(295 days)
The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.
The RotaFlow Centrifugal Pump is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to incoming liquid, directing it through a spiral housing to the outflow port.
This submission (K090515) is for a medical device called the MAQUET RotaFlow Centrifugal Pump with Softline Coating. It's important to note that this 510(k) summary does not contain acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/software-driven devices.
This is a premarket notification for a Class III physical medical device (a centrifugal pump for cardiopulmonary bypass). The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, not on showing performance against specific, quantifiable acceptance criteria typically associated with software or AI performance.
Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I will address the relevant sections and explain why others cannot be answered from the provided text.
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary for K090515. For physical devices like this, the "performance" demonstrated for substantial equivalence typically involves engineering tests (e.g., flow rates, pressure handling, durability, biocompatibility) rather than quantifiable metrics like sensitivity or specificity seen in diagnostic AI. The summary states that "Performance" was evaluated, but it does not present specific criteria or results in a table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As this is a physical device, "test sets" in the context of data points for algorithm evaluation are not relevant here. The evaluation would involve physical prototypes or manufactured units of the pump.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable to a physical medical device submission like this. Ground truth, in the context of expert consensus, is typically for diagnostic interpretation, not for evaluating the mechanical function of a pump.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable.
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
This information is not provided and is not applicable. This type of study relates to the performance of diagnostic AI with human readers, not a physical pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. There is no algorithm discussed for diagnostic or interpretative purposes in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided and is not applicable in the way you've described. For a physical pump, "ground truth" might refer to engineering specifications, validated test methods for flow, pressure, material integrity, and biocompatibility standards. The submission highlights that "Integrity", "Performance", "Biocompatibility", and "Sterility" were evaluated, implying various testing methodologies were used, but details are not given.
8. The sample size for the training set
This information is not provided and is not applicable. There is no training set for an AI/ML algorithm in this submission.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
Summary of Relevant Information from the K090515 Submission:
- Device Name: RotaFlow Centrifugal Pump with Softline Coating
- Submission Type: 510(k) Premarket Notification
- Purpose of Study/Evaluation: To demonstrate substantial equivalence to legally marketed predicate devices.
- Predicate Devices:
- Key Differences from Predicate: The only stated difference from the primary predicate is the coating (Softline instead of BIOLINE). The Softline coating itself is identical to a coating already approved in another predicate device.
- Evaluated Areas (for demonstrating substantial equivalence):
- Integrity
- Performance
- Biocompatibility
- Sterility
- Conclusion: The data demonstrated that the RotaFlow Centrifugal Pump with Softline Coating is substantially equivalent to the named predicate devices.
In essence, this 510(k) is for a manufacturing change (a new coating) on an already cleared device, leveraging the prior approval of both the pump design and the specific coating material on other devices. It does not involve AI or software development that would require the kind of performance metrics and study designs you've detailed.
§ 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.