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The Cordis BRITECROSS Support Catheters are indicated to guide and support a guide wire during access to the peripheral vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The BRITECROSS Support Catheter is a flexible single lumen catheter that is intended to cross lesions to facilitate guidewire access and/or the delivery of saline/contrast during peripheral vascular interventions. The subject device is designed to allow for fluoroscopic visualization of the catheter. The radiopaque distal tip allows for accurate placement of the tip relative to the lesion. Further, there are two (2) radiopaque marker bands incorporated along the shaft to provide the clinician with a length reference facilitating approximation of the lesion length. On the proximal end, the hub has an integrated strain relief and a standard female luer to connect with a standard syringe. The BRITECROSS Catheter is available in various lengths and diameters and the size is printed on the hub for quick identification. The device is sterile and is for single use.

The provided text describes a 510(k) premarket notification for a medical device called the "Cordis BRITECROSS Support Catheter." This is a regulatory filing that aims to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate device).

Crucially, this document focuses on the substantial equivalence of a new medical device to a predicate device based on performance testing and predicate device comparison, not on the evaluation of an AI/ML algorithm. The provided text does not contain information about an AI/ML device, its acceptance criteria, or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria using the provided text. The device described, the Cordis BRITECROSS Support Catheter, is a physical medical device (a catheter) and not an AI/ML algorithm.

The "Performance Data" section lists various physical, mechanical, and biological tests conducted on the catheter (e.g., dimensional, mechanical, in-vitro testing, biocompatibility, sterilization), which are typical for physical medical devices to demonstrate their safety and efficacy. It explicitly states "No clinical data was required" and "No animal performance data was required," further indicating that this is not an AI/ML study.

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Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and peripheral vasculature.

The INFINITI Ambi Catheter is a 0.038" guidewire compatible catheter with a 3-staged braided nylon construction. The body is a braided nylon intended for torque responsiveness and stability. The proximal segment is a non-braided nylon for flexibility and shape retention. The Distal Tip is a soft, radiopaque nylon for minimal vessel cannulation. The INFINITI Ambi product line comes in 5F and 6F size and various curve style configurations. The device is a disposable intended for single use only. It is individually packaged and sterilized by ethylene oxide gas.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "INFINITI™ Ambi Angiographic Catheter." It is not a study proving the device meets acceptance criteria for an AI/ML medical device.

The document states that the device is a catheter and its purpose is for "enabling diagnosis of various pathologies by facilitating the positioning of diagnostic devices within the coronary and peripheral vasculature." It is a physical medical device, not a software device or an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable to this document. This submission is for demonstrating "substantial equivalence" of a physical medical device to a predicate device, based on bench testing and biocompatibility testing, not AI/ML performance metrics.

The document explicitly states:

• "No clinical data was required in support of the proposed change to the predicate device cleared under K970854." (Page 9, Section VII. CLINICAL PERFORMANCE)
• The performance data section details Biocompatibility Testing, Sterilization, Packaging, and Bench Testing, which are standard for physical medical devices. (Page 7-8, Section VII. PERFORMANCE DATA)

Since the prompt asks for information about AI/ML device performance and this document concerns a traditional physical medical device, I cannot extract the requested information from the provided text.

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RAIN SheathTM Tibial Pedal Introducer is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

The RAIN Sheath™ Tibial Pedal Introducer device (hereafter referred as RAIN Sheath™ Pedal) consists of a sheath introducer, a vessel dilator (0.021" guidewire compatible), a stainless-steel entry needle, and a 0.021" guidewire (either stainless steel or nitinol). The sheath introducer has a lubricious hydrophilic coating, a smooth shoulder transition to the dilator and low-profile outer diameters (OD). To provide an atraumatic transition between the dilator tip and the 0.021" mini guide wire, the RAIN Sheath™ dilator is tapered at the distal end and the inner diameter (ID) of the dilator has been optimized. The hub is overmolded to the dilator and includes a locking mechanism between the hub of the vessel dilator and the hub of the sheath cannula to facilitate insertion of the product while preventing the vessel dilator from backing out of the cannula. The RAIN Sheath™ Pedal device is available in four (4) product configurations which differ based on the French sizes (4F and 5F) and specific wire included in the system. RAIN Sheath™ Pedal is a single-use sterile device, sterilized by ethylene oxide.

The provided text is a 510(k) summary for the RAIN Sheath™ Tibial Pedal Introducer, which is a medical device. This type of document is used to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy through rigorous clinical studies. Therefore, it focuses on non-clinical tests and comparisons rather than comprehensive clinical trial data.

Based on the provided text, here's an analysis regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the RAIN Sheath™ Pedal device uses the same fundamental technology and operating principles as the predicate device. Therefore, the acceptance criteria are implicitly tied to demonstrating that the new device meets the established performance characteristics and safety profile of the predicate. The document doesn't explicitly list specific quantitative acceptance criteria in a table format, but rather discusses successful completion of various non-clinical tests.

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

• Non-Clinical Performance (Kinking Resistance): The document does not specify a numerical sample size for the "Design Validation testing" which addressed kinking. It simply states "Design Validation testing was performed."
• Usability: The document states that "devices were tested in the simulated use condition using a clinically relevant bench top model." It does not specify the number of devices or number of users (sample size).
• Biocompatibility: The biocompatibility data was leveraged from the previously cleared RAIN Sheath™ Transradial (K181592). The sample size for these original tests is not provided in this document, nor is the provenance of the biological materials/samples used within those tests.
• Sterilization: The sterilization validation was leveraged from the RAIN Sheath™ Transradial (K181592) and followed ISO 11135. The sample size for the validation and provenance is not detailed here.

Data Provenance: For the RAIN Sheath™ Pedal, the primary "data" for equivalence comes from its identical design, materials, and manufacturing process to the RAIN Sheath™ Transradial (the reference device) and from non-clinical benchtop testing. The origin of the non-clinical testing is implied to be internal (Cordis US Corp). There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical data, as no clinical data was used for this submission.

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

• Not applicable / Not explicitly stated for non-clinical tests. For device performance tests like kinking or usability, the "ground truth" is typically objective measurements or observations by test engineers and subject matter experts. The document does not specify the number or qualifications of experts involved in conducting or evaluating these non-clinical tests.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based AI studies where there are subjective interpretations that need consensus. Since the tests described are non-clinical and product-level, such adjudication methods are not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document explicitly states: "No clinical studies were deemed necessary to support substantial equivalence." Therefore, an MRMC comparative effectiveness study was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done:

• Not applicable. This device is a physical medical device (an introducer sheath), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The Type of Ground Truth Used:

• Non-clinical objective measurements and industry standards. For kinking resistance, the ground truth would be physical observation of kinking under simulated use conditions and evaluation against reasonable force. For usability, the ground truth would be successful completion of critical tasks by users on a benchtop model. For biocompatibility and sterilization, the ground truth is compliance with recognized international standards (ISO 10993-1, ISO 11135) and successful results from the leveraged tests.

8. The Sample Size for the Training Set:

• Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context. The "design validation" and "usability testing" can be considered as verification and validation activities rather than training.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As explained above, there is no training set for this type of device.

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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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