(133 days)
The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
The CT Midline Catheter is designed for peripheral vein catheterization and power injection of contrast media. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid contamination. Female luer connectors provide the connection for intravenous administration.
The CT Midline Catheter is available in a 4Fx20cm single-lumen, or 5Fx20cm double-lumen configuration. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every fifth centimeter. The CT Midline is packaged sterile with the necessary accessories to facilitate insertion.
The provided document is a 510(k) premarket notification for a medical device (CT Midline) and primarily discusses its substantial equivalence to a predicate device, rather than presenting a study of the device's performance against specific acceptance criteria.
The submission states that the purpose of this particular 510(k) is to "remove a contraindication that was once cited in the Journal of Infusion Nursing but has since been revised." This is a change to the labeling, not a new performance claim or a new device design that would necessitate a comprehensive performance study with acceptance criteria and reported results.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.
Here's a breakdown of why each point cannot be thoroughly answered from the provided text:
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A table of acceptance criteria and the reported device performance:
- The document implies that the device's performance (e.g., flow rates for power injection) is identical to the predicate device K141151.
- Table 5.1 "Design Comparison Matrix" lists "Performance Testing" with "Power Injection: 5cc/sec (4F), 7cc/sec (5F)" for both the proposed and predicate devices, stating "Identical, no change." This indicates the expected performance, but not explicit acceptance criteria, nor the results of a new study designed to meet those criteria for this specific submission. It's a statement of equivalence.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No test set is described for evaluating new performance. The comparison is based on the predicate device's existing performance data.
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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):
- Not applicable as no new performance test set requiring expert ground truth is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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 device is an intravascular catheter, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" here is the established performance of the predicate device, against which the proposed device is declared equivalent.
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The sample size for the training set:
- Not applicable as this is a physical medical device, not an algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary from the document:
The submission explicitly states under "Bench / Performance Data / Non-Clinical Testing":
"No performance testing was required for the revision to the instructions in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, CT Midline, is equivalent to the predicate device, CT Midline (K141151)."
The basis for equivalence is that the "Proposed CT Midline is substantially equivalent to the predicate device. CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization." The only difference is a "revision to the instructions for use (labeling)" to remove a contraindication.
Therefore, for this specific 510(k) submission (K170770), no new study was conducted to prove the device meets performance acceptance criteria, because the device itself and its performance characteristics are deemed identical to a previously cleared predicate device. The change is solely in the labeling information, specifically removing a contraindication.
§ 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).