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The catheters are primarily intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

The Versa-Cath Arterial Catheter is a dual lumen nylon tube with a natural latex balloon attached to a distal end. There are two stopcocks affixed to the proximal end, one for balloon inflation and the other for fluid irrigation and/or aspiration. It will be packaged with a syringe and a stylet. The syringe is a pre-amendment device and the stylet is marketed under 510(k) K832023. The catheter will be available in 5 sizes and 3 lengths.

This document describes a medical device, the Versa-Cath Arterial Catheter, for which a 510(k) premarket notification was filed (K961883). The provided text is a summary of the device description and its substantial equivalence argument, not a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested table and study details because the input does not contain information about acceptance criteria or a study that evaluated the device's performance against specific criteria. The document focuses on describing the device, its intended use, and materials to establish substantial equivalence to predicate devices, which is a regulatory pathway, not a performance study.

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to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling.

The Ideas' Dual Port is a totally implantable system designed to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling. Port access is performed by percutaneous needle insertion using a "Huber type" non-coring needle. The system includes an injection portal with self sealing septum, compression lock and Tecoflex® catheter.

This document, a 510(k) Notification for the Ideas Dual Port, does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria in the way you've outlined.

The provided text is a summary for regulatory clearance (510(k)) and focuses on safety, effectiveness, classification, device description, and substantial equivalence to previously marketed devices. It does not include:

• Specific performance metrics: There are no reported device performance values like sensitivity, specificity, accuracy, etc.
• Acceptance criteria: No numerical or qualitative targets are defined for device performance.
• Study design details: No information about sample sizes, data provenance, expert qualifications, ground truth establishment, or specific study types (MRMC, standalone).

The document states: "It meets or surpasses the performance specifications in the guidelines on competitive ports and has superior tensile strength at the junction of the catheter and port." However, it does not specify what those performance specifications are or how "superior tensile strength" was demonstrated (e.g., through a specific test, its methodology, or results).

Therefore, I cannot populate the table and answer the questions based on the provided text.

To answer your request, I would need a detailed study report, a clinical trial summary, or a more comprehensive technical document that outlines the device's performance testing and validation against predefined criteria.

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The catheters are intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

The Vaso-Safe Arterial Embolectomy Catheter is a single lumen nylon tube with a natural latex balloon attached to a distal end and a stopcock affixed to the proximal end. It will be packaged with a syringe. The catheter will be available in 5 french sizes and 3 lengths.

This document describes a medical device, the "Vaso-Safe Arterial Embolectomy Catheter," and its classification, description, and intended use. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The provided text is a summary of the device for regulatory purposes, not a clinical study report.

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The intended use of these devices is to provide a temporary bypass during carotid endarterectomy.

The Pruitt-Inahara Carotid Shunt (Model 400-40-8F) and the Inahara-Pruitt Carotid Shunt (Model 500-50-8F) are dual lumen balloon shunts which channel and divert blood in the carotid artery during endarterectomy. The 8 French shunts are for use in arteries too small to accommodate a 9 French shunt. Both the 400-40-8F and 500-50-8F have a T Port to confirm patency and allow back-bleeding after insertion. There is an external safety balloon on the inflation port for the balloon which lies in the internal carotid artery. The safety balloon is designed to inflate when the internal carotid balloon reaches 17 psi; this reduces the possibility of balloon overinflation and resultant vessel damage. All the materials are identical to those used in other models of Ideas for Medicine's shunts. These materials have been used for years and were certified to meet the requirements of the USP Class VI testing for biocompatibiltiy. Every lot is supplied sterile and non-pvrogenic.

This document is a 510(k) summary for a medical device (Pruitt-Inahara Carotid Shunt and Inahara-Pruitt Carotid Shunt). It describes the device, its intended use, and its substantial equivalence to other devices. However, this document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement that would be relevant to evaluating AI/ML-based device performance.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a physical medical device, not for a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool.

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The intended use of this device is for occlusion of the internal carotid artery during endarterectorny.

The Pruitt Safety Occlusion Catheter is a single lumen balloon catheter. There is an external safety balloon designed to inflate when the intraluminal balloon reaches 17 psi. This reduces the possibility of balloon overinflation. All materials have been used by Ideas for Medicine, Inc. for many years to manufacture other Class II devices. All materials have been subject to Biocompatibility testing. Every lot is supplied sterile and nonpyrogenic.

I am sorry, but the provided text only contains a device description and regulatory classification information. It does not include any details about acceptance criteria, study methodologies, performance data, or ground truth establishment. Therefore, I cannot generate the requested information based on the input provided.

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The Pruitt Biliary Catheters are intended for use in the removal of stones, ductal debris and the exploration of the biliary tube.

The Pruitt biliary catheter is a radiopaque multi lumen, balloon catheter. The ancillary lumen(s) are for injection and/or irrigation: another lumen inflates the balloon. All materials have been used by Ideas for Medicine, Inc. in cardiovascular catheters and/or laparoscopic instruments with no report of adverse events. All materials have been subject to testing per the Biocompatibility testing.

This document is a 510(k) summary for a medical device (Pruitt Biliary Catheter) submitted in 1996. It describes the device, its intended use, and claims substantial equivalence to existing devices.

The information requested in your prompt (acceptance criteria, details of a study proving device performance, sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary.

510(k) summaries from this era (and most 510(k)s) primarily focus on demonstrating substantial equivalence to a predicate device, often through material comparisons, intended use comparisons, and performance data if available, but not typically a detailed clinical study demonstrating meeting specific acceptance criteria in the way envisioned by your prompt for AI/diagnostic devices.

Therefore, I cannot provide the requested information based on the provided text. The document acts as a declaration of substantial equivalence, not a detailed study report.

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