(35 days)
Not Found
No
The description focuses on the mechanical function of the applicator as an accessory for brachytherapy, with no mention of AI/ML terms or functionalities.
Yes
The device is described as an "accessory to the Nucletron remote afterloading equipment" and is used to deliver a "prescribed dose of radiation" for "surface Brachytherapy procedures," which are medical treatments.
No
The device is a "Skin Applicator Set" used for surface Brachytherapy procedures, which is a treatment method involving the delivery of radiation. Its purpose is to provide a treatment path for a radioactive source, not to diagnose conditions.
No
The device description clearly describes a physical applicator set made of materials that provide a treatment path for a radioactive source and prevent contact with body fluids. It is a hardware accessory to a remote afterloading equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surface Brachytherapy procedures involving the Nucletron remote afterloading equipment." This describes a therapeutic procedure using radiation, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical applicator used to guide a radioactive source for treatment. It emphasizes its role in delivering radiation and preventing contact with body fluids, which are characteristics of a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Valencia Skin Applicator Set is intended for surface Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.
Product codes
JAO
Device Description
The Valencia Skin Applicator Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, microSelectron and is intended for surface Brachytherapy procedures.
The Valencia Skin Applicator is placed over the treatment area. The applicator is then attached to the afterloader (treatment head), using transfer tubes. 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 afterloader and the clinical staff verify that the applicator is properly attached prior to the 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. After the treatment the applicator is disconnected from the attached transfer tubes, and removed from the patient.
The device is the same as the legally marketed predicate device cited. The only change is that the device is equipped with a fixed flattening filter that provides a flat homogeneous isodose pattern. The Valencia Skin Applicator Set is used as an accessory to the Nucletron microSelectron.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
Image /page/0/Picture/1 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square logo. The logo contains a black shape with two white circles inside.
DEC 0 7 2007
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 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: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | Valencia Skin Applicator Set |
|---|---|
| Common/Usual Name: | Remote Afterloading for Intracavitary Brachytherapy applications |
| 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 | Leipzig Applicator Set | K953946 |
7.1 Description of Modified Device
The Valencia Skin Applicator Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, microSelectron and is intended for surface Brachytherapy procedures.
The Valencia Skin Applicator is placed over the treatment area. The applicator is then attached to the afterloader (treatment head), using transfer tubes. 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 afterloader and the clinical staff verify that the applicator is properly
1
attached prior to the 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. After the treatment the applicator is disconnected from the attached transfer tubes, and removed from the patient.
The device is the same as the legally marketed predicate device cited. The only change is that the device is equipped with a fixed flattening filter that provides a flat homogeneous isodose pattern. The Valencia Skin Applicator Set is used as an accessory to the Nucletron microSelectron.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
Valencia Skin Applicator Set is intended for surface Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.
Summary of technological considerations:
The Valencia Skin Applicator Set is substantially equivalent to the cleared predicate device, Leipzig Applicator Set, 510(k)#: K953946.
Name: Erik Agterhuis Title: Manager Product Marketing Nucletron B.V. Veenendaal, The Netherlands - -
25-04-2007
Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2007
Ms. Lisa Dimmick Director Quality Assurance & Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive Columbia, MD 21046
Re: K073107
Trade/Device Name: Valencia Skin Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Control Radionuclide Applicator System Regulatory Class: II Product Code: JAO Dated: November 2, 2007 Received: November 5, 2007
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 iddications 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 Amendmouts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr w 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, l'usti in 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 (1 vire 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 (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.
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/cdrb/industry/support/index.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
Indications for Use Statement
510(k) Number
Device Name Valencia Skin Applicator Set The Valencia Skin Applicator Set is intended for surface Brachytherapy Indications for procedures involving the Nucletron remote afterloading equipment: mHDR. Use
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) | |
|---|---|
| OR | |
| Over-The-Counter |
(División Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K1075107
Use