(31 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 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, 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 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 also incorporates a mechanism that provides passive needle stick safety.
The presented document describes the 510(k) premarket notification for the POWERWAND® Safety Introducer with an Extended Dwell Catheter. This submission is for a modified device with a change in the material of the female Luer hub from Pellathane® (polyurethane) to Makrolon® (polycarbonate). The aim of the submission is to demonstrate substantial equivalence to the predicate device, not to introduce a new AI-powered diagnostic or assistive tool.
Therefore, many of the typical acceptance criteria and study aspects related to AI/ML devices (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this medical device submission.
Here's an analysis based on the provided text, focusing on the device's performance through engineering verification testing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it describes "performance requirements" and "satisfies requirements of the product design specification," implying that the modified device met pre-defined internal benchmarks based on the predicate device's performance. The reported "performance" is that the device passed these tests and was found to be substantially equivalent to the predicate.
| Component / Test Area | Specific Tests Conducted | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| IV Catheter with Makrolon® Luer Hub | Biocompatibility testing in accordance with ISO 10993-1:2009 | Meets ISO 10993-1:2009 standards for biocompatibility. | Passed (implied by "substantially equivalent" conclusion) |
| IV Catheter with Makrolon® Luer Hub - Standard Performance Testing | • Tensile Strength | ||
| • Burst Pressure | |||
| • Hub Gauging | |||
| • Leakage Test - Liquid | |||
| • Leakage Test - Air | |||
| • Air Leakage during Aspiration | |||
| • Hub Separation Force | |||
| • Hub Unscrewing Force | |||
| • Hub Ease of Assembly | |||
| • Hub Resistance to Overriding | |||
| • Hub Stress Cracking | |||
| • Strain Relief Cover Tensile Test | |||
| • Strain Relief Cover Flex Test | Meets product design specifications and is equivalent to predicate device performance for each metric. | Passed for all listed tests (implied by "substantially equivalent" conclusion) | |
| IV Catheter with Makrolon® Luer Hub - Testing after Pre-Conditioning | • Visual Inspection | ||
| • Burst Pressure | Maintains integrity and specified burst pressure after pre-conditioning, equivalent to predicate. | Passed for all listed tests (implied by "substantially equivalent" conclusion) | |
| Introducer System | • Dilator Hub to Catheter Hub Removal Torque | ||
| • Dilator Hub to Catheter Hub Separation Force | Meets product design specifications and is equivalent to predicate device performance for these forces. | Passed for all listed tests (implied by "substantially equivalent" conclusion) |
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: The document does not specify the sample size for any of the performance tests conducted. For device verification testing, sample sizes are typically determined by statistical methods or industry standards.
- Data Provenance: The testing was "prospective" in the sense that it was conducted specifically for this submission to verify the new material. "TABLE 11.1: PROSPECTIVE TESTING OF THE POWERWAND®" indicates the testing was planned and executed for the modified device. The country of origin of the data is not specified, but the submitter is Access Scientific, LLC. (USA).
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)
This question is not applicable. The device is a physical medical instrument, and its performance is assessed through engineering and bench testing, not through expert-evaluated clinical data or image interpretation. "Ground truth" in this context refers to the physical properties and performance characteristics measured against established standards or specifications, not expert consensus on medical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert review processes for clinical data, which were not part of this device's performance testing.
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
This question is not applicable. An MRMC study is relevant to AI/ML-driven diagnostic or assistive devices involving human readers (e.g., radiologists interpreting images). This submission is for a physical medical device (an introducer with a catheter) and does not involve AI or human readers for diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical instrument and does not involve an algorithm working in "standalone" mode.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering and materials science standards, regulatory requirements (e.g., ISO 10993-1 for biocompatibility), and internal product design specifications derived from the predicate device's performance. It is not based on expert consensus, pathology, or outcomes data in the medical diagnostic sense.
8. The sample size for the training set
This question is not applicable. This is a modified physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth in that context.
§ 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).