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510(k) Data Aggregation
(151 days)
The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
The Urology Monopolar Snare is a sterile device and consists of single lumen catheter attached to a 3-ring handle at the proximal end. The Urological Snare incorporates a braided stainless steel wire in a loop or hexagonal configuration that is attached to a stainless steel drive-wire and is extendable and retractable with respect to the catheter distal tip. The Urological snare is a Monopolar radio frequency device. The handle contains an active cord connection to make the connection to an electrosurgical generator.
The Urology Monopolar Snare is intended for single patient use only. The packaging consists of a peel pouch technology to preserve the sterile condition prior to use.
The US Endoscopy Urology Monopolar Snare is a sterile, single-patient use device intended for tissue transection in the urological tract for histopathologic examination. It operates by entrapping tissue with a braided stainless steel wire in a loop or hexagonal configuration and applying monopolar radio frequency current to resect the tissue and provide hemostasis.
1. Table of acceptance criteria and the reported device performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a numerical format. Instead, it relies on substantial equivalence to predicate devices and general performance statements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs as intended | "The performance data found in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended." |
| No new issues of safety or effectiveness compared to predicates | "The US Endoscopy Monopolar Snare operates comparably to the listed predicate device and raises no new issues of safety or effectiveness." |
| Substantially equivalent to predicate devices (US Endoscopy Flexible Snare K924105 and Cook Urological Endosnare K923031) | "The data presented in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended and in a manner that is substantially equivalent to the predicate devices." |
| Sterile | "Yes" (stated in Device Comparison Table) |
| Single Patient Use | "Single Patient" (stated in Device Comparison Table) |
| Uses Monopolar Radio Frequency current | "Monopolar Radio Frequency current" (stated in Device Comparison Table) |
2. Sample size 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 the sample size used for the test set or information about data provenance (e.g., country of origin, retrospective or prospective). The submission largely relies on a comparison to predicate devices, implying that testing may have focused on demonstrating equivalence rather than a large-scale clinical trial with a defined test set.
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 information is not provided in the document. Given the nature of a 510(k) submission for a medical device cleared via substantial equivalence, detailed expert reviews for establishing ground truth on a specific test set are typically not a primary focus, unlike software or AI-driven diagnostic devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method for a test set.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument and does not involve human readers or AI assistance in its operation, therefore, such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance study for an algorithm was not done. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not explicitly state the type of ground truth used for performance evaluation. Given the device's function involves tissue transection for histopathologic examination, it can be inferred that the ultimate "ground truth" for successful tissue removal and histopathology would likely be confirmed by pathology (i.e., whether the resected tissue is suitable for examination and the procedure achieved its goal of removing targeted tissue). However, the submission does not detail this.
8. The sample size for the training set:
The concept of a "training set" is not applicable to this device. It is a physical instrument, not an AI or machine learning algorithm that requires training data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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