(147 days)
The Revolution Centrifugal Blood Pump is intended to be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of us to six hours. Refer to the console operator's manual for console operating procedures.
The pump has not been qualified through in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Centrifugal Blood Pump with PC Coating is intended for use only with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vained impeller design to move blood by centrifugal force. The device is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. It is indicated for use only with a LivaNova centrifugal pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for long term use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Pump consists of a rotating vained impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single -barbed, 3/8" inlet port and tangential, doublebarbed, 3/8" outlet port. The vained impeller is molded onto steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and impeller, and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the centrifugal pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
The Revolution Centrifugal Blood Pump with PC Coating is an extracorporeal blood pump that utilizes a rotating vained impeller design to move blood by centrifugal force. The device is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. It is indicated for use only with a LivaNova centrifugal pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for long term use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Pump consists of a rotating vained impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vained impeller is molded onto steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and impeller, and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the centrifugal pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.
This document is a 510(k) Premarket Notification from the FDA for two medical devices: the "Revolution Centrifugal Blood Pump" and the "Revolution Centrifugal Blood Pump with PC Coating." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a study with the information requested in your prompt.
Therefore, most of the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment cannot be found in this document. This is because the device approval is based on demonstrating equivalence to existing devices, not on a new, comprehensive performance study as might be conducted for an AI/ML medical device.
However, I can extract the following relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance:
This document does not provide specific acceptance criteria or quantitative performance data for the devices themselves. Instead, it asserts "No difference" in several characteristics when comparing the subject devices to the predicate devices. The "reported device performance" is implicitly that it performs equivalently to the predicates.
| Feature / Criterion | Acceptance Criteria (Implied) | Reported Device Performance | Comments from Document |
|---|---|---|---|
| Product Code | KFM | KFM | No difference. |
| Regulation # | 870.4360 | 870.4360 | No difference. |
| Class | II | II | No difference. |
| Indications for Use | Same as predicate (see below) | Same as predicate | No difference. |
| Environment of Use | Operating room | Operating room | No difference. |
| Limitations of Use / Intended Use | Same as predicate (see below) | Same as predicate | No difference. |
| Principles of Operation | Rotating, vained impeller designed to move blood by centrifugal force | Rotating, vained impeller designed to move blood by centrifugal force | No difference. |
| Main Performance Features | Deliver blood at certain flow and pressure | Deliver blood at certain flow and pressure | No difference. |
Indications for Use (Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating):
"Intended to be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO)."
Limitations of Use / Intended Use (Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating):
"The pump can only be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO) procedures."
2. Sample sizes used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document states, "No clinical testing was conducted in support of the Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating, as the indications for use are equivalent to those of their respective predicates." The substantial equivalence is based on engineering evaluation and non-clinical performance data (bench testing) rather than a and clinical study with a test set of patient data.
- Data Provenance: Not applicable for a clinical test set. The non-clinical performance data refers to "extensive verification and validation testing" in-house by SORIN GROUP ITALIA S.R.L. and adherence to national and international standards. This implies lab-based testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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/ML device, and no MRMC study was performed as the approval pathway is substantial equivalence based on engineering and non-clinical data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device. The document mentions "non-clinical performance data" which refers to bench testing of the physical pump, not an algorithm. "...as centrifugal blood pumps capable of delivering blood to the patient at certain reliable flow and pressure rate. The modified component... was tested to ensure that the systems as a whole can provide all the capabilities necessary to operate safely and effectively."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance data, the "ground truth" would be engineering specifications and established performance standards (e.g., flow rates, pressure, durability, hemolysis, biocompatibility), measured through bench testing. No clinical ground truth from patients is established for this submission.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device and no training set is described.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device and no training set is described.
In summary, this FDA 510(k) clearance is for a physical medical device (blood pump) based on substantial equivalence to existing devices, relying on non-clinical (bench) testing and engineering justification rather than a comprehensive clinical study with a test set or training set data, which would be typical for AI/ML device submissions.
§ 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.