The device is intended for intracavitary for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial brachytherapy.

Device Description

The Geneva is a gynecological applicator for intracavitary brachytherapy with the option for interstitial brachytherapy treatment. It can be used for the treatment of the cervix and endometrium. The applicator consists of tubes and ovoids, guiding the radioactive source of the afterloader to the target volume. Compatible components can be combined to reach a wide range of target areas.

AI/ML Overview

This document is a 510(k) summary for the Geneva Brachytherapy Applicator. It does not contain the detailed study results needed to complete all sections of your request. Specifically, it lacks quantitative performance metrics, sample sizes for specific tests, and expert qualifications for ground truth establishment.

Based on the provided text, here’s what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Intended Use	Suitable for intracavitary brachytherapy for cancer treatment of the cervix and endometrium, with optional interstitial brachytherapy.
User Needs	Tests demonstrated suitability of the device to its intended use and user needs.
Clinical Acceptance	Tests demonstrated clinical acceptance of the device.
Usability	Usability testing demonstrated the device can be used by intended users under simulated clinical conditions without serious use errors or problems.
Reprocessing	Validation of reprocessing processes performed.
Biological Evaluation	Biological evaluation performed.
Imaging Compatibility	Can be used in MR, CT, X-ray, and US environments.
Performance Requirements (General)	Bench testing shows that the device meets its performance requirements. Performs as defined in the requirements, meets clinical expectations, and is safe and effective for clinical use.
Substantial Equivalence	Determined to be substantially equivalent in intended use, function, design, and technological characteristics to the legally marketed predicate device (Nucletron B.V. Utrecht Interstitial CT/MR Applicator Set, K091154).

Missing Information for this Section: The document does not provide specific quantitative acceptance criteria (e.g., "accuracy must be > 95%") or specific quantitative performance metrics achieved by the device (e.g., "achieved 98% accuracy"). The descriptions are high-level and qualitative.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "bench testing" and "usability testing" but does not give a number of cases, applicators, or participants.
Data Provenance: The bench testing was performed at a "hospital site" under "simulated clinical conditions." This indicates prospective testing in a controlled environment, likely within the Netherlands, given the submitter's address. It is not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified. The document states "involvement of clinical personnel" and "Experienced users reviewed the device design and executed validation tests."
Qualifications of Experts: The clinical personnel and experienced users were involved, but their specific qualifications (e.g., type of physician, years of experience) are not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified. The exact method by which "experienced users reviewed the device design and executed validation tests" and how "clinical acceptance" was determined is not detailed. It likely involved expert review and consensus given the clinical context but no specific method like 2+1 is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is a physical medical device (brachytherapy applicator), not an AI software. Therefore, an MRMC study related to AI assistance for human readers is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a hardware device, not an algorithm. Performance testing was focused on the device's physical and functional capabilities, not an algorithm's standalone performance.

7. The type of ground truth used

Type of Ground Truth: The ground truth appears to be based on expert consensus/clinical judgment and engineering requirements. The "suitability of the device to its intended use and user needs," "clinical acceptance," and compliance with "performance requirements" were assessed by clinical personnel and experienced users during simulated clinical conditions. There's no mention of pathology, outcomes data, or other objective patient-specific ground truth as it was not a patient study.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. This is a physical device, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for such devices typically involves iterative design, prototyping, and internal testing, which isn't described with a formal "training set" size in this context.

9. How the ground truth for the training set was established

How Ground Truth for Training Set Was Established: Not applicable/Not specified. As this is not an AI/ML device, the concept of a training set ground truth does not apply. The development would have followed engineering design principles and standards, with requirements likely established based on existing clinical practices, predicate device characteristics, and regulatory standards.

Summary

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July 16, 2020

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Nucletron BV % Rigo Meens Head of QA Waardgelder 1 Veenendaal, Utrecht 3905 TH THE NETHERLANDS

Re: K201272

Trade/Device Name: Geneva Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: Class II Product Code: JAO Dated: March 20, 2020 Received: May 12, 2020

Dear Rigo Meens:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement A4.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K201272

Device Name Geneva

Indications for Use (Describe)

The device is intended for intracavitary for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial brachytherapy.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary A5.

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K201272

20 March 2020

Submitter of 510(k):

510(k) Summary

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
Correspondent:	Leidimar Guararima

Device Name:

Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification: Product code:

Geneva Brachytherapy Applicator Remote controlled radionuclide applicator system 21CFR892.5700, Class II JAQ

Legally Marketed Device(s)

Our device is substantially equivalent to the following legally marketed predicate device:

Manufacturer	Device	510(K)#	Device classification
Nucletron B.V.	Utrecht Interstitial CT/MRApplicator Set	K091154	Class II

Indications for use:

The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial brachytherapy.

The indications for use for the Geneva are identical to the indications for use of the legally marketed above-mentioned predicate device.

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 qualified physicians. Geneva is used in the same anatomical sites as the predicate device and is made of the same materials.

The devices are compatible with Nucletron remote afterloader systems and accessories. Section C provides an overview of the similarities and differences of Geneva with the predicate device.

The subject device is tandem and ovoid type applicator with compatible interstitial needles. Geneva is identical in principle technology, clinical function and technical and biological characteristics to the predicate device design fits in the same

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clinical workflow as the predicate device. As a result, it is determined that the Geneva is substantially equivalent to the legally marketed predicate device.

Summary of testing:

Bench testing was performed at a hospital site, under simulated clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment to patients. Experienced users reviewed the device design and executed validation tests. The test results demonstrated the suitability of the device to its intended use and user needs and demonstrated clinical acceptance of the device.

Usability testing demonstrated that the device can be used by the intended users, under simulated clinical conditions, without serious use errors or problems. Validation of reprocessing processes and biological evaluation was performed. The device can be used in the MR, CT, X-ray and US environments. Bench testing (similar to bench testing done to the Legally Marketed Device) shows that the device meets its performance requirements.

The results of the testing provided in this submission adequately demonstrate that the Geneva performs as defined in the requirements, meets clinical expectations and is safe and effective for clinical use.

Conclusion:

As a result, it was determined that Geneva is substantially equivalent in intended use, function, design and technological characteristics to the legally marketed predicate device.

Regulation Number and Section

§ 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.