Search Results
Found 2 results
510(k) Data Aggregation
(246 days)
The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.
The provided text is a 510(k) summary for a medical device (guide wire) and does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-driven device meets those criteria based on this document. The document describes traditional performance and biocompatibility testing for a physical medical device.
Ask a specific question about this device
(77 days)
The Hi-Torque Steelcore™ Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not in the cerebral vasculature.
The HT Steelcore Bare Guide Wire is classified under the product code DOX, with the regulation number 21 CFR 870.1330, Catheter guide wire. The HT Steelcore Bare Guide Wire is a steerable wire offered in only one configuration and is designed to be used with devices compatible with 0.018" guide wires.
The HT Steelcore Bare Guide Wire is developed with 300 cm length and has a maximum diameter of 0.019". The distal tip has a radiopaque length of 5.0 cm. The HT Steelcore Bare Guide Wire will be available with the features as listed below:
- Proximal Coating Single Coat Silicone Based hydrophobic coating. ●
- Distal Coating Dual Coat Silicone Based Hydrophobic Coating. .
This document describes the premarket notification (510(k)) for the HI-TORQUE Steelcore™ Bare Guide Wire. The information provided outlines the device's characteristics, its intended use, and the testing conducted to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "performance testing passed with results meeting acceptance criteria." However, it does not provide a specific table detailing the quantitative acceptance criteria for each test and the corresponding quantitative reported device performance. It generally asserts that the device passed all tests and met acceptance criteria, but lacks specific numerical metrics for these criteria or the test results.
The acceptance criteria are implicitly defined by the chosen performance tests and the relevant FDA guidance and standards. The reported "performance" is the qualitative statement that the device "passed" these tests.
| Performance Test Category | Acceptance Criteria (Implicit) | Reported Device Performance (Qualitative) |
|---|---|---|
| Biocompatibility | Meets specified biocompatibility standards (e.g., cytotoxicity, sensitization, irritation) for patient contact. | Passed |
| Sterilization | Achieves a Sterility Assurance Level (SAL) of 10⁻⁶ (as indicated for the predicate device, likely applies here through equivalence). | Passed |
| Pyrogen Validation | Meets pyrogenicity limits. | Passed |
| Shelf life and Packaging | Maintains integrity, sterility, and performance throughout its asserted shelf life (2 years) and under specified packaging conditions. | Passed |
| Non-clinical bench testing | Meets functional and physical specifications (e.g., diameter, length, radiopacity, coating performance, various mechanical properties relevant to guide wires). The text mentions adherence to FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: 2019." | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the performance testing (biocompatibility, sterilization, pyrogen validation, shelf life/packaging, and non-clinical bench testing).
Regarding data provenance:
- Country of origin: Not explicitly stated, but given the submission is to the FDA, it is implied to be relevant to the US regulatory framework.
- Retrospective or Prospective: Not applicable in the context of bench testing. These are controlled laboratory tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the "test set" here refers to physical performance characteristics of a medical device (a guide wire), not a dataset for an AI algorithm or a clinical study requiring expert consensus for ground truth. The "ground truth" is established by the specifications, standards, and validated test methods themselves.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or AI algorithm validation where multiple human readers assess data and discrepancies need to be resolved. For bench testing of a physical device, the "adjudication" is inherent in the adherence to validated test protocols and the objective measurement of physical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI systems, often involving human readers' interpretations of medical images. This submission is for a physical medical device (a guide wire) and relies on bench testing and substantial equivalence to a predicate device, not clinical effectiveness in a diagnostic or interpretive context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a "standalone" study in the context of an algorithm or AI was not done. This submission is for a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" or reference standard for evaluation was based on:
- Established engineering specifications and design requirements for guide wires.
- Relevant FDA guidance documents: Specifically, "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: 2019."
- Pertinent consensus standards (though not explicitly listed, implied by "as recommended by the FDA guidance document as applicable").
- Comparison to the predicate device: The device is considered substantially equivalent if its performance demonstrates it is "as safe and as effective" as the predicate.
This is not ground truth derived from expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As above, there is no AI/ML training set.
Ask a specific question about this device
Page 1 of 1