FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER

K955818 · Quest Medical, Inc. · DWF · Mar 26, 1996 · Cardiovascular

Device Facts

• Record ID: K955818
• Device Name: FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER
• Applicant: Quest Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Mar 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Catheter used during cardiac surgery for retrograde delivery of cardioplegia solutions into coronary sinus; transatrial introduction. Device features silicone catheter body, polyurethane foam-filled cuff for auto-inflation, and pressure monitoring port. Modified version incorporates more rigid guide stylet compared to original predicate. Operated by cardiac surgeons in OR. Output is delivery of cardioplegic solution to heart tissue; pressure monitoring allows clinician to verify placement and perfusion status. Benefits include myocardial protection during bypass. Stylet rigidity tested to ensure safety against coronary sinus damage.

Clinical Evidence

Bench testing only. Stylet guide collapse testing performed to evaluate buckling force and compare rigidity against predicate device (K880103).

Technological Characteristics

Silicone catheter body/extension tube, stainless steel stylet, polycarbonate stopcock, polypropylene clamp, polycarbonate female luer, silicone balloon, polyurethane foam. 15 Fr size. Features foam-filled auto-inflating cuff, pressure monitoring port, suture ring, malleable stylet. Sterilization: 100% EtO.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring retrograde perfusion of cardioplegia solutions via the coronary sinus.

Regulatory Classification

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.

Predicate Devices

• FoamSeal Retrograde Cardioplegia Catheter (K941916)
• Research Medical Retrograde Cardioplegia Catheter (K880103)

Submission Summary (Full Text)

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K955818

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

### I. Device Name:

Classification Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing

Common/Usual Name: Retrograde Cardioplegia Catheter

Proprietary Name: FoamSeal Retrograde Cardioplegia Catheter

### 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, therefore, that the modified device does not raise new questions of safety or effectiveness, and is substantially equivalent to legally marketed devices.

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| | 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



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