(15 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 a device consisting of catheter assembly (catheter, caulking pin and catheter hub), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, 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 (
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria (Compliance to ISO Standard) | Reported Device Performance |
|---|---|---|
| Force to needle breaking shutter (Puncture resistance of needle shield) | ISO 23908 | Conformed to ISO 23908 |
| Tensile strength of needle shaft and needle housing (Break strength of safety mechanism) | 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) | ISO 23908 | Conformed to ISO 23908 |
| Force to detach needle shaft cover from catheter hub (Force to activate safety feature) | ISO 23908 | Conformed to ISO 23908 |
| Burst pressure (whole device) | ISO 10555-1 | Conformed to ISO 10555-1 |
| Collapse (under negative pressure) | ISO 10555-1 | Conformed to ISO 10555-1 |
| Catheter to catheter hub tensile strength (Force at break of catheter / hub) | ISO 10555-1 | Conformed to ISO 10555-1 |
| Strength of union between transparent flash chamber (needle connecting part) and needle | ISO 10555-5 | Conformed to ISO 10555-5 |
| Detection of flashback at transparent flash chamber (needle connecting part) | ISO 10555-5 | Conformed to ISO 10555-5 |
| Flow rate | ISO 10555-5 | Conformed to ISO 10555-5 |
| Vent fitting | ISO 10555-5 | Conformed to ISO 10555-5 |
| Conical fittings of catheter hub | ISO 10555-1 | Conformed to ISO 10555-1 |
| Corrosion resistance | ISO 10555-1 | Conformed to ISO 10555-1 |
| Catheter body tensile strength (Force at break) | ISO 10555-1 | Conformed to ISO 10555-1 |
| Surface | ISO 10555-1 | Conformed to ISO 10555-1 |
| Catheter unit | ISO 10555-5 | Conformed to ISO 10555-5 |
| Needle point | ISO 10555-5 | Conformed to ISO 10555-5 |
| Simulated maximum pressure | Internal Standard | Conformed to internal standard |
| Needle attachment to catheter (Initial sliding friction) | Internal Standard | Conformed to internal standard |
| Detection of flashback at catheter tip | Internal Standard | Conformed to internal standard |
| Protector attachment (Drop test) | Internal Standard | Conformed to internal standard |
| Pressure monitoring | Internal Standard | Conformed to internal standard |
| Simulated use study | Internal Standard | All safety features activated effectively; no de-activations; participants could read IFU and operate device safely and effectively |
| Stiffness | Internal Standard | Conformed to internal standard |
| Elongation | Internal Standard | Conformed to internal standard |
| Flexural fatigue tolerance | Internal Standard | Conformed to internal standard |
| Radio-detectability | ISO 10555-5 (implied through "X" in column) | Conformed to ISO 10555-5 |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Pyrogen, Genotoxicity, Implantation/Subchronic toxicity, Hemolysis, Physicochemical Characterization) | FDA G95-1 / ISO 10993 | Biocompatible throughout shelf life |
Study Proving Device Meets Acceptance Criteria:
A non-clinical performance testing study was conducted to demonstrate the safety and effectiveness of the SURFLASH® Safety I.V. Catheter, its conformity to applicable ISO standards, and substantial equivalence to predicate devices. This study included:
- Compliance to ISO Standards: Tests were performed to confirm conformance with relevant parts of ISO 10555-1, ISO 10555-5, and ISO 23908, as detailed in the table above.
- Testing by Internal Standard: Additional performance tests, not covered directly by the listed ISO standards, were conducted against internal standards.
- Simulated Use Study: This study was conducted in accordance with FDA's Guidance For Industry and Staff, Medical Devices with Sharps Injury Prevention Features (August 9, 2005).
Detailed Information on the Study:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each individual test. However, the document mentions "study participants" for the simulated use study but does not quantify them. For other physical and material tests, a specific sample size is not provided, but it is implied that a sufficient number were tested to demonstrate compliance with standards.
- Data Provenance: The tests were conducted internally by Terumo Medical Corporation and its Kofu Factory in Japan. The data is retrospective in the sense that it reflects tests completed for the 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):
- Simulated Use Study: Healthcare workers (implied to be experts or trained professionals in I.V. catheter use) were the "participants" in the simulated use study. The number of participants and their specific qualifications (e.g., years of experience) are not explicitly stated, but the intent was to verify proper activation by those who use such devices.
- Physical/Material Tests: These tests rely on standardized methods and equipment, not expert consensus on individual cases. The "ground truth" for these tests is the quantitative measurement against defined ISO or internal standard thresholds.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For the simulated use study, the "adjudication" was based on direct observation of whether "All safety features activated effectively and there were no de-activations after discarding" and if "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies direct observation and evaluation against predefined criteria, not a specific 2+1 or 3+1 expert consensus method.
- For the physical and material tests, adjudication is based on whether the measured performance falls within the specified limits of the ISO standard or internal standard.
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 study mentioning AI was performed or reported. This device is a manual medical device (intravascular catheter with a passive safety feature), not an AI-assisted diagnostic or interpretative system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Physical/Material Tests: The ground truth is the objective measurement of physical properties and performance characteristics against established technical standards (ISO) and the manufacturer's internal specifications.
- Simulated Use Study: The ground truth was based on the observable successful activation of the safety feature and the user's ability to follow instructions and operate the device effectively in a simulated environment. This represents a form of performance outcome directly observed.
- Biocompatibility Tests: The ground truth for biocompatibility is whether the materials meet predefined safety criteria as per ISO 10993 and FDA G95-1, assessed through specific biological tests (e.g., cytotoxicity, sensitization, systemic toxicity).
8. The sample size for the training set:
- Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. Performance is based on engineering design, material properties, and physical testing.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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).