(7 days)
The Sarns™ Centrifugal Pump with X-Coating is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures only, and for use exclusively with Sarns centrifugal control systems. The device may be used for up to 6 hours.
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 Sarns™ Centrifugal Pump with X-Coating are the exact same materials that are used in the predicate uncoated Sarns™ Centrifugal Pump except for the addition of X-coating to the subject device.
The provided text describes the Sarns™ Centrifugal Pump with X-Coating, which is a medical device used in cardiopulmonary bypass procedures. The submission focuses on demonstrating substantial equivalence to an existing predicate device (the uncoated Sarns™ Centrifugal Pump) rather than presenting detailed performance criteria and studies for a novel device. Therefore, the response will focus on the comparison to the predicate device as described in the provided document.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For this submission, the "acceptance criteria" are essentially the performance characteristics of the predicate device, and the "reported device performance" is how the X-Coating device compared to it. The goal was to show no clinically significant performance differences.
| Performance Aspect | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Sarns™ Centrifugal Pump with X-Coating) |
|---|---|---|
| Intended Use | Extracorporeal blood pump for cardiopulmonary bypass, exclusively with Sarns centrifugal control system. Duration: up to 6 hours. | Same as predicate device. |
| Principles of Operation & Technology | Centrifugal force to propel blood. | Same as predicate device (utilizes centrifugal force). |
| Design and Materials | Hardshell housing with blood/non-blood compartments, rotating mechanism, magnetically couples to pump console. | Same as predicate device, except for the addition of X-Coating. The difference in materials did not raise new safety or effectiveness issues. |
| Long Duration Circulation Evaluation | Performance characteristics of the uncoated Sarns™ Centrifugal Pump. | Comparisons demonstrated no clinically significant performance differences between the two devices. |
| Priming Volume | Performance characteristics of the uncoated Sarns™ Centrifugal Pump. | Comparisons demonstrated no clinically significant performance differences between the two devices. |
| De-priming Volume | Performance characteristics of the uncoated Sarns™ Centrifugal Pump. | Comparisons demonstrated no clinically significant performance differences between the two devices. |
| Air Handling Efficiency | Performance characteristics of the uncoated Sarns™ Centrifugal Pump. | Comparisons demonstrated no clinically significant performance differences between the two devices. |
| Hemolytic Effects on Cellular Blood Components | Performance characteristics of the uncoated Sarns™ Centrifugal Pump. | Comparisons demonstrated no clinically significant performance differences between the two devices. |
| Mechanical Integrity | Performance characteristics of the uncoated Sarns™ Centrifugal Pump. | Comparisons demonstrated no clinically significant performance differences between the two devices. |
| Strength of Tubing Connection | Performance characteristics of the uncoated Sarns™ Centrifugal Pump. | Comparisons demonstrated no clinically significant performance differences between the two devices. |
| Sterilization Assurance Level (SAL) | 10⁻⁶ (AAMI guidelines). | Validated in accordance with AAMI guidelines to provide a SAL of 10⁻⁶. |
| Ethylene Oxide Residues | Not to exceed maximum residue limits (Federal Register of June 23, 1978). | Will not exceed proposed maximum residue limits. |
| Biocompatibility | Meets ISO 10993 standards for blood-contacting devices (Limited Exposure ≤ 24 hours). | Blood-contacting materials found to be biocompatible according to FDA General Program Memorandum #G95-1 (Use of International Standard ISO 10993). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each performance evaluation (e.g., number of pumps tested for circulation, priming volume, etc.). However, it refers to "performance evaluations" and "comparisons," implying a controlled testing environment.
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: The studies were conducted by Terumo Cardiovascular Systems Corporation. The nature of these tests (e.g., laboratory bench testing, in-vitro, ex-vivo) is implied for performance evaluations like hemolytic effects and mechanical integrity, but not explicitly stated. It is considered retrospective in the sense that the predicate device's established performance serves as the benchmark for the comparative study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on direct performance comparisons against a predicate device and established engineering/biological standards, not expert interpretation of diagnostic images or clinical outcomes that would require a ground truth panel. The "ground truth" for each performance criterion is the measured performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. There's no mention of an adjudication method as the performance evaluations are objective measurements and comparisons against established specifications/predicate performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a cardiopulmonary bypass pump, not an AI-assisted diagnostic tool.
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 algorithm. The performance evaluations are intrinsic to the device's function.
7. The Type of Ground Truth Used
The ground truth is based on:
- Predicate Device Performance: The established performance characteristics of the uncoated Sarns™ Centrifugal Pump for most operational aspects (flow, pressure, hemodynamics, etc.).
- AAMI Guidelines & ISO Standards: For sterilization and biocompatibility.
- Federal Regulations: For Ethylene Oxide residues.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The device is evaluated based on its physical and biological performance characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.