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510(k) Data Aggregation
(55 days)
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
The TERUMO® SURFLO® FLEX I.V. Catheters and the TERUMO® SURFLASH™ I.V. Catheters are devices consisting of a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term use to withdraw samples, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula, placed in the catheter to maintain rigidity, is withdrawn after the catheter is placed in the vascular system.
The TERUMO SURFLO FLEX I.V. CATHETER AND THE TERUMO SURFLASH I.V. CATHETER are sterile, single use devices consisting of a slender tube (catheter) made of polyurethane. The devices are inserted into the patient's vascular system for short-term use to withdraw samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors.
Each device consists of a catheter assembly-catheter, caulking pin, catheter hub; a needle assembly-cannula, needle hub; and a filter cap with an air filter
The catheters are made of polyurethane, which allows appropriate stiffness for proper insertions into the vein, and flexibility during retention in the vein. Each catheter contains barium sulfate radio-opaque stripes along the length of the catheter to allow radio detectability. A stainless steel caulking pin fastens the catheter to the catheter hub.
Each catheter hub is color coded according to the outside diameter as specified in ISO 10555-5, "Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters".
The needle assembly has the same specifications as the Terumo® Surflo® I.V. Catheter, which is the subject of K891087. The transparent needle hubs permit flashback detection when the cannula enters the vessel.
The filter cap with an air filter is provided as a vent fitting.
The Terumo Surflo Flex I.V. Catheter is available in 14 sizes with different combinations of 6 catheter diameters and 5 catheter lengths (see following specifications table). The Terumo Surflash I.V. Catheter is available in 24G by 19mm currently. Additional sizes will be implemented at a later date.
The cannula of the Surflash I.V. Catheter are grooved from the heel of the cannula tip bevel to the end of the catheter tip, which allows flashback detection at the catheter tip after the catheter tip enters the vessel.
The only difference between the TERUMO SURFLO FLEX and the TERUMO SURFLASH I.V. catheters is the grooved cannula feature of the SURFLASH. All other specifications are the same.
The provided text is a 510(k) summary for a medical device (intravascular catheters) seeking substantial equivalence to already cleared devices. This type of submission does not typically involve the kind of elaborate clinical studies or AI performance metrics that the requested questions imply.
Therefore, many of the requested sections about acceptance criteria, detailed study designs, expert involvement, and AI performance cannot be answered from the provided document. The purpose of this 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through performance testing and material comparisons, rather than a comparative clinical trial with human and AI readers.
Here's an attempt to answer the questions based only on the provided text, and explicitly noting when information is not present:
Description of Acceptance Criteria and Device Performance Study
The TERUMO® SURFLO® FLEX I.V. Catheters and TERUMO® SURFLASH™ I.V. Catheters demonstrated substantial equivalence to predicate devices (Becton Dickinson (B-D®) Insyte® I.V. Catheter, B-D Insyte (N) I.V. Catheter, and Terumo® Surflo® I.V. Catheter) through a series of performance tests. The acceptance criterion for these tests was that the performance of the proposed devices be equivalent to that of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted to demonstrate equivalence. However, it does not provide specific quantitative acceptance criteria or detailed numerical results for the proposed device's performance, nor does it explicitly detail the predicate device's performance for direct comparison in the format below. The "reported device performance" is implicitly stated as meeting the equivalence standard.
| Performance Test | Acceptance Criteria (Implicit: Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Catheter body tensile strength (force at break of catheter) | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Stiffness | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Elongation | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Burst pressure | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Collapse | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Flexural fatigue tolerance | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Radio detectability | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Flow rate | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Corrosion resistance of caulking pin | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Catheter body to catheter hub tensile strength (force at break of catheter/hub) | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Catheter/needle attachment (fitting strength) | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Vent fitting | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Detection of flashback at catheter tip and needle hub | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Detection of flashback at needle hub | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Strength of union between needle hub and needle | Equivalent to predicate devices | Demonstrated substantial equivalence |
| Sterility (SAL of 10^-6) | Sterility assurance level (SAL) of 10^-6 | Validated to provide SAL of 10^-6 (via EN 550) |
| Ethylene oxide residual levels | Ethylene oxide: |
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