(135 days)
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
The Sleek OTW PTA Catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (0.014"). The balloon expands to a known diameter at specific pressure.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document describes a medical device, the Sleek OTW PTA Catheter, and its equivalence to a predicate device, the Bantam α PTA Catheter. The "study" here refers to non-clinical bench testing to demonstrate this equivalence and the device's safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters tested for in both the predicate device (Bantam α) and the Sleek OTW, as well as the additional tests performed for the Sleek OTW. The acceptance criteria for the Sleek OTW are broadly that it "PASSES" these tests.
| Acceptance Criteria (Test) | Reported Device Performance (Sleek OTW) |
|---|---|
| Inflation/Deflation Time | PASS - VP577 ([29 of 5x120mmx150cm]) |
| Introducer Sheath Withdrawal | PASS ([29 of 5x120mmx150cm]) |
| Leak and Rated Burst Pressure | *PASS with deviation |
| Tensile Test for Proximal Bond | PASS ([29 of 5x120mmx150cm]) |
| Tensile Test for Hub Bond | PASS ([29 of 5x120mmx150cm]) |
| Measurement of the Working Surface, | PASS ([13 of 1.25x15mmx150cm], [13 of |
| OD and TL of the Balloon | 5x120mmx150cm]) |
| Balloon Compliance | PASS ([13 of 1.25x15mmx150cm], [16 of |
| 5x120mmx150cm]) | |
| Average Burst Pressure Testing | PASS ([13 of 1.25x15mmx150cm], [13 of |
| 5x120mmx150cm]) | |
| Profile Measurements of Distal Tip | PASS – VP577 ([29 of 1.25x15x150], [29 |
| of 5.0x120x150]) | |
| Tensile Test of the Distal Tip | PASS ([29 of 1.25x15mmx150cm], [29 of |
| 5x120mmx150cm]) |
Note on "PASS with deviation" for Leak and Rated Burst Pressure: The document states "Conclusion: All products had acceptable balloon fatigue performance, noted deviation accepted." This implies that while there might have been a minor deviation from the initial target, it was deemed acceptable for the intended use and did not compromise safety or effectiveness.
2. Sample Size Used for the Test Set and the Data Provenance
The sample sizes for the test sets (grouped by specific catheter dimensions and lengths) are indicated in brackets within the "Results Sleek OTW" column of the tables. Examples include:
- Inflation/Deflation Time: 29 samples of 5x120mmx150cm catheters.
- Introducer Sheath Withdrawal: 29 samples of 5x120mmx150cm catheters.
- Leak and Rated Burst Pressure: 29 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
- Profile Measurements of Distal Tip: 29 samples each of 1.25x15x150 and 5.0x120x150 catheters.
- Tensile Test of the Distal Tip: 29 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
- Measurement of Working Surface, OD, TL of Balloon: 13 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
- Balloon Compliance: 13 samples of 1.25x15mmx150cm and 16 samples of 5x120mmx150cm catheters.
- Average Burst Pressure Testing: 13 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
Data Provenance: The data is from non-clinical design verification and design validation bench tests conducted by ClearStream Technologies Ltd. The country of origin of the data is not explicitly stated but is implicitly the location of the manufacturing and testing, which is likely Ireland, where ClearStream Technologies Ltd is based. The data is prospective in the sense that these tests were performed specifically for this submission to validate the Sleek OTW PTA Catheter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes a submission for a medical device (catheter), not an AI/software device. Therefore, the concept of "ground truth established by experts" in the context of medical imaging or diagnostic algorithms is not applicable here. The ground truth for device performance is established by engineering specifications and scientific measurement protocols (e.g., ISO 10555-1 and ISO 10555-4).
4. Adjudication Method for the Test Set
As this is a physical medical device and the tests are objective engineering measurements, an "adjudication method" in the sense of expert consensus for medical diagnoses is not applicable. The test results are quantitative and pass/fail criteria are based on predefined specifications.
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, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (catheter), not an AI/software product. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone algorithm-only performance study was not done. This submission is for a physical medical device (catheter), not an AI/software product.
7. The Type of Ground Truth Used
The "ground truth" for the performance of this physical medical device is based on engineering specifications, established industry standards (ISO 10555-1 and ISO 10555-4 requirements), and objective measurements derived from bench testing. It's essentially a set of predefined performance targets that the device must meet to be considered safe and effective.
8. The Sample Size for the Training Set
There is no training set in the context of this traditional medical device submission. The device is not learning or being trained from data. The tests performed are for validation of the final product.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this traditional medical device, this question is not applicable.
§ 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).