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510(k) Data Aggregation
(87 days)
The ac Wire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The ac Wire may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).
The ac Wire device is a 0.035"" outside diameter, single use, disposable guidewire. The ac Wire device consists of a flexible guidewire that incorporates a low profile, radiopaque alignment element consisting of three loops with radiopaque markers that when open, form a "tulip" configuration designed to assist the physician in acquiring a reference plane under fluoroscopy.
The MediValve acWire is a guidewire intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. It may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly list quantitative acceptance criteria with numerical targets. Instead, it states that "descriptive information, laboratory bench testing, and biocompatibility testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use." The performance is evaluated against the predicate devices for substantial equivalence.
| Category | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Functional Testing | The guidewire should exhibit equivalent mechanical and functional performance to predicate devices (Ostial Pro Stent Positioning System and Lake Region Manufacturing Catheter Guidewire) in areas such as tip flexibility, torque strength, fracture resistance, coating integrity, particulate generation, tensile strength, repeated use durability, corrosion resistance, shelf-life, radiopacity, loop deflection, usability, stiffness, and compatibility with other interventional devices. This implies meeting industry standards or demonstrating comparable performance to the predicate devices in these specific tests. "Performs as intended" means it facilitates delivery and acts as an alignment tool. | Demonstrated safety through design verification testing for: Tip Flexibility, Torque Testing, Torque Strength, Fracture Test, Resistance to Coating Damage, Coating Adhesion, Particulate Residual, Tensile Testing, Repeated Use Test, Corrosion Test, Shelf-Life Test, Radiopacity Test, Loop Deflection Test, Usability Test, Stiffness Test, Compatibility Test, Austenite Finish Test, Ex-vivo Performance Test. The submission asserts that the "performance as evaluated in bench tests, demonstrates that the ac Wire device is as safe and effective as the predicate devices." |
| Biocompatibility | The guidewire materials should be biocompatible and not elicit adverse biological reactions when in contact with human tissue and blood, as per ISO 10993-1. This includes acceptable levels for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, thrombus formation, and complement activation. | Biocompatibility testing performed in accordance with ISO 10993-1, including: Cytotoxicity Study, Maximization Sensitization, Intracutaneous Study, Systemic Toxicity Study, Pyrogen Study, Material Mediated Hemolysis, In Vivo Thromboresistance Study, SC5b-9 Complement Activation Assay, C3a Complement Activation Assay. The collective results "demonstrated that the ac Wire device is safe and is substantially equivalent to the respective predicate devices." |
| Substantial Equivalence | The ac Wire device should be substantially equivalent to the predicate devices (Ostial Pro Stent Positioning System (K062192) and Lake Region Manufacuring (LRM) Catheter Guidewire (K011084)) in terms of design, intended use, principles of operation, and technological characteristics, without raising new issues of safety or effectiveness. This is the overarching "acceptance criteria" for a 510(k) submission. | The submission concludes, "The design, intended use, principles of operation, and technological characteristics of the ac Wire are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon descriptive characteristics of the various cited predicate devices and upon the testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to safely perform as a cardiovascular guide wire. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes laboratory bench testing and biocompatibility testing. It does not specify a "test set" in the context of patient data or clinical images. The testing involved physical samples of the device or its components. The document does not provide details on the specific number of units tested for each functional test (e.g., how many guidewires were used for the tensile test, or how many loops for the loop deflection test).
- Data Provenance: The testing appears to be primarily laboratory-based and ex-vivo (as indicated by "Ex-vivo Performance Test" and "In Vivo Thromboresistance Study" which refers to animal studies rather than human clinical data). There is no mention of country of origin for any human data, as no human data is presented in the summary.
3. Number of Experts and their Qualifications for Ground Truth:
This information is not applicable as the summary describes bench and biocompatibility testing of a physical medical device, not an AI/software device that requires expert-established ground truth from medical images or clinical data.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as above. There is no "test set" requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or imaging devices to compare human performance with and without AI assistance. The MediValve acWire is a physical guidewire that does not involve AI assistance for human readers.
6. Standalone (Algorithm Only) Performance:
No, a standalone performance evaluation (algorithm only without human-in-the-loop performance) was not done. This concept applies to AI algorithms and is not relevant to a physical guidewire device like the MediValve acWire.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance in this context is defined by:
- Engineering specifications and design requirements: Functional tests aim to verify that the device meets predetermined mechanical, physical, and performance specifications.
- Biocompatibility standards (ISO 10993-1): The "ground truth" for biocompatibility is conformance to established biological safety standards as determined by specific assay results.
- Predicate device characteristics: The ultimate "ground truth" for safety and effectiveness in a 510(k) submission is substantial equivalence to a legally marketed predicate device. This means the new device performs as well as, or better than, the predicate in relevant tests without raising new safety or effectiveness concerns.
8. Sample Size for the Training Set:
This information is not applicable. The MediValve acWire is a physical medical device and does not involve AI algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical guidewire device.
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