Search Results

The Argyle™ Polyurethane Umbilical Vessel Catheter is intended for short-term vascular access via umbilical vessels in neonatal patients.

The Argyle™ Polyurethane Umbilical Vessel Catheter is a single-lumen catheter made of a polyurethane catheter tube which is insert molded to a polypropylene hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion. Encapsulated within the catheter walls are three barium sulfate strips spaced 120° apart, which run the length of the catheter. Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 25 cm from the tip. Catheter placement must be confirmed by x-ray. The Argyle Polyurethane Umbilical Vessel Catheter will continue to be available in three sizes: 2.5 Fr.; 3.5 Fr.; and 5 Fr. Each device will continue to be packaged in a Tyvek pouch; 10 pouches are packaged in a carton. The Argyle Polyurethane Umbilical Vessel Catheter does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging is not made of natural rubber latex.

The provided document is a 510(k) summary for a medical device called the Argyle™ Polyurethane Umbilical Vessel Catheter. It describes the device, its intended use, and states that it has undergone non-clinical performance testing to demonstrate substantial equivalence to a predicate device.

Crucially, this document notes that no clinical testing was performed for the determination of substantial equivalence (Section 8. Clinical Data).

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets those criteria from this document. The device's approval was based on non-clinical performance data (laboratory testing) demonstrating that the modified device continues to meet product specifications and is substantially equivalent to an existing device.

The document states:

• "Laboratory testing was completed to support substantial equivalence between the modified device and the current device. The modified device was evaluated to show compliance to the standards requirements as well as performance characteristics related to the modification of the device. The results of the testing show that the modified device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence." (Section 7. Non-Clinical Performance Data)
• "No clinical testing was performed for the determination of substantial equivalence." (Section 8. Clinical Data)

Without clinical data, the concept of "acceptance criteria" and "device performance" in the context of clinical studies, human readers, ground truth established by experts, etc., as requested in your prompt, does not apply to this specific submission. The non-clinical performance data would involve engineering tests (e.g., material strength, fluid flow, biocompatibility) against predetermined specifications, but these are not equivalent to the clinical study parameters you've asked for.

Ask a specific question about this device

DOBBHOFF™ Dual Port Feeding Tubes, with and without Flow-Through Stylet, are for the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

The DOBBHOFF nasogastric enteral feeding tubes are small bore enteral access catheters. These feeding tubes include an external proximal access port for connection to enteral feeding sets and to oral tip, enteral syringes. The tubing is constructed with a radiopaque material and with a hydrophilic coating to assist with insertion of the tube and, if a stylet was in place during tube insertion, to assist with removal of the stylet. The stylet is made of specially designed metal wire which may be optionally utilized to assist with tube placement. The tubes are each equipped with external markings in units of centimeters to assist in measuring the amount of tube inserted into the alimentary tract.

The provided text is a 510(k) summary for the DOBBHOFF™ Dual Port Feeding Tubes. It describes the device, its intended use, and its comparison to legally marketed predicate devices. Critically, it states:

"No clinical evaluations were performed or relied upon for a determination of substantial equivalence."

This means that the information needed to answer the user's request, which focuses on acceptance criteria and a study proving the device meets those criteria, is not present in the provided text. The device's clearance was based on nonclinical testing (EN1615:2000 for performance and ISO 10993-1:2009 for biocompatibility) and a demonstration of substantial equivalence to predicate devices, not on a clinical study with acceptance criteria for device performance.

Ask a specific question about this device

The Palindrome P Hemodialysis Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion.

The Palindrome P Catheter Repair Kit is indicated to repair the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s) of the Palindrome P Hemodialysis Catheter

The Palindrome Reverse Tunneled Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion.

The Palindrome reverse-tunneled catheter repair kit is intended for the repair of the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s). A repair can only be made if the tubing length between the hub snap connector and the exit sit is a minimum of 5.5 cm

The Palindrome P Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The Catheter will be supplied with a detached connector assembly allowing for the catheter tip to be positioned in the vein and tunneled retrograde to the exit site. The hub and back end of the catheter is then assembled with a snap lock connector with compression ring.

A Palindrome™ Reverse Tunneled catheter repair kit will be offered to replace damaged extensions and / or extension adaptors.

The provided text describes the 510(k) Premarket Notification for the PalindromeTM P Hemodialysis Catheter. It outlines the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does NOT contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's a breakdown of why and what information is missing:

• Acceptance Criteria and Reported Device Performance: While the document states "Testing was performed to compare the proposed Palindrome™ P Reverse Tunneled Catheter to predicate device. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed predicate devices," it does not provide a table of specific acceptance criteria (e.g., flow rates, material biocompatibility thresholds, tensile strength limits) or the quantitative results from these tests. It only makes a general claim of substantial equivalence.

• Sample Size and Data Provenance for Test Set: This information is completely absent. The document mentions "testing was performed" but provides no details on the number of catheters tested, the source of any data (e.g., in-vitro, in-vivo, animal studies, human clinical data), or whether this data was retrospective or prospective.

• Number and Qualifications of Experts for Ground Truth: Since no specific clinical or image-based studies are detailed, there is no mention of experts, their qualifications, or their role in establishing ground truth. This type of information would typically be relevant for diagnostic devices that rely on expert interpretation.

• Adjudication Method: Similar to the above, without specific clinical or diagnostic study details, an adjudication method is not mentioned.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This document pertains to a medical device (hemodialysis catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not applicable or mentioned. There's no AI component in this device.

• Standalone (Algorithm Only) Performance: As this is a physical medical device and not an algorithm, the concept of "standalone performance" for an algorithm is not applicable.

• Type of Ground Truth Used: The document implies that the "ground truth" for substantial equivalence would be the performance characteristics of the predicate devices. However, the specific metrics and how they were established for either the predicate or the new device are not detailed.

• Sample Size for Training Set: Since this is a physical device and not an AI model, there is no concept of a "training set" in the machine learning sense.

• How Ground Truth for Training Set was Established: Not applicable for the same reason as above.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence through a general statement of "verification/validation" against predicate devices. It does not offer the granular detail concerning acceptance criteria, study methodologies, expert involvement, or data characteristics that your questions are looking for, particularly those questions relevant to AI/ML or diagnostic devices.

To answer your questions accurately, a much more detailed technical report or study protocol usually submitted to the FDA (beyond the public 510(k) summary) would be required. This summary is intended to provide an overview to justify commercialization based on equivalence, not to fully detail all underlying testing.

Ask a specific question about this device