(268 days)
The BONREE Nelaton Catheter is used for clean intermittent catheterization (CIC) treatment. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old) for draining urine from the bladder.
The BONREE Nelaton Catheter is sterile, single patient use, urinary drainage catheter that is made from PVC. The catheter is comprised of shaft, tip and funnel. It has two drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The tip is available in a straight or coude configuration. The tip of the catheter passes through the urethra into the bladder to allow urine to drain into the eyelets and then through the catheter shaft, exiting through the funnel.
The BONREE Nelaton Catheters are produced with two different models—Straight Tip and Coude Tip. Both models will be available for male, female and pediatric. The difference between two models is the tip design.
For Straight Tip catheters, the dimensions range from 6Fr to 22Fr which is a range of 2.0 mm to 7.33 mm in Outer Diameter with a straight tip shape.
For Coude Tip catheters, the dimensions range from 10Fr to 18Fr which is a range of 3.33 mm to 6.0 mm in Outer Diameter with a bent catheter tip shape.
The difference between the Female and Male type is the tube lengths. The Male type is offered in a 400mm tube overall length and 370mm tube effective length, whereas the Female type is offered in a 200mm tube overall length and 170mm tube effective length.
The provided document is a 510(k) Premarket Notification for a medical device (BONREE Nelaton Catheter). It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain information related to an AI/ML-based medical device study. It describes a traditional medical device (catheter) and its physical and biological performance testing.
Therefore, I cannot extract the information required to answer your questions as they pertain to AI/ML device acceptance criteria and study details. Specifically:
- Acceptance Criteria/Reported Device Performance: The document lists general performance testing standards (ASTM F623-19, ISO 20696:2018) and biocompatibility standards (ISO 10993-1). It states that the device "meets all the pre-determined testing and acceptance criteria" and "All evaluation acceptance criteria were met," but it does not provide a table of specific quantitative acceptance criteria or reported device performance metrics in the way one would for an AI/ML diagnostic or prognostic device (e.g., sensitivity, specificity, AUC).
- Sample Size/Data Provenance: Not applicable as it's not an AI/ML study. Performance testing would be on physical samples of the catheter, not patient data in the context of an AI/ML algorithm.
- Experts/Ground Truth Establishment/Adjudication/MRMC/Standalone: These concepts are entirely irrelevant to the type of device and study described in the document. This is not an AI/ML algorithm that identifies or diagnoses anything from medical images or data.
- Training Set/Ground Truth for Training: Also irrelevant for this traditional medical device submission.
In summary, the provided text describes the submission for a physical medical catheter, not an AI/ML-based device. Thus, the questions posed about AI/ML device acceptance criteria and studies cannot be answered from this document.
§ 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.