(266 days)
The Micro Guide Catheter ELITE accessory is to be used with the Frontrumer® CTO Catheter. The Frontrumer® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
The Micro Guide Catheter ELITE is a 6F sheath compatible catheter designed to navigate and place guidewires in the peripheral vasculature and to provide additional support for the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Micro Guide Catheter ELITE is a single lumen torqueable tube containing a PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The Micro Guide Catheter ELITE is available in various configurations and several lengths. The Micro Guide Catheter ELITE is provided sterile (by EO) and is intended for single use only.
The provided document is a 510(k) summary for the Micro Guide Catheter ELITE. It outlines the device description, intended use, and comparison to a predicate device, along with performance data. However, it does not explicitly present acceptance criteria in a table format with reported device performance for specific clinical or diagnostic metrics as one would expect for an AI/ML powered device.
Instead, the document details various types of performance tests conducted to demonstrate substantial equivalence to a predicate device. For the purpose of answering your request, I will interpret "acceptance criteria" as the successful completion and meeting of specifications for each listed performance test, and "reported device performance" as the documented successful outcome of these tests.
It's important to note that this device is a physical medical device (catheter), not an AI/ML-powered diagnostic tool. Therefore, many of your specific questions regarding AI/ML study design (ground truth, expert consensus, MRMC studies, training sets, etc.) are not applicable in this context.
Here's an attempt to structure the information based on your request, with a focus on how the provided document does address performance and testing, and explicitly stating where information requested for AI/ML devices is not present or not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | In vitro Cytotoxicity | Meet ISO 10993-1 & GLP Req. | Successfully passed |
| In vitro Hemolysis | Meet ISO 10993-1 & GLP Req. | Successfully passed | |
| USP Containers | Meet ISO 10993-1 & GLP Req. | Successfully passed | |
| Extraction Testing | Meet ISO 10993-1 & GLP Req. | Successfully passed | |
| Device Dimensional & Functional Testing | Dimensional | Meet specifications | Verified |
| Tensile | Meet specifications | Verified | |
| Leak | Meet specifications | Verified | |
| Coating Integrity | Meet specifications | Verified | |
| Lubricity | Meet specifications | Verified | |
| Stiffness and Pushability | Meet specifications | Verified | |
| Kink | Meet specifications | Verified | |
| Torque Strength & Transmission | Meet specifications | Verified | |
| Corrosion Resistance | Meet specifications | Verified | |
| Particulate | Meet specifications | Verified | |
| Simulated Use | Meet specifications | Verified | |
| Packaging & Sterilization | Bioburden | Meet specifications | Verified |
| EO Residuals | Meet specifications | Verified | |
| Bacterial Endotoxin | Meet specifications | Verified | |
| Animal Study | Radiopacity | Equivalent to predicate | Scored successfully |
| Rotation | Maintained/Improved | Scored successfully | |
| Advancement | Maintained/Improved | Scored successfully | |
| Retraction | Maintained/Improved | Scored successfully | |
| Vessel Damage/Perforation | No increase in risk | No evidence of tissue damage or perforation |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Animal Study: Two animals were used. Within each animal, four devices were evaluated (2 test articles, 2 control articles). This gives a total of 4 uses of the test device (Micro Guide Catheter ELITE) across two animals.
- Other Testing (Biocompatibility, Dimensional, Functional, Packaging/Sterilization): The document does not specify the exact number of units or samples used for each of these in vitro/bench tests. It mentions "finished and sterilized catheters" for biocompatibility.
- Data Provenance:
- Animal Study: Prospective, conducted in a porcine model. The country of origin is not specified but it was a GLP (Good Laboratory Practice) study.
- Biocompatibility & Other Tests: Likely lab-based (in vitro/bench) testing of manufactured devices. Provenance (country of origin) not specified. These were not human data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This is a physical medical device, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is determined by physical measurements, chemical analyses, and biological responses in animal models.
4. Adjudication Method for the Test Set
- Not applicable. There was no expert adjudication in the context of diagnostic interpretation. For the animal study, evaluation was done by the study investigators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is relevant for diagnostic devices, especially those using AI, to assess reader performance. It does not apply to a physical catheter.
6. Standalone (Algorithm Only) Performance Study
- No. This applies to AI/ML algorithms, not physical medical devices.
7. Type of Ground Truth Used
- Physical/Chemical Measurements and Biological Observations:
- For biocompatibility: Adherence to ISO standards and observed biological responses (cytotoxicity, hemolysis, etc.).
- For dimensional/functional: Engineering specifications and measurements.
- For packaging/sterilization: Measured levels of contaminants or residuals against safety limits.
- For animal study: Direct observation of device performance (radiopacity, rotation, advancement, retraction) and gross pathological evaluation of tissues for damage.
8. Sample Size for the Training Set
- Not applicable. This device does not involve an AI/ML algorithm that requires a training set. The device design and testing are based on engineering principles and preclinical evaluations.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, there is no ground truth related to it.
§ 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).