The Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area.

Device Description

The Nucletron Intracavitary Mould Applicator Set as described in this submission is designed for Intracavitary Brachytherapy procedures. The device consists of a disposable silicone cylinder, with eight radial placed catheters to the surface of the cylinder, which is inserted Intracavitary into the target volume, i.e. the rectum. The cylinder is fixated, by using an applicator introduction tool and the filling wires are removed, which protected the catheters from kinking during transport. In the center of the cylinder a central catheter can be placed. X-ray catheters or CT markers are inserted into the application. Radiographic images, planal images or transverse images of the target volume are taken to determine the precise position of the applicator. This information is then used for Brachytherapy treatment planning purposes. The Intracavitary Mould Applicator Set is a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the radioactive source. The afterloader is the treatment unit, it strictly provides a treatment path for the treatment source. The physicist and the clinical staff verify that the applicator is properly attached prior to treatment. For the first treatment the Intracavitary Mould Applicator Set is attached to the afterloader (treatment head), doing transfer tube. After the applicator is properly attached, a check cable run is performed to ensure that there are no obstructions, which will interest the transfer of the cable run. In a province of cable run, the radioactive source will be transferred into the applicator and the prescribed dose of radiation will be delivered. After the treatment is completed the Intracavitary Mould Applicator Set is removed from the patient. The device uses similar (implantable) materials as in the legally marketed predicate device cited the Freiburger Flap. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set. The Intracavitary Mould Applicator Set is used as an accessory to the Nucletron microSelectron.

AI/ML Overview

Here's an analysis based on the provided document, addressing your request for acceptance criteria and study information.

Important Note: The provided document is a 510(k) summary for a medical device (Intracavitary Mould Applicator Set) that demonstrates substantial equivalence to a predicate device. This type of submission generally does not include rigorous clinical studies with acceptance criteria, sample sizes, and expert ground truth establishment in the same way a de novo or PMA submission would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device. Therefore, many of your requested points will either be "Not Applicable" (N/A) or indicate that such detailed studies were not required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Intended Use Equivalence	The modified device must have the same intended use as the legally marketed predicate device (K953946, Miami Vaginal Applicator Set).	The "Intracavitary Mould Applicator Set is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment." This is stated to be the same intended use as the predicate device.
Technological Characteristics Equivalence	The device must be "substantially equivalent" in design, materials, and operating principles to the predicate device.	The device consists of a disposable silicone cylinder with eight radial catheters for brachytherapy. X-ray catheters/CT markers are used for planning. It's a closed system to prevent source contact with body fluids. It uses similar (implantable) materials and similar implant techniques as the predicate device (Freiburger Flap and Miami Vaginal Applicator Set). The manufacturer explicitly states the device is "substantially equivalent to the cleared predicate...K953946."
Safety and Effectiveness (Implied)	The device must be as safe and effective as the predicate device for its intended use. This is demonstrated through equivalence claims.	The device is designed to correctly position radiation sources for intracavitary brachytherapy. The closed system design prevents radioactive source contact with body fluids. A check cable run is performed to ensure proper applicator attachment and absence of obstructions. The materials are similar to legally marketed implantable devices. No specific quantitative safety/effectiveness metrics or studies are reported in this 510(k) summary beyond the substantial equivalence claim.
Applicator Functionality and Use with Afterloader	The applicator must function correctly with Nucletron remote afterloading equipment and facilitate the delivery of prescribed radiation doses.	The device is explicitly designed for use with "Nucletron remote afterloading equipment" and "strictly provides a treatment path for the treatment treatment unit." The "Adler the treatment" describes the process of checking the applicator position and ensuring the absence of obstructions before treatment, which implies functional verification. The "Indications for Use Statement" mentions "The applicator set provides a means of delivering the prescribed radiation dose to the treatment area." No quantitative performance data for dose delivery accuracy or applicator reliability are provided.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable. This 510(k) summary does not describe a formal "test set" or a clinical study that would have such a sample size. The substantial equivalence argument is based on comparison of design, materials, and intended use against a predicate device.
Data Provenance: Not applicable for a traditional test set. The information provided is descriptive of the device and its relation to a predicate device, not data from a specific clinical evaluation.

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. No formal ground truth establishment process for a test set is described in this 510(k) summary.
Qualifications of Experts: N/A.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication is described.

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 an accessory for brachytherapy and does not involve AI or human "readers" in the diagnostic sense.
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: No. This device is a physical applicator, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable for a formal study. The "ground truth" here is the prior FDA clearance of the predicate device (K953946), implying its safety and effectiveness have already been established. The new device is compared against this established benchmark.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable.

Summary of the K041715 Submission:

This 510(k) submission for the Nucletron Intracavitary Mould Applicator Set relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (Nucletron's Miami Vaginal Applicator Set, K953946). The key argument is that the new device has:

The same intended use.
Similar technological characteristics (design, materials, operating principle).
Raises no new questions of safety or effectiveness.

Therefore, the submission does not contain or require the types of detailed clinical performance studies (with acceptance criteria, sample sizes, expert ground truth, etc.) that would typically be associated with AI/ML devices or novel high-risk devices undergoing a De Novo or PMA pathway. The "acceptance criteria" are effectively satisfied by a successful argument for substantial equivalence, which the FDA concurred with, allowing the device to be marketed.

