Real Time HDR is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

Device Description

Real Time HDR (RT HDR) is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source. Modifications to SPOT previously cleared K992303, have been made to add functionality for: - o Post Planning , ----- - . Auto activation dwell positions The Ultrasound acquisitation has been changed form longitidinal to transversal. The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206. Real Time HDR (RT HDR) is an accessory to the microSelectron-HDR (V2). The program constists of two modules: - Treatment Planning Software: Real Time HDR ● - Database: Smoothbase ● The software runs on a Windows 2000 platform.

AI/ML Overview

The provided document is a Special 510(k) submission for the Nucletron Real Time HDR system, an accessory to a radiotherapy device. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or most of the other detailed study-related information requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted, and why:

Information NOT available in the document:

1. A table of acceptance criteria and the reported device performance: The document describes the device modifications and its intended use, but it does not specify any quantitative performance metrics or acceptance criteria for those metrics.
2. Sample sized used for the test set and the data provenance: There is no mention of a "test set" in the context of device performance evaluation, nor any sample size or data origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This device is a treatment planning system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a software system that assists physicians; it does not present a standalone algorithm being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: There is no mention of a "training set" as this is not an AI/ML device in the modern sense that would typically involve supervised learning with a training set.
9. How the ground truth for the training set was established: Not applicable.

Information that CAN be extracted or inferred:

Description of the Device and its Purpose (from the "study" context):

The "study" in this context is the Special 510(k) submission itself, which aims to demonstrate that a modified medical device ("Real Time HDR") is "substantially equivalent" to a previously cleared predicate device ("SPOT - Sonographic Planning of Oncology Treatments," K992303). The "proof" is the FDA's clearance letter (K022739), stating that the device is substantially equivalent for its stated indications for use.

The document highlights modifications made to the predicate device:

Added "Post Planning" functionality (derived from Plato BPS K983343).
Added "Auto activation dwell positions."
Changed Ultrasound acquisition from longitudinal to transversal.
Added Dicom 3 Import/Export (derived from Plato External Beam K964206).

The intended use is stated as: "Real Time HDR is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources."

The device is a "real time" treatment planning system for brachytherapy, specifically for prostate cancer. It uses 3D Ultrasound imaging to update dwell positions, provides plan evaluation tools (dose volume histograms, dose verification points, dose profiles), and supplies anatomical and dosimetric information for source positioning and loading.

Conclusion:

The provided text is a regulatory submission for device clearance based on substantial equivalence, not a clinical or performance study evaluating specific acceptance criteria with detailed statistical results. Therefore, most of the requested information regarding "acceptance criteria" and "study results" is not present in this document.

Summary

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Special 510(k) Nucletron Real Time HDR August 2002

OCT 2 5 2002

Page 7-4

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NUCLETRON B.V.

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

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 DriveColumbia, MD 21046-2133
Phone:	410-312-4100
Fax:	410-312-4197
Correspondent:	Lisa DimmickDirector Assurance & Regulatory Affairs

Modified Device Name:

Trade/Proprietary Name:	Real Time HDR
Common/Usual Name:	Radiation Therapy Planning System
Classification Name:	Acessory to Radiotherapy Device
Classification:	21Cfr892.5050 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	SPOT (Sonographic Planning of OncologyTreatments)	K992303

Description:

Real Time HDR (RT HDR) is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the

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Special 510(k) Nucletron Real Time HDR August 2002

treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient.

The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source.

Modifications to SPOT previously cleared K992303, have been made to add functionality for:

o Post Planning
, -----
. Auto activation dwell positions
The Ultrasound acquisitation has been changed form longitidional to transversal.

The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206.

Real Time HDR (RT HDR) is an accessory to the microSelectron-HDR (V2). The program constists of two modules:

Treatment Planning Software: Real Time HDR ●
Database: Smoothbase ●

The software runs on a Windows 2000 platform.

Intended use:

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

Real Time HDR is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources.

Summary of technological considerations;

Real Time HDR is substantially equivalent to the cleared predicate device, SPOT (Sonographic Planning of Oncology Treatments), 510(k)#: K992303.

Name: J. W. M. Meiis Title: a.i. Business Segment Manager Nucletron B.V. Veenendaal. The Netherlands

8/8/2002
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 0 Corporate Boulevard kville MD 20850

Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133

Re: K022739

Trade/Device Name: Real Time HDR Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II

Product Code: 90 JAQ and MUJ Dated: October 4, 2002 Received: October 7, 2002

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 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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Page 2

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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

Nancv 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

510(k) Number K022739

Device Name

Real Time HDR

Indications for Use

Real Time HDR is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

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__________________________________________________________________________________________________________________________________________________________

Elaine R. Ingram

(Division Sign-Off) Division of Reproductive Abdomi and Radiological Davings 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.