(94 days)
The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.
NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.
The provided text describes a 510(k) premarket notification for a medical device called "NeoWire PTA/PTCA Guidewire." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a clinical study with acceptance criteria in the way one might for a diagnostic AI device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to the type of submission described in this document.
Here's an analysis based on the provided text, focusing on how the device meets the criteria for substantial equivalence rather than acceptance criteria for a novel clinical performance claim:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating that the NeoWire Guidewire is as safe and effective as its predicate devices. This is achieved by showing similar technological characteristics and performing a battery of non-clinical tests. The "performance" reported is that the device meets these specifications.
| Acceptance Criterion (Similarity to Predicate / Meeting Standards) | Reported Device Performance (NeoWire) |
|---|---|
| Same intended use | Meets: "The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature." (Matches predicate's intended use) |
| Same operating principle | Meets: Operating principle is the same. |
| Same shelf life and sterilization process | Meets: Same shelf life and sterilization process. |
| Similarities in Design, Material Types, and Technology | Meets: Nominal diameters: 0.014" and 0.018"Similar Lengths: 80, 180, 190, and 300cmNitinol alloy core wiresDistal radiopaque coilsFlexible, shapeable distal tip segmentsJoined by a combination of adhesive and weldsLubricious coatings |
| Adherence to Guidewire Dimensions (FDA Guidance Jan 1995) | Meets: Testing conducted on overall length, radiopaque tip length, and diameter. |
| Adherence to Torqueability and Torque Strength (FDA Guidance Jan 1995) | Meets: Testing conducted. |
| Adherence to Coating Adherence (FDA Guidance Jan 1995) | Meets: Testing conducted. |
| Adherence to Tip Flexibility (FDA Guidance Jan 1995) | Meets: Testing conducted. |
| Sterile Package Integrity (ASTM F 1929-98, ASTM F 88-09) | Meets: Testing conducted. |
| Reverse Bend (Fatigue Failure) (ISO 11070) | Meets: Testing conducted. |
| Tensile testing (ISO 11070) | Meets: Testing conducted. |
| Fracture Resistance (ISO 11070) | Meets: Testing conducted. |
| Corrosion Resistance (ISO 11070) | Meets: Testing conducted. |
| Tip Load (NeoMetrics' test method TM-3010) | Meets: Testing conducted. |
| Rail Support (NeoMetrics' test method TM-3002) | Meets: Testing conducted. |
| Biocompatibility (ISO 10993 series and ASTM F-756-00) | Meets: Specific tests (Partial Thromboplastin Time, Hemolysis, Cytotoxicity, Acute Systemic Injection, Intracutaneous Reactivity, Guinea Pig Maximization Sensitization, Complement Activation, In Vivo Thrombosis) were either tested on NeoWire components or leveraged from previously cleared NeoMetrics products. The table indicates "Tested on NeoWire" or "Leveraged" for each material and test, implying all necessary biocompatibility aspects were addressed. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a non-clinical performance testing study comparing the NeoWire Guidewire to predicate devices and assessing compliance with recognized standards. This is explicitly stated in "Section 5.6 Technological Characteristics" and "Section 5.7 Summary of Non-Clinical Testing."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for each test. It states "To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices" and "competetive devices were tested along with the proposed device in each test." This implies a comparative bench study using physical device samples.
- Data Provenance: The data is generated from bench testing conducted by NeoMetrics, Inc., following FDA Guidance and ISO standards. This is not patient-derived data, so "country of origin" or "retrospective/prospective" in a clinical sense are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This is not a clinical study involving expert interpretation or ground truth establishment in that manner. The "ground truth" for these tests comes from established engineering principles, reference materials, and the defined performance characteristics of the predicate devices and relevant standards.
4. Adjudication Method for the Test Set
N/A. There is no adjudication method described as it's not a clinical or interpretive study. Performance is assessed against quantitative engineering specifications and comparison to predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. No MRMC study was done, as this is a physical medical device (guidewire) and not an AI or diagnostic imaging system that would involve human readers.
6. Standalone Performance Study (Algorithm Only)
N/A. Not applicable, as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests is derived from:
- Established engineering specifications and performance benchmarks defined by FDA guidance documents (e.g., "FDA Coronary and Cerebrovascular Guidewire Guidance January 1995").
- International ISO standards (e.g., ISO 11070, ISO 10993 series).
- ASTM standards (e.g., ASTM F 1929-98, ASTM F 88-09, ASTM Guideline F-756-00).
- NeoMetrics' internal test methods (e.g., TM-3010, TM-3002).
- The performance characteristics of the legally marketed predicate devices, against which the NeoWire is compared to demonstrate substantial equivalence.
8. Sample Size for the Training Set
N/A. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable.
§ 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.