(62 days)
The Mira-Flex™ 18 microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. This device is intended for one-time use.
The Mira-Flex™ 18 microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including neuro, peripheral, or coronary use. This device has a small inner lumen, a tapered tip, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be sterilized and is intended for one-time use. The Mira-Flex™ 18 will be available in 100, 110, 135, and 150 cm lengths.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study.
It's important to note that 510(k) summaries, especially for devices like microcatheters, often do not include the granular detail you're asking for, particularly concerning AI/machine learning specific metrics like sample sizes for test/training sets, expert qualifications, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device through engineering tests and general performance.
Acceptance Criteria and Device Performance for the Mira-Flex™ 18 Microcatheter
The provided 510(k) summary for the Mira-Flex™ 18 Microcatheter does not explicitly list quantitative acceptance criteria in a table format alongside specific numerical performance results for the device. Instead, it describes types of tests conducted to ensure "reliable design and performance." The implicit acceptance criterion for these tests is that the device performed adequately or within engineering specifications to demonstrate substantial equivalence to the predicate device.
The document indicates that the device's performance was considered acceptable as the FDA granted 510(k) clearance, implying that the results of the conducted tests provided "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implicit from 510(k) Clearance) | Reported Device Performance (Implicit from 510(k) Clearance) |
|---|---|---|
| Tensile tests | Device withstands specified tensile forces without failure. | Performed reliably; results supported intended use. |
| Burst and pressure tests | Device withstands specified internal pressures without bursting or leaking. | Performed reliably; results supported intended use. |
| Biocompatibility tests | Device materials are biocompatible and do not cause adverse biological reactions. | Materials are biocompatible (implied by clearance). |
| Leakage tests | Device mainains integrity and does not leak under specified conditions. | Performed reliably; results supported intended use. |
| Acute animal study | Device performs safely and effectively in vivo, demonstrating features for intended use. | Demonstrated reliable design and performance in a live animal model. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document only lists the types of tests performed (e.g., Tensile, Burst, Leakage, Biocompatibility, Acute Animal Study). Typical sample sizes for these types of engineering and animal studies are not detailed in 510(k) summaries.
- Data Provenance: Not explicitly stated, but engineering tests are usually conducted in a laboratory setting, and biocompatibility tests would follow ISO standards. The "Acute animal study" would have been conducted in an animal facility. The country of origin for the data is implicitly the United States, given the submitting company (Cook Incorporated, Bloomington, IN) and the FDA submission. The studies are prospective in nature, as they are conducted specifically to support the device's clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified. For engineering tests, "ground truth" would be established by validated test methodologies and specifications. For the animal study, veterinarians and potentially veterinary pathologists would be involved, but their number and specific qualifications are not detailed.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not specified. For engineering and biocompatibility tests, results are typically objective measurements against a standard, not subject to subjective adjudication. For the animal study, observations and assessments would have been made by the research team, but a formal adjudication method (like 2+1 or 3+1 for clinical endpoints) is not mentioned or typically required for an acute animal study supporting a 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is a microcatheter, a physical medical device, not an AI or imaging diagnostic tool. MRMC studies are used for evaluating diagnostic software or imaging systems where human interpretation is a critical component.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This device does not involve an algorithm or AI component.
7. Type of Ground Truth Used
- Ground Truth Type:
- For Tensile, Burst, Pressure, and Leakage tests: Engineering specifications, validated measurement equipment, and standardized test methods.
- For Biocompatibility tests: ISO standards (e.g., ISO 10993) and laboratory assays.
- For Acute animal study: Direct physiological observations, potentially necropsy findings, and expert veterinary assessment.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical medical device and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
Summary of Limitations Based on Document Content:
The provided 510(k) summary is typical for a physical medical device. It focuses on demonstrating substantial equivalence through a series of standard engineering and biocompatibility tests, along with an acute animal study. It does not contain the detailed information related to AI/machine learning model development, validation, or human reader studies, as those concepts are irrelevant to this particular device submission. The "acceptance criteria" and "performance" are framed in terms of general reliability and conformance to requirements rather than specific quantitative thresholds for each test, implying that the raw data and detailed reports were provided to the FDA but are not part of the public summary.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).