(18 days)
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:
- A table of acceptance criteria and reported device performance.
- 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.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- 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).
- Type of ground truth used.
- Sample size for the training set.
- 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.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.