K Number

Device Name

Manufacturer

NUCLETRON-OLDELFT CORP.

Date Cleared

1996-08-13

(358 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K864210,K925956

Intended Use

The intended use for the microSelectron HDR version 2 is identical to the predicate device as described in 21CFR § 892.5700 as; "intended.to angly.a radionuclide source into the body or to the surface of the body for radiation therapy". This device is classified as a prescription device and will be operated only under the direct supervision of a physician in the course of the practice of medicine. There no additional Safety and Effectiveness issues raised in the intended use or indications for use of the microSelectron HDR version 2.

Device Description

The microSelectron HDR version 2 is an improvement over its predicate device, primarily in the areas of eronomics and user interface. The Control Box and PC Console are designed to work with both the existing treatment unit and the new treatment unit (described below).

4.1 Control Box: The Treatment Control Unit of the predicate device has been redesigned to remove the user programmable functions from this electronics interface unit. This new control box retains only the key switches, Start, interrupt, and Print push buttons from the predicate design and includes additional visual indicators of device operation. The CPU board in the Control Box was redesigned to support higher processor speeds and a processor chosen which supports the larger program size.

4.2 Treatment Console The user programmable functions removed from the Control Box as deacribed in 4.1 above, have been functionally relocated to the treatment console. This console consists of a PC based graphics terminal utilizing a commercially available window management program. All device programming functions are carried out at the treatment console, including default setup parameters for the treatment unit and the data entry for radioactive source specification. The design goal of the treatment console was to present device specific information to the user in a graphical environment consistent with the current technology in personal computers. All functions and outputs of its predicate device have been retained and more extensive (plain language) explanation for device status codes are incorporated into the software functions of the treatment console. Data structures necessary to initiate and complete a programmed treatment are stored in both the Control Box and the Treatment Unit: the treatment console merely echoes the functions being performed by the treatment unit itself.

4.3 Treatment Unit The mechanics have been modified to create a more stable, movable, platform for precise positioning of the Treatment Unit adjacent to the patient. The center of gravity and stability of the shielded safe has been improved by relocating the largest mass (shielded safe) closer to the center line of the Treatment Unit . Structural nigidity between the treatment safe, the optical coupler, and the indexer is enhanced by using an annular structure rather than a linear (backbone) design. The source drive mechanism remains very similar to its predicate, with some minor improvements in the yaw angle of the source cable trajectory. The enclosure and covers for the Treatment Unit have been upgraded to a more contemporary design, in keeping with company's exterior design and esthetics philosophy.

4.4 Radioactive Source The radioactive source designed for the microSelectron HDR version 2 treatment unit is functionally identical to the source contained in the predicate device. The exemplary track record of over 10,000 correct source assembly operations with the predicate source showed that minor dimensional changes to the source to enhance its suitability for clinical use would not decrease the safety of the source. To this end, the diameter of the source and its driving cable have been reduced from 1.1 mm outer additionally qualified as Special Form Radioactive Material in accordance with ISO 2855.

4.5 Optional Accessories Optional accessories have been included in the design of this modified device including the provision of a radiation detector.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study details as requested. It's important to note that this document is a 510(k) summary (meaning a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device), and therefore the "study" described is primarily focused on demonstrating this equivalence rather than a detailed clinical trial to prove a novel device's efficacy and safety from scratch.

Device Name: microSelectron HDR version 2

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Original/Predicate Device Performance (Implied)	microSelectron HDR version 2 Reported Performance
Intended Use	"apply a radionuclide source into the body or to the surface of the body for radiation therapy" (Identical to predicate)	"apply a radionuclide source into the body or to the surface of the body for radiation therapy" (Identical to predicate)
Mechanical Design	Functionally sound, adequate for purpose.	Meets/Exceeds: Minor improvements for stability, movability, improved center of gravity, enhanced structural rigidity. Increased shielding (commercial need). Aesthetical upgrade.
Electronics (Control Box)	Original CPU and interface board.	Meets/Exceeds: Redesigned CPU board for higher processor speeds, supports larger program size. Retains key switches, Start, interrupt, Print push buttons, adds visual indicators.
Electronics (Console/User Interface)	Command-line driven liquid crystal display.	Meets/Exceeds: PC-based graphics terminal with a commercial window management program. All programming functions, default setup, data entry for source specification relocated here. More extensive (plain language) explanations for device status codes.
Software/Firmware	EPROM program functions.	Meets/Exceeds:Flash Programmable firmware duplicates EPROM functions. Utilizes graphical display and commercial Window Manager. Increases information displayed.
Radioactive Source	1.1 mm outer diameter, exemplary track record.	Meets/Exceeds: Functionally identical. Reduced diameter (from 1.1 mm) as minor dimensional change to enhance suitability. Additionally qualified as Special Form Radioactive Material in accordance with ISO 2855.
Safety and Effectiveness	Demonstrated as a predicate device.	No new Safety and Effectiveness issues raised. Performs as well as its predicate.
Backward Compatibility	(Not applicable as a criterion for the predicate itself)	Meets: Designed for backward compatibility with over 800 existing microSelectron HDR units.
Voluntary Standards	(Implied compliance with relevant standards at the time)	Meets/Exceeds: Developed under ISO 9001 Quality Systems Requirements. Utilizes voluntary performance standards where appropriate. Radioactive source adheres to ISO voluntary standards for design and construction, with independent certification.

