(64 days)
The GuardWire 3-6 Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:
- · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
- · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
The GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in coronary saphenous bypass grafts. The system is used to contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures and is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal® Adapter and the Export® Aspiration Catheter and the EZ Flator Inflation Device. The GuardWire may also be used during these procedures alone or in conjunction with the Export Catheter to locally infuse diagnostic or therapeutic agents with or without vessel occlusion. The modification to the GuardWire system addressed with this submission entails the introduction of the EZ-Adapter as a replacement for the MicroSeal Adapter (MSA), as the device that actuates the MicroSeal of the GuardWire device. Both the EZ Adapter and the MicroSeal Adapter provide the same mechanical functions: hold the GuardWire in a static fixed position, actuate, through linear movement, the MicroSeal plug system of the GuardWire, and provide direct communication from the EZ Flator inflation device to the GuardWire balloon to facilitate inflation or deflation of the GuardWire balloon.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GuardWire Temporary Occlusion and Aspiration System, focusing on the EZ-Adapter modification:
This submission (K023878) concerns a modification to an existing device, the GuardWire Temporary Occlusion and Aspiration System. The core of this submission is the replacement of the MicroSeal Adapter (MSA) with a new component called the EZ-Adapter.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list quantitative acceptance criteria for the EZ-Adapter. Instead, the basis for clearance is substantial equivalence to the predicate device's component (MicroSeal Adapter). The primary "acceptance criteria" appear to be functional equivalence and equivalent manufacturing.
| Acceptance Criteria Category | Specific Criteria (Implicit from text) | Reported Device Performance (EZ-Adapter) |
|---|---|---|
| Functional Equivalence | - Hold GuardWire in a static fixed position | "EZ Adapter... provide the same mechanical functions: hold the GuardWire in a static fixed position" |
| - Actuate MicroSeal plug system (linear movement) | "EZ Adapter... provide the same mechanical functions: actuate, through linear movement, the MicroSeal plug system of the . GuardWire" | |
| - Provide direct communication to GuardWire balloon for inflation/deflation | "EZ Adapter... provide the same mechanical functions: provide direct communication from the EZ Flator inflation device to the . GuardWire balloon to facilitate inflation or deflation of the GuardWire balloon." | |
| Material Equivalence | - Made from equivalent materials | "EZ Adapter is manufactured... using the similar processes and equivalent materials, as the MicroSeal Adapter" |
| Process Equivalence | - Manufactured under similar conditions/processes | "EZ Adapter is manufactured under the same conditions, using the similar processes... as the MicroSeal Adapter" |
| Indications for Use | - No change in intended use | "the indications for use have not changed." |
| Performance Testing | - Determination of substantial equivalence | "The EZ Adapter has been subjected to performance testing and it has been determined that the EZ Adapter is substantially equivalent to the MicroSeal Adapter." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The EZ Adapter has been subjected to performance testing and it has been determined that the EZ Adapter is substantially equivalent to the MicroSeal Adapter." However, no specific details regarding the sample size used for this testing are provided. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. Given the nature of a component replacement and the focus on functional equivalence, this testing would likely be bench testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a 510(k) submission based on substantial equivalence of a component, the "ground truth" is primarily established through engineering and performance testing against defined specifications and comparison to the predicate component's known performance. Expert clinical input might be involved in defining the functional requirements, but there's no mention of a formal expert panel to establish ground truth for a test set in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
Since the "test set" and "ground truth" in the typical sense of clinical trials or AI/diagnostic device evaluation are not explicitly described, an adjudication method is not mentioned and is likely not applicable in this context. The evaluation would have been based on direct measurement and engineering comparison.
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. This type of study is typically performed for diagnostic devices (especially those involving human interpretation) to assess the impact of a device on reader performance. The GuardWire system and its EZ-Adapter component are interventional medical devices, and the submission focuses on functional equivalence of a mechanical component, not human interpretational effectiveness.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" (usually for an algorithm) also does not apply here. The EZ-Adapter is a physical component of a medical device intended for use in an interventional procedure by a clinician. Its "performance" is inherent to its mechanical function, not an algorithm's output. The performance testing would have evaluated the physical attributes and operational capabilities of the EZ-Adapter.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering specifications, functional requirements, and direct comparison to the performance of the predicate MicroSeal Adapter. The document emphasizes "functional equivalence," "similar processes and equivalent materials," and "performance testing" to determine substantial equivalence. This is not derived from expert consensus, pathology, or outcomes data in the way a diagnostic device's ground truth would be.
8. The Sample Size for the Training Set
No training set is mentioned or applicable for this type of device modification. Training sets are relevant for machine learning or AI algorithms, which are not involved in the EZ-Adapter.
9. How the Ground Truth for the Training Set Was Established
As there is no training set and no AI component, this question is not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).