Search Results

The EndoClamp Aortic Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The EndoClamp Aortic Catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

The EndoClamp aortic catheter is a 10.5 Fr, wire-reinforced, three-lumen catheter with an elastomeric balloon near its tip for occluding the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes. The large central lumen of the catheter serves two functions: delivery of cardioplegic solution to the aortic root and venting of fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation and aortic root pressure monitoring. The shaft is marked to indicate the insertion depth. A Clamp-Lock™ device, provided on the shaft, allows the catheter to be locked in position. A colorcoded 3-way stopcock is attached to each lumen for fluid injection, balloon inflation and aortic root pressure monitoring. A rotating hemostasis valve (RHV) is attached to the large central lumen for guidewire insertion on the 100 cm catheter. The Y-connector with three tubing clamps, which enables alternation between cardioplegic solution delivery and aortic root venting, is attached to the central lumen. A vacuum relief valve is included for aortic root venting. Pressure monitoring lines are attached to the balloon inflation lumen and to the aortic root pressure monitoring lumen. Two colorcoded 35 mL syringes are included for contrast injection and balloon inflation. A guidewire is provided with the 100 cm EndoClamp catheter. The devices are provided sterile and non-pyrogenic, and intended for single use only.

This FDA 510(k) summary describes a medical device, not an AI/ML powered device, so many of the requested categories are not applicable. I will extract the information that is available in the provided text.

The Edwards Lifesciences EndoClamp Aortic Catheter is a medical device intended for use in patients undergoing cardiopulmonary bypass. The summary details the device's functional and safety testing to demonstrate its substantial equivalence to a predicate device, K974175, the HeartPort Endoaortic Clamp Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify the sample sizes used for the biocompatibility, pull, or burst/leak tests.
• Data Provenance: The tests were conducted internally by Edwards Lifesciences LLC, as part of their "Risk Management and Design Controls systems" for a "material formulation change" to the Y-connector. The testing is described as functional/safety testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is a medical device approval based on functional and safety testing against engineering specifications, not a diagnostic or prognostic device requiring expert-established ground truth from clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is a medical device approval based on functional and safety testing against engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a medical device, not an AI/ML powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device, not an AI/ML powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the functional/safety tests, the "ground truth" was established by pre-determined engineering and regulatory acceptance criteria (e.g., ISO 10993-1 for biocompatibility, and unspecified criteria for bond strength and leakage during pull and burst/leak tests). This is based on objective, measurable performance standards for the device components.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this device's approval, as it is not an AI/ML powered device.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set" or corresponding ground truth for this device approval.

Ask a specific question about this device