(112 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.
The provided text describes a 510(k) premarket notification for a medical device, the PICC WAND™ Peelable Safety Introducer. The document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information (e.g., sample size for test set, data provenance, ground truth establishment, MRMC study, training set details) is not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract information related to the device performance and the study conducted to demonstrate equivalence.
Here's a summary based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail form for a new device's performance. Instead, it focuses on demonstrating equivalence to a predicate device. The "performance characteristics" and "requirements of the product design specification" serve as the de facto acceptance criteria, implying that the modified device must perform at least as well as, or be equivalent to, the predicate and meet established design requirements.
| Acceptance Criteria Category (Implied) | Specific Performance Test/Characteristic | Intended Outcome (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Mechanical Strength | Dilator Distal/tip columnar strength | Equivalent to predicate device | Testing conducted to demonstrate equivalence |
| Mechanical Strength | Dilator Tensile strength of union (tube to hub) | Equivalent to predicate device | Testing conducted to demonstrate equivalence |
| Mechanical Strength | Sheath Introducer Distal/tip columnar strength | Equivalent to predicate device | Testing conducted to demonstrate equivalence |
| Mechanical Strength | Sheath Introducer Tensile strength of union (tube to hub) | Equivalent to predicate device | Testing conducted to demonstrate equivalence |
| System Functionality | System insertability | Equivalent to predicate device | Testing conducted to demonstrate equivalence |
| Visual Indicators | System Intraluminal visual indicators | Equivalent or superior to predicate device | Testing conducted to verify (equivalent or superior) |
| Fast-flash Functionality | System Fast-flash function and timing | Equivalent or superior to predicate device | Testing conducted to verify (equivalent or superior) |
| Shelf Life | Shelf life (accelerated aging) to labeled expiration date | Meets labeled expiration date | Testing conducted to demonstrate (meets) |
| Size Compatibility (new model) | 5 Fr model accommodation | Satisfies performance characteristics required to accommodate a 5 Fr PICC or midline catheter | Testing conducted to satisfy requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document. The testing was "in vitro bench testing," implying laboratory-based testing rather than patient data.
- Data Provenance: Not applicable in the context of patient data, as the tests were in vitro bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device's performance is determined by physical measurements and functional tests in a laboratory setting, not by expert interpretation of data or images.
4. Adjudication Method for the Test Set
Not applicable. This device's performance is assessed through objective physical and functional tests, not by human adjudication of ambiguous results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often with AI assistance. The PICC WAND™ is a medical instrument, and its performance is evaluated through engineering and functional bench tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The PICC WAND™ is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context does not apply.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this product is derived from engineering specifications, established physical testing methodologies, and performance standards for such introducer devices. For instance, "columnar strength" would be determined by a force gauge, and "Fast-flash function and timing" would be measured with a stopwatch or similar timing device under controlled conditions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this 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).