Brachytherapy planning with Oncentra manual Low Dose Rate Treatment Planning is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal including bronchial and surface applicator treatments, involving manually loaded radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to inserting. The software also provides the treatment time and dose distribution for the specific loading. Form this information the patient can be treated with radioactive sources.

Device Description

Oncentra manual Low Dose Rate Brachytherapy v1.0 is a software package designed for treatment planning of manually loaded low dose rate radioactive sources. This software runs on an Oncentra radiation therapy treatment planning system workstation. Oncentra manual Low Dose Rate Brachytherapy v1.0 is capable of reconstructing the brachytherapy implant from radiographic images or the specification of coordinates, defining the location of the radioactive sources within the implant, and identifying a reference point, e.g. software program calculates the treatment data which includes dose distributions and treatment/implantation time. The brachytherapy treatment planning session allows the physician to evaluate the implant prior to insertion of the low dose radioactive sources, e.g. tubes, wires, in order to determine the most optimal dose distribution within the treatment volume. Once the physician approves the treatment plan the implant is manually loaded with radioactive sources. The program provides a variety of plan evaluation tools to assist in the assessment of the implant quality, e.g. dose volume histogram, dose verification to defined points, dose profiles within the implant, etc. This software program is for manually loaded low dose radioactive sources and does not interface with an external treatment machine, software programs or control units; it strictly provides hard copy output related to the dose distribution, total treatment time, and other treatment related information.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the Nucletron Oncentra mLDR v1.0 device:

Acceptance Criteria and Device Performance

Criteria Category	Acceptance Criteria (Stated)	Reported Device Performance
Treatment Planning Output	Not explicitly stated with numerical thresholds. Implied as functional equivalence and "within an acceptable range" compared to the predicate device.	"The results demonstrated that the treatment planning output between the two products [Oncentra manual Low Dose Rate Treatment Planning and the predicate device] were within an acceptable range." The device is stated to be "the same device as the predicate device with a new user interface and Windows computer platform." Functionally, it reconstructs implants, defines source locations, identifies reference points, calculates treatment data (dose distributions, treatment/implantation time), and provides evaluation tools (dose volume histogram, dose verification, dose profiles).

Study Information

Sample size used for the test set and the data provenance:
- The document mentions "Comparison testing was performed," but it does not specify a sample size for the test set.
- Data provenance is not mentioned. It's unclear if the data was retrospective or prospective, or its country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide any information about experts used or their qualifications for establishing ground truth specifically for the comparison testing.
Adjudication method for the test set:
- The document does not describe an adjudication method.
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:
- No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical comparison between the new device and a predicate device, focusing on "treatment planning output." The concept of "human readers improving with AI vs. without AI assistance" is not relevant here as the device is a treatment planning system, not an AI diagnostic tool that assists human readers in interpreting images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone comparison was essentially done. The "Comparison testing" was between the Oncentra manual Low Dose Rate Treatment Planning software and the predicate device's software output. This is an evaluation of the algorithm's output (treatment planning data) in isolation, rather than in the context of human interaction or clinical outcomes derived from that interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the comparison testing was essentially the output of the legally marketed predicate device (PLATO Brachytherapy, K983343). The new device's output was compared to this established and previously cleared device to demonstrate "substantial equivalence."
The sample size for the training set:
- The document does not mention a training set sample size. This is likely because the device is a treatment planning system based on established physics and algorithms, rather than a machine learning model that requires a "training set" in the traditional sense. The development would have involved software engineering and validation against known physical models and clinical requirements, rather than a data-driven training approach.
How the ground truth for the training set was established:
- As no training set is mentioned in the context of machine learning, this question is not applicable. The "ground truth" for the device's functionality would be derived from fundamental physics of radiation dosimetry and brachytherapy principles, inherent in the design and validation of such a system. The predicate device's performance serves as the benchmark for equivalence.

