(174 days)
The Ultraverse™ Small Vessel Peripheral Balloon Dilatation Catheters are recommended for use in the peripheral vascular system, in the following vessels: renal, tibial, popliteal, femoral, and peroneal. This catheter is not for use in coronary arteries. The device is for single use only and must not be resterilized or reused.
The Vas-Cath Ultraverse™ PTA Catheter is a duai lumen catheter with a balloon mounted on its distal tip. One lumen accomodates the insertion guidewire and the second provides a channel for inflation on the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.016 inch diameter guidewire. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature. The balloon inflates to the stated diameter and length at an 8 atmosphere operating pressure.
Here's a breakdown of the acceptance criteria and study information for the Ultraverse™ PTA Balloon Dilatation Catheters, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative manner as typically seen in modern regulatory submissions (e.g., "sensitivity must be > X%", "accuracy must be > Y%"). Instead, the acceptance criteria are implicitly defined by demonstrating that the new catheter sizes maintain the same performance characteristics as the predicate device (K925485). The "reported device performance" refers to the results of the tests conducted to confirm this consistency.
| Characteristic Tested | Predicate Device (K925485) Performance / Implicit Acceptance Criterion (Same performance as predicate) | Proposed New Sizes (K964881) Reported Device Performance |
|---|---|---|
| Balloon Minimum Burst Strength | Consistent with predicate (implied to meet predicate's burst pressures) | Tested and found to be consistent with predicate |
| Balloon Distensibility | Consistent with predicate | Tested and found to be consistent with predicate |
| Balloon Inflation/Deflation Time | Consistent with predicate | Tested and found to be consistent with predicate |
| Balloon Fatigue | Consistent with predicate | Tested and found to be consistent with predicate |
| Joint Strength | Consistent with predicate | Tested and found to be consistent with predicate |
| Catheter Shaft and Balloon Profile | Consistent with predicate | Tested and found to be consistent with predicate |
| Introducer Sheath Compatibility | Consistent with predicate | Tested and found to be consistent with predicate |
| Catheter Flow/Maximum Pressure | Consistent with predicate | Tested and found to be consistent with predicate |
| Trackability/Deflatability | Consistent with predicate | Tested and found to be consistent with predicate |
| Tip Torque | Consistent with predicate | Tested and found to be consistent with predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact numerical sample sizes for each characteristic test. It generally states that "The additional balloon and shaft sizes proposed in this submission were tested for the following characteristics." This implies a sufficient number of units were tested to demonstrate consistency.
- Data Provenance: Not explicitly stated, but given the device manufacturer is Vas-Cath Incorporated from Canada, the testing likely occurred internally or at a contracted lab. The data is retrospective in the sense that it's a report of completed tests for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a medical instrument (catheter), and its performance evaluation involves engineering and material testing, not subjective expert assessment of images or clinical outcomes to establish a "ground truth" in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation is based on objective measurements from engineering tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a medical device (catheter) for angioplasty, not an AI diagnostic algorithm. Therefore, an MRMC comparative effectiveness study involving human readers is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by engineering specifications, material properties, and established performance characteristics of the predicate device. For example, the "ground truth" for burst strength would be the pressure at which the balloon is designed to withstand before bursting. The comparison is made against known and accepted standards for such devices and the performance of the previously cleared predicate.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #8)
§ 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).