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510(k) Data Aggregation
(211 days)
The ULTRASKIN™ Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure.
The ULTRASKIN™ Hydrophilic Guide Wire consists of a Nitinol core wire, a plastic jacket with hydrophilic coating. The wire distal curve comes in different shapes such as straight, J angled and angled. The guide wire is radiopactitive under fluoroscopy.
The provided text describes the ULTRASKIN™ Hydrophilic Guide Wire, a medical device, and its supporting data for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely derived from international standards and internal performance testing, demonstrating safety and effectiveness compared to a predicate device.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 (Guidance on selection of tests for External Communicating Device in contact with Circulating Blood for a Limited Duration (<24 hours)) | Device produced by Lepu Medical was assessed against this standard. |
| Cytotoxicity (ISO 10993-5) | The test article extract showed no evidence of causing cell lysis or toxicity. | |
| Maximum Sensitization (ISO 10993-10) | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | |
| Intracutaneous Irritation (ISO 10993-10) | The test article met the requirements for the SC and SO test extracts. | |
| Systemic Toxicity (ISO 10993-11) | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. | |
| Haemolysis (ISO 10993-4) | Both the test article in direct contact with blood and the test article extract were non-hemolytic. | |
| USP Pyrogen Study (ISO 10993-11) | The test article was judged as nonpyrogenic. | |
| In Vivo Thromboresistance (ISO 10993-4) | The test article and control were thromboresistant and comparable. | |
| Partial Thromboplastin Time (ISO 10993-4) | The test article would be considered a minimal activator and met the requirements of the test. | |
| C3a Complement Activation Assay (ISO 10993-4) | The test article was not considered to be a potential activator of the complement system. | |
| SC5b-9 Complement Activation Assay (ISO 10993-4) | The test article was not considered to be a potential activator of the complement system. | |
| Sterilization | AAMI / ANSI / ISO 11135:2007 | Provides a Sterility Assurance Level (SAL) of 10-6. |
| Shelf Life | ISO 11070 (Real-time aging) | Demonstrated that the performance of specific components met standard requirements without significant difference to product performance requirements before aging. Product is stable. |
| Performance Testing | Dimension Verification, Corrosion resistance, Fracture, Flexing test, Tensile strength, Torque strength, Torqueability, Tip flexibility, Coating integrity and particulate evaluation, Appearance, Chemical performance, Radiodetectability. (ULTRASKIN™ Hydrophilic Guide Wire Performance Testing) | The ULTRASKIN™ Hydrophilic Guide Wire successfully passed all these performance tests. The materials comparison showed no new issues of safety or effectiveness compared to the predicate device, despite the addition of Wolfram Carbide in the plastic jacket. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample sizes used for each specific biocompatibility and performance test (e.g., number of animals for toxicity tests, number of guide wires for mechanical tests). It generally states that "The ULTRASKIN™ Hydrophilic Guide Wire successfully passed all of the following performance tests" and provides "Results" for each biocompatibility test.
- Data Provenance: The data is generated from testing conducted by Lepu Medical Technology (Beijing) Co., Ltd. The document does not specify the country of origin for the studies themselves (e.g., where the animal studies were conducted), but the manufacturer is based in Beijing, P.R. China. The studies are assumed to be prospective as they were conducted for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes technical and biological performance testing, not studies requiring expert interpretation of clinical data or images. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable here. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified ISO standards and validated internal engineering tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against predefined criteria in scientific standards, not 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
Not applicable. This is a medical device (guide wire), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance of systems, often involving human readers and AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the ULTRASKIN™ Hydrophilic Guide Wire is based on:
- International Standards: Primarily ISO 10993 series for biocompatibility and ISO 11070 for shelf life, which define the acceptable limits and methodologies.
- Engineering Specifications/Internal Standards: For performance tests like dimension verification, tensile strength, etc., the "ground truth" or acceptance criteria are derived from the device's design specifications and industry safety/performance expectations for guide wires.
- Predicate Device Comparison: The ultimate "ground truth" for FDA 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device (Radifocus® Glidewire® Advantage, K063372) by showing that any differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The device's performance is established through direct physical, chemical, and biological testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
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