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

Device Description

The Interstitial Ring CT/MR Applicator Set is based on the Ring CT/MR Applicator Set enhanced with the addition of nine guiding holes in the ring tube (seven holes for part number 110.130). These guide holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The device is similar to the legally marketed predicate device Vienna Ring CT/MR Applicator Set. The difference between this device and the Vienna Ring CT/MR Applicator Set is that this device allows the use of Proguide needles instead of the titanium needles used with the Vienna Ring CT/MR Applicator Set

The Utrecht Interstitial Fletcher CT/MR Applicator Set is based on the legally marketed predicate device Standard CT/MR Applicator Set enhanced with five similar guiding holes in each ovoid as the guiding holes in the ring of the Interstitial Ring CT/MR Applicator Set. These guiding holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ovoids. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The MR line markers are optional devices that can make the channels of the Nucletron CT/MR applicators visible using magnetic resonance imaging. The markers consist of a thin Teflon tube that can be filled with an appropriate fluid that is clearly visible on magnetic resonance images.

The tubes are inserted before imaging in the channels of the CT-MR applicator and are removed before the treatment of the patient.

The devices are used as accessories to the Nucletron microSelectron Afterloaders

AI/ML Overview

This document is a 510(k) summary for a medical device (Nucletron's Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set) seeking clearance. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment for a standalone or comparative effectiveness study is not available in the provided text.

Based on the provided text, here's what can be extracted:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a structured table as it would be for a performance study. The core "acceptance criteria" for this submission is demonstrating substantial equivalence to a legally marketed predicate device. The "performance" described relates to the features and intended use of the new device being similar to the predicate.
- Acceptance Criteria (Implicit for 510(k) Special): Substantial equivalence to the predicate devices (Ring CT/MR Applicator Set and Standard CT/MR Applicator set, K983341) regarding:
  - Intended Use (Gynecological brachytherapy for cancer treatment of cervix and endometrium, with optional interstitial brachytherapy).
  - Technological Characteristics (Polymer construction for CT/MR compatibility, similar design with added guiding holes for interstitial needles).
  - Safety and Effectiveness (Not explicitly stated in detail, but inferred by substantial equivalence).
- Reported Device Performance (Implicit):
  - Allows placement of guiding tubes for Proguide needles.
  - Enables asymmetric alteration of dose distribution.
  - Fully CT/MR compatible due to polymer composition, eliminating distortion.
  - MR line markers can make channels visible on MR images.
  - Functions as an accessory to Nucletron microSelectron Afterloaders.
Sample Size Used for the Test Set and Data Provenance:
- Not applicable (N/A). This document describes a medical device seeking 510(k) clearance based on substantial equivalence, not a performance study involving a test set of data or patient samples. The "data" here refers to the device's design specifications and comparison to a predicate.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable (N/A). No test set or ground truth derived from experts is detailed in this 510(k) summary.
Adjudication Method for the Test Set:
- Not applicable (N/A). No test set or adjudication process is detailed in this 510(k) summary.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This document does not describe an MRMC comparative effectiveness study to assess human reader improvement with or without AI assistance. This is a traditional 510(k) submission for a physical medical device (applicator set), not an AI/software device.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI/algorithm-based device. No standalone performance study for an algorithm is described.
The Type of Ground Truth Used:
- Not applicable (N/A). The concept of "ground truth" as typically used in performance studies (e.g., pathology, outcomes data) does not apply directly to this 510(k) submission. The "ground" for comparison is the predicate device's established safety and effectiveness.
The Sample Size for the Training Set:
- Not applicable (N/A). This is not an AI/machine learning device that requires training data.
How the Ground Truth for the Training Set was Established:
- Not applicable (N/A). As above, this is not an AI/machine learning device.

In summary, the provided document is a regulatory submission for device clearance, not a study report detailing performance against specific acceptance criteria in the manner one might expect for a diagnostic or AI-driven device. The focus is on demonstrating that the new applicator set is "substantially equivalent" to existing, cleared devices.

Summary

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April, 2009

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font next to a square graphic. The graphic contains a black circle with two white circles on either side of it, all enclosed in a black square. The word "Nucletron" is positioned to the right of the graphic.

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal MAY 18 200gthe Netherlands Phone +31 318 557133 +31 318 550485 Fax

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 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:	Elaina Colby
Manager Quality Assurance & Regulatory Affairs

New Device Name:

Trade/Proprietary Name:	Interstitial Ring CT/MR Applicator Set &Utrecht Interstitial Fletcher CT/MR Applicator Set
Common/Usual Name:	Gynecological Brachytherapy applicator
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	Ring CT/MR Applicator Set and Standard CT/MRApplicator set	K983341

Description:

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Special 510(k) Utrecht Interstitial Fletcher CT/MR and Interstitial Ring CT/MR Applicator

Page 30 - April, 2009

perpendicular to the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The tubes are inserted before imaging in the channels of the CT-MR applicator and are removed before the treatment of the patient.

The devices are used as accessories to the Nucletron microSelectron Afterloaders

Intended use:

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

Summary of technological considerations:

The Interstitial Ring CT/MR Applicator Set and the Utrecht Interstitial Fletcher CT/MR Applicator Set are substantially equivalent to the cleared predicate devices, Ring CT/MR Applicator Set and Standard CT/MR Applicator set, K983341

Name: Dick van Waes Title: Business Manager Nucletron B.V. Veenendaal, The Netherlands

09-04-2009
Date

KC91154

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 18 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elaina M. Colby Manager, Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046-2133

Re: K091154

Trade/Device Name: Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set

Regulation Number: 21 CFR 892.5700

Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 20, 2009 Received: April 21, 2009

Dear Ms. Colby:

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 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

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.

(240) 276-0115 (Gastroenterology/Renal/Urology) 21 CFR 876.xxx (Obstetrics/Gynecology) (240) 276-0115 21 CFR 884.xxx (240) 276-0120 21 CFR 892.xxx (Radiology) (240) 276-0100 Other

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K091154

Device Name

Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set

Indications for Use

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

Prescription Use _ X (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 CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K091154
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Page 1 of 1

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.