(90 days)
The Introcan® Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.
The Introcan Safety IV Catheter consists of an over-the-needle catheter with a safety clip feature. Upon removal of the needle from the catheter, the safety clip is automatically secured over the needle tip as it exits the catheter hub. The Introcan Safety IV Catheter is available in sizes ranging from 14 Gauge through 24 Gauge.
The provided text is a 510(k) summary for the Introcan® Safety™ IV Catheter from 2002. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria or a study that quantitatively proves the device meets those criteria with performance metrics, sample sizes, or details about ground truth establishment.
The document primarily focuses on establishing substantial equivalence to previously cleared devices. It states: "The Introcan Safety IV Catheter includes the same materials, construction, design, and safety clip feature as the Introcan Safety IV Catheter previously cleared under the B. Braun Medical Inc. Premarket Notification, K982805." It also mentions a new indication for use as an introducer catheter, which is similar to a previously cleared device (K013304).
Without a dedicated performance study described within the provided text, it's impossible to create the requested table or answer most of the detailed questions about sample sizes, ground truth, expert qualifications, or MRMC studies.
Therefore,Based on the provided 510(k) summary, the following information can be extracted:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not present specific quantitative acceptance criteria or detailed device performance metrics derived from a study. Instead, it relies on demonstrating substantial equivalence to predicate devices based on materials, construction, design, and safety features.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the given document. The submission focuses on substantial equivalence rather than reporting on a new performance study with a distinct test set.
3. 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)
This information is not provided in the given document. The concept of "ground truth" and expert consensus is not applicable here as no specific diagnostic or performance study is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the given document. No performance study with adjudication is described.
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
An MRMC study is not mentioned in the provided document. This device is an IV catheter, not an AI-assisted diagnostic tool, so such a study 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 as the device is a medical instrument (IV catheter), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as there is no mention of a performance study requiring ground truth establishment in the provided document.
8. The sample size for the training set
This information is not applicable as the device is an IV catheter and not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
Summary of what the document does provide regarding acceptance:
The primary "acceptance criteria" appear to be based on the device's design, materials, construction, and safety features being substantially equivalent to the predicate devices. The document states:
- "The Introcan Safety IV Catheter includes the same materials, construction, design, and safety clip feature as the Introcan Safety IV Catheter previously cleared under the B. Braun Medical Inc. Premarket Notification, K982805."
- Its new indication for use as an introducer catheter is "the same indication previously cleared for Becton Dickinson Infusion Therapy Systems Inc.'s Premarket Notification, BD Introsyte™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer, K013304."
Therefore, the "study" proving the device meets acceptance criteria is effectively the comparison against predicate devices to demonstrate substantial equivalence, rather than a clinical or performance study with quantified metrics. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This determination by the FDA serves as the regulatory "acceptance."
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).