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

The document does not describe a test set with a specific sample size of patient data or clinical images. The evaluation is focused on demonstrating substantial equivalence to a predicate device through engineering design changes, and compliance with performance standards and regulations.

The "testing" mentioned is primarily:

Validation against voluntary performance standards: This refers to engineering and quality assurance testing of the device's components and overall system against established industry standards (e.g., ISO for the radioactive source).
Demonstration of functional equivalence: Showing that the new user interface and mechanical design perform the same functions as the predicate device.

Data Provenance: Not applicable in the context of clinical data for a "test set" as understood in clinical performance studies. The comparison is against the established performance and safety record of the predicate device (microSelectron HDR K864210 and K925956), which has a "track record of over 10,000 correct source assembly operations."

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

Not applicable. There was no "test set" of clinical cases requiring expert ground truth establishment for patient outcomes or diagnoses. The ground truth, in this context, is the established safety and effectiveness of the existing predicate device and its conformity to engineering and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring adjudication in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not done. This 510(k) submission is for design improvements to an existing device, not for a novel diagnostic or treatment algorithm that would typically require such a study to assess human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not explicitly mentioned as a standalone performance study in the sense of clinical outcomes. The device is a high-dose-rate brachytherapy unit, which by its nature requires human operation and clinical oversight. The "standalone" evaluation of the system would involve engineering tests to ensure the hardware and software function correctly according to specifications, and that the source performs as intended (as per ISO standards), but not a standalone clinical performance study typical for an AI algorithm.

7. Type of Ground Truth Used

The primary "ground truth" used for this submission is:

Predicate Device's Established Safety and Effectiveness: The regulatory finding that the microSelectron HDR (K864210) and microSelectron HDR for Mobile Environment (K925956) are safe and effective for their intended use.
Voluntary Performance Standards: ISO 9001 Quality Systems Requirements and ISO standards for Sealed Radioactive Source design and construction.
Functional Specifications of the Predicate Device: The new device was validated to perform the same functions as the predicate.

8. Sample Size for the Training Set

Not applicable. This document describes a medical device (a brachytherapy unit), not a machine learning algorithm that requires a "training set" of data in the AI sense.

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

Not applicable, as there is no "training set" in the context of an AI algorithm.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

ਣ .

AUG 1 3 1996

William G. McMahon Senior Partner Normac-Will Associates 20 Canary Court 06437-1428 Guilford, CT

Re : K953946 Microselectron HDR Version 2 Dated: July 30, 1996 Received: August 1, 1996 Regulatory class : TI 21 CFR 892.5700/Procode: 90 JAQ

Dear Mr. McMahon:

We have reviewed vour Section SIO(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce proof to May 28, 1976, the ensetment date of the Medical Device Amendments, or to devices that have been reclassified in scordance 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and produbtitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Pracise for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 finaing of substantial equivalence of your device to a legally marketed prodicate 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 disgnostic devices), please contact the Office of Complisate at (301) 594-4591 for Rediology devices, or 594-4613 for Ear, Nose and Throat devices. 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 water the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

William Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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SIOCK)

Summary of

Safety and Effectiveness

Information

1. Submitter:
  Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046-2133

Contact: Stephen P. Teague Regulatory Affairs Director Phone: 410-872-4444 FAX: 410-312-4197

Prepared: July 19, 1995

2. Device Name

microSelectron HDR version 2

3. Predicate Device

microSelectron HDR (K864210) microSelectron HDR for Mobile Environment (K925956)

ব Description:

4.1 Control Box: The Treatment Control Unit of the predicate device has been redesigned to remove the user programmable functions from this electronics interface unit. This new control box retains only the key switches, Start, interrupt, and Print push buttons from the predicate design and includes additional visual indicators of device operation. The CPU board in the Control Box was redesigned to support higher processor speeds and a processor chosen which supports the larger program size.

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Safety & Effectiveness Summary

