(179 days)
The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents.
The Medi-Dyne, Inc. Coronary Guiding Catheter is designed to be used for the intravascular introduction of medical instruments into the coronary and the peripheral vascular system.
The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents.
The Medi-Dyne device is similar in construction and materials when compared to the predicate devices. For example, both the Medi-Dyne and predicate device is manufactured with a plastic luer, radiopacifier loaded plastic shaft (jacket), a radiopacifier loaded soft tip, a teflon lined lumen, and an encapsulated layer of stainless steel braid between the inner teflon/liner and the outer plastic jacket. In addition, the lumens are similar in size, the distal ends are nontapered and sideholes are available.
The provided text is a 510(k) summary for the Medi-Dyne Powerback Coronary Guiding Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, primarily through bench testing for medical devices like catheters, rather than clinical studies with human participants that would typically involve acceptance criteria and performance metrics for an AI/ML device.
Therefore, many of the requested points are not applicable to this specific submission. However, I can extract the relevant information from the provided text.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several "nonclinical tests" (bench tests) performed. The acceptance criteria are implicitly that the Medi-Dyne catheter's performance "equaled or exceeded values obtained on competitive products." Specific numerical acceptance values or reported performance metrics are not provided in this summary.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Equaled or exceeded values obtained on competitive products | The Medi-Dyne equivalence equaled or exceeded values obtained on competitive products (for all tests 1-11). It was determined to be safe and effective. |
Tests Performed:
- Tensile strength of catheter body
- Tensile strength of catheter body to luer attachment
- Catheter stiffness
- Catheter tip (distal) attachment strength
- Catheter elongation
- Leakage at hub
- Catheter burst test (positive internal pressure)
- Catheter collapse (negative internal pressure)
- Catheter flexural fatigue tolerance
- Curve retention
- Frequency response
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This was a bench study, not a clinical study involving a "test set" of patient data. The "test set" would refer to the physical catheters subjected to the bench tests. The number of samples tested is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth was established through physical engineering measurements and comparison to predicate devices, not through expert human interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication was mentioned for these physical bench tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device (catheter) 510(k) submission, not an AI/ML device, and thus no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" was established through direct physical measurements according to established engineering and material science principles, and comparison to the performance of predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of physical device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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).