(90 days)
The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
The InCare Intermittent Catheters are intended to be used as a means of managing urinary incontinence by draining urine from the bladder. The InCare Intermittent Catheters are sterile, non-latex, PVC catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria. The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. The InCare Intermittent catheters are available in various sizes to accommodate a wide range of male, female, and pediatric end users.
The provided text is a 510(k) Summary for the InCare Intermittent Catheter. This document does not describe a study to prove the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence relies on comparing the new device's design, materials, and intended use to existing, legally marketed devices, rather than conducting new performance studies against specific acceptance criteria.
Therefore, the requested information elements related to a study (like acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, and ground truth for training data) are not available in this document.
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance
- This information is not provided. The document focuses on demonstrating substantial equivalence rather than performance against pre-defined acceptance criteria from a specific study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not applicable. No specific test set or study data is mentioned for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable. No test set or ground truth establishment by experts is described for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. No test set or adjudication method is described.
5. 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
- No MRMC study was done, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in a 510(k) for substantial equivalence relies on comparing features to existing predicate devices, not on a ground truth for performance.
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/algorithm device that requires a training set or ground truth for it.
Based on the provided text, the key information is related to the substantial equivalence determination:
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Acceptance Criteria for Substantial Equivalence: The criteria implicitly accepted by the FDA for substantial equivalence in this context are:
- Identical Intended Use: The new device must have the same intended use as the predicate device(s).
- Same Technological Characteristics: If the technological characteristics are the same, the device is substantially equivalent.
- Different Technological Characteristics but as Safe and Effective: If the technological characteristics are different, the device must not raise different questions of safety and effectiveness, and information must be provided that demonstrates the device is as safe and effective as the legally marketed device.
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Reported Device Performance (in terms of Substantial Equivalence):
- Intended Use: The InCare Intermittent Catheter is "indicated for use by male, female and pediatric patients for the purpose of bladder drainage" which is stated as substantially equivalent to the predicate devices.
- Technological Characteristics: The device is described as "substantially equivalent to the predicate devices in design, materials used, and intended use." Specifically, it is made of "PVC material that is substantially equivalent to the predicate devices."
- Biocompatibility: A biocompatibility assessment was conducted based on established guidelines (USP, G95-1, ISO 10993-1). The materials are "considered biocompatible and appropriate for their intended use." This addresses a key aspect of safety.
In summary, this 510(k) document is a declaration of substantial equivalence, not a report of a performance study against specific acceptance criteria.
§ 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.