4.2 Treatment Console The user programmable functions removed from the Control Box as deacribed in 4.1 above, have been functionally relocated to the treatment console. This console consists of a PC based graphics terminal utilizing a commercially available window management program. All device programming functions are carried out at the treatment console, including default setup parameters for the treatment unit and the data entry for radioactive source specification. The design goal of the treatment console was to present device specific information to the user in a graphical environment consistent with the current technology in personal computers. All functions and outputs of its predicate device have been retained and more extensive (plain language) explanation for device status codes are incorporated into the software functions of the treatment console. Data structures necessary to initiate and complete a programmed treatment are stored in both the Control Box and the Treatment Unit: the treatment console merely echoes the functions being performed by the treatment unit itself.
4.3 Treatment Unit The mechanics have been modified to create a more stable, movable, platform for precise positioning of the Treatment Unit adjacent to the patient. The center of gravity and stability of the shielded safe has been improved by relocating the largest mass (shielded safe) closer to the center line of the Treatment Unit . Structural nigidity between the treatment safe, the optical coupler, and the indexer is enhanced by using an annular structure rather than a linear (backbone) design. The source drive mechanism remains very similar to its predicate, with some minor improvements in the yaw angle of the source cable trajectory. The enclosure and covers for the Treatment Unit have been upgraded to a more contemporary design, in keeping with company's exterior design and esthetics philosophy.
4.4 Radioactive Source The radioactive source designed for the microSelectron HDR version 2 treatment unit is functionally identical to the source contained in the predicate device. The exemplary track record of over 10,000 correct source assembly operations with the predicate source showed that minor dimensional changes to the source to enhance its suitability for clinical use would not decrease the safety of the source. To this end, the diameter of the source and its driving cable have been reduced from 1.1 mm outer additionally qualified as Special Form Radioactive Material in accordance with ISO 2855.
4.5 Optional Accessories Optional accessories have been included in the design of this modified device including the provision of a radiation detector.
1. Intended Use The intended use for the microSelectron HDR version 2 is identical to the predicate device as described in 21CFR § 892.5700 as; "intended.to angly.a radionuclide source into the body or to the surface of the body for radiation therapy". This device is classified as a prescription device and will be operated only under the direct supervision of a physician in the course of the practice of medicine. There no

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additional Safety and Effectiveness issues raised in the intended use or indications for use of the microSelectron HDR version 2.

Technological Considerations 6.

6.1 Mechanical The minor mechanical improvements in the design of the microSelectron HDR version 2 treatment unit are well known and do not constitute any new technology in mechanical design. Ease of manufacturing and maintenance were two of the criteria used in developing the mechanical modifications to the predicate device. The Functional Specifications of the predicate device have not been enhanced or modified with the new mechanical design. There are no new Safety and Effectiveness issues that are raised with this new design. The increase in the amount of radioactive source shielding in the new Treatment Unit head design is a result of commercial need rather than a result on inadequacy of the predicate design. The aesthetic improvement of the Treatment Unit and Control Unit is part of Nucletron's commitment to state of the art design and manufacturing, rather than an indication that hazards or poor design existed in its parent device.
6.2 Electronics The electronics design of the predicate device is approaching Sysars old, and significant development have taken place in the electronics industry since that time. The current CPU and Interface board design reflects contemporary design and manufacturing practices and will reduce the overall manufacturing cost of the electronic boards. The current device will use flash programmable memory as opposed to the predicate's EPROM memory to reduce the company's expenditure in providing additional upgrades to the installed base for the new device. Serial communications between the different electronic components of the device follow both RS232 and RS422 staards. To insure backward compatibility of the new electronics to the current predicate davice Treatment Unit , a 20MA current loop serial protocol is used for this reason.
6.3 Software/Firmware The functions performed by the Flash Programmable firmware in the current device duplicates the EPROM program functions of the predicate device. The use of a graphics display terminal and a commercially available Window Manager in the new device is an improvement over the command line driven liquid crystal display of the predicate device. The use of commercially available personal computers as an interface to the operator increases the amount of information that can be displayed concerning the patient, the treatment, and the function of the device during the treatment. The same information was available in the predicate device in the printed record of the treatment including the indication of any status messages and service information.
Ergonomics and Human Factors: Enhancement in the mechanical ergonomics have 6.4 been described previously in eections 6.1 and certain human factors engineering considerations were used in section 6.3 in the design of the User Interface software. As the professionals in the field become more familiar with the use of personal computers,

S/W

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the learning curve necessary to achieve competency in the operation of the device shortens.

Backward Competibility A global technical consideration in the design of the 6.5 microSelectron HDR version 2 was backward compatibility to the existing installed base of over 800 microSelectron HDR's, the predicate device. The Commercial Requirements Specifications for this product design addresses those issues, and the minor modifications made in the current device from its predicate have eliminated any new Safety and Effectiveness considerations during the design of this new device.

7.0

1. 1 Performance Standards No performance standards have been published by the Food and Drug Administration regarding this classification of medical device. Nucletron has developed this new product under ISO 9001 Quality Systems Requirements, and additionally, has used voluntary performance standards, where appropriate, to validate the design and manufacturing capabilities of components used in the system. The radioactive source adheres to the ISO voluntary standards published for Sealed Radioactive Source design and Sealed Radioactive Source construction. An independent certification to the ISO Standards for the source has been achieved.
.2 Indication Statements This device has the same Indication Statements and Indications for Use as the predicate device. Therefore , clinical tests were not required, as the predicate functional specifications were not modified.
7.3 Validation Successful validation to the aforementioned voluntary performance standards demonstrate that the device is safe, effective and performs as well as its predicate device and merely takes advantage of contemporary mechanical, electronically, and software design practices.

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.