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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 Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The reusable Rezum 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 a modified medical device, the Rezum System, and does not contain information about the original acceptance criteria or a study proving its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (K190093) based on minor modifications (labeling, sterilizer, and sterilization cycle).

Here's a breakdown of why the requested information cannot be found in the provided text:

• No specific acceptance criteria are listed for the device's performance for this submission. The submission is for a modification to an already cleared device, not for the initial clearance of a new device with novel performance claims.
• No clinical study to prove device performance is described. Performance testing is mentioned, but it refers to sterility testing (lethality and sterilant residual testing) repeated due to changes in sterilization, and leveraging of other performance testing from the predicate. This is not a study assessing the clinical efficacy or safety of the device against acceptance criteria.

Therefore, most of the specific questions cannot be answered from the provided text.

However, I can extract information related to the performance testing that was conducted for this specific submission, which primarily focuses on demonstrating that the modifications did not negatively impact safety or function.

Information that can be extracted or inferred about this specific 510(k) submission (K191505) related to performance:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide a table for acceptance criteria related to clinical performance (e.g., symptom relief, prostate tissue reduction) or a study proving those. For this modification, the acceptance criteria were implicitly that the changes in labeling, sterilizer, and sterilization cycle should not alter the device's intended function or safety.

   • Acceptance Criteria (for this specific modification): The device continues to function as intended, is biocompatible, and maintains a sterility assurance level (SAL) of 10^-6, with no new issues of safety or effectiveness compared to the predicate.
   • Reported Device Performance (for this specific modification): The conclusion of assessments demonstrates that the modified device continues to function as intended in a manner equivalent to the predicate device and raises no new issues of safety or effectiveness. Sterility testing (lethality and sterilant residual testing) was repeated and confirmed.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is provided for this submission. The "test set" for this modification would involve engineering and sterility validation tests.

   • Data Provenance: The device continues to be sterilized by ethylene oxide (EO) to an SAL 10^-6 level.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert-evaluated clinical test set is mentioned.

4. Adjudication method for the test set: Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done for this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used: For the sterility performance, the ground truth would be established through standard microbiological and chemical testing methodologies to confirm sterility and residual levels. For overall device function, the ground truth is its equivalence to the predicate device, K190093.

8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

To obtain the information about the acceptance criteria and supporting studies for the original Rezum System's performance (i.e., its clinical efficacy in relieving BPH symptoms and reducing prostate tissue), one would need to refer to the 510(k) submission for the predicate device, K190093, or any prior PMA/clinical trial data if applicable to that original clearance.

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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.

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.

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