(191 days)
The SABER™ PTA Dilatation catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.
The SABER™ PTA Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub and distal dilatation balloon, connected by a . coaxial, concentric dual lumen shaft. Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. A hydrophilic coating covers the distal tip, balloon, and sections of the shaft, to facilitate balloon placement. The SABER® PTA Catheter is compatible with 4F, 5F, and 6F catheter introducer sheaths, and with guidewires having a maximum diameter of 0.018 inches. The SABER" PTA Catheter is available in a variety of sizes, ranging from 2 to 10 mm in diameter and 20 to 300 mm in length, and useable length of either 90 or 150 cm. It is packaged as a single use, sterile device.
Here's a breakdown of the acceptance criteria and the study information for the SABER™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not describe a clinical trial with human subjects for the device's efficacy or safety. Therefore, many of the typical questions related to human-AI interaction or clinical outcomes are not applicable here. The "device performance" in this context refers to its physical and functional characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The Saber PTA Catheter met all predetermined acceptance criteria of design verification and validation." However, it does not explicitly list the specific quantitative acceptance criteria for each test and then provide the measured performance values. Instead, it lists the types of tests performed.
Therefore, the table below will list the categories of tests as "Acceptance Criteria" that were met, and generally describe the "Reported Device Performance" as successful conformance to requirements.
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Performance Tests | |
| Dimensional Verification (Usable length, Marker band spacing/placement, Balloon working length) | Conformed to specified requirements. |
| Visual inspection | Conformed to specified requirements. |
| Catheter sheath introducer withdrawal | Conformed to specified requirements. |
| Guidewire compatibility | Conformed to specified requirements. |
| Preparation verification | Conformed to specified requirements. |
| Kink diameter | Conformed to specified requirements. |
| Balloon deflation time | Conformed to specified requirements. |
| Balloon inflation time | Conformed to specified requirements. |
| Proximal seal tensile test | Conformed to specified requirements. |
| Hub to shaft tensile test | Conformed to specified requirements. |
| Tip to balloon tensile test | Conformed to specified requirements. |
| Minimum burst strength, shaft | Conformed to specified requirements. |
| Balloon Burst | Conformed to specified requirements. |
| Balloon diameter compliance at nominal inflation | Conformed to specified requirements. |
| Balloon diameter compliance at rated burst pressure inflation | Conformed to specified requirements. |
| Particulate test | Conformed to specified requirements. |
| Outer Surface Friction test | Conformed to specified requirements. |
| System fatigue without stent | Conformed to specified requirements. |
| System fatigue with stent | Conformed to specified requirements. |
| Balloon burst in stent | Conformed to specified requirements. |
| Torque | Conformed to specified requirements. |
| Packaging (Dye leak and Seal strength) | Conformed to specified requirements. |
| Biocompatibility Tests | |
| Cytotoxicity | Device demonstrated appropriate biocompatibility. |
| Sensitization | Device demonstrated appropriate biocompatibility. |
| Irritation | Device demonstrated appropriate biocompatibility. |
| Acute systemic toxicity | Device demonstrated appropriate biocompatibility. |
| Pyrogenicity | Device demonstrated appropriate biocompatibility. |
| Hemocompatibility (hemolysis, partial thromboplastin, platelet/leukocyte counts, complement activation, in vivo thrombogenicity) | Device demonstrated appropriate hemocompatibility. |
| Genotoxicity | Device demonstrated appropriate biocompatibility. |
| Physicochemical tests | Device demonstrated appropriate biocompatibility. |
| Animal Study | |
| User needs (insertion, withdrawal, trackability, crossability, visibility, marker band visibility, placement, inflation/deflation time) | The Saber PTA Catheter met all predetermined acceptance criteria, demonstrating conformance to user needs in a swine model. (Results identified no new questions of safety or effectiveness). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Bench Testing: The document does not specify the exact number of units or iterations per test for the extensive list of performance and biocompatibility tests. It broadly states "tests were performed."
- Animal Study: The device was validated in one animal study using a swine model. The number of animals or specific procedures within that study is not detailed.
- Data Provenance: The data is prospective as it was generated specifically for the device's verification and validation. The studies were conducted by Cordis Corporation, the manufacturer, or their contracted labs. The country of origin for the bench tests is not specified but would typically be the manufacturing or testing facilities of the company or its contractors. The animal study was also performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Three physicians were involved in the animal study.
- Qualifications of Experts: The document only states "three physicians." It does not specify their specialties (e.g., interventional cardiologists, radiologists) or their years of experience.
4. Adjudication method for the test set
- Adjudication Method: The document does not describe an explicit "adjudication method" in the sense of reconciling differing expert opinions. For the animal study, it simply states that the "Saber PTA Catheter met all predetermined acceptance criteria of design verification and validation," implying a consensus or individual assessment by the physicians that the criteria were fulfilled. There is no mention of a formal 2+1 or 3+1 system.
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: This device is a physical medical device (a balloon catheter) and not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess human reader improvement with or without AI assistance was not performed and is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: As mentioned, this is a physical medical device, not an algorithm or AI. Standalone algorithm performance is not applicable.
7. The type of ground truth used
- For Performance Bench Tests: The "ground truth" was established by engineering specifications and international standards (ISO 10555-1 and 10555-4). The device's physical and functional properties were measured against these predefined, objective criteria.
- For Biocompatibility Tests: The "ground truth" was established based on biological evaluation standards (ISO 10993-1). The biological responses to the device materials were evaluated against established safety thresholds.
- For Animal Study (User Needs): The "ground truth" was based on physician consensus/assessment of the device's performance characteristics (insertion, withdrawal, trackability, etc.) in a live biological model, comparing them against the "user needs" defined during the design phase.
8. The sample size for the training set
- Not Applicable: This device does not involve a "training set" in the context of machine learning or AI. The design verification and validation were based on testing physical prototypes and samples, not on training a model with data.
9. How the ground truth for the training set was established
- Not Applicable: There is no training set for this type of device.
§ 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).