(28 days)
The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (
The SURFLASH® Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter.
The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin, and catheter hub), needle assembly (needle, needle housing, transparent flash chamber (needle connecting part) with filter, and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, and junction cylinder).
The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (
Here's a summary of the acceptance criteria and study information for the SURFLASH® Safety I.V. Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission declares that the device "complies with the acceptance criteria established based on the predicate" and that "No deviations from ISO standards were identified in the testing to standards." However, specific numerical acceptance criteria (e.g., minimum force for needle breaking shutter) are not explicitly stated in the provided text. The table below lists the performance tests conducted and confirms that the device conformed to the relevant standards or internal requirements.
| Performance Test | Acceptance Criteria (Implicitly: Conformance to relevant ISO standards or internal requirements) | Reported Device Performance |
|---|---|---|
| Force to needle breaking shutter (Puncture resistance of needle shield) | Required by ISO 23908 | Conformed to ISO 23908 |
| Tensile strength of needle shaft and needle housing (Break strength of safety mechanism) | Required by ISO 23908 | Conformed to ISO 23908 |
| Force to release shutter and reactive force when the shutter opens to cover the cannula tip (Reaction force generated by the activation mechanism) | Required by internal standard | Conformed to internal standard |
| Force to detach needle shaft cover from catheter hub (Force to activate safety feature) | Required by ISO 23908 | Conformed to ISO 23908 |
| Simulated maximum pressure | Required by internal standard | Conformed to internal standard |
| Burst pressure (whole device) | Required by ISO 10555-1 | Conformed to ISO 10555-1 |
| Collapse (under negative pressure) | Required by ISO 10555-1 | Conformed to ISO 10555-1 |
| Catheter to catheter hub tensile strength (Force at break of catheter / hub) | Required by ISO 10555-1 | Conformed to ISO 10555-1 |
| Strength of union between transparent flash chamber (needle connecting part) and needle | Required by ISO 10555-5 | Conformed to ISO 10555-5 |
| Needle attachment to catheter (Initial sliding friction) | Required by internal standard | Conformed to internal standard |
| Detection of flashback at catheter tip | Required by internal standard | Conformed to internal standard |
| Detection of flashback at transparent flash chamber (needle connecting part) | Required by ISO 10555-5 | Conformed to ISO 10555-5 |
| Flow rate | Required by ISO 10555-5 | Conformed to ISO 10555-5 |
| Vent fitting | Required by ISO 10555-5 | Conformed to ISO 10555-5 |
| Drop test | Required by internal standard | Conformed to internal standard |
| Conical fittings of catheter hub | Required by ISO 10555-1 | Conformed to ISO 10555-1 |
| Pressure monitoring | Required by internal standard | Conformed to internal standard |
| Simulated use study | Required by ISO 23908 | All safety features activated effectively, no de-activations after discarding. All participants could read IFU and activate safety feature without further explanation. |
| Surface | Required by ISO 10555-1 | Conformed to ISO 10555-1 |
| Corrosion resistance | Required by ISO 10555-1 | Conformed to ISO 10555-1 |
| Radio-detectability | Required by ISO 10555-5 | Conformed to ISO 10555-5 |
| Catheter unit | Required by ISO 10555-5 | Conformed to ISO 10555-5 |
| Material | Required by ISO 10555-5 | Conformed to ISO 10555-5 |
| Needle point | Required by ISO 10555-5 | Conformed to ISO 10555-5 |
| Catheter body tensile strength (Force at break) | Required by ISO 10555-1 | Conformed to ISO 10555-1 |
| Catheter Stiffness | Required by internal standard | Conformed to internal standard |
| Catheter Elongation | Required by internal standard | Conformed to internal standard |
| Biocompatibility Tests | Adherence to ISO 10993-1 and FDA G95-1 guidelines | Materials are biocompatible throughout shelf life. Biocompatibility established under K122544, no re-testing needed. |
| Cytotoxicity | N/A | Satisfactory |
| Sensitization | N/A | Satisfactory |
| Intracutaneous reactivity | N/A | Satisfactory |
| Systemic toxicity (acute) | N/A | Satisfactory |
| Pyrogen | N/A | Satisfactory |
| Genotoxicity | N/A | Satisfactory |
| Implantation / Subchronic toxicity | N/A | Satisfactory |
| Hemolysis | N/A | Satisfactory |
| Physicochemical Characterization | N/A | Satisfactory |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 | Achieved SAL of 10^-6 using Ethylene Oxide |
| Risk Analysis | Conformity to ISO 14971:2007 | Determined no new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size for each performance test. It mentions that "Performance testing was conducted to ensure the safety and effectiveness... verify conformity to the applicable part of ISO standards, and demonstrate substantial equivalence to the predicate device." For the "Simulated Use Study," it refers to "study participants" without specifying their number.
- Data Provenance: The testing was non-clinical performance and biocompatibility testing. The data originates from internal testing conducted by Terumo Corporation's Kofu Factory in Japan, as indicated by the manufacturer's location and the context of the submission. The text implicitly suggests retrospective data collection as these are standardized tests assessing device properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This section is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies requiring expert ground truth in a clinical setting (e.g., image interpretation). The "ground truth" for these tests consisted of established ISO standards and internal specifications.
- For the Simulated Use Study, "healthcare workers who use these types of Safety I.V. Catheters" were involved, but their number and specific qualifications (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set
- Not applicable. This was non-clinical testing against established standards and internal requirements, not a study requiring adjudication of expert interpretations.
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 submission is for a physical medical device (I.V. catheter) and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This submission is for a physical medical device and does not involve an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical performance tests was rooted in established international standards (ISO standards), FDA guidance documents (e.g., for sharps injury prevention features), and internal specifications derived from the predicate device. For the biocompatibility tests, it was adherence to ISO 10993-1 and FDA G95-1 guidelines.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not a machine learning or AI device that would require a training set.
§ 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).