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The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.

The indications for use of the catheter are in urological applications.

The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endossopic procedures.

The SESSR Delivery Catheter is introduced into the desired anatomical location through the SESS sheath with a minimum working channel diameter of 4.3mm. The distal tip of the SESSR is straight or benefit at minimum of 6.5 mm from the distal tip of 10 degrees providing the physician with (when using visualization devices) a wider field of view.

The provided document (K083788) describes the Stonebuster Endoscopic System for Stone Removal (SESSR) and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or clinical trial data as requested.

The basis for clearance is demonstrating substantial equivalence to legally marketed predicate devices, not through a study proving predefined acceptance criteria. Therefore, most of the requested fields cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and explanations for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" assessment is based on a comparison to predicate devices, focusing on design, materials, and intended use.

2. Sample size used for the test set and the data provenance
Not applicable. This was a 510(k) submission based on substantial equivalence, not a clinical study with a "test set" in the context of AI/algorithm performance. The data provenance includes material specifications and sterilization validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" was established by experts for a test set in this 510(k) submission.

4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.

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 device is a medical instrument (catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related performance metrics are irrelevant.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an algorithm's ground truth. The "truth" for this submission was demonstrating that the device's design, materials, and intended use were comparable to existing, legally marketed predicate devices, and that it met relevant standards for sterility.

8. The sample size for the training set
Not applicable. No training set was used, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

Summary of what the document does provide regarding device evaluation:

• Sterility Testing: A full cycle, single lot batch validation was completed to ensure sterility using ethylene oxide (EtO) gas, contracted with STS Life Sciences Division of Ethox. The reports of these results were included in Section 14.1 of the submission.
• Shelf Life: Currently set at six months, with ongoing monitoring of samples to ensure sterility and functionality, with plans to adjust the shelf life based on these observations.
• Bench Testing: The conclusion mentions "bench test results conducted with the Stonebuster Endoscopic System for Stone Removal (SESSR)." However, the document does not detail these bench tests, their methodologies, or specific quantitative results beyond stating they support substantial equivalence.
• Comparison to Predicate Devices: The primary "proof" of meeting safety and effectiveness is through a detailed comparison (Table 1) to two predicate devices:
  • Boston Scientific Corporation UASS Ureteral Access Sheath (K022135)
  • Bard Dual Lumen Ureteral Catheter (K032521)
    This comparison covers indications for use, shaft material, hub material, sterility, single-use nature, and number of lumens. The sponsor argues that any differences are "insignificant with respect to safety and effectiveness."

In essence, for a traditional 510(k) such as this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices, supported by foundational tests like sterility validation and general engineering/material specifications, rather than a clinical trial or algorithm performance study.

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The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.

Not Found

This document is a 510(k) clearance letter for the "Advanced Urological Catheter" by EntraCare LLC. It details the regulatory approval process but does not contain information regarding
acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific study-related details requested.

Therefore, I cannot provide the requested information from the given text.

The document primarily focuses on:

• The product name and applicant.
• The regulatory classification and product codes.
• Confirmation of substantial equivalence to a legally marketed predicate device.
• General regulatory requirements the manufacturer must adhere to.
• The intended use of the device: "The Advanced Urological Catheter is used to pass fluids to or from the urinary tract."

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The Dfiner is indicated for catheterization of the male urethra for the introduction of contrast materials.

The Dfiner Urological Catheter is a dual lumen flexible co-axial catheter. The main lumen contains a flexable sheath which houses is a solid flexible rod. Attached to the distal end of the rod is an array of wires. The wire bundle can be advanced and deployed in the bladder to assist with anatomical imaging. Contrast material is introduced through the main lumen. The catheter has a rigid "Y" connector at the proximal end that allows the wire bundle/sheath to be deployed/retracted and access to the main lumen.

The provided text is a 510(k) Summary for the Dfiner Urological Catheter. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML medical devices.

The document describes a traditional medical device (a catheter) and references a "comparison of technological characteristics" to predicate devices, rather than a clinical performance study with acceptance criteria, sample sizes, ground truth, or expert involvement.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to already legally marketed devices based on design, intended use, and materials of manufacture, not on the performance of an AI algorithm.

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The Apogee Medical,Inc. Urinary Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder

Urinary Catheter

The provided text is a U.S. FDA 510(k) clearance letter for the Apogee Medical, Inc. Urological Catheter. This document does not contain information about acceptance criteria, device performance studies, or details about AI algorithms. It is a regulatory clearance document.

Therefore, I cannot fulfill your request as the necessary information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device performance study is not present in the provided text.

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The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram.

The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram. Materials that comprise these devices are polurethane, polyethylene, vinyl and hydrophilic coating. The hydrophilic coating will allow the catheters to become lubricious which will reduce friction.

This 510(k) premarket notification for the "AQ Hydrophilic Urological Catheters" is a very early regulatory submission (from 1996) and does not contain the kind of detailed performance study information typically found in more recent submissions, especially those involving AI/ML devices. The document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use, rather than presenting a performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the given document:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify any quantitative acceptance criteria or report performance metrics (e.g., success rates, friction reduction values, specific drainage efficiency) for the AQ Hydrophilic Urological Catheters. The focus is on design and material equivalence to predicates, implying that if the design and materials are equivalent, the performance will also be considered equivalent for this type of device at that time.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. No test set or related study data is mentioned.

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)

• Cannot be provided. No test set or ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Cannot be provided. No test set or adjudication process is mentioned.

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

• Cannot be provided. This document is for a physical medical device (catheter), not an AI/ML device, and therefore, an MRMC study with AI assistance is entirely irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. As above, this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No ground truth is established as no performance study is detailed.

8. The sample size for the training set

• Cannot be provided. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Cannot be provided. No training set or ground truth is mentioned.

Summary of what is present:

• Device: AQ Hydrophilic Urological Catheters
• Intended Use: Drainage, irrigation, and/or retrograde pyelogram.
• Materials: Polyurethane, polyethylene, vinyl, and hydrophilic coating.
• Key Feature: Hydrophilic coating makes the catheters lubricious to reduce friction.
• Predicate Devices: Slip-Coat™ Catheters (Cook Incorporated) and uncoated urological catheters (Cook Urological).
• Basis for Substantial Equivalence: Indications for use, design, and materials of construction are substantially equivalent to predicate devices. The document also mentions manufacturing according to specified process controls, a Quality Assurance Program, and similar packaging and sterilization procedures to currently marketed devices.

This submission relies entirely on demonstrating substantial equivalence to already legally marketed devices, rather than providing new performance data from a specific study against predefined acceptance criteria. For devices like this in 1996, the FDA often accepted equivalence based on material composition, design, manufacturing processes, and intended use without requiring explicit clinical performance trials or new performance data, especially if the changes were incremental (like adding a coating to an existing catheter design).

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