Nucletton CET Prostate Applicator Set is intended for use with Interstitial Prostate brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

Device Description

The Nucletron CET Prostate Applicator as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR, for Interstitial Prostate brachytherapy procedures. The CET Prostate Applicator Set consists of a template and needles used for the Interstitial Prostate brachytherapy. The template is sutured to the skin surface and is designed to guide the needles into the prostate tissue. The needle while positioning around the template will anatomically encompass the prostate volume. Once the needles are in position the fixing screws are tightened to immobilize the needles within the tissue. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic, mPDR and mLDR, by the Nucletron transfer tubes. The transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there is no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete, the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device called the "Nucletron CET Prostate Applicator Set." It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the acceptance criteria or results from a study proving the device meets acceptance criteria in the way you've outlined for performance studies.

Instead, this document focuses on demonstrating substantial equivalence to a previously marketed predicate device, which is the primary route for many Class I and Class II medical devices to gain FDA clearance.

Here's a breakdown of why your requested information isn't present and what the document does provide:

No "Acceptance Criteria" or "Reported Device Performance" Table: The document doesn't define specific performance metrics or acceptance criteria because it's not a clinical trial or performance validation study. Its goal is to show the new device is as safe and effective as an existing one.
No "Sample Size" (for test set), "Data Provenance," "Number of Experts," "Adjudication Method," "MRMC Study," or "Standalone Performance" information: These are all elements of a clinical or performance study. As this is a 510(k) submission based on substantial equivalence, such studies are typically not required, especially for an accessory like this applicator. The focus is on comparing design, materials, and intended use to a known device.
No "Type of Ground Truth" or "Sample Size for Training Set" or "How Ground Truth for Training Set was Established": These concepts apply to AI/ML device development and validation. This document describes a physical medical device (an applicator set) and doesn't involve AI or machine learning.

What the document does describe that is relevant to regulatory clearance:

Device Name: Nucletron CET Prostate Applicator Set
Intended Use: For Interstitial Prostate brachytherapy procedures with specific Nucletron remote afterloading equipment (mHDR, mHDR-Classic, mPDR, mLDR). It provides a means of delivering prescribed radiation and is a closed system to prevent radioactive source contact with body fluids.
Classification Name: Accessory to remote afterloader (21 CFR 892.5700, Class II).
Predicate Device: The document states, "Our device is substantially equivalent to the legally marketed predicate device cited in the table below," but the table provided (labeled "1 11 501" and then generic text) is incomplete or corrupted in the provided text and does not list the specific predicate device(s). In a proper 510(k), this table would clearly name the predicate device(s) and provide their 510(k) numbers.
Technological Considerations: The new device "combines the functionality, components and design of the predicate device while incorporating a new material." This is the core argument for substantial equivalence.

In summary: This document is a regulatory filing for a physical medical device, not a performance study. It establishes "substantial equivalence" based on similar intended use, design, materials, and technological characteristics to a legally marketed predicate device, rather than providing detailed performance metrics from a clinical or validation study. Therefore, the specific information requested in your prompt (acceptance criteria, study details, expert involvement, etc.) is not present in this type of document.

Summary

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Premarket Notification Nucletron CET Prostate Applicator Set Date : 26 February 1999

OCT 7 1999

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 containing a black shape with two white circles. The black shape appears to be a stylized representation of an atom. The overall design is simple and modern.

K990990

NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaai P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 +31 318 550485 Fax

Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Pre-Market Notification Section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by section 807.92(c)

Submitter of 510(k) a.

Nucletron Corporation Company name: Registration # 1121753 7080 Columbia Gateway Drive Address: Columbia, MD 21046-2133 Contact Person: Ralph E. Shuping Regulatory Affairs Manager 410-312-4100 Phone:. Fax: 410-312-4197 Device Name: Trade/Proprietary Name: CET Prostate Applicator Set Common/Usual Name:

Classification Name:

Remote Afterloading Interstitial Prostate Brachytherapy Applicator Accessory to remote afterloader 21 CFR 892.5700, Class II.

Legally Marketed Predicate Device(s) C.

Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

1 11 501	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	- 4 0 /1 /
.	LEN LE LEBER BLEMILE BALLER BALLER BALLER COLLEGE OF LEE BEAR------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	COLOR CONSULERS OF A SAMERICA CALLERYACO010Company of the children and

Description ರ.

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Premarket Notification

Nucletron CET Prostate Applicator Set

Date : 26 February 1999

The CET Prostate Applicator Set consists of a template and needles used for the Interstitial Prostate brachytherapy. The template is sutured to the skin surface and is designed to guide the needles into the prostate tissue. The needle while positioning around the template will anatomically encompass the prostate volume. Once the needles are in position the fixing screws are tightened to immobilize the needles within the tissue. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic, mPDR and mLDR, by the Nucletron transfer tubes. The transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there is no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete, the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient.

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

Intended use e.

Nucletron CET Prostate Applicator Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR, for Interstitial Prostate brachytherapy procedures. The applicator provides a means of delivering the orescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

ಕೆ. Summary of technological considerations

The Nucletron CET Prostate Applicator Set is substantially equivalent to the predicate device. It combines the functionality, components and design of the predicate device while incorporating a new material.

Ludwig Haas

26-2-59

Date

Name: L. A. Johnson Title: Product Manager Nucletron B.V. Veenendaal Netherlands

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Public Health Service

OCT 7 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ralph Shuping, Sc.D Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Drive Columbia, Maryland 21046-2133 Re:

K990990 CET Prostate Applicator Set Dated: July 7, 1999 Received: July 9, 1999 Regulatory Class: II 21 CFR 892.5700/Procode: 90 JAQ

Dear Dr. Shuping:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdch/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of indications for use

510(k) Number (if known): K990990

Device Name: CET Prostate Applicator Set Indications for Use:

(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
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(Optional Format 1-2-96)

Signature
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 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.