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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.

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 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 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.

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:

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The Crosperio OTW PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infrapoplited and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Crosperio OTW PTA Balloon Dilatation Catheter (Crosperio OTW) is an over-the-wire type of balloon dilatation catheter, which consists of an outer tube, inner tube, balloon, radiopaque markers, manifold, outer reinforcement tube and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Crosperio OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the inner tube to the guidewire port of the manifold for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Crosperio OTW in a PTA procedure is 0.014 inches. Additionally, the compatible size of a sheath introducer is 4 Fr. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1500 mm.

The provided text is a 510(k) summary for the Crosperio OTW PTA Balloon Dilatation Catheter, a medical device. It describes the device, its intended use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The Crosperio OTW met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not explicitly list the quantitative acceptance criteria for each test or the specific reported device performance values in a table format. It lists the types of tests performed.

Types of In Vitro Tests Performed:

• Dimensional Verification
• Balloon Preparation, Deployment and Retraction
• Balloon Rated Burst Pressure
• Balloon Fatigue (Repeat Balloon Inflations)
• Balloon Compliance
• Balloon Inflation and Deflation Time
• Catheter Bond Strength
• Flexibility and Kink Test
• Torque Strength
• Radiopacity
• Coating Integrity
• Particulate Evaluation
• Balloon Rated Burst Pressure (in Stent)
• Balloon Fatigue (Repeat Balloon Inflations; in Stent)
• Shelf Life Testing

Types of Biocompatibility Tests Performed:

• Cytotoxicity
• Sensitization
• Intracutaneous reactivity (irritation)
• Systemic toxicity (acute)
• Pyrogenicity
• Hemocompatibility (thrombogenicity, hemolysis, and immunology)
• Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay)

Reported Device Performance (General Statement):

"The results from these tests demonstrate that the technological characteristics and performance criteria of the Crosperio OTW are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the test sets used in the in vitro or biocompatibility tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as these were bench and lab tests on the device itself, not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not applicable and therefore not provided in the document. The tests performed are engineering and biological evaluations of the device's physical properties and material safety, not diagnostic imaging or clinical performance requiring expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert assessment of data, not for bench testing of medical devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and therefore not provided. The Crosperio OTW PTA Balloon Dilatation Catheter is a physical medical device, not an AI software/algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable and therefore not provided. As stated above, this is a physical medical device, not an algorithm, so standalone AI performance is not relevant.

7. The type of ground truth used:

The "ground truth" for the performance and biocompatibility tests was established by engineering specifications, recognized standards, guidance documents (like the FDA's "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and established biological safety testing protocols (like ISO 10993). It is based on objective, measurable criteria inherent to the device's design and manufacturing, rather than expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set:

This information is not applicable and therefore not provided. Training sets are relevant for machine learning algorithms, not for physical medical devices being evaluated through bench testing.

9. How the ground truth for the training set was established:

This information is not applicable and therefore not provided. As there is no training set for a machine learning algorithm, there is no ground truth establishment method for it.

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