention of AI or ML 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 diseases.
No
Explanation: The device is described as an "Applicator Set" intended for "delivering the prescribed radiation dose to the treatment area" during interstitial brachytherapy. It is an accessory to radiation delivery equipment and provides a path for the radioactive source; it does not diagnose or detect a disease or condition. While radiographic images (CT, MR) are used to determine the precise location of the applicator for treatment planning, the device itself is not performing the diagnostic imaging or analysis.
No
The device description clearly outlines physical components like insertion needles, plastic sheaths, catheters, buttons, and treatment needles, which are hardware. The device provides a physical path for a radioactive source, indicating it is a hardware 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nucletron Implant Guidance System Applicator Set is a medical device used during a medical procedure (interstitial brachytherapy). It provides a physical path for a radioactive source to deliver radiation directly to a treatment area within the body.
- Lack of Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely mechanical and related to the delivery of radiation.
- Intended Use: The intended use clearly states it's for "interstitial brachytherapy procedures" and provides a "means of delivering the prescribed radiation dose." This is a therapeutic application, not a diagnostic one.
Therefore, the Nucletron Implant Guidance System Applicator Set falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nucletron Implant Guidance System Applicator Set is intended for interstitial brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR. 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 (comma separated list FDA assigned to the subject device)
90 JAQ
Device Description
The Nucletron Implant Guidance System as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR, and is intended for interstitial brachytherapy procedures.
The Nucletron Implant Guidance System Applicator Set consists of an insertion needle with a plastic sheath, which is inserted through the skin surface into the target volume. The insertion needle is then removed and a closed end plastic catheter is placed into the sheath. A marker on the side of the insertion obturator insures the proper depth of catheter placement. Once the catheter is in place the sheath is removed and a button is placed over the plastic catheter and slid into contact with the skin surface. The catheter is then cut level with the button and attached. A closed end treatment needle is then inserted into the catheter, once in position a metal needle stopper is slid over the needle to the button surface and locked. Radiographic images, planar films or transverse slices, i.e. CT. MR is 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 treatment needle is then attached to the Nucletron remote afterloading equipment (treatment head), mHDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment needles 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 session is complete, the treatment needles are detached from the transfer tube and remote afterioading equipment. The treatment needles are then removed from the patient. When the course of treatment is completed the catheters and buttons are 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Nucletron Implant Guidance System Applicator 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): 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
Special 510(k) K020015: reply to questions Nucletron Implant Guidance System Applicator Set Februari 2002
Image /page/0/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 black circle is tilted at an angle within the square. The word "Nucletron" is written in a simple, sans-serif font.
MAR 1 3 2002
Fax
K020015
p. 1 of 2
NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133
+31 318 550485
Department of Health and Human Services Center 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: Registration number: Address:
Phone: Fax: Correspondent: Nucletron Corporation 1121753 7080 Columbia Gateway Drive Columbia, MD 21046-2133 410-312-4100 410-312-4197 Lisa Dimmick Regulatory Affairs Manager
Modified Device Name:
| Trade/Proprietary Name: | Implant Guidance System Applicator Set |
|---|---|
| Common/Usual Name: | Remote Afterloading for interstitial brachytherapy applications |
| Classification Name: | Remote controlled radionucide applicator system accessory |
| Classification | 21 CFR 892.5840, Class II |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | A Device Device C
のではないという
No. of the Comment of the
A 1440 A Product of Property Top A 2012 2 | 510(k) # = |
|----------------|---------------------------------------------------------------------------------------------------------|------------|
| Nucletron B.V. | Speiser Needle Set | K953946 |
| Nucletron B.V | Flexible Implant Tubes | K953946 |
| Nucletron B.V | Interstitial Needle Set | K953946 |
Description:
The Nucletron Implant Guidance System as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR, and is intended for interstitial brachytherapy procedures.
The Nucletron Implant Guidance System Applicator Set consists of an insertion needle with a plastic sheath, which is inserted through the skin surface into the target
1
Special 510(k) K020015: reply to questions Nucletron Implant Guidance System Applicator Set Februari 2002
volume. The insertion needle is then removed and a closed end plastic catheter is placed into the sheath. A marker on the side of the insertion obturator insures the proper depth of catheter placement. Once the catheter is in place the sheath is removed and a button is placed over the plastic catheter and slid into contact with the skin surface. The catheter is then cut level with the button and attached. A closed end treatment needle is then inserted into the catheter, once in position a metal needle stopper is slid over the needle to the button surface and locked. Radiographic images, planar films or transverse slices, i.e. CT. MR is 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 treatment needle is then attached to the Nucletron remote afterloading equipment (treatment head), mHDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment needles 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 session is complete, the treatment needles are detached from the transfer tube and remote afterioading equipment. The treatment needles are then removed from the patient. When the course of treatment is completed the catheters and buttons are 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:
Nucletron Implant Guidance System Applicator Set is intended for interstitial brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR. 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.
Summary of technological considerations:
The Nucletron Implant Guidance System Applicator Set is substantially equivalent to the cleared predicate devices, Speiser Needle Set (#K953946), Flexible Implant Tubes (#K953946) and Interstitial Needle Set (#K953946).
Leslie E. Fe
Name: U. Lutz Title: Business Seament Manager HDR Brachytherapy Nucletron B.V. Veenendaal, The Netherlands
11.02.02
Date
2
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures in profile, with a triple-bar design above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2002
Ms. Lisa C. Dimmick Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133
Re: K020015
Trade/Device Name: Implant Guidance System Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: February 11, 2002
Received: February 19, 2002
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 (OS) 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
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 nouticate 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 If you desire specific ac ne of the following numbers, based on the regulation number at the top of this letter:
8xx.1xxx 876.2xxx, 3xxx, 4xxx, 5xxx 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx 892.2xxx, 3xxx, 4xxx, 5xxx Other
(301) 594-4591 (301) 594-4616 (301) 594-4616 (301) 594-4654 (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 Office of Cotopremarket notification" (21 CFR Part 807.97). Other general information on by relected to premiered the Act may be obtained from the Division of Small Manufacturers, Jour responsiblement 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
Special 510(k) Nucletron Implant Guidance System Applicator Set December 10, 2001
Image /page/4/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 word "Nucletron" is written in a sans-serif font and is slightly larger than the square graphic.
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 Special 510(k) section
Kozoo15
Statement of intended use
Device Name:
Implant Guidance System Applicator Set
Intended Use:
Nucletron Implant Guidance System Applicator Set is intended for interstitial brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR. 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 Implant Guidance System Applicator Set is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
Leslie-& R
10.12.01
Date
Name: U. Lutz Title: Business Segment Manager HDR Brachytherapy Nucletron B.V. Veenendaal, The Netherlands
Nancy Brandon