(107 days)
The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.
The pORTAL Steerable Hydrophilic Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid in the use of the device.
The pORTAL EXT Extension Wire is intended to interface with pORTAL Steerable Hydrophilic Guidewire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL quidewire to 315cm (see table 1 for dimensional specifications). This enable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Guidewire.
This is a 510(k) summary for a medical device (guidewire and extension wire), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details (sample size, provenance, expert adjudication, MRMC study, standalone performance, ground truth, training set), which are relevant for AI/ML device evaluations, are not applicable here.
Instead, the document details engineering bench testing and biocompatibility testing to demonstrate substantial equivalence to predicate devices. Here's what can be extracted from the provided text, formatted to address as many of your points as possible given the non-AI context:
1. A table of acceptance criteria and the reported device performance
The document provides a series of tables (Table 4, 5, 6, 7, 8, 9, 10, 11) detailing biocompatibility, performance, sterility, packaging integrity, and shelf-life testing. The "Results" column in these tables can be interpreted as the device performance relative to an implicit or explicit acceptance criterion. The acceptance criteria themselves are explicitly stated (e.g., "within specification," "meets acceptance criteria," "no evidence of damage").
Here is a summary table, combining some of the provided information, focusing on the guidewire as an example:
| Acceptance Criterion (Test) | Reported Device Performance (Guidewire) |
|---|---|
| Biocompatibility | |
| Chemical Characterization (NVR) | Low amounts of residue detected. |
| Chemical Characterization (FTIR) | Matches cellulose acetate ester, polyurethane, phenolic antioxidant. |
| Chemical Characterization (Trace Metals) | Contained trace amounts, most significant was tungsten. |
| Chemical Characterization (GC/MS) | No semi-volatile compounds detected > 1.0 ppm. |
| Chemical Characterization (LC/MS) | Indicated presence of antioxidant Irganox 1010. |
| Cytotoxicity | No evidence of cell lysis or toxicity (grade 0). |
| Sensitization | No evidence of delayed dermal contact sensitization. |
| Intracutaneous Reactivity/Irritation | Overall mean score difference from control was 0.0. |
| Acute Systemic Toxicity | No mortality or evidence of systemic toxicity. |
| Hemocompatibility (Hemolysis) | Hemolytic index 0.0% (direct contact) and 0.3% (extract), both non-hemolytic. |
| Hemocompatibility (Thromboresistance) | Minimal to slight thrombus formation, appeared equivalent to control. |
| Acute Systemic Toxicity (Pyrogenicity) | Total rise of rabbit temperatures within acceptable USP limits, nonpyrogenic. |
| Performance - Bench | |
| Dimensional | Dimensional results meet acceptance criteria. |
| Tip Tensile Strength | Tensile strength meets specification. |
| Catheter Compatibility | Performed acceptably, compatible with tested microcatheters. |
| Coating Adherence/Integrity | No coating rubbed off during or after testing. |
| Tip Stiffness (Gram Weight) | Equivalent or less than predicate, within specification. |
| Tip Shape Retention | Better than or equivalent to predicate, within specification. |
| Lubricity and Durability | Better than or equivalent to predicate, meets acceptance criteria. |
| PTFE Coating Adherence (Saline Soak & Wipe Test) | All devices passed. |
| PTFE Coating Mandrel Adhesion (Saline Soak & Wrap Test) | All devices passed. |
| PTFE Adhesion / Durability (Eraser Test) | All devices passed. |
| Radiopacity | Comparable to predicate device, meets specification. |
| Torque Strength (Combined Load/Turns to Failure) | Demonstrated within specification. |
| ISO Flex Resistance Test (Bending Durability) | Comparable to predicate device. |
| Corrosion Resistance | Meets acceptance criteria, no evidence of corrosion. |
| FDA Tip Flexibility | Comparable or less atraumatic than predicate, peak load within specification. |
| Kink Resistance / Flexibility | Equivalent or better than predicate device. |
| Particle Residue | All parts & calculated tolerance interval below max specification. |
| Torque Response | Equivalent to predicate device, fresh and fatigued devices within specifications. |
| Packaging Inspection (Shelf Life) | Packaging did not incur any damage or defects. |
| Sterility | |
| Residual Study (EtO, ECH) | All test articles passed acceptance criteria. |
| LAL Testing (Endotoxin) | All test articles passed acceptance criteria. |
| Product Bioburden Testing | All test articles passed bioburden acceptance criteria. |
| Packaging Integrity | |
| Visual Inspection | All samples passed visual inspection. |
| Seal Integrity: Dye Penetration | All samples passed. |
| Pouch Peel Test | All samples passed. |
| Seal Tensile Strength | All samples within specifications. |
| Sterilization (Residuals) | All samples passed. |
| Seal integrity: Bubble leak test | All samples passed. |
| Cytotoxicity | All samples within cytotoxicity specifications. |
| Physiochemical | All samples within physiochemical specifications. |
| Age Testing (Visual Inspection) | All samples met age testing criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each bench test conducted. It typically refers to "All devices," "All samples," or plural forms like "guidewires tested." Medical device bench testing often uses a representative sample per test, but the exact number isn't quantified here.
Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of non-clinical, bench testing. The tests are conducted in a controlled laboratory environment.
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 is not applicable as the device is not an AI/ML diagnostic tool requiring expert interpretation for ground truth. The "ground truth" for these tests is established by objective physical measurements and standardized test methods (e.g., ISO, ASTM standards, USP limits for pyrogenicity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically associated with human interpretation of data, such as in clinical trials or AI/ML evaluations. Bench testing results are typically objectively measured and compared against predefined specifications.
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
Not applicable. MRMC studies are designed to evaluate the performance of AI-assisted human readers in diagnostic tasks. This device is a physical guidewire and extension wire, not an AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by:
- Standardized Test Methods: Adherence to recognized national and international standards (e.g., AAMI/ANSI/ISO 10993-1:2009 for biocompatibility, ISO 11070 for guidewires, ASTM F1929, ASTM F88, ASTM F2096 for packaging, USP for pyrogenicity).
- Engineering Specifications: Internal design specifications that the device must meet (referred to by phrases like "meets specification," "within acceptable limits").
- Predicate Device Comparison: Performance often compared to that of the already-marketed predicate devices to demonstrate "equivalent" or "better" performance.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.