The Nucletron microSelectron HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited. This device is 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.

Device Description

The entry-level microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels. The operators console of the microSelectron®HDR - GENIE Afterloading System concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device microSelectron-HDR (V2). In the microSelectron®HDR - GENIE Afterloading System there is on the operators console a second completely independent software program for radiotherapy treatment planning. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. It is the same as in the predicate device where treatment plans are transferred to the Treatment Console Software from radiotherapy treatment planning software running on a separate computer. The radiotherapy treatment planning software is covered by a separate 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System. The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "microSelectron®HDR - GENIE Afterloading System". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (microSelectron-HDR V2, K953946), rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a novel AI/software medical device.

Therefore, many of the requested categories related to studies, sample sizes, ground truth, and expert evaluation are not directly applicable or present in this specific 510(k) summary. The information provided is primarily about the device's technical description, intended use, and its relation to a predicate device.

Here's an attempt to address the points based only on the provided text, noting where information is not available:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

This submission is for a medical device (a remote-controlled afterloading system for radiation therapy) that is demonstrating substantial equivalence to a predicate device (microSelectron-HDR V2). It is not presenting a performance study against predefined acceptance criteria for accuracy or efficacy in the same way a software or AI device submission would. The "acceptance" is based on the FDA's determination of substantial equivalence.

Therefore, a table of acceptance criteria and reported device performance, in the context of a new performance study, cannot be generated from this document. The performance is implicitly deemed acceptable because it is substantially equivalent to a device already on the market.

Additional Requested Information (Based on provided text)

A table of acceptance criteria and the reported device performance:
- N/A. As explained above, this document is a 510(k) for substantial equivalence, not a performance study against novel acceptance criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. This type of information is typically associated with performance studies, which are not detailed in this 510(k) summary. The submission focuses on the technical characteristics and intended use being similar to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. This information is relevant for performance studies involving expert review, which is not described here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. This is relevant for performance studies involving expert review, which is not described here.
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. This device is a "Remote Controlled Afterloading System" for radiation therapy, not an AI or imaging diagnostic device that would involve human readers interpreting cases. Therefore, an MRMC study is not applicable in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, to some extent. The document states: "The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device." While this refers to the hardware system, the core of the submission (and the "study" in a very broad sense) is about the technical specifications of the device itself, functioning independently of real-time human interpretation or decision-making in a diagnostic sense. It's a control system for radionuclide application.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this submission is implicitly the functional and safety performance of the predicate device (microSelectron-HDR V2). The new device is asserted to be substantially equivalent in its design and intended use. The "truth" being established is that the device safely and effectively performs its stated function of applying a radionuclide source, similar to the predicate.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context.
How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.

Summary of the "Study" and "Acceptance Criteria" for K021286:

The document K021286 is a Special 510(k) Premarket Notification for the Nucletron microSelectron®HDR - GENIE Afterloading System. The "study" presented here is a demonstration of substantial equivalence to a previously cleared predicate device, the microSelectron-HDR V2 (K953946).

Acceptance Criteria (Implicit for Substantial Equivalence): The primary acceptance criterion for a 510(k) is that the new device has the same intended use as a legally marketed predicate device and has technological characteristics that are sufficiently similar to the predicate device that it can be determined to be as safe and effective as the predicate device. Minor differences in technological characteristics must not raise different questions of safety and effectiveness.
Reported Device Performance (Implicit): The functional performance is asserted to be equivalent to the predicate device. The description highlights that the new system is an "entry-level" version with only three treatment channels and uses similar software and applicators as the predicate. The statement "The Nucletron microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels" and "The operators console ... concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device" serves as the core of this claim.
Proof: The entire 510(k) submission, by outlining the similarities in intended use, technological characteristics, and specifications, serves as the "proof" for substantial equivalence. The FDA's letter (pages 2-4) confirms that they found the device to be substantially equivalent.

Summary

{0}------------------------------------------------

Page 7-9

K021286
Page 1 of 2

MAY 2 3 2002 Special 510(k) Nucletron microSelectron®HDR - GENIE Afterloading System April 2002

Image /page/0/Picture/3 description: The image shows the word "Nucletron" in bold, black font next to a square logo. The logo contains a black circle with two white circles on either side of it. The logo is enclosed in a black square.

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

Modified Device Name:

Trade/Proprietary Name:	microSelectron®HDR - GENIE Afterloading System
Common/Usual Name:	Remote Controlled Afterloading System
Classification Name:	Radiotherapy Device
Classification:	Class II

Legally Marketed Device(s)

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

	. Manufacturer
l Nucletron BV------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	' K953946 microSelectron-HDR V2Comments of the first of the property would with the will and the comments of the first of the may be andand the more of the completed of the first to the first and the first for the first and the many and the comments of the comments of the comments of the comments of the comme------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	K953946

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

Page 7-10

K021286
Page 2 of 2

Special 510(k) Nucletron microSelectron®HDR - GENIE Afterloading System April 2002 Description:

The radiotherapy treatment planning software is covered by a separate 510(k) submission.

Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System.

The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.

Intended use:

The Nucletron microSelectron®HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited:

This device is 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.

Summary of technological considerations:

The Nucletron microSelectron®HDR - GENIE Afterloading System is substantially equivalent to the cleared predicate device, microSelectron-HDR V2, 510(k)#: K953946.

Signature

10 APRIL 2002
Date

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850

MAY 2 3 2002

Ms. Lisa Dimmick Director Quality Assurance and Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133

Re: K021286

Trade/Device Name: MicroSelectron® HDR - GENIE Afterloading System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system

Regulatory Class: II Product Code: 90 JAQ Dated: April 10, 2002 Received: April 23, 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.

Image /page/2/Picture/12 description: The image shows the 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. In the center of the circle is a stylized image of an eagle with three lines representing its wings and legs.

{3}------------------------------------------------

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

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

Enclosure

{4}------------------------------------------------

NUMBER (IF KNOWN): K021286 510 (k)

MICROSELECTRON HDR-GENIE AFTERLOADING SYSTEM DEVICE NAME :

INDICATIONS FOR USE:

The Nucletron microSelectron HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited.

This device is 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.

(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)

ાર

Over - The - Counter - Use er The -Councer 1-2-96

(Division Sian. Division of R and Radiolog 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.