(105 days)
The product is intended for intermittent catheterization to drain urine from the urinary bladder. The product is intended for use on patients who are not capable of voluntary urination.
The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed active intermittent catheterization on patients who are not capable of rno production. This product is not designed for use as an indwelling catheter.
The Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter is a sterile, single use, Intermittent urinary drainage catheter extruded from thermo-sensitive Polyvinyl chloride (PVC) material.
This 510(k) summary (K040897) describes a medical device, the Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter, which is a urological catheter. It is a sterile, single-use, intermittent urinary drainage catheter made from thermo-sensitive PVC, intended for intermittent catheterization to drain urine from the urinary bladder in patients who are not capable of voluntary urination.
This submission is a Predicate-based submission and therefore does not include a study to prove the device meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter, 510(K) number K810216). This type of submission typically focuses on comparing the new device's intended use, technological characteristics (materials, design), and performance to the predicate device, rather than conducting new clinical performance studies with acceptance criteria, ground truth, or expert review.
Here's a breakdown of the information requested, based on the provided document:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Substantial Equivalence to Predicate Device: The proposed DOVER® ROB-NEL Catheter is substantially equivalent to the predicate device (K810216) in intended use, physical, functional, and performance characteristics, materials, and design. Biocompatibility: Meets requirements of ISO 10993, Part 1, with the FDA modified matrix presented in memorandum G95-1. -
Sample size used for the test set and the data provenance: Not applicable. No specific test set to evaluate performance against acceptance criteria in the manner described for algorithmic devices. The "test set" here is essentially the comparison of the new device's design and materials to the predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts in the context of a performance study for this device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method described as there was no performance study with a test set of data points requiring expert review.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device (catheter), not an AI/software device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate device, as demonstrated through its history of use and compliance with regulatory standards.
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI/software device requiring a training set.
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How the ground truth for the training set was established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" proving the device meets acceptance criteria is a substantial equivalence comparison to a legally marketed predicate device (Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter, K810216) and nonclinical biocompatibility testing.
- Substantial Equivalence: The manufacturer asserts that the proposed device is substantially equivalent to the predicate device in its intended use, function, mode of operation, physical characteristics, functional characteristics, performance characteristics, materials, and design. This means the new device is considered as safe and effective as the predicate device without requiring new clinical trials to demonstrate effectiveness.
- Biocompatibility Testing: The device underwent biocompatibility testing to ensure its materials are safe for contact with the human body. This testing demonstrated that the device "meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." This is a standard nonclinical evaluation for medical devices to assess potential adverse biological reactions.
§ 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.