(49 days)
The SAILOR™ PLUS PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The SAILOR PLUS Balloon Dilatation Catheter is OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It has a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. Two radiopaque markers indicate the dilating portion of the balloon and help in correctly positioning the balloon within the vessel. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. The maximum recommended guidewire diameter is 0.035". The device is available in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths of 130. 80 and 40cm
Here's an analysis of the acceptance criteria and study information for the SAILOR PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter, based on the provided text:
This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on novel clinical trials with predefined acceptance criteria for AI/ML performance. For a medical device like a PTA catheter, the "acceptance criteria" primarily relate to engineering and biocompatibility performance data, ensuring it functions safely and effectively as intended, similar to existing devices.
1. A table of acceptance criteria and the reported device performance
Based on the provided 510(k) Summary, the acceptance criteria and reported device performance are related to in-vitro testing and biocompatibility, demonstrating the device's functional integrity and safety. Specific numerical acceptance criteria are not explicitly stated in this summary, but the general performance categories are listed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance (In-vitro) | |
| Balloon Compliance | Testing was conducted to demonstrate safety and effectiveness. (Details on specific compliance values or thresholds are not provided in this summary.) |
| Balloon Burst Pressure | Testing was conducted to demonstrate safety and effectiveness. (Details on specific burst pressure values or thresholds are not provided in this summary.) |
| Balloon Fatigue | Testing was conducted to demonstrate safety and effectiveness. (Details on specific fatigue cycles or thresholds are not provided in this summary.) |
| Shaft Burst Pressure | Testing was conducted to demonstrate safety and effectiveness. (Details on specific burst pressure values or thresholds are not provided in this summary.) |
| Bond Strength | Testing was conducted to demonstrate safety and effectiveness. (Details on specific bond strength values or thresholds are not provided in this summary.) |
| Catheter Dimensions | Testing was conducted to demonstrate safety and effectiveness, including comparisons to predicate device characteristics. (No specific numerical dimensions are provided as "acceptance criteria" in this summary, but the device description outlines dimensions like balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm, and catheter lengths of 130, 80 and 40cm.) |
| Guidewire & Introducer Compatibility | Testing was conducted to demonstrate safety and effectiveness. (The maximum recommended guidewire diameter is 0.035" as per device description.) |
| Biocompatibility | All materials used in SAILOR PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter are biocompatible based on the biocompatibility testing. (No specific tests or thresholds are detailed in this summary.) |
It is important to note: This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device. For such devices, the "acceptance criteria" are generally met by showing that the new device performs similarly and safely in the specified in-vitro tests and materials are biocompatible, aligning with the predicate device and established standards. Specific numerical acceptance criteria would typically be found in detailed test reports, not usually in a high-level 510(k) summary.
Here's the additional information requested, based on the provided text, recognizing that this is for a physical medical device (a catheter), not an AI/ML algorithm. Therefore, many questions related to AI/ML studies (like test sets, ground truth experts, MRMC studies) are not applicable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device and submission. The "test set" for this device refers to physical prototypes undergoing in-vitro testing, not a dataset for an AI/ML algorithm. The summary does not specify the number of devices tested in vitro, nor does it provide details on the provenance of test data beyond stating it was "in vitro testing."
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 applicable. This device is a physical catheter, not an AI/ML diagnostic or predictive tool. "Ground truth" in the context of AI/ML algorithms, established by expert consensus or pathology, is not relevant for the in-vitro performance testing of a PTA catheter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This question relates to the adjudication of expert labels for AI/ML ground truth, which is not relevant for the in-vitro performance testing of a physical medical device.
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
- Not applicable. An MRMC study is designed for evaluating diagnostic accuracy, particularly with AI assistance, which is outside the scope of this device (a physical interventional catheter).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For this physical device, "ground truth" concerning in-vitro performance would be defined by engineering specifications, material properties, and physical measurements/observations during testing, not clinical expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML diagnostics.
8. The sample size for the training set
- Not applicable. There is no "training set" for this physical device as it does not involve AI/ML.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this physical device as it does not involve AI/ML.
§ 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).