(91 days)
No
The summary describes a mechanical catheter with a modified stylet and provides performance data related to stylet rigidity. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is described as a "FoamSeal Retrograde Cardioplegia Catheter" intended for "perfusing cardioplegia solutions retrograde through the coronary sinus," which directly treats a physiological condition (cardiac arrest during surgery) by delivering therapeutic agents.
No
This device is a catheter intended for perfusing cardioplegia solutions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "Retrograde Cardioplegia Catheter," which is a physical medical device used for perfusing solutions. The modification mentioned is to a "guide stylet," also a physical component. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perfuse cardioplegia solutions retrograde through the coronary sinus. This is a direct intervention on a patient's body during surgery.
- Device Description: The device is a catheter, a physical instrument used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body for a therapeutic/procedural purpose.
N/A
Intended Use / Indications for Use
The FoamSeal Retrograde Cardioplegia Catheter is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
| | Proposed Modified
FRCC | Original FRCC
K941916 | Research Medical
RC-014
K880103 |
|------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Intended Use | Intra-operative
delivery of
cardioplegia solution | Intra-operative
delivery of
cardioplegia solution | Intra-operative
delivery of
cardioplegia solution |
| Material | Silicone catheter
body & extension
tube | Silicone catheter
body & extension
tube | PVC catheter body &
extension tube |
| | Stainless steel stylet | Stainless steel stylet | Stainless steel stylet |
| | Polycarbonate
stopcock | Polycarbonate
stopcock | Polycarbonate/
polyethylene
stopcock |
| | Polypropylene clamp | Polypropylene clamp | Polypropylene clamp |
| | Polycarbonate female
luer connector | Polycarbonate female
luer connector | PVC female luer
connector |
| | 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 monitoring
port | Pressure monitoring
port | Pressure monitoring
port |
| | Pinch clamp on
delivery lumen | Pinch clamp on
delivery lumen | Pinch clamp on
delivery lumen |
| | Suture ring | Suture ring | Suture ring |
| | Malleable stylet | Flexible guidewire
stylet | Malleable stylet |
figure 1 - Comparison Table
Krista Oakes
Regulatory Affairs Specialist
12/22/95
Date
Date
32 26