(30 days)
The CAPIOX® SP Pump with X-Coating is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours. The pump is a non-roller type pump and is a sterile device for single use only. The pump will be used with, and is electrically driven by BioMedicus BioConsole Models 540 and 550 via the SP Pump Head adaptor. A biocompatible coating, polymethoxyethylacrylate (PMEA), is intended to reduce the adhesion of platelets to the blood-contacting surfaces of the device.
The device is a hardshell housing that contains a blood compartment and a non-blood compartment. Within the blood compartment is a rotating mechanism that imparts centrifugal force upon blood as it enters the device. The centrifugal force moves the blood out of the device via the outlet port. The non-blood compartment is designed to magnetically couple with a pump console so that it can be electrically driven by the console. The materials of construction for the CAPIOX® SP Pump with X-Coating are the exact same materials that are used in the predicate uncoated CAPIOX® SP Pump – except for the addition of X-coating to the subject device.
Here's an analysis of the provided text regarding the CAPIOX® SP Pump with X-Coating, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating equivalence to a predicate device rather than setting specific, quantifiable acceptance criteria. The "performance evaluations" are comparative, aiming to show "no clinically significant performance differences." Therefore, the "acceptance criteria" are implicitly that the X-Coated pump performs no worse than the uncoated predicate device.
| Performance Test / Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Long Duration (9-hour) Circulation Evaluation | No clinically significant performance differences compared to predicate device. |
| Priming Volume | No clinically significant performance differences compared to predicate device. |
| Air Handling Efficiency | No clinically significant performance differences compared to predicate device. |
| Hemolytic Effects on Cellular Blood Components | No clinically significant performance differences compared to predicate device. |
| Evaluation for Heat Generation | No clinically significant performance differences compared to predicate device. |
| Mechanical Integrity | No clinically significant performance differences compared to predicate device. |
| Strength of Tubing Connection | No clinically significant performance differences compared to predicate device. |
| Sterility Assurance Level (SAL) | Validated in accordance with AAMI guidelines to provide an SAL of 10-6. |
| Ethylene Oxide Residues | Will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978. |
| Biocompatibility | Blood contacting materials found to be biocompatible (per ISO 10993). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the performance tests. It only mentions that Terumo Cardiovascular Systems Corporation "conducted performance evaluations." This is a premarket notification (510(k)) seeking substantial equivalence, and often such submissions rely on internal testing results without publishing detailed sample sizes in the public summary.
The data provenance is internal testing performed by Terumo Cardiovascular Systems Corporation. The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, but given it's a new device being compared to a predicate, the performance tests would typically be prospective laboratory or bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies described are primarily technical and engineering performance tests on the device itself (e.g., hemolytic effects, mechanical integrity), which would likely be evaluated by engineers, biologists, or lab technicians rather than clinical experts like radiologists. There is no mention of "ground truth" in the diagnostic sense, as this is a blood pump, not an imaging or diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving expert review of diagnostic cases (e.g., in radiology studies) to resolve disagreements among reviewers. The performance tests described here are technical measurements, not subjective expert interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and therefore not provided. The device is a cardiopulmonary bypass pump, not an AI-powered diagnostic or assistive tool for human readers. Thus, no MRMC study, human reader improvement, or AI assistance is relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore not provided. The device is a mechanical blood pump, not an algorithm.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" would be the established scientific and engineering measurement standards and methodologies for evaluating device performance parameters like priming volume, air handling, hemolysis, heat generation, mechanical integrity, and tubing connection strength. For sterility and biocompatibility, the ground truth refers to validated methods and adherence to international standards (AAMI guidelines for SAL, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of these specific performance evaluations as described.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The device is a mechanical pump, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no training set for this device.
§ 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.