Summary

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DEC 1 2 2011

Page 27 September 2011

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Nucletron Oncentra mLDR v1.0

Traditional 510(k)

Nucletron Corporation 7021 Columbia Gateway Drive Suite 200 Columbia, MD 21046-2133 U.S.A. Phone 410-312-4100 Fax 443-769-1570

. .

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92

Submitter of 510(k):

Company name:	Nucletron Corporation
Registration number:	3006624729
Address:	7021 Columbia Gateway Drive
	Columbia, MD 21046-2133
Phone:	443-545-2182
Fax:	443-769-1574
Correspondent:	Michael Paul,
	Quality Assurance & Regulatory Affairs Manager
Date:	September 15, 2011
New Device Name:
Trade/Proprietary Name:	Oncentra manual Low Dose Rate Treatment Planning v1.0
Common/Usual Name:	Treatment Planning System for Radiation Therapy
Classification Name:	System, Planning, Radiation Therapy Treatment
Classification:	21CFR 892.5050 Class II

Legally Marketed Device(s)

Our modified device is based on the legally marketed device cited in the table below:

Product Code MUJ

Manufacturer	Device	510(k)#
Nucletron BV	PLATO Brachytherapy (BPS14)	K983343

Device description:

. .....

Oncentra manual Low Dose Rate Brachytherapy v1.0 is capable of reconstructing the brachytherapy implant from radiographic images or the specification of coordinates, defining the location of the radioactive sources within the implant, and identifying a reference point, e.g.

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software program calculates the treatment data which includes dose distributions and treatment/implantation time.

The brachytherapy treatment planning session allows the physician to evaluate the implant prior to insertion of the low dose radioactive sources, e.g. tubes, wires, in order to determine the most optimal dose distribution within the treatment volume. Once the physician approves the treatment plan the implant is manually loaded with radioactive sources. The program provides a variety of plan evaluation tools to assist in the assessment of the implant quality, e.g. dose volume histogram, dose verification to defined points, dose profiles within the implant, etc.

This software program is for manually loaded low dose radioactive sources and does not interface with an external treatment machine, software programs or control units; it strictly provides hard copy output related to the dose distribution, total treatment time, and other treatment related information.

Intended use:

Brachytherapy planning with Oncentra manual Low Dose Rate Treatment Planning is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal including bronchial and surface applicator treatments, involving manually loaded radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specific loading. From this information the patient can be treated with radioactive sources.

Summary of the Technical Characteristics

Oncentra manual Low Dose Rate Treatment Planning is the same device as the predicate device with a new user interface and Windows computer platform. The software provides treatment planning data for manually loaded low dose radioactive sources, e.g. wires, tubes and seeds.

Summary of Non- clinical testing

Comparison testing was performed between Oncentra manual Low Dose Rate Treatment Planning and the predicate device. The results demonstrated that the treatment planning output between the two products were within an acceptable range.

Summary of Clinical testing

Clinical testing was not required to demonstrate substantial equivalence.

Conclusion

The Oncentra manual Low Dose Rate Teatment Planning device is substantially equivalent to the cleared predicate device BATO Brachytherapy (#K983343).

Name: John Lapre

Sept. 27, 2011

Date

Name: John Lapre
Title: Vice President Research & Development
Nucletron B.V.
Veenendaal, The Netherlands

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

DEC 1 2 2011

Mr. Michael Paul QA/RA Manger Nucletron Corporation 7021 Columbia Gateway Drive, Suite 200 COLUMBIA MD 21046-2133

Re: K113102

Trade/Device Name: Oncentra Manual Low Dose Rate Treatment Planning v1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: October 15, 2011 Received: October 19, 2011

Dear Mr. Paul:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) KU3102 Number

Device Name Oncentra manual Low Dose Rate Treatment Planning v1.0

Indications for Usc

Prescription Use X (Part 21 CFR 801 subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 subpart C)

(Division Sign-Off)

Division of Radiological Device Office of In Vitro Diagnostic Device Evaluation and Safety

510K K11362

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.