(132 days)
The Bard LubriGuard Foley Catheter is intended for use in the drainage and/or measurement of urine. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.
The LubriGuard Foley Catheter is a biocompatible, hydrogel-coated, synthetic polyisoprene Foley catheter used in the drainage of urine. The catheter consists of a shaft with eyelets near the tip, balloon, drainage funnel and inflation arm with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon once inflated retains the catheter within the bladder. There are two lumens: one for urine drainage and the second for balloon inflation. The two-way valve, upon activation, permits flow in either direction and allows for inflation and deflation of the balloon. The cap retains the valve and provides identification for the catheter.
This document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI-driven device.
Instead, this is a 510(k) premarket notification for a Bard LubriGuard Foley Catheter, which is a physical medical device. The "performance data" referred to in the document relates to nonclinical functional performance testing and biocompatibility testing, rather than statistical performance metrics of an AI or diagnostic algorithm.
Therefore, the specific information requested in the prompt (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set details) cannot be extracted from this document as it pertains to a different type of device and evaluation.
Here's what can be extracted regarding the "performance" and "acceptance criteria" as implied by the document for this physical device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance | Performed per ASTM F623-99 (2006), Standard Performance Specification for Foley Catheter and Coefficient of Friction testing. |
| Biocompatibility | Conducted in accordance with ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1. |
| Sterilization | Ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical devices). |
| Substantial Equivalence | Demonstrated similar design features and indications for use as the predicate device (Bard Hydrogel-Coated Foley Catheters, K910195). Nonclinical test data demonstrates that the subject device is safe and effective. |
Missing Information (not applicable to this device type or document):
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.