(41 days)
Not Found
No
The device description focuses on the mechanical components and materials of a brachytherapy applicator. There is no mention of AI or ML in the intended use, device description, or performance studies. The mention of CT imaging is for treatment planning, not necessarily involving AI/ML for image analysis or decision support.
Yes
The device is used for intracavitary brachytherapy, which is a form of radiation therapy for cancer treatment, indicating its therapeutic intent.
No
The device is described as being for "treatment of the cervix and endometrium" and for "intracavitary brachytherapy" and "cancer treatment." It guides a radioactive source for treatment, not for diagnosis.
No
The device description clearly outlines physical components made of Titanium and PPSU, designed for intracavitary brachytherapy and guiding radioactive sources. This indicates a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Henschke Titanium Applicator Set is a medical device used for delivering radiation therapy directly to the cervix and endometrium for cancer treatment. It is an applicator that guides a radioactive source.
- Lack of Specimen Analysis: The description clearly states the device's purpose is to guide a radioactive source for treatment. There is no mention of analyzing any biological specimens.
Therefore, based on the provided information, the Henschke Titanium Applicator Set is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Henschke Titanium Applicator Set is designed for treatment of the cervix and endometrium.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Henschke Titanium Applicator Set is a modification of the Henschke Applicator Set (K953946). It is intended for intracavitary brachytherapy and is used for cancer treatment of the cervix and endometrium.
The Henschke Titanium Applicator Set is a gynecological applicator for Brachytherapy procedures. The applicator uses an intrauterine tube and two colpostat tubes. A colpostat cap can be placed on each colpostat tube.
The tubes guide the radioactive source of the afterloader to the location where treatment is to be applied. Transfer tubes are required to connect the applicator to the afterloader.
With the adjustable cervical stopper, the intrauterine tube-length can exactly be fitted to the patient's anatomy. The intrauterine tube has adjustment centimeter-markings.
The device is compatible with Nucletron afterloaders.
The applicator is made of Titanium and PPSU, to minimize distortion on CT imaging. This enables conformal treatment planning with the use of CT images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging
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)
Henschke Titanium Applicator Set has been tested to meet the product requirements, requirements from (safety) standards and clinical expectations. Verification covers functional verification testing. Bench testing was performed at a hospital site, under clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment of patients. Experienced users reviewed the device design and executed validation tests.
The results of the testing provided in this submission adequately demonstrate that the Henschke Titanium Applicator Set performs as defined in the requirements, meets clinical expectations and is safe and effective for clinical use.
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized design of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nucletron B.V. % Ms. Lizette van de Streek RA Engineer and Export Control Specialist Waardgelder 1 3905 TH Veenendaal THE NETHERLANDS
June 23, 2015
Re: K151272
Trade/Device Name: Henschke Titanium Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: May 12, 2015 Received: May 13, 2015
Dear Ms. van de Streek:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K151272 |
|---|---|
| Device Name: | Henschke Titanium Applicator Set |
| Indications for Use: | The Henschke Titanium Applicator Set is designed for |
| treatment of the cervix and endometrium |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 Center for Devices and Radiological Health (CDRH)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the Elekta company logo. The logo consists of a circle with a broken line and four dots inside, followed by the word "ELEKTA" in capital letters. The circle and the word are in a gray color. The logo is simple and modern.
510(k) Summary
12 May 2015
Submitter of 510(k):
| Company name: | Nucletron B.V. |
|---|---|
| Registration number: | 611894 |
| Address: | Waardgelder 1, 3905 TH Veenendaal, The Netherlands |
| Phone: | +31 318 557 133 |
| Fax: | +31 318 557 118 |
| Correspondent: | Lizette van de Streek |
Device Name:
| Trade/Proprietary Name: | Henschke Titanium Applicator Set |
|---|---|
| Common/Usual Name: | Intracavitary Brachytherapy applicator |
| Classification Name: | Remote controlled radionuclide applicator system |
| Classification: | 21CFR892.5700, Class II |
| Product code: | JAQ |
Legally Marketed Device(s)
Our device is substantially equivalent to the predicate device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron B.V. | HENSCHKE APPLICATOR SET (included in 510(k) for | |
| MICROSELECTRON-HDR VERSION 2) | K953946 |
Description:
The Henschke Titanium Applicator Set is a modification of the Henschke Applicator Set (K953946). It is intended for intracavitary brachytherapy and is used for cancer treatment of the cervix and endometrium.
The Henschke Titanium Applicator Set is a gynecological applicator for Brachytherapy procedures. The applicator uses an intrauterine tube and two colpostat tubes. A colpostat cap can be placed on each colpostat tube.
The tubes guide the radioactive source of the afterloader to the location where treatment is to be applied. Transfer tubes are required to connect the applicator to the afterloader.
With the adjustable cervical stopper, the intrauterine tube-length can exactly be fitted to the patient's anatomy. The intrauterine tube has adjustment centimeter-markings.
The device is compatible with Nucletron afterloaders.
ELEKTA | Nucletron B.V. | P.O. Box 930, 3900 AX Veenendaal | Visiting address: Waardgelder 1 | 3905 TH Veenendaal | The Netherlands | Phone: +31 318 557 133 | brachytherapy@elekta.com| www.elekta.com
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The applicator is made of Titanium and PPSU, to minimize distortion on CT imaging. This enables conformal treatment planning with the use of CT images.
Indications for use:
The Henschke Titanium Applicator Set is intended for intracavitary brachytherapy and is used for cancer treatment of the cervix and endometrium.
The indications for use of the modified Henschke Titanium Applicator Set are the same as the indications for use of the predicate device.
Summary of technological considerations:
The Henschke Titanium Applicator Set is used by the same users as the predicate device, at the same location and the general operating principle is the same. The device is used for the same anatomical sites and insertion techniques. The sterilization method does not change.
The device its environmental specifications are changed: the device can now also be used in combination with CT imaging by changing the device materials to a type of material that has been used in other legally marketed devices within the same classification regulation.
These differences do not affect the similarity in principal technology, function and operational characteristics of the devices. As a result, it is determined that the Henschke Titanium Applicator is substantially equivalent to the predicate device.
Summarv of testing:
Henschke Titanium Applicator Set has been tested to meet the product requirements, requirements from (safety) standards and clinical expectations. Verification covers functional verification testing. Bench testing was performed at a hospital site, under clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment of patients. Experienced users reviewed the device design and executed validation tests.
The results of the testing provided in this submission adequately demonstrate that the Henschke Titanium Applicator Set performs as defined in the requirements, meets clinical expectations and is safe and effective for clinical use.
Conclusion:
Nucletron considers the Henschke Titanium Applicator Set to be substantially equivalent to legally marketed predicate device through the data and information presented. No safety or effectiveness issues were identified.