(56 days)
The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors indicated for use exclusively with Spectrum Medical Systems is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods up to 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 (i.e., patients greater than 12 through 21 years of age).
The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours.
The device is non-toxic, non-pyrogenic, EtO-sterilized, and packaged in a single blister. Blood contact surfaces are coated with a stable, biocompatible compound to reduce platelet activation and adhesion while preserving platelet function.
This document describes the 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors. This is a medical device, not an AI/ML powered device, so several aspects of your request (e.g., number of experts, adjudication method, MRMC study, ground truth for AI/ML models) are not applicable.
Here's an analysis of the provided text in relation to your request, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format as one might find for an AI/ML device where metrics like sensitivity, specificity, or AUC are reported against specific thresholds.
Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device (K220842) through non-clinical performance testing. The reported performance is an affirmation that the device met these implicit criteria by performing comparably to the predicate.
The non-clinical performance tests conducted to demonstrate this are listed:
- Operating Parameters
- Dynamic Blood Damage
- Heat Generation
- Air Entrapment
- Mechanical Integrity
- Durability/Reliability
The conclusion is that "Performance data confirmed that the subject device is equivalent to the predicate device and any differences in the device do not raise new questions of safety or effectiveness." This statement is the reported device performance in the context of a 510(k) for this type of device – it met the standards for substantial equivalence. No specific numerical thresholds or results are provided in this summary, as is common for non-AI/ML 510(k) submissions unless a specific performance standard requires it to be explicitly stated in the summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent Operating Parameters to Predicate | Confirmed to be equivalent to predicate. |
| Equivalent Dynamic Blood Damage to Predicate | Confirmed to be equivalent to predicate. |
| Equivalent Heat Generation to Predicate | Confirmed to be equivalent to predicate. |
| Equivalent Air Entrapment to Predicate | Confirmed to be equivalent to predicate. |
| Equivalent Mechanical Integrity to Predicate | Confirmed to be equivalent to predicate. |
| Equivalent Durability/Reliability to Predicate | Confirmed to be equivalent to predicate. |
| Biocompatibility (via predicate data) | Validated by predicate device data (K220842). |
| Sterilization (via predicate data) | Validated by predicate device data (K220842). |
| Shelf-life (via predicate data) | Validated by predicate device data (K220842). |
| Packaging Validation (via predicate data) | Validated by predicate device data (K220842). |
2. Sample Size Used for the Test Set and Data Provenance
The document states "In vitro performance tests have been performed to support claimed substantial equivalence."
- Sample Size: The document does not specify the exact sample sizes (e.g., number of pumps tested) for each of the non-clinical performance tests. This information is typically detailed in the full 510(k) submission, not necessarily in the public summary.
- Data Provenance: The tests are described as "In vitro performance tests," implying laboratory-based testing. "Performance testing in accordance with the special controls of 21 CFR 870.4360 was performed with the subject device (CP20V-NG)." This is prospective testing performed on manufactured devices. The country of origin of the data is not specified, but the applicant company is located in Italy (Spectrum Medical S.r.l., Mirandola, Italy).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable. This is a physical medical device, not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" for a device like this comes from standardized engineering and biocompatibility testing methods, not expert consensus on medical images or patient outcomes.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This question is not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Performance is measured against physical properties and engineering specifications.
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 question is not applicable. This is not an AI-powered diagnostic or assistive device. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is established through:
- Engineering Specifications and Standards: The device's performance is measured against established engineering parameters and standards (e.g., relating to flow, pressure, heat, mechanical durability, blood damage).
- Biocompatibility Standards (ISO 10993-1:2018): Ensuring the materials are safe for biological contact.
- Sterilization Standards (ISO 11135:2014): Verifying the sterility of the device.
- Packaging Standards (ISO 11607-1:2019): Ensuring the integrity of the packaging.
- Regulatory Special Controls (21 CFR 870.4360): Specific performance requirements for nonroller-type blood pumps.
The "ground truth" is not based on expert consensus, pathology, or outcomes data in the traditional sense of an AI/ML diagnostic.
8. The Sample Size for the Training Set
This question is not applicable. This is not an AI/ML device that uses a "training set." The device is designed, manufactured, and tested, not "trained."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no "training set" or corresponding "ground truth" establishment in the context of this device.
§ 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.