(204 days)
The Metricath™ System is intended for measuring intravascular diameter and cross-sectional area, in the coronary arteries only.
The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary vasculature. Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of an artery.
The Metricath™ System consists of two parts, the Metricath™ 1000 computer console, and the sterile, disposable Metricath™ Balloon Catheter. The Metricath™ System measures both artery lumen diameter and cross sectional area using a low-pressure balloon catheter inserted into the artery using standard interventional procedures and techniques. The Metricath™ System is indicated for use in patients who are candidates for percutaneous transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of an artery.
The provided text describes the Metricath™ System, a device for measuring intravascular diameter and cross-sectional area in coronary arteries. It details the regulatory submission (K024000) and the FDA's clearance.
However, the provided document does not contain a table of acceptance criteria or the reported device performance in the way typically expected for a medical device study showing specific metrics (e.g., accuracy, precision) against predefined thresholds. The document focuses on regulatory compliance, substantial equivalence to predicate devices, and general safety and effectiveness.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific numerical acceptance criteria for performance metrics (like accuracy of diameter measurement) nor does it report specific numerical performance results from a clinical study for these metrics. Instead, it states that the device "met or exceeded the requirements" of various standards and was found "safe and effective for its intended use."
Here's a table summarizing the stated compliance and general findings:
| Acceptance Criteria Category | Description / Standard Met | Reported Device Performance |
|---|---|---|
| Functional & Safety (Console) | IEC 60601-1 (medical electrical equipment safety) | Met or exceeded requirements |
| IEC 60601-1-2 (electromagnetic compatibility) | Met or exceeded requirements | |
| Software Validation (Console) | (Implied robust validation process) | Successfully validated |
| Sterile Intravascular Catheter (Catheter) | ISO 10555-1 (general requirements for sterile, single-use intravascular catheters) | Met or exceeded requirements |
| ISO 10555-4 (balloon catheters) | Met or exceeded requirements | |
| Biocompatibility (Catheter) | ISO 10993 (biological evaluation of medical devices) | Met or exceeded requirements |
| Catheter Physical Characteristics | Tensile strength of catheter bonds, leakage, burst, kinking, tortuosity, fatigue | Met or exceeded requirements (evaluated positively) |
| Clinical Safety & Effectiveness | Safe and effective for intended use (inferred from intended use and substantial equivalence claims) | Found safe and effective in-vivo for its intended use |
| Substantial Equivalence | Comparison to predicate devices (Galaxy Intravascular Ultrasound System, UltraCross™ 2.9, 30MHz Coronary Imaging Catheter, Equinox™ Occlusion Balloon Catheter, Amplatzer® Sizing Balloon) | Found to be substantially equivalent with regards to device safety and intended use |
Regarding the study that proves the device meets the acceptance criteria:
The document broadly refers to "testing" and "evaluation" rather than detailing a specific, comprehensive clinical trial with explicit acceptance criteria and corresponding performance data. The core of the proof appears to be based on:
- Compliance with international standards: IEC 60601-1, IEC 60601-1-2, ISO 10555-1, ISO 10555-4, and ISO 10993.
- Software validation.
- In-vivo testing: It states, "The Metricath™ System has been tested in-vivo, and found safe and effective for its intended use." No further details on this in-vivo test (e.g., sample size, protocol, specific results) are given.
- Comparison to predicate devices: "The Metricath™ System has been tested and compared to the predicate devices, and found to be substantially equivalent with regards to device safety and intended use." Again, no specific comparative study details are provided.
The following information cannot be fully answered from the provided text as it primarily an FDA 510(k) summary focused on regulatory clearance based on substantial equivalence, not a detailed clinical study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified. The document only mentions "tested in-vivo" without providing the number of subjects or cases.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. The document does not describe a process for establishing ground truth via expert review for the in-vivo testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- This device is not an AI-assisted diagnostic tool for human readers; it is a physical measurement device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed/reported for this device. The comparison was for substantial equivalence to predicate devices, not diagnostic performance improvement for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a standalone system for measurement. The "in-vivo" testing and comparison to predicate devices would effectively be an assessment of its standalone performance. However, specific performance metrics (e.g., accuracy, precision) are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For a device measuring lumen diameter and cross-sectional area, the "ground truth" in comparative testing would likely involve measurements from the predicate devices or potentially a highly accurate reference method (e.g., a gold standard imaging technique or physical model), but this is not specified.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. Its software was "successfully validated," which refers to standard software development lifecycle validation, not machine learning model training.
9. How the ground truth for the training set was established:
- Not applicable.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).