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The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5 ml/sec at up to 300 psi fluid pressure.

The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following basic components: Introducer Needle, Guidewire, Dilator and an Extended Dwell Catheter. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.

This is a 510(k) summary for a medical device (a catheter introducer), which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against explicit acceptance criteria in the way an AI/software as a medical device (SaMD) study would.

Therefore, many of the requested categories (2-9) which are typical for SaMD studies involving machine learning or sophisticated algorithms are not directly applicable or extractable from this document. The document describes engineering and design verification testing against internal product specifications for a physical device, not "performance" in the sense of diagnostic accuracy or clinical outcomes of an AI system.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a pass/fail format with corresponding "reported device performance" values for a clinical or diagnostic outcome as would be common for AI/SaMD. Instead, it lists various engineering tests performed to confirm the device's physical properties and functionality. The "acceptance criteria" here are implicitly tied to meeting the design specifications and demonstrating equivalence to the predicate device. The "reported performance" is that the device "satisfies performance requirements" and "is equivalent to the predicate device."

• Resistance to Breakage | Meet specified strength and breakage resistance. | Equivalent to predicate; satisfies requirements. |
  | 0.012" Guidewire| - Fracture Test
• Flex Test
• Strength of Union: Core-to-Coil
• Strength of Union: Wire-to-Cap | Meet specified resistance to fracture, flex, and union strength. | Equivalent to predicate; satisfies requirements. |
  | Dilator | - Distal Tip Columnar Strength
• Strength of Union: Tube-to-Hub
• Insert Leak | Meet specified columnar strength, union strength, and no leaks. | Equivalent to predicate; satisfies requirements. |
  | 4 Fr IV Catheter – Standard Testing | - Collapse Pressure
• Distal Tip Columnar Strength
• Flow Rate
• Tensile Strength
• Priming Volume
• Burst Pressure
• Leakage Test - Liquid
• Leakage Test - Air
• Catheter Tip Movement during Power Injection | Meet specified pressures, strengths, flow rates, volumes, and leakage integrity. | Equivalent to predicate; satisfies requirements. |
  | 4 Fr IV Catheter – after Pre-Conditioning | - Visual Inspection
• Fatigue Test
• Power Injection
• Elongation
• Burst Pressure | Maintain integrity and performance after pre-conditioning, meet power injection specs. | Equivalent to predicate; satisfies requirements. |
  | Introducer System | - Axial Forces
• Fast-flash™ Evaluation
• Insertability
• Needle-Stick safety
• Particulate Test | Meet specified axial forces, fast-flash feedback, ease of insertion, needle-stick safety, and particulate limits. | Equivalent to predicate; satisfies requirements. |

Overall Conclusion: "The results of testing demonstrate that the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (4 Fr Model) is substantially equivalent to the predicate device in design, function, and indications for use."

2. Sample size used for the test set and the data provenance

The document specifies "Prospective testing conducted for the 4 Fr Model POWERWAND®" (Table 11.2) for the listed physical and performance tests. However, it does not provide specific sample sizes (e.g., number of devices tested for each parameter) for these engineering tests. It also does not mention data provenance in terms of country of origin or whether it's retrospective/prospective clinical data because this is not a clinical study, but rather engineering verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This summary relates to the clearance of a physical medical device (catheter introducer) based on engineering performance testing, not an AI/SaMD device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for these tests would be the measurement against a defined engineering specification or standard.

4. Adjudication method for the test set

Not applicable. See point 3.

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; no human readers or AI assistance are involved in its operation or assessment in a diagnostic context.

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

Not applicable. This is a physical medical device; there is no algorithm in this context.

7. The type of ground truth used

The "ground truth" for this device's testing would be defined by engineering specifications, industry standards, and regulatory requirements (e.g., ISO standards for medical devices, ASTM standards for material properties, etc.). For example, a "burst pressure" test would have an internal specification for the minimum pressure it must withstand, which serves as the ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD device; there is no "training set."

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

Not applicable. See point 8.

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The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

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.

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.

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.

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