Summary

{0}------------------------------------------------

KO41715

MAR * 4 7005

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo with a black background and two white circles. The circles are positioned on opposite corners of the square, with a curved line connecting them.

NUCLETRON B.V

Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O. Box 930 The Nether ands Phone +31 318 5!57133 +31 318 550485 Fax

Department of Health and Human Services Dopartino of Device and Radiological Health Office of Device Evaluation Special 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 DriveColumbia, MD 21046
Phone:	410-312-4100
Fax:	410-312-4197
Correspondent:	Lisa DimmickDirector Assurance & Regulatory Affairs

Modified Device Name:

Trade/Proprietary Name:	Intracavitary Mould Applicator Set
Common/Usual Name:	Remote Afterloading for Intracavitary Brachytherapy applications
Classification Name:	Remote controlled radionuclide applicator system accessory
Classification:	21Cfr892.5700 Class II

Legally Marketed Device(s)

Legally Marketed Device(o)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

	Manufacturer: トーム
		K953946
Nucletron BV	l Miami Vaqinal Applicator Set
	A Company of Children Comments of Children Comments of Children

{1}------------------------------------------------

Description:

The Nucletron Intracavitary Mould Applicator Set as described in this submission is designed
ed for The Nucletion intracavitary Mould Application of the equipment and is intended for Intracavitary Brachytherapy procedures.

The device consists of a disposable silicone cylinder, with eight radial placed catheters to the recture The device consists of a unsposable shirts of into the target volume, i.e. the rectum.
surface of the cylinder, which is inserted Intracavitary into the insertion tool and th surface of the cylinder, which inserted introduction of the insertion tool and the I he cylinder is lixated, by using an uppliouted the cathers from kinking during transport. The cylings and filling wires are removed, which protected the catholors in a consisted on the manage the central catheter can be placed.

X-ray catheters or CT markers are inserted into the application. Radiographic X-ray catheters of CT markers are into in the interest the precised to determine the precises lmages, planal limis of transvoros of one of this information is then used for Brachytherapy treatment planning purposes.

The Intracavitary Mould Applicator Set is a closed system to prevent the radioactive source The Intracavitary Modio Applicator Git ... The treatment catheter does not control the from coming in contact with body nulles The Cadioactive source. The afterloader
treatment unit, it strictly provides a treatment path for the treatment treatment unit, it strictly provided a treatment.
and the clinical staff verify that the applicator is properly attached prior to treatment.

For the first treatment the Intracavitary Mould Applicator Set is attached to the affection the sherita For the first treatment the intradurities would be applicator is attached, a check cable run is (treatment nead), doing transfer tusator is properly attached and that there are no penormed to ensure that the applicate. In a province of cable run, the radioactive source obstructions, which will interest and the prescribed dose of radiation.

After the treatment the Intracavitary Mould Applicator Set is disconnected from the attached Atler the treatment the miradamary motion is completed the Intracavitary Mould Applicator Set is removed from the patient.

The device uses similar (implantable) materials as in the legally marketed predicate device rited the Freiburger Flap. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set.

The Intracavitary Mould Applicator Set is used as an accessory to the Nucletron microSelectron.

Intended use:

The modified device has the same intended use as the legally marketed predicate device cited:

The Intracavitary Mould Applicator Set is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment.

Summary of technological considerations:

{2}------------------------------------------------

The Intracavitary Mould Applicator Set is substantially equivalent to the cleared predicate The Intracavitary Moura Applicator Set, 510(k)#: K953946.

14-6-2004

Name: Frits van Krieken Title: Business Segment Manager Nucietron B.V. Veenendaal, The Netherlands

Date

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046

Re: K041715

MAR 2 4 2005

Trade/Device Name: Intracavitary Mould Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ

Dated: March 1, 2005 Received: March 2, 2005

Dear Ms. Dimmick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in we have reviewed your Security premainter in substantially equivalent (for the indications for use stated in above and have determined the devices is accession interstate commerce prior to the enclosure) to regarly maneled predical Device Amendments, or to devices that have been May 26, 1970, the elactificant date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provinsions of approval application (PMA). You may, therefore, market the do not require approval of a premainer approval spfth Act. The general controls provisions of the Act. device, subject to the general volusions provinces, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classined (see as re) hitional controls. Existing major regulations affecting your Approval), it thay be subject to sublications, 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 r lease oc advised mat 1 Dr. i issues of the see complies with other requirements of the Act or any FDA has made a accemination mad your as a more of the Federal agencies. You must comply with all the rederal statues and regulations administrited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, metading, but not minute requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k)
This in the supportunity of the of a light of sectiol seguinlence of your device This letter will allow you to begin makemig of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence and thi market notification. The FDA Imanig of substantial equilable of your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labering regarded. (
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misorialians of our responsibilities under the Act from the 180 807.97). You may obtain other general mornation on Jour September Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k)Number	K041715
Device NameIndications forUse	Intracavitary Mould Applicator SetThe Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Maurice Hayden

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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.