(136 days)
The MIVI Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
The MIVI Q Distal Access Catheter (Q Catheter) is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The Q Docking Station may be used to facilitate insertion and extraction of the Q Catheter through a hemostasis valve attached to the 8F guide catheter/6F guide sheath. The pin vise may be used to advance the catheter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MIVI Q Distal Access Catheter:
The document provided is a 510(k) Summary for the MIVI Q Distal Access Catheter, which is a premarket notification to the FDA for a medical device seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than proving novel effectiveness.
Given the nature of a 510(k) submission for a catheter, the "acceptance criteria" and "device performance" in this context refer to the ability of the device to meet specified engineering and biocompatibility standards, and to perform its intended function without significant differences from the predicate. There is no clinical study in the traditional sense (e.g., patient trials with efficacy endpoints) described for this device, as it's a substantially equivalent determination based on non-clinical testing.
Here's the information extracted and organized according to your request:
Acceptance Criteria and Device Performance for MIVI Q Distal Access Catheter
1. Table of Acceptance Criteria and Reported Device Performance
For Bench Testing (Non-Clinical Performance):
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Verification | The device must meet dimensional specifications. | Pass |
| System Introduction (Simulated Use) | The device must function as intended. | Pass |
| Liquid Leakage under Pressure | The device must hold a hydrostatic pressure. | Pass |
| Tensile Strength | Tensile strength pull force minimum must be met. | Pass |
For Biocompatibility Testing:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Non-toxic to cells (determined by specific extract and cell line). | PASS |
| Irritation or Intracutaneous Reactivity | No significant irritation or reactivity in vivo (animal model). | PASS |
| Sensitization | No significant sensitization reaction (animal model). | PASS |
| Acute Systemic Toxicity | No acute systemic toxicity (animal model). | PASS |
| Pyrogenicity (Material-mediated) | Non-pyrogenic (no fever-inducing substances in vivo). | PASS |
| Hemolysis | No significant hemolysis (destruction of red blood cells) in vitro. | PASS |
| Unactivated Partial Thromboplastin Time | No significant impact on blood clotting time (in vitro). | PASS |
| Complement Activation | No significant complement activation (immune response) in vitro. | PASS |
For Sterilization and Shelf Life:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization | Confirmed sterility of the final packaging configuration and method. | Met specification |
| Shelf Life and Expiration Dating | Maintain performance and integrity for the specified period. | 3 years (same as predicate) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each individual non-clinical (bench and biocompatibility) test. Such details are typically found in the full test reports, not in the summary document.
Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting (in vitro or in animal models), not on human subjects. Therefore, there is no country of origin for human patient data. The provenance of the data is the laboratory where the tests were performed. The studies are prospective in the sense that they were designed and executed to test the characteristics of the MIVI Q Distal Access Catheter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided document. The "ground truth" in this context is established by objective measurements and standardized test methods (e.g., ISO standards for biocompatibility, engineering specifications for bench tests), not by expert consensus on clinical data. No human "experts" were used to establish ground truth for this type of non-clinical testing.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for interpreting imaging or clinical outcomes where there might be inter-reader variability. For non-clinical bench and biocompatibility tests, results are typically objective (e.g., a tensile strength value, a cytotoxicity rating) and do not require expert adjudication in this manner.
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 is not applicable. The MIVI Q Distal Access Catheter is a physical medical device (a catheter), not an AI algorithm, and therefore does not involve human readers interpreting output from an AI system. The submission is for substantial equivalence of a physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As explained above, this device is a physical catheter, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Bench Testing: Ground truth is defined by engineering specifications and objective physical measurements (e.g., specified dimensions, force thresholds, pressure integrity).
- Biocompatibility Testing: Ground truth is established by standardized biological assays and observation in animal models and in vitro systems, as per recognized international standards (e.g., ISO 10993 series). The results are objective measurements against defined pass/fail criteria.
8. The sample size for the training set
This is not applicable. There is no AI algorithm involved that requires a training set. The "study" here consists of non-clinical performance and biocompatibility testing of the physical catheter.
9. How the ground truth for the training set was established
This is not applicable, as there is no AI algorithm or training set.
§ 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).