(24 days)
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
The UroLift System is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UL400 (most recently cleared in K173087), consists of two main components, the UroLift Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.
This document is a 510(k) summary for the UroLift System (UL400) by NeoTract, Inc. It describes a submission concerning a modification to a contraindication, specifically increasing the maximum prostate volume from >80 cc to >100 cc for patients indicated for treatment with the UroLift System.
Based on the information provided in the document, here's a description of the acceptance criteria and the study that proves the device meets them, specifically regarding the change in contraindication:
Acceptance Criteria and Study for Modified Contraindication (Increased Prostate Volume)
The core of this submission is not about proving a new device's performance from scratch, but rather demonstrating that a modification to a contraindication (increasing the prostate volume limit) does not negatively impact the device's established safety and effectiveness. Therefore, the "acceptance criteria" and "study" described herein are focused on demonstrating non-inferiority or equivalence of outcomes in the expanded patient population.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for expanded prostate volume) | Reported Device Performance (as demonstrated by clinical literature review) |
|---|---|
| Device Performance Equivalence (Safety & Effectiveness): | Outcomes (from sponsored and independent clinical studies): |
| - Symptom response in patients with prostate volumes >80cc is equivalent to those with prostate volumes 80cc is equivalent to those with prostate volumes 80cc are equivalent to those with prostate volumes 80cc are equivalent to those with prostate volumes 80cc are equivalent to those with prostate volumes 80cc is established by the aggregate findings and conclusions of the respective clinical studies included in that review. |
- The document does not specify the number of experts, their qualifications, or their role in reviewing the literature for this specific submission. The "review" itself would have been conducted by the sponsor's clinical/regulatory team, and ultimately evaluated by the FDA.
4. Adjudication Method for the Test Set
- Given that the evidence is based on a "clinical literature review" rather than a de novo test set with expert reads, there is no explicit adjudication method described for this submission. The "adjudication" effectively comes from the scientific rigor and peer review (if published) of the underlying studies themselves, and the FDA's assessment of the presented literature review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done for this specific 510(k) submission. This submission is focused on a change to a contraindication based on existing clinical evidence, not on evaluating the performance of an AI model or the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The UroLift System is a medical device (implantable system), not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the claim that outcomes (symptom response, quality of life, uroflowmetry, adverse events, catheterization rates) are equivalent for patients with prostate volumes >80cc compared to those
§ 876.5530 Implantable transprostatic tissue retractor system.
(a)
Identification. An implantable transprostatic tissue retractor system is a prescription use device that consists of a delivery device and implant. The delivery device is inserted transurethrally and deploys the implant through the prostate. It is designed to increase prostatic urethral patency by providing prostate lobe tissue retraction while preserving the potential for future prostate procedures and is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia in men.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(3) Performance data must support shelf life by demonstrating continued sterility of the device (of the patient-contacting components), package integrity, and device functionality over the requested shelf life.
(4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing must be conducted.
(ii) Mechanical strength must be conducted.
(iii) Resistance-to-degradation testing must be conducted.
(5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance environment.
(6) In vivo testing must demonstrate safe and effective use, assess the impact of the implants on the ability to perform subsequent treatments, document the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing must be conducted.
(ii) Implant migration must be conducted.
(7) Labeling must bear all information required for safe and effective use of the device, and must include:
(i) Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
(ii) Information on the patient population for which the device has been demonstrated to be effective.
(iii) A detailed summary of the device technical parameters.
(iv) Information on how the device operates and the typical course of treatment.
(v) An expiration date/shelf life.
(vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.