(30 days)
The TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (
The TERUMO® Surshield® Safety I.V. Catheter are devices consisting of an over-the needle, peripheral catheter made of an a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term (
The provided text describes the TERUMO® Surshield® SAFETY I.V. CATHETER. The performance section indicates that several tests were performed on the device. However, the document does not explicitly state acceptance criteria for these tests, nor does it provide a detailed study that proves the device meets specific acceptance criteria with quantifiable results. The information mainly lists the types of tests conducted and specifies the materials and sterilization methods used.
Therefore, for aspects like "reported device performance" against "acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone study," "ground truth type," "training set size," and "ground truth establishment for training set," the information is not available in the provided document.
Here's an attempt to structure the answer based on the available information, indicating where data is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reactive force to close shutter (Safety mechanism) | Not specified | Not specified |
| Force to detach safety cover from catheter hub (Safety feature activation) | Not specified | Not specified |
| Initial sliding friction (Catheter and Needle attachment) | Not specified | Not specified |
| Tensile strength of safety cover and needle (Safety mechanism break strength) | Not specified | Not specified |
| Force to needle breaking safety cover (Puncture resistance of needle shield) | Not specified | Not specified |
| Flow rate | Not specified | Not specified (Table G provides typical flow rates for different gauges, but not performance against a specific criterion for this test) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information is not relevant or applicable for the device described, as it is a physical medical device and not an AI/diagnostic software. No ground truth was established by experts in this context.
4. Adjudication method for the test set
- Not applicable as no expert adjudication for ground truth was involved.
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 is a physical medical device, not an AI/diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an AI/diagnostic system.
7. The type of ground truth used
- Not applicable. For this type of physical medical device, "ground truth" would be objective measurements and functional tests according to established standards (e.g., force measurements, flow rate, biocompatibility tests). The document indicates such tests were performed but does not detail the "ground truth" methodology beyond listing the test types.
8. The sample size for the training set
- Not applicable. This is a physical medical device and does not involve AI training sets.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device and does not involve AI training sets or ground truth establishment in that context.
Summary of available performance claims related to acceptance:
The document states that the listed tests (Reactive force to close shutter, Force to detach safety cover, Initial sliding friction, Tensile strength, Force to needle breaking safety cover, Flow rate) were performed. It also specifies material equivalence to predicate devices and validated sterilization methods (ISO 11135-2007 to a SAL of 10-6, and EtO residual limits per ISO 10993-7). These aspects imply compliance with relevant standards and safety requirements, which effectively serve as "acceptance criteria" for regulatory clearance, even if explicit performance results against those criteria are not detailed in this specific summary. The 510(k) clearance itself (K082362) indicates that the FDA found the device "substantially equivalent" to predicate devices based on the submitted information, which would have included data demonstrating safety and effectiveness.
§ 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).