(358 days)
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.
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.
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.
§ 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.