(248 days)
The FULL CARE Disposable PVC Nelaton Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
The FULL CARE Disposable PVC Nelaton Catheter is a sterile, single use device designed as an intermittent pathway for drainage of the bladder. It is available for male, female and pediatric, in uncoated and coated variants and in two different tip configurations (straight and rounded). There are two drainage eyelets on the catheter. The PVC catheter is designed as an intermittent pathway for drainage of the bladder. The devices consist of the following parts (with different combination): Intermittent Urinary Catheter; hydrophilic coated Nelaton Catheter; water sachet; collection bag; gauze tissue; povidone iodine swabs; two gloves; underpad; BZK; Lubricant; Interface tube; pouch. The device is made of polyvinyl chloride. The catheter is provided sterile in a variety of lengths and sizes.
This document is a 510(k) premarket notification for a medical device called the "FULL CARE Disposable PVC Nelaton Catheter." It aims to demonstrate that this new device is substantially equivalent to existing legally marketed predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies, mapped to your requested points:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for performance in a quantitative table format. Instead, it relies on demonstrating compliance with recognized standards and successful completion of specific tests. The reported performance is summarized qualitatively.
| Criterion Type | Standard/Test Name | Reported Device Performance |
|---|---|---|
| Biocompatibility | FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995" | "The biocompatibility evaluation for the Disposable PVC Nelaton Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 ... and International Standard ISO 10993-1 ... as recognized by FDA. The catheter testing included the following tests: Cytotoxicity, Sensitization, Irritation." (Implied: met requirements, as no adverse findings are noted) |
| Biocompatibility - Tests | International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" (Specifically, tests for surface-contacting devices for duration less than 24 hours) | Cytotoxicity, Sensitization, Irritation. (Implied: met requirements) |
| Bench Testing | EN 1616:1997+A1:1999 (No further detail on what this standard covers provided in the document) | "It's found from the test results that the proposed devices meet the requirements." |
| Bench Testing | EN 1618:1997 (No further detail on what this standard covers provided in the document) | "It's found from the test results that the proposed devices meet the requirements." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for the biocompatibility or bench testing. It only states that these tests were conducted.
- Data Provenance: The tests would likely have been conducted in a laboratory setting, presumably in China where Shaoxing Fuqing Health Products Co., Ltd. is located, or by a certified testing facility contracted by them. The document does not specify the country of origin of the testing data.
- Retrospective or Prospective: These tests are prospective in nature, as they are performed specifically to evaluate the new device for premarket submission.
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 question is not applicable to the type of device and studies described. The "ground truth" concept is typically relevant for diagnostic devices that require expert interpretation of results (e.g., imaging, pathology). For a urological catheter, the "ground truth" is established by direct measurement and standardized chemical/biological assays (e.g., for biocompatibility) or physical performance tests (e.g., for bench testing) against defined criteria. There were no human experts involved in establishing a "ground truth" for interpretation, only laboratory personnel conducting standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is also not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a consensus ground truth. Since the studies conducted were lab-based biocompatibility and bench tests, there's no mention or need for such adjudication.
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 comparative effectiveness study was performed or mentioned. This type of study is relevant for AI-powered diagnostic tools, not for a physical medical device like a PVC Nelaton Catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device with no AI component, and therefore no algorithm-only performance study was conducted.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. For this device, the "ground truth" or reference for evaluating performance is based on:
- Standardized Test Methods and Criteria: For biocompatibility, this refers to the pass/fail criteria defined by ISO 10993-1 (e.g., absence of cytotoxicity, sensitization, irritation).
- Engineering Standards: For bench testing, this refers to the requirements set forth in EN 1616:1997+A1:1999 and EN 1618:1997. The device is reported to "meet the requirements," implying it satisfied objective, predetermined specifications within these standards.
8. The sample size for the training set
This question is not applicable. This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.