The Nucletron Comfort Catheter System as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment. mHDR and is intended for interstitial Brachytherapy procedures. The device consists of a Leader insertion needle with an opturator which is inserted through the skin surface into the target volume. I.e. breast. The opturator is ther removed and the flexible implant tube is inserted into hollow needle, the hollow needle is retracted when the flexible implant tube is in place. Optional a template can be used for positioning the insertion needles. Once the catheter is in place the insertion needle is removed and a button is placed over the plastic catheter and slid into contact with the skin surface. .The Flexible implant tube is pulled in position until the distal button is in contact with the skin surface. The proximal button is pulled over the flexible implant tube, until the button is in contact with the skin surface. The flexible implant tubes are cut off. at a predetermined length with the cutter. A flange is molded on the flexible implant tube with the flange molding tool, to fixate the proximal button. X-ray catheters or CT markers are inserted into the Proguide treatment needles for visualisation. Radiographic images, planar films or transverse slices, i.e. CT, MR is obtained to determine the precise location of the applicator within the body. This information is then used for Brachytherapy treatment planning purposes. The Proguide treatment needles are a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The afterloader and the clinical staff verify that the applicator is properly attached prior to treatment. For the first treatment a closed end Proguide treatment needle is inserted up to the distal end of the flexible implant tube. The Proguide treatment needle is immobilised with a stoptag. The Proquide treatment needle is attached to the afterloader (treatment head), using transfer tubes. When the applicator is attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions, which will interrupt treatment, After the check cable run, the radioactive source will step through the applicator to deliver the prescribed dose of radiation. After the treatment the Proguide treatment needles are disconnected from the attached transfer tubes and from the implant (flexible implant tubes) by using the stop tags. In between treatment fractions the Proquide treatment needle are stored in a patient treatment box. The Stop tags must remain fixed on the Proguide treatment needles for the next fraction. When the course of treatment is completed the flexible implant tubes and buttons are removed from the patient. The device uses similar (implantable) materials as the legally marketed predicate device cited (Implant Guidance System). With respect to the legally marketed predicate device cited (MicroSelectron HDR V2: Breast Template), the implant technique has been optimised for interstitial techniques such as breast implants, no longer the catheters are protruding from the patients body in between fractions. This increases the patient comfort and flexibility. It is also easier for the hospital staff to apply and remove the catheters. The Comfort Catheter System is used as an accessory to the Nucletron microSelectron.

AI/ML Overview

This appears to be a 510(k) premarket notification summary for a medical device called the "Comfort Catheter System." It establishes the substantial equivalence of the new device to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested points regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not present in this type of regulatory document.

Here's an analysis based on the provided text, indicating what information is present and what is not:

1. Table of acceptance criteria and the reported device performance:

Not present. This document doesn't define specific quantitative performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) for the device. Instead, it focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.

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

Not applicable/Not present. As this is a 510(k) summary focused on substantial equivalence, there is no "test set" in the context of evaluating algorithm performance or clinical outcomes. The regulatory filing implicitly relies on the safety and effectiveness of the predicate device.

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

Not applicable/Not present. No ground truth establishment (in the sense of expert review for data labeling) is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not present. No adjudication method 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:

Not applicable/Not present. This is not an AI/algorithm-focused device. No MRMC study is mentioned.

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

Not applicable/Not present. This is not an AI/algorithm-focused device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not present. No specific ground truth methodology is described in the context of performance evaluation. The "ground truth" for this submission is adherence to regulatory requirements and demonstration of substantial equivalence to a safe and effective predicate device.

8. The sample size for the training set:

Not applicable/Not present. There is no "training set" described as this is not an AI/machine learning device.

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

Not applicable/Not present.

Summary of available information related to "acceptance criteria" and "study":

The "study" in this context is the 510(k) premarket notification process, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device.

Acceptance Criteria (Implied for 510(k) substantial equivalence):

The primary "acceptance criterion" for this submission is that the Comfort Catheter System is substantially equivalent to the predicate device, the I Implant Guidance System (K020015), with respect to safety and effectiveness for its intended use. This is achieved by demonstrating:

Same Intended Use: The modified device has the same intended use as the legally marketed predicate device: "Comfort Catheter System is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR."
Similar Technological Considerations: The document states, "The Comfort Catheter System is substantially equivalent to the cleared predicate device, Comfort Catheter System, 510(k)#: K020015." It also highlights:
- It's designed as an accessory to Nucletron remote afterloading equipment (mHDR) for interstitial Brachytherapy.
- It uses similar (implantable) materials as the predicate device.
- It has optimized implant technique for interstitial procedures (e.g., breast implants) leading to increased patient comfort and flexibility, and easier application/removal for hospital staff (compared to MicroSelectron HDR V2: Breast Template, which is mentioned in the context of technique optimization, but K020015 is the primary predicate for substantial equivalence).
- The device is a closed system to prevent radioactive source contact with body fluids.
- The treatment catheter provides a treatment path but does not control the treatment unit; verification by afterloader and clinical staff is required.

