(30 days)
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm³ and ≤ 80cm². The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
The reusable Rezūm Generator is provided with the following reusable components:
- Generator
- One Power Cord
The Rezūm Delivery Device Kit contains the following disposable components:
- One sterile Delivery Device with cable and tubing
- One sterile Syringe
- One sterile Spike Adaptor
- One 50 ml Sterile Water Vial
Additional spike adaptor and syringe accessory is provided as an Accessory Pack.
Here's a breakdown of the acceptance criteria and study information for the NxThera Rezūm System, based on the provided FDA 510(k) summary:
Important Note: This document is a 510(k) summary for a modified device, seeking substantial equivalence to a prior predicate device (K150786). Therefore, the performance data presented primarily focuses on demonstrating that the modifications do not negatively impact safety and effectiveness, rather than establishing de novo safety and effectiveness for the original device. The original clinical studies cited were for the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implied by repeated tests on modified device,
as the specific acceptance thresholds are not explicitly stated, but are assumed to be met if "compliance to initial specifications" is achieved)
| Test Category | Specific Tests | Reported Device Performance |
|---|---|---|
| Bench Testing | Dimensions, Tensile strength tests, Full functional tests, Calories tests, Hardware tests, Software verification and validation, Packaging tests, Distribution tests, Tensile/Bond strength tests (including new vented drip chamber and flush tubing before and after 12-month aging), Tubing tests (tubing compliance, kink, burst, etc.), Functional tests (temperature, pressure, etc.), Calories tests, Biocompatibility | The predicate Rezūm System met all its physical and performance specifications on the bench. The design changes to the candidate Rezūm System were tested to ensure compliance to the initial specifications. All repeated tests (Tensile/Bond strength, Tubing tests, Functional tests, Calories tests, Biocompatibility) demonstrated that the device continues to function as intended and is as safe and effective as the predicate. |
| Clinical Studies | Safety and effectiveness in relieving symptoms, obstructions, and reducing prostate tissue associated with BPH. | 3 clinical studies (65 patients in feasibility and pilot open-label studies, and a 197-patient randomized placebo-controlled study) on the predicate device showed that it is safe and effective. (Note: These studies were not repeated for the modified device, as substantial equivalence was based on the minor nature of the changes and successful bench testing). |
2. Sample Size Used for the Test Set and Data Provenance
-
For the Modified Device (K160417):
- Test Set Sample Size: Not applicable in terms of human subjects. The testing described for the modified device was primarily benchtop testing (e.g., tensile/bond strength, tubing tests, functional tests, biocompatibility). The number of individual units or samples used for these bench tests is not specified, but the focus was on validating engineering changes.
- Data Provenance: Not applicable as no new human clinical data was generated for this specific 510(k) for the modified device. The bench testing data would be from the manufacturer's internal labs.
-
For the Predicate Device (K150786) clinical studies (referenced):
- Test Set Sample Size:
- Feasibility and pilot open-label studies: 65 patients
- Randomized placebo-controlled study: 197 patients
- Data Provenance: Not explicitly stated, but generally, clinical trials for FDA submissions are often multi-center and could involve various countries, but the specific origins are not in this summary. These were prospective clinical studies.
- Test Set Sample Size:
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- For the Modified Device (K160417): Not applicable, as detailed human subject ground truth establishment (e.g., by experts for diagnostic accuracy) was not the focus of this 510(k) for device modifications. Bench testing does not typically involve expert ground truth in this way.
- For the Predicate Device (K150786) clinical studies: The document does not provide details on the number or qualifications of experts for establishing ground truth for the clinical outcomes in the referenced studies. Clinical trial outcomes (e.g., symptom relief, prostate volume reduction) are typically measured objectively or reported by patients using validated questionnaires, with physician assessment of adverse events.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- For the Modified Device (K160417): Not applicable, as no human subject adjudication is mentioned for the bench tests.
- For the Predicate Device (K150786) clinical studies: The document does not specify any adjudication methods for clinical outcomes or adverse events in the referenced studies. In multi-center clinical trials, independent data monitoring committees or clinical events committees often perform adjudication, but this is not mentioned here.
5. 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
- Not applicable. The Rezūm System is an endoscopic electrosurgical unit for BPH treatment, not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The Rezūm System is a medical device for direct treatment, not an algorithm. Its performance is evaluated by its function in ablating prostate tissue and the clinical outcomes achieved when used by a physician.
7. The Type of Ground Truth Used
- For the Modified Device (K160417): For the bench testing, the "ground truth" was the initial specifications of the predicate device and engineering standards.
- For the Predicate Device (K150786) clinical studies:
- Clinical Outcomes/Symptoms: Likely patient-reported outcomes (e.g., IPSS scores for BPH symptoms), objective measurements (e.g., prostate volume reduction via imaging, uroflowmetry for obstruction), and adverse event monitoring.
- Effectiveness: Reduction in symptoms, improvement in quality of life, reduction in prostate tissue, and relief of obstruction.
- Safety: Incidence and severity of adverse events.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" for such a device involves engineering development and testing to meet specifications.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, this is not an AI/machine learning algorithm. The "ground truth" for its development would be based on engineering principles, scientific understanding of thermal ablation, and clinical requirements for BPH treatment.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).