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510(k) Data Aggregation
(143 days)
The SilverSpeed guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the mural, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
The SilverSpeed™ Hydrophilic Guidewire is a .010" diameter stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated from the shapeable platinum coil up to the proximal 30cm of the guidewire. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introduction of the guidewire into the catheter hub and or hemostasis valve.
The provided text describes the regulatory submission for the "SilverSpeed™ Hydrophilic Guidewire" and focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and proving performance against them through extensive clinical studies.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the information that is present.
Acceptance Criteria and Device Performance Study for SilverSpeed™ Hydrophilic Guidewire
This submission focuses on demonstrating substantial equivalence to predicate devices rather than setting and proving new acceptance criteria through a large-scale clinical study with specific performance metrics. The testing performed aimed to show that the new device performs as well as or similarly to existing legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for external communicating, blood contact, short duration (<24 hrs.) device. | Test results confirmed biocompatibility. |
| In-vitro Performance | Substantially equivalent to predicate devices for: - Dimensional inspection - Tensile strength - Flexibility - Trackability - Particulate compatibility | All testing yielded acceptable results substantially equivalent to the predicate devices. |
| In-vivo Performance | Substantially equivalent to predicate devices in animal models. | Studies demonstrated that the guidewire is substantially equivalent to the predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size (In-vitro): Not explicitly stated, but implies a sufficient number of devices were tested for each performance characteristic to demonstrate substantial equivalence to predicate devices.
- Sample Size (In-vivo): Not explicitly stated, but included testing in "rabbit and swine models." The exact number of animals or guidewires used per animal is not provided.
- Data Provenance: The studies were conducted by Micro Therapeutics, Inc. (the manufacturer). The text does not specify the country of origin for the data beyond being part of the manufacturer's internal testing program. The studies were likely prospective for the specific purpose of this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of submission (510(k) for substantial equivalence) does not typically involve external experts establishing ground truth in the way a diagnostic AI study would. The "ground truth" for proving substantial equivalence relies on established engineering principles, recognized standards (like ISO 10993-1), and comparative testing against predicate devices. The internal teams at Micro Therapeutics, Inc. and potentially external contract labs (for biocompatibility) would have performed and analyzed these tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is typically relevant to studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need expert resolution. The testing described here is primarily physical, chemical, and animal model performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This study type is highly specific to assessing the impact of a diagnostic aid (like AI) on human reader performance, which is not the nature of this guidewire submission.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Study: Yes, in a sense, the in-vitro and in-vivo animal studies represent "standalone" device performance evaluations without human intervention influencing the device's inherent physical properties or biological interactions. However, this is not an "algorithm-only" study as the device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
- Ground Truth (Biocompatibility): Compliance with recognized international standard ISO 10993-1.
- Ground Truth (In-vitro Performance): Engineering specifications, validated test methods, and performance characteristics established for the predicate devices.
- Ground Truth (In-vivo Performance): Observational outcomes and measurements in animal models against the established performance of predicate devices.
- The overall "ground truth" for the submission is the demonstration of substantial equivalence to previously cleared predicate devices, meaning the new device is as safe and effective as the predicate.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical medical instrument, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable, as there is no "training set" for this type of device submission.
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