(160 days)
The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system
The Enpath Safety Introducer is designed to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system. Sheath needles consisting of a peelable sheath over a needle, or peelable micro-introducers using the Seldinger Technique, are common methods for placing such devices. This Safety Introducer device combines various attributes of both the needle and the micro-introducer with the inclusion of a safety feature. The Safety Introducer allows for a one-step process of accessing the body. The Safety Introducer includes a safety shield which is spring-loaded in position during the ready-to-use state. After gaining vessel access, the needle subassembly is undocked from the introducer sheath and removed, leaving the sheath in the vessel for Removing the introducer sheath during standard practice passively catheter placement. advances (activates) the safety shield that locks in place. The safety shield covers the sharp of the needle bevel to protect patients and healthcare workers from accidental needle sticks.
The sheath body is constructed of PTFE and is filled with bismuth trioxide as a radiopacifier. The sheath handles, made of polypropylene resin, are overmolded onto the PTFE sheath tubing. The dilator is made of HDPE (high density polyethylene) and has a hub made of HDPE resin overmolded onto the dilator shaft. The front bub and the luer components are both molded of Polycarbonate resin. The needle and spring are stainless steel. The swivel luer cap and needle cover are both made of Polypropylene. UV cured adhesive is used during the assembly to hold the needle to the luer. The final assembly is coated with silicone lubricant from the tip of the needle to the handles of the sheath to reduce insertion force.
Sizes of the assembly range from 3.5 FR to 7FR. The needle is 21gauge for all French sizes, and the materials and construction are the same for all French sizes. The Safety Introducer will be packaged and EtO sterilized for one time use in a Tyvek pouch. The packaging configuration may include sterile kit containing a stainless steel guidewire or a bulk, nonsterile configuration.
The provided text describes a medical device called the "Enpath Safety Introducer" and outlines its 510(k) summary for FDA approval. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics in the way requested by the prompt.
The document states:
- "The performance testing for this device included testing to verify that the device safety function performed effectively. Additional testing verified that the device performed per specification requirements."
- "A Risk Analysis for the Safety Introducer was performed per Enpath Medical, Inc internal procedure, WI42020, Hazard Analysis, FMEA and Risk Analysis. This document is modeled closely after European Standard ISO 14971: 2000 Medical Devices - Application of Management to Medical Devices."
This indicates that studies were done, but the details of those studies, including acceptance criteria, sample sizes, ground truth establishment, or specific performance results (e.g., sensitivity, specificity, accuracy, or quantitative measures of safety function effectiveness), are not present in the provided text.
Therefore, I cannot populate the table or answer most of the questions based on the given information.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
- Cannot be created. The document mentions "performance testing" and "per specification requirements" but does not define these specifications or report specific performance metrics against them.
2. Sample size used for the test set and the data provenance
- Cannot be determined. No sample sizes for any testing (whether "test set" or other performance testing) are provided. Data provenance is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be determined. There is no mention of ground truth establishment by experts for any test set.
4. Adjudication method for the test set
- Cannot be determined. No information on adjudication is provided.
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
- Cannot be determined. This device is a physical medical introducer, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Cannot be determined. This device is a physical medical introducer, not an algorithm. This question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be determined. No details about how ground truth (or verification of safety function effectiveness) was established are given.
8. The sample size for the training set
- Cannot be determined. This device is a physical medical introducer, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Cannot be determined. As above, this question is not applicable to the device described.
Summary of available information:
- Device Name: Enpath Safety Introducer
- Intended Use: To minimize needle stick injuries when used to introduce catheters, pacemaker leads, and similar devices into the venous system.
- Performance Testing Mentioned: "performance testing for this device included testing to verify that the device safety function performed effectively. Additional testing verified that the device performed per specification requirements."
- Risk Analysis: Performed according to Enpath Medical, Inc internal procedure, WI42020, Hazard Analysis, FMEA and Risk Analysis, modeled after ISO 14971:2000.
In conclusion, the provided 510(k) summary focuses on general device description, intended use, technological characteristics, and mentions that performance and risk analysis studies were conducted, but it does not provide the detailed results, acceptance criteria, or study methodologies asked for in your prompt.
§ 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).