(66 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 ≤ 80cm3. 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 single-use Rezum Delivery Device contains the following disposable components:
- One sterile Delivery Device with integrated cable and tubing
- One sterile Syringe
- One sterile Spike Adaptor
- One 50 ml Sterile Water Vial
This document is a 510(k) summary for the Rezum System, a device intended to relieve symptoms of BPH. It describes the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving the device meets them:
Important Note: The provided text is a 510(k) summary for a device modification, not a new device. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to testing demonstrating that the modified device performs identically to the predicate device, which had already established its safety and effectiveness. This explains why some typical AI/ML study components (like expert consensus for ground truth, MRMC studies, training set details) are not present or applicable here. The focus is on demonstrating that the modifications do not introduce new safety or effectiveness concerns and maintain the same performance as the previously cleared predicate.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for the clinical performance of the device (e.g., symptom relief, prostate tissue reduction metrics) in the context of this 510(k) for a modified device. Instead, it focuses on demonstrating that the modified device meets the same physical and performance specifications as the predicate device.
The performance testing mentioned is primarily related to engineering and material specifications. The acceptance criteria are implied to be meeting the prior specifications of the predicate device.
| Acceptance Criteria (Implied: Meets same specifications as predicate) | Reported Device Performance |
|---|---|
| Dimensions | Tested with passing results; meets specifications |
| Tensile strength tests | Tested with passing results; meets specifications |
| Full functional tests (temperature, pressure, etc.) | Tested with passing results; meets specifications |
| Calories tests / Calorimetry | Tested with passing results; meets specifications |
| Hardware tests | Tested with passing results; meets specifications |
| Software verification and validation | Tested with passing results; meets specifications and current V&V |
| Packaging tests | Tested with passing results; meets specifications |
| Distribution tests | Tested with passing results; meets specifications |
| Applicable IEC 60601 tests | Tested with passing results; meets specifications |
| Tubing (compliance, kink, burst, etc.) | Tested with passing results; meets specifications |
| Corrosion Resistance | Tested with passing results; meets specifications |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity) | All tests performed with passing results per ISO 10993-1:2009 and FDA guidance |
| Sterilization (SAL 10⁻⁶ level) | Device continues to be sterilized by ethylene oxide (EO) to this level |
| Shelf life | Extended shelf life demonstrated through testing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the engineering and material tests, nor does it specify the country of origin or whether the data was retrospective or prospective. These are typically bench tests performed on a defined number of device units. The provenance for this type of testing is usually the manufacturer's facility.
3. 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)
This 510(k) is for a physical device modification, not an AI/ML diagnostic or image analysis tool. Therefore, there were no clinical experts (like radiologists) involved in establishing ground truth for the "test set" in the sense of clinical interpretations or diagnoses. The ground truth for the device's functional integrity is established by engineering specifications and direct physical/chemical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is for a physical device modification, not a diagnostic AI/ML tool requiring human expert adjudication of clinical outcomes.
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. This is for a physical device modification, not an AI/ML product where MRMC studies are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This describes a medical device (Vapor Ablation Device), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is its adherence to predeteremined engineering, material, and functional specifications, as well as established biocompatibility standards (e.g., ISO 10993). This is determined by bench testing results against defined physical and chemical parameters, not clinical expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
§ 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).