FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the WAND™ MicroAccess Safety Introducer:

It's important to note that this 510(k) summary is for a medical device, specifically a catheter introducer, not an AI/ML-based diagnostic device. Therefore, many of the requested categories (like MRMC studies, AI effect size, ground truth for training sets, etc.) are not applicable to this type of submission. The performance evaluation for this device focuses on physical and biological characteristics, not diagnostic accuracy.

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are implicitly defined by demonstrating equivalence to predicate devices and meeting established biomechanical and biocompatibility requirements for the intended use. Specific numerical acceptance criteria are not detailed in this summary; rather, it refers to a full application (K081697) for the details.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility: Device materials are biologically safe for in-body contact.	"A program of design verification testing including biocompatibility testing... has been completed to demonstrate the biological safety... Test results indicate that the device is equivalent to the predicate devices..." (Section 5.6 & 5.8)
Biomechanical Performance: Device meets mechanical requirements for its intended function (e.g., integrity, ease of use, safety mechanism).	"A program of design verification testing including... in vitro bench testing has been completed to demonstrate the... biomechanical performance characteristics... Test results indicate that the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use." (Section 5.6 & 5.8)
Sterility: Device is sterile at the point of use.	"The WAND™ MicroAccess Safety Introducer is provided 'STERILE' by ethylene oxide gas to a sterility assurance level of 10-6." (Section 5.7)
Substantial Equivalence: Device is equivalent in design, function, and indications for use to predicate devices.	"The results of testing demonstrate that the WAND™ MicroAccess Safety Introducer is substantially equivalent to the predicate devices in design, function, and indications for use." (Section 5.8)

Predicate devices listed: Arrow International Emergency Infusion Device (K840455), BD Introsyte Precision Introducer (K020834), Stiffer Coaxial Micro-Introducer Set (K071574). |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in this summary. The summary refers to the original 510(k) application (K081697) for details on device performance evaluation and testing.
Data Provenance: Not specified, but generally, bench and biocompatibility testing are conducted in laboratories according to established standards.

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)

Not Applicable. This is a medical device for facilitating catheter placement, not a diagnostic AI/ML device requiring expert interpretation for ground truth establishment. Performance is evaluated through engineering and biological testing, not clinical reads by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is a medical device, not a diagnostic AI/ML device requiring adjudication of interpretations.

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 a physical medical device, not an AI/ML system, so an MRMC study and AI assistance effect size are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This question typically applies to AI/ML software. The device itself is "standalone" in the sense that its physical functionality is tested, but it's not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility: Ground truth is typically based on established biological safety standards, in vitro testing (e.g., cytotoxicity, sensitization, irritation), and in vivo animal studies, rather than expert clinical consensus.
For biomechanical performance: Ground truth is based on engineering specifications, industry standards, and functional testing to ensure the device performs as intended (e.g., strength, integrity, flow rates).

8. The sample size for the training set

Not Applicable. This device does not involve machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established

Not Applicable. This device does not involve machine learning algorithms and therefore has no "training set" or associated ground truth establishment.

Summary of Relevant Information from the K090372 Summary:

Device Type: Catheter Introducer (physical medical device).
Performance Evaluation: Focused on biocompatibility, in vitro bench testing for biomechanical performance, and sterility.
Key Conclusion: Substantial equivalence to predicate devices (Arrow International Emergency Infusion Device, BD Introsyte Precision Introducer, Stiffer Coaxial Micro-Introducer Set) in design, function, and indications for use.
Missing Details: Specific test protocols, numerical results, and sample sizes for the performance studies are not included in this summary but are referenced as being in the original 510(k) application K081697.

Summary

Regulation Number and Section

§ 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).