(38 days)
The HEALTH LINE CT MIDLINE CATHETER is indicated for short term (less than 30 days) access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The HEALTH LINE CT MIDLINE CATHETER is suitable for use with power injectors.
The HEALTH LINE CT MIDLINE CATHETER is a family of peripherally inserted peripheral catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous micro introducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access.
The HEALTH LINE CT MIDLINE CATHETER is indicated for dwell times shorter than 30 days. The HEALTH LINE CT MIDLINE CATHETER product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The HEALTH LINE CT MIDLINE CATHETER's are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
This document is a 510(k) summary for the Health Line CT Midline Catheter (K200263). The core argument for its substantial equivalence relies on its technological identity to a predicate device, the NEXUS MIDLINE CT CATHETER (K140270). Therefore, the "acceptance criteria" here refers to the equivalence to the predicate device, especially in performance, rather than a separate set of numerical thresholds for a new, independent study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criterion for this device is substantial equivalence to the predicate device (NEXUS MIDLINE CT CATHETER, K140270). The "reported device performance" is the claim of identity or sameness with the predicate device for all critical performance aspects.
| Acceptance Criterion (vs. Predicate Device K140270) | Reported Device Performance (Health Line CT Midline Catheter K200263) |
|---|---|
| Indications for Use: Identical | Identical (word-for-word match shown in table on page 5) |
| Intended Use: Identical | Identical |
| Target Population: Identical | Identical (Adults) |
| Duration of Use: Identical | Identical (Less than 30 days) |
| Insertion Method: Identical | Identical (Seldinger Technique) |
| Sizes: Identical | Identical (3Fr, 4Fr, 5Fr Single Lumen; 4Fr & 5Fr Dual Lumen) |
| Biocompatibility: Complies with ISO-10993 (leveraged from predicate) | Complies with ISO-10993 (stated as "Identical" - leveraged from predicate) |
| Sterilization Method: Complies with ISO 11135-1:2007 and AAMI TIR 28 (leveraged from predicate) | Complies with ISO 11135-1:2007 and AAMI TIR 28 (stated as "Identical" - leveraged from predicate) |
| Materials: Identical (for key components like female luer connectors, hub, catheter tubing, pinch clamps, informational clamp inserts) | Identical |
| Priming Volume: Identical to predicate's specifications | Identical to predicate's specifications |
| Max Flow Rate (ml/sec): Identical to predicate's specifications | Identical to predicate's specifications |
| Max Internal Catheter Pressure at Max Flow Rate (psi): Identical to predicate's specifications | Identical to predicate's specifications |
| Rated Burst Pressure (psi): Identical to predicate's specifications | Identical to predicate's specifications |
The document states changes only include a name change, added priming instructions in the IFU, and a catheter trim tool in the kit, none of which impact the core functional characteristics used for demonstrating substantial equivalence to the predicate product.
2. Sample size used for the test set and the data provenance
This FDA 510(k) summary does not describe a specific "test set" in the context of an AI/algorithm performance study. Instead, it relies on the "technological identity" of the new device to an already cleared predicate device.
Therefore:
- Sample size for test set: Not applicable, as there was no independent clinical/performance test set for this device beyond demonstrating it is identical to the predicate. Performance data was "leveraged from the predicate device."
- Data provenance: Not applicable in the context of a new test set. The provenance of the predicate device's data would be from its original clearance. The changes made to this device were assessed through a risk analysis, which found "no risks... identified with these changes."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm-based diagnostic device. It's a medical device clearance based on substantial equivalence to an existing device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was performed as this is a substantial equivalence submission for a physical medical catheter, not an AI/diagnostic algorithm.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this submission is the established performance and safety of the legally marketed predicate device (NEXUS MIDLINE CT CATHETER, K140270), to which the new device is claimed to be technologically identical. The assessment relies on a comparison of specifications, materials, and intended uses.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).