(61 days)
The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.
The Bardex I. C. 4-Way Foley Catheter is a new catheter design incorporating the addition of a fourth lumen for prostatic drainage and the addition of several prostatic drainage eyes proximal to the balloon.
The provided text is a 510(k) summary for the Bardex I. C. 4-Way Foley Catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving experts, AI, or controlled ground truth assessment.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this specific document. The document highlights the technological characteristics and intended use of the device and compares them to existing predicate devices. It states that performance and functional testing standards are based on a "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters."
Here's an attempt to answer the questions based on the available information, noting where information is not present:
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with corresponding performance metrics in the format of a clinical or performance study. Instead, it focuses on qualitative and structural characteristics compared to predicate devices for substantial equivalence.
| Acceptance Criteria Category (Derived from predicate comparison) | Reported Device Performance (Bardex I.C. 4-Way Foley Catheter) |
|---|---|
| Indications or Intended Use | Bladder/urinary tract drainage/irrigation, assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate. (Equivalent to predicates, with the added prostatic drainage feature). |
| Disposable | Yes |
| Sterile | Yes |
| Catheter Base Material | Red Latex |
| X-Ray Opaque | Yes |
| Coating | Silver/Hydrogel |
| Drainage Eyes Proximal to Balloon | 5 Drainage Eyes (New feature) |
| Tip Type – Drainage Eyes Distal to Balloon | Open Concave Tip (Couvelaire) and 3 additional eyes |
| Fr. Sizes Available | 18-24 Fr. |
| Foley Balloon Size | 30cc |
| Available Packaged Singly | Yes |
| Tip Shape | Coude |
| Number of Lumens | 4 lumens (New feature) |
Note: The document states "Performance and functional testing standards are based on the 'Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters' dated September 12, 1994." However, the results of these tests, specific acceptance criteria, or a detailed study report are not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical or performance test set for evaluating the device against acceptance criteria in the manner typically associated with AI/software device evaluation. It focuses on device characteristics for regulatory submission.
- Sample Size: Not applicable/Not provided in this summary.
- Data Provenance: Not applicable/Not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not describe a process for establishing ground truth using experts, as it's not a study evaluating diagnostic or prognostic performance requiring expert interpretation.
- Number of Experts: Not applicable/Not provided.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set
Not applicable, as no expert-adjudicated test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned as this is not an AI/diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device (catheter), not an algorithm or software.
7. The Type of Ground Truth Used
Not applicable in the context of device performance claims based on this 510(k) summary. The "ground truth" here is the physical and functional specifications of the device itself and its comparison to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable, as this is a physical medical device and not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.