(215 days)
The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder. It must be connected to a standard urinary collector.
The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra and is an improved version of the straight urinary catheter. The Hakki catheter has built-in expandable/retractable Malecot type wings permitting holding capabilities less than that of a Foley catheter, but allows greater holding power than a straight catheter. By design the Hakki catheter has the ability to maximize drainage of a bladder, due to the location of its drainage opening at the natural drainage point within the bladder. The Hakki catheter is activated by expanding and contracting the catheter through the built-in patented bellows, which open and close the wing tip. The newly designed Hakki urinary catheter functions in the same manner as a straight or Foley catheter and is inserted through the urethra into the bladder.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow rate | Substantial equivalence with international standard ASTM F 623-99 (Reapproved 2006) |
| Expanded leaflet integrity | Substantial equivalence with international standard ASTM F 623-99 (Reapproved 2006) |
| Response to pullout | Substantial equivalence with international standard ASTM F 623-99 (Reapproved 2006) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each performance test (flow rate, expanded leaflet integrity, response to pullout), nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Testing was performed in accordance to Food and Drug Administration guidance's and recognized international standard ASTM F 623-99 (Reapproved 2006)."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing was described as "Non-clinical device performance testing," which implies laboratory-based tests rather than expert-driven clinical evaluations for ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. As the tests were non-clinical performance tests, an adjudication method for human interpretation would not typically be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was mentioned. The device is a urinary catheter, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical medical device (urinary catheter), not an algorithm or AI system. The performance tests described (flow rate, leaflet integrity, pullout response) are standalone physical tests of the device's mechanical properties.
7. The Type of Ground Truth Used
The ground truth for the non-clinical performance tests (flow rate, expanded leaflet integrity, response to pullout) was based on the specifications and requirements outlined in the recognized international standard ASTM F 623-99 (Reapproved 2006).
8. The Sample Size for the Training Set
This information is not applicable. The Hakki Urinary Catheter is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical medical 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.