(265 days)
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. It consists of a Nickel-Titanium alloy core wire; a polymer coating (Pebax containing BaSO4 for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The Inno-Hydrowire includes a 3cm flexible tip. The Inno-Hydrowire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire utilized for rotating and controlling the guidewire. The Hydrowires are packaged within a cardboard box which contains five individual guidewires.
The provided text describes a 510(k) summary for the Inno-Hydrowire, a catheter guide wire. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically relies on non-clinical performance testing and biocompatibility testing, rather than studies involving expert readers, AI assistance, or complex ground truth establishment as seen in diagnostic AI devices.
Therefore, many of the requested categories are not applicable to this type of device submission.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a directly comparable format for each test. Instead, it lists the performance tests conducted and then states that "The results of the following performance tests have demonstrated substantial equivalence to the predicate device" and that "Test results for all biocompatibility testing met the applicable test requirements."
Inferred Acceptance Criteria (Based on tested parameters): The acceptance criteria are implicitly defined by compliance with established medical device standards and the substantial equivalence to the predicate device for each performance characteristic.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Tensile Strength (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Torque Strength (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Tip Flexibility (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Surface Lubricity (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Corrosion (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Kink Resistance (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Torqueability (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Particulate (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Coating Adherence/Integrity (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Dimensional Verification (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Radiodetectability (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Cytotoxicity (compliance with ISO 10993-5) | Met applicable test requirements |
| Sensitization (Kligman Maximization) (compliance with ISO 10993-10) | Met applicable test requirements |
| Intracutaneous Injection (compliance with ISO 10993-10) | Met applicable test requirements |
| Acute Systemic Toxicity (compliance with ISO 10993-11) | Met applicable test requirements |
| Rabbit Pyrogen (compliance with ISO 10993-11) | Met applicable test requirements (did not elicit a material mediated pyrogenic response) |
| Hemolysis (compliance with ASTM F756-08 / ISO 10993-4) | Met applicable test requirements |
| In Vitro Hemocompatibility (compliance with ISO 10993-4) | Met applicable test requirements |
| Lee & White Clotting Time (compliance with ISO 10993-4) | Met applicable test requirements |
| Dog Thrombogenicity (compliance with ISO 10993-4) | Met applicable test requirements |
| Complement Activation Assay (C3a) (compliance with ISO 10993-4) | Met applicable test requirements |
| Complement Activation Assay (Sc5b-9) (compliance with ISO 10993-4) | Met applicable test requirements |
| Sterility Assurance Level (SAL) (compliance with ISO 11135) | Achieved 10^-6 SAL |
| Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals (compliance with ISO 10993-7) | Met requirements for limited exposure devices |
2. Sample size used for the test set and the data provenance
The document describes non-clinical performance testing and biocompatibility testing. These tests are typically conducted on a specific number of device samples or using specific biological models (e.g., rabbits for pyrogenicity, dogs for thrombogenicity). The document does not specify the exact sample sizes for each individual test, nor does it refer to a "test set" in the context of human data or image data. Data provenance (country of origin, retrospective/prospective) is not relevant for these types of non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The device is a physical guidewire; there is no "ground truth" established by human experts in the context of diagnostic performance or image interpretation. The "ground truth" for its performance is instead defined by objective physical and chemical properties measured according to international standards (e.g., tensile strength, biocompatibility profiles).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, often in diagnostic contexts. The tests performed for this guidewire are objective and standardized, not requiring human adjudication of results.
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. This document describes the substantial equivalence evaluation for a medical device (a guidewire), not an AI-powered diagnostic tool. Therefore, MRMC studies, human reader improvement with AI, or effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The Inno-Hydrowire is a manually operated 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 evaluating the Inno-Hydrowire is defined by:
- International Standards: Compliance with ISO 11070:2014 for physical performance and ISO 10993 series for biocompatibility, and ISO 11135 for sterilization.
- Predicate Device Performance: The primary method of demonstrating safety and effectiveness for a 510(k) device is by showing substantial equivalence to a legally marketed predicate device (Terumo Radifocus® Guidewire, K863138). This means the Inno-Hydrowire's performance characteristics must fall within acceptable ranges similar to the predicate under the specified test conditions.
8. The sample size for the training set
This is not applicable. The Inno-Hydrowire is a physical medical device, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.