(30 days)
The Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:
(i) Full of 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.
Devices are intended for adult patients.
The Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors.
The device is non-toxic, non pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
This document is a 510(k) premarket notification for a medical device called the "Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors." The purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a predicate device already on the market. In this case, the predicate device is the "Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors" (K201320), and a reference device is the "Quantum Perfusion Centrifugal Blood Pump CP37" (K202169).
The filing states that the new device, CP37 with Integrated Sensors, is essentially a variant introduced into the existing product family, aligning with the general structure, principle of operation, intended use, manufacturing, and sterilization processes of the previously cleared predicate and reference devices.
Based on the provided text, the device's acceptance criteria and the study that proves it meets those criteria are described as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of crisp, quantitative acceptance criteria and corresponding reported device performance metrics in the format typically seen for a new algorithmic or diagnostic device. Instead, the approach taken is to demonstrate substantial equivalence to existing cleared devices (CP22 with Integrated Sensors and CP37).
The implicit "acceptance criteria" appear to be that the new device variant (CP37 with Integrated Sensors) performs equivalently to the predicate (CP22 with Integrated Sensors) and reference (CP37) devices for its intended use, without raising new issues of safety or effectiveness.
The reported device performance is conveyed through the statement:
"Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices. Applicable testing activities demonstrated that the proposed device model does not raise any issues of safety and effectiveness as compared to the currently cleared predicate and reference product."
Therefore, the "performance" is that it met the same standards as the cleared devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain the same general structure, principle of operation, intended use, manufacturing, and sterilization processes as predicate and reference devices. | The new REF code introduced is aligned with the original submission K201320 in these aspects. |
| Technical specifications verified according to applicable standards/protocols used for original cleared devices. | Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices. |
| No new issues of safety and effectiveness are raised compared to the predicate and reference products. | Applicable testing activities demonstrated that the proposed device model does not raise any issues of safety and effectiveness as compared to the currently cleared predicate and reference product. |
| Appropriate for its intended use. | The proposed devices have been demonstrated to be appropriate for their intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states:
"The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact:
- ...
- Review and Assessment of data available on predicate( K201320) and reference (K202169) devices submission and applicability to new variant introduced in the product family portfolio."
This indicates that the "test set" for demonstrating safety and effectiveness was primarily based on a review and assessment of existing data from the previously cleared predicate (K201320) and reference (K202169) devices. There is no mention of a new, distinct "test set" with a specific sample size.
Data Provenance: The original data for the predicate and reference devices would have been generated during their respective premarket clearances. The current submission is a Special 510(k) for a device variant, often relying on existing data and non-clinical bench testing. The document does not specify the country of origin or whether the original data was retrospective or prospective beyond referring to previous submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable/provided in the document. The submission is for a physical medical device (blood pump with sensors), not an AI/software diagnostic device that requires expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance would be engineering specifications, physical measurements, and biocompatibility testing, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. Since the "test set" primarily involved a review of existing data and non-clinical testing for a physical device, there isn't an "adjudication method" in the sense of reconciling differences in expert interpretations of data as would be found in diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that are interpreted by human readers, often with and without AI assistance, to measure the impact of AI on reader performance. This submission is for a physical device, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
No, a standalone study was not done in the context of an algorithm's performance without human intervention. This device is a physical centrifugal blood pump with integrated sensors, not an AI algorithm. Its performance is measured by its mechanical and biocompatibility characteristics, not by an algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used:
The "ground truth" for this device relates to its engineering specifications, functional performance (e.g., pumping efficiency, pressure monitoring accuracy), material properties, and biocompatibility. This is established through:
- Engineering specifications and design documents.
- Bench testing results measuring flow rates, pressure accuracy, material strength, etc.
- Biocompatibility testing (e.g., ISO 10993 standards).
- Sterilization validation data.
- Compliance with applicable standards (e.g., ISO 15223-1:2021 for labeling).
The document explicitly states: "Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices." This implies that the "ground truth" and verification methods align with the established standards and protocols used for similar devices.
8. The Sample Size for the Training Set:
This information is not applicable/provided. This device is a physical medical device, not an AI/machine learning model that undergoes "training." Therefore, there is no training set sample size to report.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided. As the device is not an AI/machine learning model, there is no training set or corresponding ground truth establishment process in that context.
§ 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.