Study Proving Device Meets Criteria:

The "study" is the 510(k) submission itself, where Nucletron B.V. presents a comparison of their device to the predicate device. The FDA's review of this submission culminated in the issuance of a substantial equivalence determination letter (AUG 15 2003, K032372).

The FDA's letter explicitly states: "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..." This statement serves as the "proof" that the device met the implicit acceptance criteria for substantial equivalence under the 510(k) pathway.

Summary

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AUG 15 2003

K∅32372

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square graphic. Inside the square is a black shape with two white circles on either side.

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The 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 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:	7080 Columbia Gateway Drive
	Columbia, MD 21046-2133
Phone:	410-312-4100
Fax:	410-312-4197
Correspondent :	Lisa Dimmick
	Director Assurance & Regulatory Affairs

Modified Device Name:

Trade/Proprietary Name:	Comfort Catheter System
Common/Usual Name:	Remote Afterloading for interstitial Brachytherapy applications
Classification Name:	Remote controlled radionucide 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:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Manufacturerwith the first and states and the different of the different to the distribution of the distribution of the distribution of the distribution of the discussion of the discussi	Device	510(k) #Party Comment of the free and reserved reality of the first of the first and the first and the first and the first and the first and the first and the first and the first and
Nucletron BV	I Implant Guidance System	K020015

Description:

The device consists of a Leader insertion needle with an opturator which is inserted through the skin surface into the target volume. I.e. breast. The opturator is ther removed and the

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

K 43237Z

flexible implant tube is inserted into hollow needle, the hollow needle is retracted when the flexible implant tube is in place. Optional a template can be used for positioning the insertion needles.

Once the catheter is in place the insertion needle is removed and a button is placed over the plastic catheter and slid into contact with the skin surface. .The Flexible implant tube is pulled in position until the distal button is in contact with the skin surface. The proximal button is pulled over the flexible implant tube, until the button is in contact with the skin surface. The flexible implant tubes are cut off. at a predetermined length with the cutter. A flange is molded on the flexible implant tube with the flange molding tool, to fixate the proximal button.

X-ray catheters or CT markers are inserted into the Proguide treatment needles for visualisation. Radiographic images, planar films or transverse slices, i.e. CT, MR is obtained to determine the precise location of the applicator within the body. This information is then used for Brachytherapy treatment planning purposes.

The Proguide treatment needles are a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The afterloader and the clinical staff verify that the applicator is properly attached prior to treatment.

For the first treatment a closed end Proguide treatment needle is inserted up to the distal end of the flexible implant tube. The Proguide treatment needle is immobilised with a stoptag. The Proquide treatment needle is attached to the afterloader (treatment head), using transfer tubes. When the applicator is attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions, which will interrupt treatment, After the check cable run, the radioactive source will step through the applicator to deliver the prescribed dose of radiation.

After the treatment the Proguide treatment needles are disconnected from the attached transfer tubes and from the implant (flexible implant tubes) by using the stop tags. In between treatment fractions the Proquide treatment needle are stored in a patient treatment box. The Stop tags must remain fixed on the Proguide treatment needles for the next fraction. When the course of treatment is completed the flexible implant tubes and buttons are removed from the patient.

The device uses similar (implantable) materials as the legally marketed predicate device cited (Implant Guidance System). With respect to the legally marketed predicate device cited (MicroSelectron HDR V2: Breast Template), the implant technique has been optimised for interstitial techniques such as breast implants, no longer the catheters are protruding from the patients body in between fractions. This increases the patient comfort and flexibility. It is also easier for the hospital staff to apply and remove the catheters.

The Comfort Catheter System 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:

Comfort Catheter System is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.

Summary of tecnnological considerations:

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K032372

The Comfort Catheter System is substantially equivalent to the cleared predicate device, Comfort Catheter System, 510(k)#: K020015.

ts van Krieken

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

13-06-2003
Date

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Image /page/3/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized bird or a wing-like shape, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 15 2003

Re: K032372

Trade/Device Name: Comfort Catheter System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: July 31, 2003 Received: August 1, 2003

Dear Mr. Ruys:

Nucletron B.V.

% Mr. Peter N. Ruys

KEMA Quality B.V.

NL-6812 AR Arnhem

THE NETHERLANDS

Utrechtseweg 310

Responsible Third Party Official

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.

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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

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Indications for Use Statement

510(k) Number

K$\phi$32372

Device Name

Comfort Catheter System

Indications for Use

Comfort Catheter System is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.

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__________________________________________________________________________________________________________________________________________________________

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devic 510(k) Numb

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.