(29 days)
Not Found
No
The description focuses on the mechanical design and material changes of a physical applicator for guiding needles in brachytherapy, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used to deliver a prescribed radiation dose for the treatment of breast cancer, which is a therapeutic purpose.
No
The device is an applicator set used for delivering radiation therapy, specifically brachytherapy, to the breast. Its purpose is to guide needles for radiation delivery, not to diagnose a condition.
No
The device description clearly describes a physical applicator set made of materials, with a specific shape, holes for guiding needles, and intended for use with physical brachytherapy equipment. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in "Interstitial breast brachytherapy procedures" and provides a "means of delivering the prescribed radiation dose to the treatment area." This describes a therapeutic procedure involving radiation delivery, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical applicator used to guide needles for radiation delivery within the breast. It mentions guiding needles, placing catheters, and connecting to an afterloader. These are all components of a radiation therapy delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
In summary, the Kuske Breast Applicator Set is a medical device used for delivering radiation therapy, which is a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Kuske Breast Applicator Set has the same intended use as the legally marketed predicate device cited:
Nucletron Kuske Breast Applicator Set is intended for use with Interstitial breast brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR.
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 purpose of the Modification of the Device is to is to provide a tool for guiding the needles on a well determined position through the breast. The Kuske Breast Applicator Set is based on the microSelectron HDR V2 Breast Template for interstitial breast treatment. The template has been slightly modified in shape and hole alignment to accommodate dimensions of the breast.
The main shape of the Kuske Breast Applicator is a bridge supporting 2 templates which will be positioned at both sides of the breast. Each template contains well dimensioned holes which quide the needles in a straight way through the breast. Coordinates for each hole provide position information. The needles are exchanged after placing the flexible implant catheters, which will be connected to the afterloader.
The material for the Kuske Breast Applicator has been changed, to accommendate the use of CT/MR techniques. The Kuske Breast Applicator Set uses similar materials as the legally marketed predicate device cited (MicroSelectron HDR V2: CT/MR Ring Applicator). With respect to the the legally marketed predicate device cited (MicroSelectron HDR V2: Breast Template), the shape has been changed and the number of holes has been increased to accommendate better needle placement.
The Kuske Breast Applicator Set is an accessory to the microSelectron-HDR (V2).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/MR techniques
Anatomical Site
breast
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.
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) Nucletron Kuske Breast Applicator Set July 2002
02
K022635
Nucletron
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
Page 7-11
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: | 7080 Columbia Gateway Drive |
| Columbia, MD 21046-2133 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | Kuske Breast Applicator Set |
|---|---|
| Common/Usual Name: | Remote Controlled Afterloading System |
| Classification Name: | Radiotherapy Device |
| Classification: | Class II |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | 10.04 - 1.0 2008 200 - 1.4 1.2
Device Device
1 5 5 6 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
. I
1000 1000 100 100 2002 100 100 100 100 100 100 100 100 100 100 100 100 100 100 | 510(k) # |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Nucletron BV | 1 K953946 microSelectron-HDR V2 | K953946 |
Description:
The purpose of the Modification of the Device is to is to provide a tool for guiding the needles on a well determined position through the breast. The Kuske Breast Applicator Set is based on the microSelectron HDR V2 Breast Template for interstitial breast treatment. The template has been slightly modified in shape and hole alignment to accommodate dimensions of the breast.
6 2002
1
Special 510(k) Nucletron Kuske Breast Applicator Set July 2002
The main shape of the Kuske Breast Applicator is a bridge supporting 2 templates which will be positioned at both sides of the breast. Each template contains well dimensioned holes which quide the needles in a straight way through the breast. Coordinates for each hole provide position information. The needles are exchanged after placing the flexible implant catheters, which will be connected to the afterloader.
The material for the Kuske Breast Applicator has been changed, to accommendate the use of CT/MR techniques. The Kuske Breast Applicator Set uses similar materials as the legally marketed predicate device cited (MicroSelectron HDR V2: CT/MR Ring Applicator). With respect to the the legally marketed predicate device cited (MicroSelectron HDR V2: Breast Template), the shape has been changed and the number of holes has been increased to accommendate better needle placement.
The Kuske Breast Applicator Set is an accessory to the microSelectron-HDR (V2).
Intended use:
The Nucletron Kuske Breast Applicator Set has the same intended use as the legally marketed predicate device cited:
Nucletron Kuske Breast Applicator Set is intended for use with Interstitial breast brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR.
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 Kuske Breast Applicator Set is substantially equivalent to the cleared predicate device, microSelectron-HDR V2, 510(k)#: K953946.
Hllschet
22-7-2002
Name: H. Schot Title: i.a. Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands
Date
2
Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized image of an eagle. The eagle is facing left and has three lines representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2002 SEP
Re: K022635
Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133
Trade/Device Name: Kuske Breast Applicator Set Model 189.006 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator set Regulatory Class: II
Product Code: 90 JAQ Dated: August 6, 2002 Received: August 8, 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 (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
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-459 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4610 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4610 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (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 by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page_ _of
KO22635 510(k) Number (if known) :_
Model 189.006 Breast Applicator Set Device Name:
Indications For Use:
The Kuske Breast Applicator Set has the same intended use as the legally marketed predicate device cited:
Nucletron Kuske Breast Applicator Set is intended for use with Interstitial breast brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Gi. Seymm
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)