(27 days)
No
The device description focuses on the physical components and their function in guiding needles for brachytherapy, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for gynecological brachytherapy procedures for cancer treatment, which is a therapeutic application.
No.
The device is used for cancer treatment (brachytherapy procedures) and for guiding needles into tumors to alter dose distribution, which are therapeutic functions, not diagnostic ones. While it mentions CT/MR compatibility for imaging, this is to aid in treatment delivery and planning, not for diagnosing a condition.
No
The device description explicitly details physical components made of polymers and mentions the use of needles and tubes, indicating it is a hardware device.
Based on the provided text, 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.
- Device Function: The described device is an applicator set used in brachytherapy procedures. It is a physical tool inserted into the body to deliver radiation for cancer treatment. It does not analyze biological samples.
- Intended Use: The intended use is for "gynecological brachytherapy procedures for cancer treatment," which is a therapeutic procedure, not a diagnostic test.
- Device Description: The description focuses on the physical components and how they are used to guide needles for radiation delivery.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on biological analysis.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Interstitial Ring CT/MR Applicator Set is based on the Ring CT/MR Applicator Set enhanced with the addition of nine guiding holes in the ring tube (seven holes for part number 110.130). These guide holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. The device is composed of polymers, 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 device is similar to the legally marketed predicate device Vienna Ring CT/MR Applicator Set. The difference between this device and the Vienna Ring CT/MR Applicator Set is that this device allows the use of Proguide needles instead of the titanium needles used with the Vienna Ring CT/MR Applicator Set The Utrecht Interstitial Fletcher CT/MR Applicator Set is based on the legally marketed predicate device Standard CT/MR Applicator Set enhanced with five similar guiding holes in each ovoid as the guiding holes in the ring of the Interstitial Ring CT/MR Applicator Set. These guiding holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ovoids. The applicator is fully CT/MR compatible. The device is composed of polymers, 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 MR line markers are optional devices that can make the channels of the Nucletron CT/MR applicators visible using magnetic resonance imaging. The markers consist of a thin Teflon tube that can be filled with an appropriate fluid that is clearly visible on magnetic resonance images. The tubes are inserted before imaging in the channels of the CT-MR applicator and are removed before the treatment of the patient. The devices are used as accessories to the Nucletron microSelectron Afterloaders
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
cervix and endometrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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.
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April, 2009
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 of it, all enclosed in a black square. The word "Nucletron" is positioned to the right of the graphic.
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal MAY 18 200gthe 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 Traditional 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: | 410-312-4197 |
| Correspondent: | Elaina Colby |
| Manager Quality Assurance & Regulatory Affairs |
New Device Name:
| Trade/Proprietary Name: | Interstitial Ring CT/MR Applicator Set &
Utrecht Interstitial Fletcher CT/MR Applicator Set |
|-------------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Gynecological Brachytherapy applicator |
| Classification Name: | Remote controlled radionuclide applicator system accessory |
| Classification: | 21Cfr892.5700 Class II |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron BV | Ring CT/MR Applicator Set and Standard CT/MR | |
| Applicator set | K983341 |
Description:
The Interstitial Ring CT/MR Applicator Set is based on the Ring CT/MR Applicator Set enhanced with the addition of nine guiding holes in the ring tube (seven holes for part number 110.130). These guide holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted
1
Special 510(k) Utrecht Interstitial Fletcher CT/MR and Interstitial Ring CT/MR Applicator
Page 30 - April, 2009
..
perpendicular to the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. The device is composed of polymers, 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 device is similar to the legally marketed predicate device Vienna Ring CT/MR Applicator Set. The difference between this device and the Vienna Ring CT/MR Applicator Set is that this device allows the use of Proguide needles instead of the titanium needles used with the Vienna Ring CT/MR Applicator Set
The Utrecht Interstitial Fletcher CT/MR Applicator Set is based on the legally marketed predicate device Standard CT/MR Applicator Set enhanced with five similar guiding holes in each ovoid as the guiding holes in the ring of the Interstitial Ring CT/MR Applicator Set. These guiding holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ovoids. The applicator is fully CT/MR compatible. The device is composed of polymers, 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 MR line markers are optional devices that can make the channels of the Nucletron CT/MR applicators visible using magnetic resonance imaging. The markers consist of a thin Teflon tube that can be filled with an appropriate fluid that is clearly visible on magnetic resonance images.
The tubes are inserted before imaging in the channels of the CT-MR applicator and are removed before the treatment of the patient.
The devices are used as accessories to the Nucletron microSelectron Afterloaders
Intended use:
The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
Summary of technological considerations:
The Interstitial Ring CT/MR Applicator Set and the Utrecht Interstitial Fletcher CT/MR Applicator Set are substantially equivalent to the cleared predicate devices, Ring CT/MR Applicator Set and Standard CT/MR Applicator set, K983341
Name: Dick van Waes Title: Business Manager Nucletron B.V. Veenendaal, The Netherlands
09-04-2009
Date
KC91154
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
MAY 18 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elaina M. Colby Manager, Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046-2133
Re: K091154
Trade/Device Name: Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set
Regulation Number: 21 CFR 892.5700
Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 20, 2009 Received: April 21, 2009
Dear Ms. Colby:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2
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.
(240) 276-0115 (Gastroenterology/Renal/Urology) 21 CFR 876.xxx (Obstetrics/Gynecology) (240) 276-0115 21 CFR 884.xxx (240) 276-0120 21 CFR 892.xxx (Radiology) (240) 276-0100 Other
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known)
Device Name
Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set
Indications for Use
The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy ..
Prescription Use _ X (Part 21 CFR 801 subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 subpart C)
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,
and Radiological Devices
| 510(k) Number | K091154 |
|---|---|
| --------------- | --------- |
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