(65 days)
The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.
The Arrow Echogenic Introducer Needle has the following characteristics:
Outside Diameter = 18Ga - 21Ga
Inside Diameter = 0.0240 - 0.042 in.
Usable lengths of 1 ½ - 2 ¾ in. (3.81 - 7cm)
Grit-blast echogenic surface treatment
Here's an analysis of the provided information regarding the Arrow Echogenic Introducer Needle, focusing on acceptance criteria, study details, and ground truth establishment:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) Summary, does not explicitly list quantitative acceptance criteria in a pass/fail format. Instead, it describes performance tests undertaken to demonstrate substantial equivalence to predicate devices. The and the reported device performance are generally stated as achieving "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Needle penetration comparable to predicate devices. | "The following tests were performed to demonstrate substantial equivalence: • Needle penetration test." Implies the new device performed comparably or acceptably in this test. |
| Hub bond tensile strength comparable to predicate devices. | "The following tests were performed to demonstrate substantial equivalence: • Hub bond tensile strength test." Implies the new device performed comparably or acceptably in this test. |
| Overall safety and effectiveness comparable to marketed predicate introducer needles. | "The results of the bench tests demonstrate that Arrow's echogenic introducer needle is as safe and effective as compared to the currently marketed predicate introducer needle." |
| Same intended use as predicate devices. | "The intended use is the same as the predicate devices." |
| Same indications for use as predicate devices. | "The Indication for Use is the same as the predicate device." |
| Same technological design characteristics as predicate echogenic introducer needle devices. | "The proposed echogenic introducer needle has the same technological design characteristics as the predicate echogenic introducer needle devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the "Needle penetration test" or "Hub bond tensile strength test." It only mentions that these "tests were performed."
Furthermore, there is no information provided about the data provenance (e.g., country of origin, retrospective or prospective) as these are bench tests and not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided document. The studies performed are physical, bench-top performance tests of a medical device (needle penetration and hub bond tensile strength). These do not involve human interpretation or expert evaluation for establishing ground truth in the way, for example, a diagnostic imaging study would.
4. Adjudication Method for the Test Set
This information is not applicable. As mentioned above, the tests are physical performance tests, not studies requiring expert adjudication.
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
This information is not applicable. The device is an echogenic introducer needle, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study assessing human reader improvement with AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the "Needle penetration test" and "Hub bond tensile strength test" would have been established through objective, standardized measurements and criteria for defining "penetration" and "tensile strength" in a mechanical testing environment. These are typically based on engineering and material science principles, and reference standards for medical device testing. It is not based on expert consensus, pathology, or outcomes data in this context.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of physical performance testing for a medical device like an introducer needle. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).