The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.

Device Description

Integrated Brachytherap Unit - Digital (IBU-D) is a modification to the Integrated Brachytherapy Unit (IBU) in which the Image Intensifier of the IBU is replaced by a Flat Panel image detector. The Flat Panel image detector used in the IBU-D is the same Flat Panel image detector as used in Nucletron's Simulix Evolution product (K03347).

The Integrated Brachytherpay Unit – Digital (IBU-D) is a localization and simulation device for a Brachy radiation therapy department. It consists of a gantry that supports an L-arm and a C-arm which can rotate isocentrically. The C-arm houses an X-ray tube housing assembly with collimator on one side and a flat panel image detector. The movements of the IBU-D are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient table has mechanical motions which can be controlled from a hand pendant affixed to the table. Images are displayed and managed by a PC based workstation running specialized software.

The system makes also use of the same third party X-ray tube and X-ray high tension generator as used in the Simulix Evolution system.

The Flat Panel image detector which replaces the current Image intensifier is a Amorphous silicon, digital detector, with a square image area of 41 x 41 cm.

The PC based workstation runs the same software as the workstation of the Simulix Evolution system. It supports the following functionality:

. Image acquisition
Image display .
Image annotation .
Database and DICOM Import / Export functionality
Position read out and display of the IBU-D gantry. .
Control of the IBU-D beam limiting device. .

AI/ML Overview

This 510(k) summary (K072445) describes the Integrated Brachytherapy Unit - Digital (IBU-D), a modification of an existing device. It focuses on the substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner as typically found in clinical validation studies for AI/ML devices.

The submission primarily states that the IBU-D is a modification where the Image Intensifier of the original IBU (K973848) is replaced by a Flat Panel image detector. The flat panel detector and the workstation software are the same as used in Nucletron's Simulix Evolution product (K03347). The "study" here is essentially a demonstration of substantial equivalence based on the technological similarity and identical intended use to legally marketed predicate devices, rather than a clinical trial assessing performance against specific metrics.

Therefore, many of the requested elements (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, and detailed ground truth establishment for a training set) are not typically found in this type of 510(k) summary for a hardware modification of a conventional medical device. The "reported device performance" is implicitly that it performs equivalently to the predicate devices for its intended use.

However, based on the provided text, I can infer and summarize the acceptance criteria and "study" information as best as possible within the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a hardware modification (swapping an image intensifier for a flat panel detector) and relies on substantial equivalence, explicit quantitative acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) are not provided in this document. The "acceptance criteria" are implicitly met if the device functions as intended and is substantially equivalent to the predicate device.

Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
Intended Use Equivalence: The modified device has the same intended use as the legally marketed predicate device.	The IBU-D is intended for "visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system," which is stated to be the same as the predicate device.
Technological Equivalence: The core technology changes do not raise new questions of safety or effectiveness.	The "Image Intensifier of the IBU is replaced by a Flat Panel image detector." This flat panel detector and the workstation software are the same as used in a previously cleared device (Nucletron's Simulix Evolution product, K033347). The X-ray tube and high tension generator are also the same as in Simulix Evolution.
Functional Equivalence: The device performs its functions adequately.	The system supports: image acquisition, image display, image annotation, database and DICOM Import/Export, position read-out and display of the IBU-D gantry, and control of the IBU-D beam limiting device. The last two items are specific to IBU-D, but presumably meet functional requirements. The changes are presented as "modifications" rather than entirely new functionality.
Safety and Effectiveness: No new safety concerns are introduced.	The submission implies that by using previously cleared and equivalent components, the new device maintains the same safety and effectiveness profile as the predicate.

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

This submission does not describe a clinical "test set" in the traditional sense of evaluating diagnostic performance on a patient dataset. The "study" for this 510(k) is a technical and functional verification that the modified device functions correctly and is substantially equivalent to existing devices. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As no clinical test set for diagnostic performance evaluation is described, there is no mention of experts being used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

Not applicable. Without a clinical test set requiring ground truth establishment, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This submission does not include an evaluation of human readers' performance with or without AI assistance, as it concerns a hardware replacement in a radiation therapy simulation system, not an AI/ML diagnostic aid.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a hardware system for visualization and localization in brachytherapy, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant or described.

7. Type of Ground Truth Used

Not applicable. The submission focuses on technological equivalence and functional verification, not on diagnostic accuracy against a specific ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device that requires data for model training.

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

Not applicable. As there is no training set mentioned, there is no information on how its ground truth would have been established.

In summary: K072445 is a 510(k) submission for a hardware modification to an existing medical device. The "study" conducted for this submission is a demonstration of substantial equivalence based on the technological characteristics and identical intended use compared to legally marketed predicate devices. It does not provide the detailed performance metrics, sample sizes, expert qualifications, or study methodologies typically associated with clinical validation of diagnostic or AI/ML devices.

Summary

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K072445

Image /page/0/Picture/1 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black circle with two white circles on either side of it.

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:	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:	Integrated Brachytherapy Unit - Digital
Common/Usual Name:	Fluoroscopic / radiographic radiation treatment simulation system
Classification Name:	System, Simulation, Radiation Therapy
Classification:	21Cfr892.5840 Class II
Product Code	KPQ

Legally Marketed Device(s)

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

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Description:

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The system makes also use of the same third party X-ray tube and X-ray high tension generator as used in the Simulix Evolution system.

The Flat Panel image detector which replaces the current Image intensifier is a Amorphous silicon, digital detector, with a square image area of 41 x 41 cm.

The PC based workstation runs the same software as the workstation of the Simulix Evolution system. It supports the following functionality:

. Image acquisition
Image display .
Image annotation .
� Database and DICOM Import / Export functionality
Position read out and display of the IBU-D gantry. .
Control of the IBU-D beam limiting device. .

The last two items in this list are specific for the IBU-D.

Intended use:

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

Summary of technological considerations:

Integrated Brachytherapy Unit - Digital is substantially equivalent to the cleared predicate device, Integrated Brachytherapy Unit, 510(k)#: K973848.

Signature

13 AUG 2007
Date

Name: Dick van-Waes Title: Business Director Brachytherapy & Imaqing Nucletron B.V. Veenendaal, The Netherlands

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

2007 SEP 14

Ms. Lisa Dimmick Director, Regulatory Affairs and Quality Assurance Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046

Re: K072445

Trade/Device Name: Integrated Brachytherapy Unit - Digital Regulation Number: 21 CFR 892,5840 Regulation Name: Radiation therapy stimulation system Regulatory Class: II Product Code: KPO Dated: August 13, 2007 Received: August 30, 2007

Dear Ms. Dimmick:

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 indived on for use stated in the enclosure) to legally marketed predicate devices marketed in ior un mically in 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 most therefore, market the device, subject to the general controls provisions of the Act, TTo general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultervition.

If your device is classified (see above) into either class II (Special Controls) or 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 Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a large "FDA" in bold letters. Underneath "FDA" is the word "Centennial" in a cursive font. At the bottom of the logo are three small stars.

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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 not 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 se( forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ed ecronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1150

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 logal/v marketed predicate device results in a classification for your device and thus, perceits your evice 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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on vour responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances at the toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chrogdon

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

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Indications for Use Statement

510(k) Number

Device Name

Indications for Use

K072445

Integrated Brachytherapy Unit - Digital

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, andRadiological Devices
510(k) Number	K072445

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 892.5840 Radiation therapy simulation system.

(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.