(58 days)
Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.
The Coloplast Self-Cath® CS Closed System catheter (also referred to as "SCCS") is an extension of the existing Coloplast Self-Cath product line. The device is a modification of the Coloplast (Mentor) Self-Cath Closed System catheter, which was cleared under 510(k) K003873. It is available singly and as part of a kit.
The SCCS is intended to be used to drain urine from the bladder. The SCCS is a catheter and collection bag assembly for inserting a catheter from a closed, sterile bag through an insertion tip into the bladder. It consists of a sterile, pre-lubricated catheter with a pre-lubricated introducer tip on the proximal end, which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter and introducer tip are pre-lubricated with a water-soluble hydrophilic water-based lubricant. The catheter provides a conduit for draining the bladder into the pre-attached urine collection bag.
This document is a 510(k) summary for the Coloplast Self-Cath® CS Closed Urinary Catheterization System, seeking clearance due to substantial equivalence to a previously cleared device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for diagnostic AI/ML products.
This 510(k) is for a physical medical device (a catheter system), not a software or AI-driven diagnostic device. Therefore, the questions about performance metrics (e.g., sensitivity, specificity), ground truth, expert readers, and training/test sets are largely incongruent with the information provided. The "acceptance criteria" for a device of this type would typically revolve around physical and biological compatibility, manufacturing quality, and functional performance relative to its predicate, rather than algorithmic accuracy.
However, I will extract relevant information and address the questions to the best of my ability based on the provided text, highlighting where the information is not applicable or available for this type of device submission.
Acceptance Criteria and Study Information for the Self-Cath® CS Closed Urinary Catheterization System
1. A table of acceptance criteria and the reported device performance
For this type of physical medical device, acceptance criteria are generally established against the functional, material, and safety characteristics of a legally marketed predicate device. The document states a claim of "Substantial Equivalence," which is the primary "acceptance criterion" for a 510(k) submission. Performance is assessed by demonstrating this equivalence through various tests (often mechanical, biological, and material compatibility), which are not detailed in this summary.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Implicit from Substantial Equivalence Claim) |
|---|---|
| Intended Use: Bladder drainage for male/female patients. | The device is intended for the same use as the predicate device. |
| Device Design: Catheter and collection bag assembly with a pre-lubricated catheter and introducer tip. | The device is a modification of the predicate, sharing core design elements. |
| Material Composition: (Not explicitly detailed, but implied to be equivalent or compatible) | (Implied to be equivalent or compatible with the predicate) |
| Performance Characteristics (e.g., flow rate, ease of insertion, sterility): (Not explicitly detailed, but implied to be equivalent) | (Implied to be equivalent to the predicate) |
| Safety and Effectiveness: No new questions of safety or effectiveness compared to the predicate. | The device is considered as safe and effective as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a physical medical device, "test set" would typically refer to the samples used in engineering, biocompatibility, and sterility testing, not clinical data sets in the way AI/ML products require. The document states it is a "modification" of an existing device (K003873), implying that much of the foundational testing and validation was done for the predicate, and this submission focuses on demonstrating that the modifications do not alter the substantial equivalence.
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/provided. For a physical catheter system, "ground truth" and expert consensus in the diagnostic sense are not relevant. Clinical performance might be assessed via user feedback or clinical studies (which are not detailed here), but this is different from establishing ground truth for AI/ML evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not a part of the substantial equivalence process for a physical device like a catheter.
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
This information is not applicable/provided. MRMC studies are used to evaluate the performance of diagnostic imaging devices, often involving AI. This device is a catheter, not a diagnostic imaging or AI device, so such a study would not be performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. This is a physical medical device, not an algorithm, so standalone AI performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. "Ground truth" in the context of diagnostic accuracy is not relevant for this physical device. The "truth" for a catheter would be its ability to correctly drain urine, its sterility, material safety, and physical properties, which are assessed through engineering and biological testing.
8. The sample size for the training set
This information is not applicable/provided. The concept of a "training set" is for AI/ML models. This document describes a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable/provided. Similar to point 8, this question is not relevant for the device described in the 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.