(77 days)
The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter is used when therapy requires repeated venous access for intravenous injection or infusion and/or venous blood sampling.
The modified CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters are similar in design and function to the current commercially available CliniCath® Peripherally Inserted Catheters.
The catheters are designed to permit repeated venous access for intravenous injection or infusion and/or venous blood sampling
The product consists of single- and dual-lumen, radiopaque polyurethane catheters with preinserted stylets, clamps, and attached stylet/flushing assemblies. Catheters will be made available with and without the following accessories: introducer needle, injection cap and procedural tray. Catheters will be provided in single- and multi-unit package configurations.
The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters are compared to two predicate devices: the CliniCath® Peripherally Inserted Catheters and the BIOVUE Peripherally Inserted Catheters. The study conducted was a functional in-vitro testing and biocompatibility testing to demonstrate that the new device performs according to specification and uses biocompatible materials.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices and the “Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters.” The reported device performance is presented through the various specifications shown in the "DEVICE COMPARISON" table, implying that these align with or are superior to the predicate devices, and that the functional testing confirmed these specifications.
| Acceptance Criteria (Implied) | Reported Device Performance (CliniCath® PolyFlow®) |
|---|---|
| Intended Use Equivalence: Repeated venous access for IV injection/infusion and/or blood sampling. | Met (Identical to predicate devices) |
| Catheter Insertion: Peripheral vein | Met (Identical to predicate devices) |
| Catheter Tip Placement: Peripheral/Central | Met (Identical to predicate devices) |
| Catheter Material: Radiopaque Polyurethane | Met (Similar to BIOVUE, different from original CliniCath which was silicone) |
| Available Catheter Sizes: Range of single and dual-lumen sizes. | Met (Offers a wide range, generally comparable to or expanding upon predicate sizes) |
| Catheter O.D. and I.D. (Nominal): Specific dimensions for various sizes. | Met (Detailed dimensions provided, indicating performance within expected ranges for the designated French sizes) |
| Catheter Length (Nominal): Various lengths available. | Met (Offers 20cm, 30cm, 50cm, and 65cm, greater range than original CliniCath) |
| Flow Rate (Nominal): Specific flow rates for various configurations. | Met (Detailed flow rates provided, demonstrating functionality consistent with or exceeding predicate devices where applicable) |
| Functional Performance: Functions according to specifications. | Met (In-vitro testing conducted confirms this performance) |
| Biocompatibility: Materials used are biocompatible. | Met (Biocompatibility testing conducted confirms this) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document mentions "In-vitro testing was conducted" and "Biocompatibility testing was conducted on the device" but does not specify the number of units or tests performed.
- Data Provenance: Not explicitly stated, however, the testing was "in accordance with the FDA 'Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters,' dated March 1995." This implies the testing was likely conducted in a controlled laboratory environment. It is prospective testing, as it was performed specifically for this 510(k) submission. No country of origin for the data is specified, but given the applicant's location (St. Paul, MN) and FDA submission, it's highly probable the testing was done in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study did not involve expert-based ground truth establishment for a test set in the conventional sense (e.g., image interpretation). The evaluation relied on functional performance metrics and biocompatibility standards rather than human expert opinion on a clinical outcome.
4. Adjudication Method for the Test Set
This information is not applicable as the study involved objective functional and biocompatibility testing, not an assessment requiring adjudication of human-derived observations or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical studies were not deemed necessary regarding the CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter due to its similarity in design and function to current commercially available peripherally inserted catheters." The assessment of effectiveness was based on similarity to predicate devices and in-vitro testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The concept of "standalone performance" typically applies to AI algorithms. This device is a physical medical device (catheter), not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The functional and biocompatibility tests are inherent "standalone" assessments of the device's physical properties and performance.
7. The type of ground truth used
The "ground truth" for the device's performance was established via objective physical and chemical testing standards and specifications. This includes:
- In-vitro functional testing to verify flow rates, catheter dimensions (O.D. and I.D.), and other design specifications.
- Biocompatibility testing to ensure the materials meet established safety standards for human contact.
These are based on established engineering and biological standards, not clinical outcomes or expert consensus on a subjective measure.
8. The sample size for the training set
This information is not applicable. This device is a physical medical device, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for this physical medical device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).