(14 days)
The Guidant EASYTRAK Guiding Catheter is intended to access the coronary sinus. The catheter serves as a conduit for the delivery and support of devices introduced into the venous system.
The BASYTRAK Guiding Catheter is a catheter with a 0.087" inner diameter. The catheter is available in five shapes which include a Coronary Sinus-Multi Purpose Hook (CS-MPH), Coronary Sinus-Hook (CS-H), Coronary Sinus-Multi-Purpose Long (CS-MPL), and Coronary Sinus-Amplatz 6 (CS-A6). The catheter is available in working lengths ranging from 30cm to 47cm.
The provided text describes the 510(k) summary for the EASYTRAK Guiding Catheter. However, it does not include detailed acceptance criteria or the specific study data that comprehensively demonstrates the device meets these criteria in the way you've outlined. The document focuses on regulatory clearance and substantial equivalence to predicate devices, rather than a detailed performance study with quantifiable metrics.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Not explicitly defined (e.g., burst pressure, tensile strength, kink resistance, pushability) | "demonstrated that the EASYTRAK Guiding Catheter met the acceptance criteria and performed similarly to the predicate device" |
| In Vivo (Animal) | Not explicitly defined (e.g., successful navigation, absence of vessel damage, delivery of other devices) | "results of the in vivo animal evaluation show that the EASYTRAK Guiding Catheter is acceptable. No new safety or effectiveness issues were raised" |
| Clinical Investigation | Not explicitly defined (e.g., successful access rate, complication rates, procedural success) | "The results demonstrated that the EASYTRAK Guiding Catheter is safe and effective." |
| Comparison to Predicate | Substantial equivalence in technological characteristics, product performance, design, and intended use. | "substantially equivalent to the currently marketed Cardima VUEPORT™ Coronary Sinus Balloon Occlusion Guiding Catherer (K973298) and to the Advanced Cardiovascular Systems (ACS) TOURGUIDE™ Guiding Catheter (K953987)" |
2. Sample size used for the test set and the data provenance
- Bench Testing: Sample size not specified. Data provenance: In vitro.
- In Vivo Animal Study: Sample size not specified. Data provenance: Animal study (species not specified).
- Clinical Investigation: Sample size not specified. Data provenance: Clinical investigation (human, specific country not mentioned, but generally implies a prospective human study for a medical device). "Retrospective or prospective" is not explicitly stated but a clinical investigation for regulatory clearance would typically be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The document does not describe a scenario where experts established ground truth for a test set in the context of diagnostic accuracy, which is usually where this information is relevant. This is a functional device, not an imaging or diagnostic AI device.
4. Adjudication method for the test set
- Not applicable/Not specified for the reasons above.
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
- No. This is a medical device (guiding catheter), not an AI/imaging diagnostic device. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device. The concept of an "algorithm only" or "human-in-the-loop" performance is not applicable.
7. The type of ground truth used
- For the performance evaluations:
- Bench Testing: Objective measurements and comparisons against predefined criteria (though these criteria are not detailed in the summary).
- In Vivo Animal Study: Direct observation of device performance, safety assessment, and pathological evaluation (implied by "no new safety or effectiveness issues").
- Clinical Investigation: Clinical outcomes, procedural success, and adverse events observed in human subjects.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
In summary: The provided 510(k) summary for the EASYTRAK Guiding Catheter outlines that bench testing, animal studies, and a clinical investigation were conducted, and these studies demonstrated the device met acceptance criteria and was safe and effective. However, it does not provide the specific quantitative acceptance criteria or detailed results and sample sizes that would be expected for a comprehensive performance study, particularly in the context of an AI/diagnostic device. The information is geared towards establishing substantial equivalence for regulatory clearance rather than a detailed scientific publication of performance metrics.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).