(61 days)
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
The PICC WAND® Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire. Dilator and a peelable Sheath Introducer. 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 peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PICC WAND® Peelable Safety Introducer, structured to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, it describes a series of performance tests conducted to confirm that the modified device satisfies "performance requirements" and is "equivalent to the predicate device." The reported performance is implicitly the successful completion of these tests, demonstrating substantial equivalence.
| Performance Area | Implied Acceptance Criteria (Demonstrated) | Reported Device Performance (Implicit from Study Conclusion) |
|---|---|---|
| Special 510(k) Modification (New) | ||
| Needle Hub and Dilator Hub Attachment | Attachment/detachment mechanism works as intended and is equivalent to predicate. | Satisfies performance requirements; substantially equivalent to predicate. |
| Needle Hub to Dilator Separation Force | Forces within acceptable range, equivalent to predicate. | Satisfies performance requirements; substantially equivalent to predicate. |
| Needle Hub to Dilator Removal Force | Forces within acceptable range, equivalent to predicate. | Satisfies performance requirements; substantially equivalent to predicate. |
| Axial Force Testing (New Mechanism) | Axial forces within acceptable range, equivalent to predicate. | Satisfies performance requirements; substantially equivalent to predicate. |
| Letter-to-file Modifications (Existing) | ||
| Dimensional Changes to Components | New dimensions do not negatively impact function; performance equivalent to predicate. | Satisfies performance requirements; substantially equivalent to predicate. |
| - Axial Force Tests (Dimensional) | Axial forces remain within acceptable range. | Satisfies performance requirements. |
| - Insertability Tests (Dimensional) | Device can be inserted successfully. | Satisfies performance requirements. |
| - Fast Flash Evaluation | Fast-flash feature functions correctly and provides timely feedback. | Satisfies performance requirements. |
| Change to Packaging | New packaging maintains sterility, integrity, and protects the device, equivalent to predicate packaging. | Satisfies performance requirements; substantially equivalent to predicate. |
| - Seal Testing | Packaging seals maintain integrity. | Satisfies performance requirements. |
| - Sterile Barrier/Bubble Leak Testing | Packaging maintains sterile barrier (no leaks). | Satisfies performance requirements. |
| - Shipping and Shelf Life Testing | Device and packaging integrity maintained after shipping and over shelf life duration. | Satisfies performance requirements. |
| - Sterilization Cycle Adoption Study | New sterilization cycle effectively sterilizes while maintaining device integrity. | Satisfies performance requirements. |
| Added 4 Fr. & 6 Fr. Sizes | New sizes perform comparably to existing sizes and predicate device. | Satisfies performance requirements; substantially equivalent to predicate. |
| - Dilator Distal/Tip Columnar Strength | New sizes meet columnar strength requirements. | Satisfies performance requirements. |
| - Dilator Tensile Strength of Union (Tube to Hub) | New sizes meet tensile strength requirements. | Satisfies performance requirements. |
| - Sheath Introducer Distal/Tip Columnar Strength | New sizes meet columnar strength requirements. | Satisfies performance requirements. |
| - Sheath Introducer Tensile Strength of Union (Tube to Hub) | New sizes meet tensile strength requirements. | Satisfies performance requirements. |
| - System Insertability | New sizes can be inserted successfully. | Satisfies performance requirements. |
| - System Intraluminal Visual Indicators | Visual indicators function correctly across new sizes. | Satisfies performance requirements. |
| - System Fast-flash Function and Timing | Fast-flash functions correctly across new sizes, providing timely feedback. | Satisfies performance requirements. |
| - Shelf Life (Accelerated Aging) | Device maintains performance characteristics for its labeled expiration date. | Satisfies performance requirements. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of devices tested for each parameter) for the test set. It merely lists the types of tests conducted.
The data provenance is internal to the manufacturer (Access Scientific, Inc.) and is prospective in the sense that these tests were performed on the modified device to demonstrate its performance for this specific 510(k) submission. There is no mention of external data, clinical data, or data provenance in terms of country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. The testing described appears to be primarily engineering and physical performance testing (e.g., force, dimensional, seal integrity, shelf life) rather than subjective evaluation requiring clinical experts to establish ground truth.
4. Adjudication Method for the Test Set
This is not applicable and not mentioned. The tests are objective physical and functional measurements, not requiring adjudication by multiple readers or reviewers in the traditional sense of clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through direct performance testing and comparison to a predicate device, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, this is not applicable. The device is a physical medical introducer, not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for these tests is implicitly the engineering specifications and performance characteristics of the predicate device, as well as relevant industry standards and design specifications for such devices. The goal was to show that the modified device "satisfies performance requirements" and is "equivalent to the predicate device." The "truth" is whether the measured physical properties and functional performance meet pre-defined benchmarks or match those of the predicate.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for a physical device.
§ 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).