(21 days)
A Peripherally inserted Central Catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
The Arrow International Peripherally Inserted Central Catheters are similar to the currently marketed Arrow Trimmable and Blue FlexTip® single and double lumen catheters. The catheter juncture has been modified to improve overall catheter strength. The hub colors and catheter labeling have changed to distinguish the new Arrow catheters. The catheter is available in lengths of 40 cm - 60 cm.
Here's an analysis of the provided information regarding the Arrow International Peripherally Inserted Central Catheters:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
| Flex Test | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
| Burst | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
| Fatigue | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
| Leakage | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
Explanation of "Acceptance Criteria (Stated or Implied)":
The document does not provide explicit numerical or qualitative acceptance criteria for these tests. Instead, it relies on the concept of "substantial equivalence" to predicate devices. This implies that the performance of the new device in these tests must be comparable to or not worse than the legally marketed predicate devices (Arrow International's Peripherally Inserted Central Catheter (K930129) and Two Lumen PICC with Blue FlexTip® Catheter with Integral Needle Protection (K003006)).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The term "laboratory tests" is used, implying a controlled environment, but the number of devices tested for each performance characteristic is not detailed.
- Data Provenance: The data is generated from "laboratory tests" and is therefore likely prospective, as it was specifically conducted to demonstrate the safety and effectiveness of the new device for regulatory submission. The country of origin of the data is not explicitly stated, but given the submitter's location (Reading, PA, USA) and the submission to the FDA, it's highly probable the testing was conducted in the USA or by a facility adhering to US standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device submission. The "ground truth" for the performance tests (tensile strength, flex, burst, fatigue, leakage) is established through standardized engineering and materials testing methods, not through expert consensus on medical images or clinical outcomes. These are objective physical tests with quantifiable results.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving subjective interpretation (e.g., image reading) to resolve discrepancies among multiple expert evaluations. The tests performed here are objective, mechanical evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are typically relevant for diagnostic imaging devices where human readers interpret results, and the impact of AI algorithms on reader performance is being assessed. This submission is for a physical medical device (catheter) and focuses on engineering performance tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. This device is a physical medical instrument, not a software algorithm or AI. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for these performance tests is based on objective measurement against established engineering and material science principles and comparison to the performance of predicate devices. For example, the "ground truth" for tensile strength is the maximum force a material can withstand before breaking, measured according to a standard test method. The comparison to predicate devices then establishes "substantial equivalence."
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of this device submission. Training sets are used for machine learning algorithms. The development of this medical device involves engineering design, material selection, and manufacturing processes, followed by performance testing, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”