(260 days)
The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal gas exchange support. This device can be used with a legally marketed thermal requlating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting up to six hours.
The CORx System is intended for use with Medtronic's Bio-medicus Bio-Console.
The CardioVention CORx System is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The CardioVention CORx System consists of an active venous air removal device (defoamer), a centrifugal blood pump, a membrane oxygenator, an AirVac Controller and a pump adapter. The AirVac Controller powers the detection and facilitates removal of entrained air in the air handling system (defoamer) of the disposable unit. The pump adapter, which is magnetic, allows the use of the Medtronic Biomedicus Bio-Console (K941921) with the CORx System. The Medtronic's Biomedicus Bio-Console drives the CORx System's centrifugal pump.
The following components of the CORx System disposable are provided sterile, for single use only:
| Device | Description |
|---|---|
| Defoamer (Air Removal) | A device that replaces the air removal |
| function of venous reservoirs by centralizing | |
| venous line air and actively removing the air | |
| Centrifugal Blood Pump | An eight-vaned impeller (centrifugal) pump |
| Oxygenator | A hollow fiber gas transfer device utilizing |
| polypropylene, double-mat, commercially | |
| available fiber |
The provided document describes the CardioVention CORx System, an extracorporeal hemodynamic and gas exchange support system. The submission focuses on device performance compared to predicate devices rather than a study with a test set, ground truth, or expert involvement typical of AI/ML device evaluations. Therefore, many of the requested categories are not applicable.
Here's the information that could be extracted and a note for non-applicable sections:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Blood Pathway Integrity- 6 hours | No leaks under worst-case conditions (pressure ≤ 750 mmHg) for 6 hours. | No failures of integrity detected at 750 mmHg (1.5X rated maximum pressure) for 6 hours. |
| Gas Pathway Integrity- 10 minutes | No leaks under worst-case conditions (pressure ≤ 30 mmHg) for 10 minutes. | No failures of integrity detected at 30 mmHg (1.5X rated maximum pressure) for 10 minutes. |
| Blood Pathway Volume | Static priming volume similar to predicate (not explicitly stated for acceptance, but determined for characterization). | Volume of the blood pathway was determined to be 328 mls. |
| Oxygen Transfer Rate- 6 hours | Oxygen transfer and outlet saturations must be greater than or equal to the predicate device at all blood/gas flow rates over 6 hours. | Oxygen transfer was greater than or equal to the predicate device at all blood/gas flow rates over 6 hours. Arterial saturation (outlet) was 100% at all conditions and timepoints. No loss in performance occurred over the 6 hours. |
| Carbon Dioxide Transfer Rate- 6 hours | Carbon dioxide transfer must be greater than or equal to the predicate device at all blood/gas flow rates over 6 hours. | Carbon dioxide transfer was greater than or equal to the predicate device at all blood/gas flow rates over 6 hours. No loss in performance occurred over the 6 hours. |
| Transmembrane Pressure Drop- 6 hours | Transmembrane pressure drop should be comparable to or lower than the predicate device, with no clinically significant increases. | Transmembrane pressure drop was lower than the predicate device. No clinically significant pressure increases occurred over the 6 hours. |
| Blood Cell Damage | Blood cell damage (plasma free hemoglobin, index of hemolysis, modified index of hemolysis, platelet count, white blood cell count) must be equal to or less than the predicate devices. | Blood cell damage (plasma free hemoglobin, index of hemolysis, modified index of hemolysis, platelet count, white blood cell count) was equal to or less than the predicate devices. |
| Air Handling | Arterial return bubble counts must be equal to or less than the predicate devices. | Arterial return bubble counts were equal or less than the predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "the CORx System" and "the predicate devices" in a general sense for testing, implying a certain number of units were tested but not providing specific counts.
- Data Provenance: The tests appear to be laboratory-based physical characterization and performance testing of the device itself, comparing it to predicate devices. The country of origin and whether it was retrospective or prospective is not specified, but it would typically be prospective testing conducted by the manufacturer.
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 performance submission based on physical and functional testing, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth on a patient dataset.
4. Adjudication method for the test set:
- Not Applicable. As above, no expert adjudication was involved in this type of device performance testing.
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 not an AI-assisted diagnostic device, so no MRMC study involving human readers or AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device with mechanical and fluidic functions, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by the specifications and performance of the legally marketed predicate devices, against which the CORx System was compared for substantial equivalence. For instance, the "ground truth" for oxygen transfer is the performance profile of the Optimin Hollow Fiber Oxygenator.
8. The sample size for the training set:
- Not Applicable. This is a hardware medical device, not an AI/ML system that requires a traditional training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above.
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.