(112 days)
The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.
The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. The tubing material is DEHP-free PVC and the filter has been added to prevent the flow of particulate matter.
Here's a breakdown of the acceptance criteria and study information for the Nipro SafeTouch PSV winged Infusion Set with/without filter, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Appearance | Acceptable visual inspection; free from defects. | Not explicitly stated, but results are included and deemed safe and effective. |
| Dimensional | Conformance to design specifications. | Not explicitly stated, but results are included and deemed safe and effective. |
| Package Integrity Testing | Maintain sterile barrier and component integrity. | Not explicitly stated, but results are included and deemed safe and effective. |
| Penetration force (puncture resistance) | Meet specified force requirements for needle insertion. | Not explicitly stated, but results are included and deemed safe and effective. |
| Pull force of connections | Meet specified force requirements to prevent accidental disconnection. | Not explicitly stated, but results are included and deemed safe and effective. |
| Safety Mechanism Deactivation force | Meet specified force for clinicians to activate safely. | Not explicitly stated, but results are included and deemed safe and effective. |
| Needle Clogging Test | Demonstrate resistance to clogging during use. | Not explicitly stated, but results are included and deemed safe and effective. |
| Leakage of product | Prevent fluid leakage. | Not explicitly stated, but results are included and deemed safe and effective. |
| Luer Cap Separation | Maintain secure connection but allow for intentional separation. | Not explicitly stated, but results are included and deemed safe and effective. |
| Connector Taper Leakage | Prevent leakage at tapered connections. | Not explicitly stated, but results are included and deemed safe and effective. |
| Internal/external surface of cannula | Smooth and free from defects to ensure safe insertion and flow. | Not explicitly stated, but results are included and deemed safe and effective. |
| Cannula Elasticity | Exhibit appropriate flexibility and resilience. | Not explicitly stated, but results are included and deemed safe and effective. |
| Cannula Bending Strength | Withstand bending forces without kinking or breaking. | Not explicitly stated, but results are included and deemed safe and effective. |
| Product Air Tightness | Prevent air ingress/egress. | Not explicitly stated, but results are included and deemed safe and effective. |
Note: The document states that "The results and conclusions of these tests are included in this submission," and concludes that the device is "safe and effective when used as intended," implying that the device met the acceptance criteria for all listed tests. Specific numerical acceptance criteria and performance values are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary.
- Data Provenance: The tests conducted are "Non-clinical tests," implying bench testing. The country of origin for this testing is not specified, but the applicant (Nipro Medical Corporation) is located in Miami, FL, USA. The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not as a continuous monitoring process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This was bench testing, not a study requiring expert clinical assessment for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Not applicable, as this was bench testing.
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 comparative effectiveness study was done. The document explicitly states: "No clinical testing was required or performed in support of this 510k submission." This is not an AI-based device, so a human-reader improvement metric is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a medical instrument (infusion set), not an algorithm or AI system. Its performance is evaluated through physical and functional bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the bench tests would be the pre-defined engineering specifications, industry standards, and established test methodologies for medical devices of this type. It's based on engineering validated criteria rather than clinical ground truth (like pathology or outcomes data).
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this 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).