The Fletcher CT/MR Shielded Applicator Set is a modification of the Fletcher Williamson Applicator Set (K983341). It is a gynecological applicator for brachytherapy procedures. The applicator uses one intrauterine tube and two ovoid tubes for treatment of the cervix and endometrium cancer. The tubes quide the radioactive source of the afterloader to the location where treatment is to be applied. Tungsten allov shielding is incorporated in the ovoid to lower the dose in organs like rectum and bladder during treatment. The shielding position in the ovoid is adjustable, enabling CT imaging with few artifacts. For MR data acquisition and X-ray it is not necessary to move the shields. The Fletcher CT/MR Shielded Applicator Set is available in two variations and is compatible with Nucletron afterloaders and accessories.

AI/ML Overview

This document is a 510(k) summary for the Nucletron BV Fletcher CT/MR Shielded Applicator Set. It acts as a premarket notification for a modified medical device. The information provided heavily focuses on demonstrating "substantial equivalence" to a predicate device rather than comprehensive clinical study data typical for a new AI/software device. As such, many of the requested fields cannot be directly extracted or are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or performance metrics in the format typically seen for a new AI/software medical device. The "acceptance criteria" here are implied by the demonstration of "substantial equivalence" to a legally marketed predicate device (Nucletron BV Fletcher Williamson Applicator Set, K983341).

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	The applicant states, "No safety or effectiveness issues were identified." This is the overarching claim for substantial equivalence.
Technological Equivalence	"The operating principle is the same as the marketed device. The modified design combines the characteristics of the marketed device (shielding in the ovoids) with materials that allow CT and MR imaging, enabling 3D treatment planning." "Ovoid and intrauterine dimensions of the modified device are comparable to the marketed devices."
Imaging Compatibility	"Tungsten alloy shielding is incorporated in the ovoid to lower the dose in organs like rectum and bladder during treatment. The shielding position in the ovoid is adjustable, enabling CT imaging with few artifacts. For MR data acquisition and X-ray it is not necessary to move the shields." "The device was tested for use in the MR and CT environment."
Performance Requirements	"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." (Specific performance metrics are not detailed, but the equivalence to predicate device performance is claimed).
Sterilization & Biocompatibility	"Validation of sterilization processes and biological evaluation was performed." (Details of methods and results not provided within this summary).

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

Test Set Sample Size: Not explicitly stated. The "testing" mentioned is primarily related to bench testing, sterilization, biological evaluation, and MR/CT compatibility. These tests typically involve a sample of the physical device, not an imaging dataset for AI evaluation.
Data Provenance: Not applicable in the context of an AI/software device. This is a physical medical device.

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

Number of Experts: Not applicable. Ground truth, in the context of an AI/software device, involves expert labeling of data. This document describes a physical medical device.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication method: Not applicable.

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 is not an AI/software device, but a physical brachytherapy applicator. Therefore, no MRMC study involving human readers and AI assistance was performed or described.

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

Standalone Performance: Not applicable. This is not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: For this physical device, "ground truth" would be established through engineering specifications, material properties, physical measurements, and performance benchmarks validated against the predicate device. For example, the "truth" for shielding effectiveness would be measured dose reduction, and for imaging compatibility, it would be the quality of the CT/MR images with the device in place (e.g., artifact levels). Specific details are not provided beyond the general statement of "bench testing" and "meeting performance requirements."

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not an AI/Machine Learning device.

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

Ground Truth for Training Set: Not applicable.

Summary Explanation:

This 510(k) summary is for a physical medical device, specifically a gynecological brachytherapy applicator. The "study" referenced is primarily bench testing, sterilization validation, biological evaluation, and MR/CT compatibility testing to demonstrate that the modified device (Fletcher CT/MR Shielded Applicator Set) is substantially equivalent to a previously legally marketed predicate device (Fletcher Williamson Applicator Set, K983341).

The document's purpose is to show that despite modifications (incorporating tungsten alloy shielding for CT/MR imaging compatibility), the new device operates on the same principle, has comparable dimensions, and meets performance requirements similar to the predicate device, with no new safety or effectiveness issues. The acceptance criteria are therefore implicit in proving this substantial equivalence across various engineering and performance attributes, rather than explicit statistical thresholds for diagnostic accuracy metrics typically associated with AI/software devices.

Summary

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K132889/
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NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557 133 Fax +31 318 557 118

FEB 2 6 2014

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

510(k) Summary

September 13, 2013

Submitter of 510(k):

Company name: Nucletron BV Registration number: 611894 Address: Waardgelder 1, 3905 TH Veenendaal, The Netherlands Phone: +31 318 557 133 Fax: +31 318 557 118 Correspondent: Rudolf Vos

New Device Name:

Trade/Proprietary Name:	Fletcher CT/MR Shielded Applicator Set
Common/Usual Name:	Intracavitary Remote Afterloading Applicator
Classification Name:	system, applicator, radionuclide, remote-controlled
Classification:	21 CFR 892.5700, 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 Fletcher Williamson Applicator Set·	K983341

Description:

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K132889
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Tungsten allov shielding is incorporated in the ovoid to lower the dose in organs like rectum and bladder during treatment. The shielding position in the ovoid is adjustable, enabling CT imaging with few artifacts. For MR data acquisition and X-ray it is not necessary to move the shields.

The Fletcher CT/MR Shielded Applicator Set is available in two variations and is compatible with Nucletron afterloaders and accessories.

Intended use:

The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.

Summary of technological considerations:

The operating principle is the same as the marketed device. The modified design combines the characteristics of the marketed device (shielding in the ovoids) with materials that allow CT and MR imaging, enabling 3D treatment planning. The shielding position in the ovoid is adjustable, enabling CT imaging with few artifacts. For MR data acquisition and X-ray it is not necessary to move the shields. Ovoid and intrauterine dimensions of the modified device are comparable to the marketed devices.

Summary of testing:

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.

Conclusion:

Nucletron considers the Fletcher CT/MR Shielded Applicator Set to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 26, 2014

Nucletron B.V. % Mr. Rudolf Vos QA/RA Engineer Waardgelder 1 Veenendaal, 3905 TH THE NETHERLANDS

Re: K132889

Trade/Device Name: Fletcher CT/MR Shielded Applicator Set (6 mm/4 mm) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: II Product Code: JAQ Dated: January 30, 2014 Received: February 3, 2014

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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Page 2- Mr. Vos

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.

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Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris 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):

Device Name:

Indications for Use:

K132889

Fletcher CT/MR Shielded Applicator Set

The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy 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)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _______________________________________________________________________________________________________________________________________________________________________

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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.