(13 days)
This device is indicated for use in adult males with known or suspected prostate cancer.
This device is an adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes. Provides pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units. Reusable, non-sterile. Materials: Delrin and Aluminum.
The provided document K972672 is a 510(k) summary for a medical device called BRACHYSTEPPER, which includes a stepping unit, a needle template guide, and a support and manual adjustment accessory.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state "acceptance criteria" and "reported device performance" in a quantitative manner as would be expected for a complex AI/software device. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices.
The acceptance criteria for a 510(k) submission generally involve demonstrating that the new device is as safe and effective as a legally marketed predicate device. For the BRACHYSTEPPER, this would imply that its physical and functional characteristics are comparable to the predicate devices.
| Acceptance Criteria Category | Description | Reported Device Performance (based on Substantial Equivalence Claim) |
|---|---|---|
| Function | The device should provide pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units. | The BRACHYSTEPPER Stepping Unit is substantially equivalent to the B & K Stepper (K905198 & K914945) and Civco Ultra-Step. The BRACHYSTEPPER Needle Guide Template is substantially equivalent to Civco Seed Implant Needle Guide (K875241) and B & K Stepper Matrix (K905198 & K914945). The BRACHYSTAND Support and Manual Adjustment Accessory is substantially equivalent to "Martin" Immobilizing Device (K850571) and Ultra-Step Ultrasound Probe/Stepper Fixation Device. This implies that the BRACHYSTEPPER system performs these functions comparably to the predicate devices. |
| Scientific Basis | The device should effectively provide pre-insertion fixation, gross/fine adjustment, and precise incremental lateral probe advancement to aid in volume determination and seed implantation during brachytherapy. | The device's scientific basis for facilitating accurate positioning and guiding needles is considered equivalent to the predicate devices. |
| Design | Reusable, non-sterile. | The BRACHYSTEPPER is described as reusable and non-sterile, consistent with similar predicate devices for brachytherapy procedures. |
| Materials | Delrin and Aluminum. | The materials used (Delrin and Aluminum) are considered appropriate and comparable to materials used in predicate devices, ensuring similar biocompatibility and durability. |
| Intended Use | Volume determination of prostate and radioactive seed implantation during prostatic brachytherapy in adult males with suspected or known prostate cancer. | The intended use for the BRACHYSTEPPER is identical to the established uses of the predicate devices. |
| Technological Characteristics | Manually-powered, mechanical system for probe fixation, stepping, and needle guidance. | The BRACHYSTEPPER's manually-powered, mechanical nature for probe fixation, stepping, and guiding needles is considered substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" or any clinical study involving patient data for the BRACHYSTEPPER device itself. This 510(k) submission is for a mechanical medical device, not a diagnostic or AI-powered imaging device that would typically involve a test set for performance evaluation. The substantial equivalence is based on the comparison of the device's design, materials, function, and intended use with existing predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no test set or clinical performance study for the device is described, there is no mention of experts establishing ground truth. The review process implicitly involves FDA reviewers with expertise in medical devices and relevant clinical fields, who evaluate the substantial equivalence claim.
4. Adjudication Method for the Test Set
As there is no test set described, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The BRACHYSTEPPER is a mechanical device, not an AI or imaging system, so such a study would not be relevant in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation (as would be typical for an algorithm) was not performed. This device is a component of a brachytherapy system, designed to assist medical practitioners.
7. The Type of Ground Truth Used
Given the nature of the device (mechanical support and guidance system), the concept of "ground truth" as it applies to diagnostic accuracy or AI performance is not directly applicable. The "proof" of meeting acceptance criteria is through engineering comparison to existing predicate devices, demonstrating similar physical properties, functional capabilities, and intended use, which implicitly assumes the predicate devices provide a "ground truth" for safe and effective mechanical operation within their intended clinical context.
8. The Sample Size for the Training Set
There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing would be based on engineering principles and knowledge.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this information is not applicable.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.