(147 days)
An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
The Cure Pediatric Catheter device is an intermittent urinary catheter intended to be used by pediatric males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to open, sterile, single-use packages.
The provided text describes a 510(k) premarket notification for a medical device called the "Cure Pediatric Catheter." This document is a regulatory submission, not a study report. Therefore, it does not contain the detailed information necessary to fully address all parts of your request which are typical for studies proving device performance against acceptance criteria.
However, I can extract the available information and highlight what is not present in this type of document.
Understanding the Document's Nature:
This is a 510(k) Summary, which aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than directly proving performance against pre-defined acceptance criteria in the sense of a clinical or analytical study with statistical endpoints. Substantial equivalence is established primarily through comparisons of technological characteristics, materials, and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
This type of information is not provided in a 510(k) Summary for a device like a urinary catheter. Acceptance criteria typically involve specific quantitative benchmarks (e.g., flow rate, force to insert, material strength, biocompatibility limits) that would be evaluated in a detailed test protocol.
Instead, the document states:
- "The Cure Pediatric Catheter is substantially equivalent to the predicate devices."
- "The catheter design is identical to both predicates K072539 and K080881 (except in length) and materials are identical to the predicate K080881."
- "Standard biocompatibility tests were performed on the Cure Catheter to establish device safety. All tests were performed in accordance with ISO10993-1... The studies indicated that the Cure Pediatric Catheter is biocompatible and safe for its intended use."
These statements serve as the "reported device performance" in the context of a 510(k) as they indicate compliance with established standards and similarity to devices already on the market, which inherently implies acceptable performance. Specific numerical "acceptance criteria" and "reported performance" values are not listed here.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. Biocompatibility testing for medical devices involves a variety of tests on material samples, not a "test set" of patients or images as might be seen for AI/diagnostic devices. The number of samples for ISO 10993 testing is determined by the specific methods employed (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity).
- Data Provenance: Not explicitly stated. Biocompatibility tests are typically performed in a laboratory setting, either internally by the manufacturer or by a contract research organization. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of biocompatibility testing, it is always prospective for the device being evaluated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable to this type of device and submission. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret data (like images). For a simple Class II urinary catheter, performance and safety are assessed through engineering specifications, material testing, and biocompatibility studies, not by expert interpretation of clinical cases to establish a "ground truth."
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as #3. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert opinions when establishing ground truth for diagnostic studies. This is not pertinent to the evaluation of a urinary catheter's physical and biological properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is primarily for diagnostic imaging devices or algorithms where human readers interpret cases, and the AI's impact on their performance is evaluated. A urinary catheter is a therapeutic/drainage device, not an interpretive diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone performance study in the context of an algorithm was not done. There is no AI algorithm in this device. The device itself is a physical medical instrument. Its "standalone performance" refers to its physical and material properties (e.g., sterility, biocompatibility, dimensions, material integrity) as confirmed by standard engineering and biological tests, not an algorithm's output.
7. The Type of Ground Truth Used
This question is not applicable in the conventional sense of expert consensus, pathology, or outcomes data for diagnosing a condition. For this device, the "ground truth" for demonstrating safety and effectiveness relies on:
- Compliance with recognized standards: Such as ISO 10993-1 for biocompatibility.
- Material specifications: Ensuring materials meet medical-grade requirements and match predicate devices.
- Design specifications: Confirming physical dimensions and features are appropriate and identical to predicates (except length).
- Performance specifications: While not detailed in the summary, underlying testing would verify catheter integrity, burst pressure, surface friction, etc., against defined engineering standards.
So, the "ground truth" is essentially adherence to established engineering, material science, and biological safety standards, as well as a demonstration of substantial equivalence to already approved devices.
8. The Sample Size for the Training Set
This question is not applicable as there is no AI algorithm or "training set" for a urinary catheter.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no AI algorithm or "training set" for a urinary catheter.
§ 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.