(56 days)
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 5cc/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, Nitinol 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 the 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.
The provided text describes a 510(k) premarket notification for a medical device called "the POWERWAND® Safety Introducer with an Extended Dwell Catheter." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Special 510(k) Modification: | |
| 1. Needle Hub to Dilator Separation Force | "Testing to qualify Special 510(k) modification: 1. Needle Hub to Dilator Separation Force..." (Implies successful testing to meet requirements, though specific values are not provided) |
| 2. Needle Hub to Dilator Removal Force | "...and Removal Force" (Implies successful testing to meet requirements, though specific values are not provided) |
| 3. Removal Testing (related to the modification) | "2. Removal Testing" (Implies successful testing to meet requirements, though specific values are not provided) |
| Overall Performance Equivalence: | "The results of testing demonstrate that the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter is substantially equivalent to the predicate device in design, function, and indications for use." |
| Predicate Device Performance (Implied): | The predicate device (POWER WAND® Safety Introducer with an Extended Dwell Catheter, K101422) was already cleared, implying it met its own performance criteria. The modified device aims for "equivalent" performance. |
| Letter-to-file Modifications (No Physical Performance Testing Required): | "There were no Letter-to-file Modifications... that required physical performance testing." |
Important Note: The provided text summarizes the testing and conclusions. It does not provide the specific numerical acceptance criteria (e.g., minimum separation force in Newtons) or the quantitative results achieved by the device. It states that testing was conducted to "qualify" the modifications and that the results "demonstrate substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for any of the performance tests (Needle Hub to Dilator Separation Force, Removal Force, Removal Testing).
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "Design verification testing was conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this device and submission. This is a medical device for vascular access, and the performance testing described relates to the physical and mechanical characteristics of the device (e.g., forces, removal). There is no mention of a "test set" requiring expert-established ground truth in the way it would apply to, for example, an AI diagnostic imaging device. Ground truth for mechanical testing would typically be established by calibrated instruments and engineering specifications.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as point 3. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human assessment or interpretation where there might be disagreements, such as in image analysis or clinical endpoint determination. The testing described here is for physical device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure the AI's impact on their performance. The submitted device is a physical medical instrument, not a diagnostic imaging or AI-driven interpretative system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical instrument, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to be evaluated.
7. The Type of Ground Truth Used
For the performance testing mentioned ("Needle Hub to Dilator Separation Force and Removal Force," "Removal Testing"), the ground truth would be based on engineering specifications and measurements from calibrated testing equipment. For instance, a "separation force" would have a defined minimum or maximum value that the device must meet, measured by a force gauge, which serves as the "ground truth" reference. The document does not explicitly state the specific ground truth values or methods but implies they are part of the "product design specification."
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as point 8.
§ 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).