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The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.

The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steel braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.

The provided FDA 510(k) summary (K180530) for the Imager™ II Urology Torque Catheter describes performance data related to material changes, not diagnostic accuracy. Therefore, many of the requested criteria regarding expert review, specific ground truth methods, and comparative effectiveness with human readers are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or that indicates inapplicability:

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

2. Sample size used for the test set and the data provenance

   • The document states "Verification activity has been performed on representative devices of the proposed Imager™ II Urology Torque Catheters." A specific numerical sample size is not provided.
   • Data Provenance: Not explicitly stated, but implies laboratory testing performed on manufactured devices. No information on country of origin of data or whether it's retrospective/prospective in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Not applicable. This device is a urological catheter, and the performance testing relates to physical properties and biocompatibility, not diagnostic interpretation requiring expert clinical consensus.

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

   • Not applicable, as no expert adjudication of diagnostic findings is involved for this type of device.

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 not an AI-assisted diagnostic device.

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

   • Not applicable. This is not an algorithmic or AI device.

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

   • For mechanical performance: The ground truth implicitly derives from the device's "predefined product specifications." These specifications define what constitutes acceptable shaft and tip bond, and tensile strengths.
   • For biocompatibility: The ground truth for safety and effectiveness is established by the results of standardized ISO biological evaluation tests, indicating whether the material elicits a cytotoxic, sensitization, or intracutaneous reactivity response beyond acceptable limits.

8. The sample size for the training set

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable, as there is no training set for this device.

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The Imager™ II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager™ II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.

The Imager TM II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a biocompatible polymer reinforced with a stainless steel braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.

The provided text, K102527, is a 510(k) summary for a medical device (Imager™ II Urology Torque Catheter) seeking substantial equivalence to a predicate device. It explicitly states that no new clinical or non-clinical studies were performed. Instead, the submission relies on the concept of substantial equivalence by demonstrating that the proposed device has the same technological characteristics, intended use, and performance characteristics as its predicate device (K011965).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as such studies were not conducted for this 510(k) submission.

The document states:

• "Utilizing FDA's Guidance for Industry and FDA Staff 'Format for Traditional and Abbreviated 510(k)s' a direct comparison of key characteristics demonstrates that the proposed urology catheter is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics tested."
• "The proposed Imager™ II Urology Torque Catheter is as safe, as effective, and performs as well as the predicate device."

This indicates that the "study" demonstrating adherence to "acceptance criteria" for the new device was a comparison to the predicate device based on existing data and prior approvals, rather than new, independent testing with explicit performance metrics and ground truth establishment.

Without a clinical or standalone performance study, no information can be provided for tables or sections that require data from such studies.

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The Imager™ II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may he used in conjunction with a guidewire or for the infusion of radiopaque contrast material.

The Imager™ II Urology Torque Catheter is a single-lumen urological catheter comprised of a flexible tip bonded to the distal end of a reinforced, torqueable. A lucr lock hub is attached to the proximal end of the shaft. The catherer is supplied in a variety of standard lengths and with an array of tip styles commonly used in urological procedures,

This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) Premarket Notification for the Imager II Urology Torque Catheter, which primarily focuses on establishing substantial equivalence to a predicate device.

Here's what the document does provide:

• Intended Use: "The Imager™ II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material."
• Description of Device: "The Imager™ II Urology Torque Catheter is a single-lumen urological catheter comprised of a flexible tip bonded to the distal end of a reinforced, torqueable. A lucr lock hub is attached to the proximal end of the shaft. The catherer is supplied in a variety of standard lengths and with an array of tip styles commonly used in urological procedures."
• Substantial Equivalence Claim: The device is claimed to be "substantially equivalent to other urological catheters classified under 21 CFR 876.5130, more specifically with Boston Scientific Corporation's Imager Torque Catheter (K965229). The substantial equivalence determination is based upon test results that confirm the proposed device is biocompatible and substantially similar to the legally marketed predicate device in terms of material composition and performance parameters."

Missing Information:

The document explicitly states that "test results... confirm the proposed device is biocompatible and substantially similar to the legally marketed predicate device in terms of material composition and performance parameters." However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Details about a specific "study that proves the device meets the acceptance criteria." This would typically involve performance data, measurement metrics, and specific thresholds for acceptance.
3. Sample size used for the test set and data provenance.
4. Number of experts used to establish ground truth or their qualifications.
5. Adjudication method.
6. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
7. Information about a standalone (algorithm only) performance study. (This is not an AI device, so this is not applicable but listed for completeness based on your request).
8. Type of ground truth used.
9. Sample size for the training set.
10. How the ground truth for the training set was established.

In the context of a 510(k) submission for a device like a urological catheter, "performance parameters" often refer to physical and mechanical characteristics (e.g., tensile strength, torqueability, lubricity, burst pressure, material compatibility, biocompatibility) rather than diagnostic accuracy metrics seen in AI/imaging devices. The "study" mentioned would be a series of engineering and bench tests, not a clinical study in the sense of comparing diagnostic outcomes, nor does it typically involve expert readers or ground truth in the way a diagnostic AI device would. The core of a 510(k) is demonstrating similarity to an already approved predicate device.

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