(56 days)
No
The summary describes a physical medical device (an applicator) and its components, focusing on material compatibility with imaging modalities and its function in brachytherapy. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is an applicator intended for use with brachytherapy equipment, and provides a template for needle placement to deliver radiation treatment. It is a tool used in a therapeutic procedure rather than providing therapy itself.
No
The device, the "Vienna Ring CT/MR Applicator", is described as an applicator used for gynaecological brachytherapy procedures, which is a treatment method. Its purpose is to facilitate the placement of interstitial titanium needles for achieving specific dose distributions, indicating a therapeutic rather than diagnostic function. While it is CT/MR compatible and designed to minimize imaging artifacts, this compatibility is to support the treatment delivery and monitoring, not for primary diagnostic image interpretation.
No
The device description clearly details physical components like a ring applicator, guide holes, composite fiber tubing, and titanium needles, indicating it is a hardware device used in brachytherapy procedures.
Based on the provided information, the Vienna Ring CT/MR Applicator 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.
- Device Function: The Vienna Ring CT/MR Applicator is a medical device used in vivo (within the body) for delivering radiation therapy (brachytherapy) in gynaecological procedures. It is a physical applicator used to guide radiation sources and interstitial needles.
- Intended Use: The intended use clearly states it's for "gynaecological brachytherapy procedures" and is used with "Nucletron remote afterloading equipment." This describes a therapeutic procedure, not a diagnostic test performed on a sample.
The device's use of imaging (CT/MR) is for planning and guiding the treatment, not for analyzing a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Vienna Ring CT/MR Applicator is intended for use with Nucletron remote afterloading equipment for gynaecological brachytherapy procedures.
Product codes
JAQ
Device Description
The Vienna Ring CT/MR Applicator is based on the Ring CT/MR Applicator set enhanced with the addition of nine guide holes in the ring tube (seven holes for part number 189.699). These guide holes allow placement of interstitial titanium needles within the ring tube. The addition of interstitial needles makes it possible to achieve asymmetric dose distribution while still maintaining the treatment on the standard template of the ring. The interstitial needles are placed parallel to the outer circumference of the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. Its design uses composite fiber tubing, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artifacts on the acquired images. The device is the same as the legally marketed predicate device cited. The only change is that the applicator allows placement of pre-bent Titanium Needle Sets which are based on the predicate stainless steet Interstitial Needle Sets (K953946).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
gynaecological
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Nucletron remote afterloading equipment
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
Not Found
Key Metrics
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
MAY 2 8 2008
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 circle with two white circles on either side. The graphic is enclosed in a black square.
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 Centre 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: | Nucletron Corporation |
|---|---|
| Registration number: | 1121753 |
| Address: | 8671 Robert Fulton Drive |
| Columbia, MD 21046 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4198 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | Vienna Ring CT/MR Applicator |
|---|---|
| Common/Usual Name: | JAQ, Remote controlled radionuclide applicator system |
| Classification Name: | 90 (Radiology) |
| Classification: | 21CFR892.5700 Class II |
Legally Marketed Device(s)
Legally Marketed Device(of
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
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Description:
The Vienna Ring CT/MR Applicator is based on the Ring CT/MR Applicator set enhanced The Vienna Ring C Thin Applicator is bacul of the ring tube (seven holes for part number 189.699).
with the addition of nine guide holes in the ring tube (seven holes in the with the addition of mine guide notes in the ting table (sessing the ring tube as a
r These guide holes allow placement of interstitial titanium needles The addition These guide noies allow placentent of interstition international of the ring tube. The addition of needle template while still manitating the troutinent on the dose distribution.
interstitial needles makes it possible to achieve asymmetric altern the standare . The intersitial needles makes it poolible to the ring and are parallel to the tandem. The
1
applicator is fully CT/MR compatible. Its design uses composite fiber tubing, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artifacts on the acquired images.
The device is the same as the legally marketed predicate device cited. The only change is that the applicator allows placement of pre-bent Titanium Needle Sets which are based on the predicate stainless steet Interstitial Needle Sets (K953946).
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
The Vienna Ring CT/MR Applicator is intended for use with Nucletron remote afterloading equipment for gynaecological brachytherapy procedures
Summary of technological considerations:
The Vienna Ring CT/MR Applicator is substantially equivalent to the cleared predicate device, Ring CT/MR Applicator Set, 510(k)#: K953946. The Titanium Needle Sets the Vienna Ring CT/MR Applicator is compatible with are substantial equivalent to the Interstitial Needles Setst, 510(k)#: K953946.
01-04-2008
Date
Name: Bick van Waes Title: Vice President Nucletron B.V. Veenendaal, The Netherlands
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 stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2008
Ms. Lisa Dimmick Director Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046-2133
Re: K080934
Trade/Device Name: Vienna Ring CT/MR Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 2, 2008 Received: April 2, 2008
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 such 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.
3
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number
Device Name
Indications for Use
Vienna Ring CT/MR Applicator
The Vienna Ring CT/MR Applicator is intended for use with Nucletron The Vienna Ring equipment for gynaecological brachytherapy procedures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) ાર
Over-The-Counter Use_
Aonni M. Wham
(Division Division of Reproductive. Abdomin and Radiological Devi 510(k) Number.