(17 days)
To facilitate the placement of devices used during diagnostic and interventional procedures.
To facilitate the placement of devices for diagnostic and interventional procedures.
Nitinol or stainless steel core wire with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. Additionally, the proximal end of the coil is secured to the core either at the proximal end of the core (where the entire core is enclosed in the coil as in K779077 design) or at a design-driven location on the core (where a portion of the core is exposed as in K011084 design). A portion of the guidewire is coated with hydrophilic coating. The guidewires are bound by the following parameters: .014" - . 018" Outside Diameter: Lengths: 40cm - 150cm Tips: Straight or shaped with various tip flexibilities NOTE: None of these guidewires are for PTCA use.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or numerical performance metrics. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual/Tactile Attributes | "The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices." |
| Dimensional Attributes | "The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices." |
| Mechanical Attributes | "The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices." |
| Hydrophilic Properties | Must meet established criteria for hydrophilic properties. (No specific metrics provided, but implied to have been met). |
| Biocompatibility | Acceptable, established by testing and market history of proven biocompatibility. |
| Design Control Requirements | Conforms to 21 CFR 820.30, and all verification/validation demonstrated that predetermined acceptance criteria were met. |
| Quality Systems | Formal quality systems are in place to ensure equivalence to predicate and no adverse effects. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "Test pieces were tested and inspected according to established specific inspection criteria requirements..." but does not specify the sample size for these tests.
- Data Provenance: The study was conducted by Lake Region Manufacturing, Inc. (LRM) to demonstrate equivalence to its own predicate devices. Therefore, the data provenance is internal to the company, and it's a prospective study as it was performed specifically for this 510(k) submission to show the new device meets requirements.
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. The testing appears to be primarily engineering and physical performance tests, rather than a clinical study requiring expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. The tests described are objective engineering and physical measurements rather than subjective assessments requiring adjudication.
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?
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a guidewire, and the submission is focused on demonstrating physical and performance equivalence, not on AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests described appears to be predetermined engineering specifications and established inspection criteria. For biocompatibility, it refers to testing results and market history of proven biocompatibility. There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in this context.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This is not a machine learning or AI-driven device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no training set for this 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.