(185 days)
Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
The Hi-Slip Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of sizes and lengths.
The Hi-Slip Plus Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer and water sachet (sterile water). Coating is activated by the water of integrated water sachet. Water is let down by squeezing the water sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PLUS is provided in a variety of sizes and lengths.
Hi-Slip Kit includes a single use coated PVC (medical arade) catheter, urine bag (medical grade PVC urine bag), water sachet (sterile water) and povidone iodine swab for cleaning urethra outlet prior to catheterization. The catheter is coated with a hydrophilic polymer (polyvynil pyrolidone, PVP) which makes the catheter surface slipperv when dipped into the water. Patient clean the urethra outlet by using povidone iodine swab and lets the water fill the catheter place in the urine bag by squeezing the sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. Patient disposes the urine directly into urine bag. The KIT is provided in a variety of sizes and lenaths.
The provided text describes a 510(k) summary for Hi-Slip, Hi-Slip Plus, and Hi-Slip Kit urinary catheters, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to already marketed devices based on technological characteristics and intended use.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an attempt to answer the questions based only on the provided text, noting its limitations:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a table of reported device performance in the context of comparative effectiveness or specific performance metrics for the Hi-Slip products. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of device composition, sizes, function, indications for use, features, sterility, and packaging. The "Summary of Safety Testing" section (Table 3.7) provides results for biocompatibility tests, but these are pass/fail criteria against ISO standards, not performance metrics.
| Test | Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|---|
| Investigation of Acute Systemic Toxicity | ISO 10933-11 | "Did not cause any acute toxicity" (Passed) |
| Closed Patch Sensitization Test | DIN ISO 10933-10 | "Did not cause any sensitization" (Passed) |
| Salmonella typhimurium Reverse Mutation Assay | DIN ISO 10933-3 | "Did not cause any genotoxic activity" (Passed) |
| Cytotoxicity Assay | DIN ISO 10993-5 (EN 30993-5) | "Caused no toxicological/biological critical cell damages and growth inhibition." (Non-cytotoxic) |
| Skin Irritation Test | DIN ISO 10993-10 | "Did not cause any irritation under the selected test conditions" (Passed) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention any specific "test set" in the context of a clinical performance study. The safety tests listed in Table 3.7 would have involved samples of the device material, but the sample sizes (e.g., number of animals or cell cultures) are not specified. Data provenance (country of origin, retrospective/prospective) is not provided for these safety tests.
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)
Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The safety tests typically rely on standardized laboratory protocols and measurements, not expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical 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
Not applicable. This device is a medical catheter, not an AI diagnostic tool involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the safety tests (biocompatibility), the "ground truth" or reference is adherence to the specified ISO/DIN standards and observed biological responses (e.g., absence of toxicity, sensitization, genotoxicity, irritation, or critical cell damage).
8. The sample size for the training set
Not applicable. This device is a physical medical catheter, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.