(30 days)
Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.
Merit InQwire® Amplatz Super Stiff Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure that the guide wire components remain together The outside coil is PTFE coated and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated. The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch and 0.038-inch outer diameter with a 1cm, 3cm, 3.5cm ,4cm, 6cm and 7cm straight and J tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length. The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices.
The provided text describes testing conducted for the InQwire Amplatz Super Stiff Guide Wire (K170700) to demonstrate its substantial equivalence to predicate devices, not specifically for a software algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable.
However, I can extract the information that is present regarding the acceptance criteria and the study performed for this medical device.
1. Table of acceptance criteria and the reported device performance
| Test Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Radiopacity | Based on risk analysis, guidance documents, and industry standards (e.g., FDA guidance Coronary and Cerebrovascular Guide Wire Guidance, ISO 11070:2014) | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Tensile Strength | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Torque Strength | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Tip Flexibility | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Coating Adherence/Integrity | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Catheter and Needle Compatibility | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Lubricity | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Fracture | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Flex | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Particulate Evaluation | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Surface | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Biocompatibility | Based on ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile G95-1 | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Corrosion | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Tip Shape | Based on risk analysis, guidance documents, and industry standards | "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria." |
| Sterilization (Ethylene Oxide) | Based on ISO 11135:2014 | Not explicitly detailed, but implied to be met as part of "All test results..." |
| Packaging (Shelf Life, Integrity) | Based on ASTM F1980-07 and ISO 11607-1:2006 | Not explicitly detailed, but implied to be met as part of "All test results..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each performance test. It states that "A battery of testing was conducted" and implies these were laboratory-based tests comparing the subject device to existing predicate devices.
- Sample Size: Not specified.
- Data Provenance: The tests are implied to be conducted by the manufacturer, Merit Medical Systems, Inc., which has locations in South Jordan, UT, USA, and Galway, Ireland. The data is from laboratory testing of the physical device, not patient data (retrospective or prospective).
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 a physical medical device, not an AI/software device requiring expert interpretation of results for ground truth. Therefore, this information is not applicable. Ground truth was established through validated engineering and scientific testing methods against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as it refers to expert consensus for interpreting results, which is not relevant for the performance testing of a physical guide wire.
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 as this is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the reported tests was established by:
- Reference to predicate devices (Merit InQwire® Amplatz Super Stiff Guide Wire [K163575] and Amplatz Super Stiff Guidewire [K843012]).
- Adherence to industry standards and guidance documents (e.g., FDA guidance Coronary and Cerebrovascular Guide Wire Guidance, ISO 11070:2014, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006).
- Risk analysis.
The "ground truth" for a physical device is its measurable physical and chemical properties and performance characteristics against established benchmarks.
8. The sample size for the training set
This is not applicable as this is not an AI/software device.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/software 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.