The FoamSeal Retrograde Cardioplegia Catheter is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

Device Description

AI/ML Overview

The provided text is a 510(k) summary for the FoamSeal Retrograde Cardioplegia Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria in the context of a machine learning or AI-powered medical device.

The document describes a physical device, a catheter, and the "study" mentioned is a mechanical engineering test to compare the rigidity of a stylet. It's a non-clinical, bench-top test of a physical characteristic, not a clinical study or a performance evaluation of a device with "acceptance criteria" in the way that would apply to an AI system.

Therefore, I cannot fulfill your request for the specific information points as they relate to AI/ML device performance. The information you're asking for (sample size, data provenance, experts, adjudication, MRMC, standalone performance, ground truth, training set size) is relevant to AI/ML device validation, which is not what this 510(k) describes.

The document states:

Study: "Stylet guide collapse testing was performed on the stylet guide from the proposed modified FoamSeal Retrograde Cardioplegia Catheter, and was compared to collapse values from the stylet guide used in the Research Medical retrograde cardioplegia catheter..."
Purpose of Study: "The purpose of this test was to evaluate the force that can be generated by the stylet before buckling occurs, thereby providing a means for comparing stylet rigidity."
Outcome/Finding: "Test results demonstrate that the modified FoamSeal Retrograde Cardioplegia Catheter stylet is less rigid than the Research Medical stylet, thereby presenting less of a potential for damage to the coronary sinus."

This is a physical test result, not an AI/ML performance metric.

Summary

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K955818

FoamSeal Retrograde Cardioplegia Catheter 510(k) Summary of Safety and Effectiveness

I. Device Name:

Cardiopulmonary Bypass Vascular Catheter, Cannula, or Classification Name: Tubing Retrograde Cardioplegia Catheter Common/Usual Name: FoamSeal Retrograde Cardioplegia Catheter Proprietary Name:

II. Predicate Devices:

FoamSeal Retrograde Cardioplegia Catheter - # K941916 Research Medical Retrograde Cardioplegia Catheter - K880103

III. Intended Use:

The FoamSeal Retrograde Cardioplegia Catheter is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

IV. Summary of Substantial Equivalence:

The proposed modified FoamSeal Retrograde Cardioplegia Catheter is identical to the original FoamSeal Retrograde Cardioplegia Catheter (marketed under 510(k) # K941916), with the exception of a more rigid guide stylet. Research Medical, Inc., markets a retrograde cardioplegia catheter (model # RC-014) under 510(k) # K880103. A comparison of the devices is shown in figure 1 below.

Stylet guide collapse testing was performed on the stylet guide from the proposed modified FoamSeal Retrograde Cardioplegia Catheter, and was compared to collapse values from the stylet guide used in the Research Medical retrograde cardioplegia catheter (Retroplegia® Cannula Model # RC-014, marketed under 510(k) # K880103). The purpose of this test was to evaluate the force that can be generated by the stylet before buckling occurs, thereby providing a means for comparing stylet rigidity.

Test results demonstrate that the modified FoamSeal Retrograde Cardioplegia Catheter stylet is less rigid than the Research Medical stylet, thereby presenting less of a potential for damage to the coronary sinus. We believe, that the modified device does not raise new questions of safety or effectiveness, and is substantially equivalent to legally marketed devices.

રેર

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	Proposed ModifiedFRCC	Original FRCC# K941916	Research MedicalRC-014# K880103
Intended Use	Intra-operativedelivery ofcardioplegia solution	Intra-operativedelivery ofcardioplegia solution	Intra-operativedelivery ofcardioplegia solution
Material	Silicone catheterbody & extensiontube	Silicone catheterbody & extensiontube	PVC catheter body &extension tube
	Stainless steel stylet	Stainless steel stylet	Stainless steel stylet
	Polycarbonatestopcock	Polycarbonatestopcock	Polycarbonate/polyethylenestopcock
	Polypropylene clamp	Polypropylene clamp	Polypropylene clamp
	Polycarbonate femaleluer connector	Polycarbonate femaleluer connector	PVC female luerconnector
	Silicone balloon	Silicone balloon	Polyurethane balloon
	Polyurethane foam	Polyurethane foam	No foam
Packaging	Tyvek/polymylar	Tyvek/polymylar	Tyvek/paper
Sterilization	100% EtO	100% EtO	EtO
Biocompatibility	Tripartite	Tripartite	Unknown
Features	Foam-filled cuff/auto inflating	Foam-filled cuff/auto inflating	Self-inflating cuff
	15 fr.size	15 fr. size	14 fr. size
	Pressure monitoringport	Pressure monitoringport	Pressure monitoringport
	Pinch clamp ondelivery lumen	Pinch clamp ondelivery lumen	Pinch clamp ondelivery lumen
	Suture ring	Suture ring	Suture ring
	Malleable stylet	Flexible guidewirestylet	Malleable stylet

figure 1 - Comparison Table

Krista Oakes
Regulatory Affairs Specialist

12/22/95
Date

Date

32 26

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).