(422 days)
The Quantum Perfusion Centrifugal Blood Pump CP20, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended 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
Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)
The Quantum Perfusion Centrifugal Blood Pump CP20 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:
Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on (i) the heart or great vessels; or
Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.
Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)
Quantum Perfusion Centrifugal Blood Pump CP20 and Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors are standalone single use device intended to pump blood into the extracorporeal circulation circuit and to monitor pressure for periods lasting less than 6 hours.
Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors is equipped with two sensors integrated in the blood inlet and outlet connectors.
Devices are 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 describes the Qura S.r.l. Quantum Perfusion Centrifugal Blood Pump CP20 and CP20 with Integrated Sensors (K220842).
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" with numerical targets in a table format for each performance test. Instead, it lists the types of performance tests conducted to demonstrate substantial equivalence to the predicate and reference devices, implying that the acceptance criterion for each test was to perform comparably or within expected safety limits as per relevant standards and guidance.
Below is a table summarizing the reported device characteristics relevant to performance and the tests conducted. The "Acceptance Criteria" column will be inferred as "Compliance with applicable standards and demonstration of substantial equivalence to predicate/reference devices."
| Performance Characteristic/Test Area | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Operating Parameters | Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference. | In-vitro performance tests performed. Device designed to pump blood, with CP20 with Integrated Sensors also monitoring pressure. Maximum blood flow rate: 1.5 L/min. Maximum pump operating pressure: 550 mmHg. (Compared favorably to predicate and reference) |
| Dynamic Blood Damage | Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference. | In-vitro performance tests performed. Blood contact surfaces coated with phosphorylcholine-based biocompatible surface to reduce platelet activation and adhesion while preserving platelet function. |
| Heat Generation | Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference. | In-vitro performance tests performed. |
| Air Entrapment | Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference. | In-vitro performance tests performed. |
| Mechanical Integrity | Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference. | In-vitro performance tests performed. |
| Durability/Reliability | Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference. | In-vitro performance tests performed. Intended for periods lasting less than 6 hours. |
| Product Shelf Life | Compliance with applicable standards and substantial equivalence to predicate/reference. | Evaluation performed. |
| Sterilization Process (EtO) | Validation per ISO 11135 (Recognition Nr.: 14-529). | Validation performed, device is EtO sterile. |
| Packaging Validation | Validation per ISO 11607-1 (Recognition Nr. 14-530). | Validation performed. |
| Biocompatibility | Compliance with ISO 10993-1:2018 (Recognition Nr. 2-258) and FDA Guidance "Use of International Standard ISO 10993-1..." | Evaluation performed, including mandatory animal tests. Devices are non-toxic. |
| Integrated Sensors (for CP20 with S.) | Ability to measure pressure at inlet and outlet; substantial equivalence to reference device (CP22 with Integrated Sensors). | Equipped with two sensors positioned on the blood inlet and outlet connectors, both able to measure pressure at the same time. |
| Priming Volume | Comparable to predicate device (14 mL for PediMag); appropriate for intended patient population. | 20 mL. |
| Intended Use Duration | Less than 6 hours for cardiopulmonary bypass or temporary circulatory bypass. (Matches predicate and reference.) |
§ 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.