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The SABER™ .014 and SABERX™ .014 PTA Dilatation Catheters are intended to dilate stenoses in the peripheral vasculature, including femoral, popliteal and infra popliteal arteries. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Device Description

The SABER™ .014 and SABERX™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are single-use sterile devices, sterilized by ethylene oxide.

The SABER™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is an over-the-wire (OTW) coaxial lumen catheter with a semi-compliant balloon mounted on its distal end. It is compatible with 0.014" (0.3556 mm) guidewire. The catheter is available in working lengths of 90 cm and 150 cm with balloon diameters ranging from 1.25 mm to 5.0 mm, and balloon lengths ranging from 15 mm to 300 mm.

Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100 mm, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100 mm, the distal and proximal section will each have one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABER™ .014 balloons are coated with a dual-layer hydrophilic material designed to increase lubricity throughout the lifetime of the device.

The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance chart on the tray label for typical diameters of the balloons at given pressures.

The balloon lumen is used to inflate and deflate the balloon. The nominal balloon size in printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire.

The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.

The SABERX™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon. The catheter is available in working lengths of 90 cm, 150 cm and 200 cm with balloon diameters ranging from 1.25 mm to 6.0 mm, and balloon lengths ranging from 15 mm to 300 mm. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guidewire lumen. The guidewire lumen begins at the distal tip and terminates at the guidewire exit port. The proximal hub is used as a balloon inflation port.

Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100 mm, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100 mm, the distal and proximal section will each have one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABERX™ .014 balloons are coated with a dual-layer hydrophilic material designed to increase lubricity throughout the lifetime of the device.

The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.

The associated accessories for SABERX™ .014 PTA Dilatation Catheter include:

Flushing Needle

The SABER™ .014 and SABERX™ .014 PTA Dilatation Catheter are for use in a catherization lab, hospital or other suitable healthcare facility by appropriately trained medical professionals only.

AI/ML Overview

The Cordis US Corp's SABER™ .014 and SABERX™ .014 PTA Dilatation Catheters, intended to dilate stenoses in peripheral vasculature and for post-dilation of stents, demonstrated substantial equivalence to predicate devices through various performance tests.

Here's an overview of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Biocompatibility	MEM Elution, Hemolysis Assay, Complement Activation, In Vitro Mouse Lymphoma, Bacterial Mutagenicity, Guinea Pig Maximization Sensitization, Acute Systemic Injection, Intracutaneous Irritation, Materials Mediated Rabbit Pyrogen, Thromboresistance Evaluation	All tests successfully completed, indicating the devices are biocompatible for their intended use (limited contact duration ≤ 24 hours with circulating blood), in accordance with ISO 10993-1 and ISO 10993-1:2009/Cor 1:2010.
Sterilization	Ethylene Oxide Sterilization Cycle Validation	Sterilization cycle validated per ISO 11135:2014 to provide a Sterility Assurance Level (SAL) of 10^-6. Ethylene oxide and ethylene chlorohydrin residuals meet requirements for limited exposure devices (< 24 hours) per ISO 10993-7:2018.
Bench Testing - Catheter	Dimensional verification, Balloon Preparation, Balloon Rated Burst Pressure (with/without stent), Balloon Fatigue (with/without stent), Balloon Compliance, Balloon Deflation Time, Catheter Bond Strength, Flexibility and Kink Test, Torque Strength, Particulate Evaluation/Coating Uniformity-Integrity, Radiopacity	All tests successfully completed per FDA PTCA Guidance, USP-788, and internal test methods. Passing results provide reasonable assurance of meeting intended use and raised no new safety/effectiveness issues compared to predicate.
Bench Testing - Packaging	Visual inspection, Component position, Peel strength, Bubble test, Particulate	All tests successfully completed per ISO 11607-1:2019 and ISO 11607-2:2019.
Animal Study	Insertion and withdrawal force, Kinking, Pushability, Crossability, Atraumatic Tip, Guidewire compatibility, Fluoroscopy, Balloon visibility, Radiopacity, Balloon inflation and deflation, Luer lock compatibility, Aseptic presentation and product removal, Torque and kink resistance	All tests successfully completed, demonstrating safety and effectiveness through design validation.

2. Sample Size and Data Provenance for Test Set:

The provided document does not specify explicit sample sizes for individual tests within the biocompatibility, sterilization, bench, or animal studies. It states that tests were conducted "per applicable sections of the indicated standards and/or validated internal test methods."

Biocompatibility: Testing was performed generally to ISO 10993 standards.
Sterilization: Validation per ISO 11135:2014.
Bench Testing: Performed per "FDA PTCA Guidance, USP-788 and internal test methods."
Animal Study: Data collected during "Design Validation (Animal Study) tests and analyses." The species of animal used is not specified.

The provenance of this data is from the manufacturer's internal testing and analysis in support of their 510(k) submission. It is retrospective in the sense that the data was generated to support the already designed device. There is no mention of specific country of origin for the data collection other than that it supports a US FDA submission.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

This information is not provided in the document. For device validation, ground truth is typically established by the results of the standardized tests themselves, rather than human expert consensus on interpretations of raw data, especially in the context of physical and material properties. For example, a "rated burst pressure" test has an objective outcome, not one requiring expert interpretation of an image.

4. Adjudication Method for Test Set:

Not applicable for the types of tests described. The tests are objective measurements (e.g., burst pressure) or standardized biological/chemical assays with clear pass/fail criteria from established guidelines. There is no indication of a need for adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states: "No clinical studies were deemed necessary to support substantial equivalence." This implies that no human reader studies (MRMC or otherwise) were conducted or presented for this device. The device is a physical medical instrument (catheter), not a diagnostic imaging AI algorithm that would typically involve MRMC studies.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical medical catheter, not a software algorithm. Therefore, there is no "standalone performance" of an algorithm.

7. Type of Ground Truth Used:

The ground truth for proving the device meets acceptance criteria is based on:

International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, ISO 11607 for packaging.
National Standards/Guidance: e.g., FDA PTCA Guidance, USP-788 for catheter bench testing.
Validated Internal Test Methods: Manufacturer's own established and validated test protocols.
Objective Measurements and Observation: Physical properties (dimensions, pressures, forces, times), chemical analyses (residuals), and biological responses (cytotoxicity, irritation).

8. Sample Size for Training Set:

Not applicable. This device is a physical medical catheter and does not involve AI or machine learning algorithms that require a "training set."

9. How Ground Truth for Training Set Was Established:

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.

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