(221 days)
Not Found
No
The description focuses on the mechanical components and function of a brachytherapy applicator, with no mention of AI or ML capabilities. The performance studies described are bench testing and usability testing, not studies typically associated with validating AI/ML algorithms.
Yes
The device is explicitly stated for use in cancer treatment of the cervix and endometrium, guiding a radioactive source for brachytherapy.
No
This device is for cancer treatment using brachytherapy, not for diagnosis. It guides radioactive sources to target volumes.
No
The device description explicitly states it consists of physical components like tubes, caps, templates, and optional needles, which are hardware. The performance studies also involve bench testing of the physical device.
Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Advanced Gynecological Applicator is a physical device used to deliver radiation therapy (brachytherapy) directly to cancerous tissue within the body (intracavitary and interstitial). It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is "intracavitary for cancer treatment of the cervix and endometrium." This clearly describes a treatment modality, not a diagnostic test.
- Device Description: The description focuses on the physical components used to guide a radioactive source for treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Advanced Gynecological Applicator falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Advanced Gynecological Applicator is intracavitary 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 Advanced Gynecological Applicator is a gynecological applicator for intracavitary and interstitial brachytherapy treatment. It can be used it for treatment of the vagina, cervix and uterus. The applicator consists of tubes, caps and templates to place needles. Components can be combined to reach a wide range of target areas. The tubes and the needles, if used, guide the radioactive source of the afterloader to the target volume.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, endometrium, vagina, uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital by trained professionals
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
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.
Usability testing demonstrates that the device can be used by the intended users, under simulated clinical conditions, without serious use errors or problems.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 test results demonstrated suitability of the device to its intended uses and clinical acceptance of the device.
Usability testing demonstrates that the device can be used by the intended users, under simulated clinical conditions, without serious use errors or problems.
Validation of sterilization processes and biological evaluation was performed. The device was tested for use in the MR and CT environment. Bench testing (similar to bench testing done to the Legally Marketed Device) shows that the device meets its performance requirements, and that the modified device performance is equivalent to the marketed devices.
The results of the testing provided in this submission adequately demonstrate that the Advanced Gynecological Applicator performs as defined in the requirements, in accordance with the recognized standards, 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Nucletron B.V. % Mr. Rudolf Vos QA Engineer Waardgelder 1 Veenendaal 3905 TH THE NETHERLANDS
Re: K161688
Trade/Device Name: Advanced Gynecological Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: December 22, 2016 Received: December 29, 2016
Dear Mr. Vos:
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 D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161688
Device Name Advanced Gynecological Applicator
Indications for Use (Describe)
The intended use of the Advanced Gynecological Applicator is intracavitary for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
3
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510(k) Summary
17 June 2016
Submitter of 510(k):
Company name: Registration number: Address: Phone: Correspondent:
Nucletron B.V. 611894 Waardgelder 1, 3905 TH Veenendaal, The Netherlands +31 318 557 133 Rudolf Vos
Device Name:
| Trade/Proprietary Name: | Advanced Gynecological Applicator |
|---|---|
| Common/Usual Name: | 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 these legally marketed predicate devices:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron B.V. | Interstitial Ring CT/MR Applicator Set | K091154 |
| Nucletron B.V. | Utrecht Interstitial CT/MR Applicator Set | K091154 |
| Nucletron B.V. | MUPIT Applicator Set | K953946 |
Description:
The Advanced Gynecological Applicator is a gynecological applicator for intracavitary and interstitial brachytherapy treatment. It can be used it for treatment of the vagina, cervix and uterus. The applicator consists of tubes, caps and templates to place needles. Components can be combined to reach a wide range of target areas. The tubes and the needles, if used, guide the radioactive source of the afterloader to the target volume.
Indications for use:
The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
The indications for use for the Advanced Gynecological Applicator are identical to the indications for use for the legally marketed Interstitial Ring CT/MR Applicator Set and the Utrecht Interstitial CT/MR Applicator Set.
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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Summary of technological considerations:
The subject device and the predicate devices are intended to provide a path for the isotope source to travel to the target volume. The devices are used in the hospital by trained professionals. The Advanced Gynecological Applicator is used in the same anatomical sites as the primary predicate device and is made of the same materials. The devices are compatible with Nucletron remote afterloader systems and accessories.
The subject device combines features from more predicate devices with the same intended use into a single device. It is a tandem and ovoid type applicator with interstitial needles. Together, two ovoids make a ring shape. The device includes a needle templates to place needles and intracavitary cylinders to treat the vaginal wall. The configuration of the needles through ovoids of the Advanced Gynecological Applicator differ from the predicate devices; some needles can be placed perpendicular to the ovoids and some are angled outwards (oblique).
These differences do not affect the similarity in principal technology, function and operational characteristics of the device design fits in the same clinical workflow as the primary predicate device. As a result, it is determined that the Advanced Gynecological Applicator is substantially equivalent to the legally marketed predicate devices.
Summary of 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 test results demonstrated suitability of the device to its intended uses and clinical acceptance of the device.
Usability testing demonstrates that the device can be used by the intended users, under simulated clinical conditions, without serious use errors or problems.
Validation of sterilization processes and biological evaluation was performed. The device was tested for use in the MR and CT environment. Bench testing (similar to bench testing done to the Legally Marketed Device) shows that the device meets its performance requirements, and that the modified device performance is equivalent to the marketed devices.
The results of the testing provided in this submission adequately demonstrate that the Advanced Gynecological Applicator performs as defined in the requirements, in accordance with the recognized standards, meets clinical expectations and is safe and effective for clinical use.
Conclusion:
As a result, it was determined that the Advanced Gynecological Applicator is substantially equivalent in intended use, function, design and technological characteristics to the legally marketed predicate devices.