(256 days)
The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
The Anivia SG1000 Pump Console is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The Anivia SG1000 Pump Console consists of the following modules: Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, and Backup Battery Module. It is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.
The provided text describes the Anivia SG1000 Pump Console, a device intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures (up to 6 hours). The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Medtronic Bio-console® 560 Extracorporeal Blood Pumping Console, K131964).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list a table of acceptance criteria with specific numerical targets and corresponding reported device performance values for the Anivia SG1000 Pump Console. Instead, it broadly states that "All testing met predetermined acceptance criteria." The performance characteristics are described in comparison to the predicate and reference devices in the "Technological Characteristics" table, implying that the acceptance criteria for these characteristics are met by being "Same as predicate" or by having differences that "do not raise different questions of safety and effectiveness."
Here's a breakdown of the performance characteristics provided, and where the device's performance aligns with or is considered equivalent to the predicate:
| Acceptance Criteria (Implied from Predicate/Reference) | Reported Device Performance (Anivia SG1000 Pump Console) |
|---|---|
| Indications for Use: Pump blood through extracorporeal bypass circuit for up to 6 hours. | Met: Intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours). (Same as predicate) |
| Duration of Use: Up to 6 hours. | Met: Up to 6 hours (limited by disposables, not limited by Console electro-mechanical modules). (Same as predicate) |
| Intended Use: Pump Speed Control, CPB Machine Console. | Met: Pump Speed Control, CPB Machine Console (not including sterile, blood-contacting accessories). (Same as predicate) |
| Intended Users: Cardiopulmonary physicians, perfusionists, trained physician assistants. | Met: Cardiopulmonary physicians, perfusionists, trained physician assistants. (Same as predicate) |
| Intended Use Environment: Cardiopulmonary procedure rooms, intensive care units. | Met: Cardiopulmonary procedure rooms, intensive care units. (Same as predicate) |
| Intended Patients: As prescribed by cardiopulmonary specialists. | Met: As prescribed by cardiopulmonary specialists. (Same as predicate) |
| Compatible Disposable Centrifugal Pump Heads: Medtronic BPX-80, BP-50, RotaFlow® RF-32. | Met: Medtronic BPX-80, BP-50 centrifugal pump heads (w/ Pump Driver Module SG1000-PDM-001); RotaFlow® RF-32 centrifugal pump heads (w/ Pump Driver Module SG1000-PDM-002). (Matches/expands on predicate and reference) |
| Centrifugal Pump Driver: Non-contact, magnetically coupled. | Met: Non-contact, magnetically coupled. (Same as predicate) |
| Control Function: Speed Control. | Met: Speed Control, Flow Control (Stability), Mechanical Knob and Touch Display. (Similar to predicate's speed control, adds flow control and touch display, considered not to raise new safety/effectiveness questions). |
| Pump Speed (RPM): 0 – 4500 (predicate), 0 – 5000 (reference). | Met: 0 – 4500 for CS-0210-ASY-00002 (Medtronic BPX-80 compatible); 0 – 5000 for CS-0210-ASY-00010 (Maquet Rotaflow RF-32 compatible). (Matches/exceeds predicate) |
| Visual and Auditory Alarms on Abnormal Conditions: Yes, preset limits for Speed, Flow Rate, Back Flow, Bubble, Pressure, Temperature. | Met: Yes, preset limits: Speed, Flow Rate, Back Flow, Bubble, Pressure, Temperature. (Same as predicate) |
| Blood Flow Rate (L/min): Up to 0 – 9.9 L/min. | Met: Dependent on external circuit, up to 0 – 9.9 L/min. (Same as predicate) |
| Interface to Blood Flow Sensor: Yes (Qty 1). | Met: Yes (Qty 1). (Same as predicate) |
| Air Bubble Detector: Yes (Qty 1), integrated with Blood Flow Sensor. | Met: Yes (Qty 1), integrated with Blood Flow Sensor. (Integrated with BFS, which is implicitly similar to predicate's separate detector for safety/effectiveness) |
| Blood Flow and Bubble Detector Sensor Technology: Non-contact, various methods. | Met: Non-contact, ultrasound Clamp-On around blood tube. (Different technology than predicate's electrical conductivity, but implicitly determined not to raise new safety/effectiveness questions, aligning with reference device technology). |
| Pressure Sensors: Yes (Qty 2, external), previously 510(k)-cleared. | Met: Yes (Qty 2, external), previously 510(k) cleared accessories manufactured by third parties. (Same as predicate) |
| Temperature Sensors: Yes (Qty 2, external), previously 510(k)-cleared. | Met: Yes (Qty 2, external), previously 510(k) cleared accessories manufactured by third parties. (Same as predicate) |
| Power Input: Universal 90-264 VAC/50-60 Hz, 2.5A / 1.3A, up to 250 W. | Met: Universal 90-264 VAC/50-60 Hz, 2.5A / 1.3A, up to 250 W. (Stated as "Same as predicate – single universal power supply, instead of different models, no effect on safety and effectiveness.") |
| Backup Battery: Lead acid (predicate), NiCad (reference). | Met: LiFePO4. (Improvement in technology stated to "not raise question on safety and effectiveness.") |
| Backup Battery Capacity: 24 VDC (predicate), 24 VDC, 5 AH, 120 WH (reference). | Met: 25.6 VDC, 12 AH, 307 WH, minimum 1 hour, up to 3 hours depending on speed and flow. (Stated as "Same as predicate" in terms of function, despite numerical differences, indicating functional equivalence for backup power duration). |
| Backup Pump: Hand-crank. | Met: Yes, backup electrical Pump Driver Module on standby, and hand-crank. (Improvement over predicate by adding an electrical backup, stated as "Same as predicate" for safety/effectiveness). |
| Pump Motor Technology: Brushless DC motor. | Met: Brushless DC motor. (Same as predicate) |
| Display Screen Size: 26 cm (10.4") (predicate). | Met: 31 cm (12.1"). (Difference stated to have "no impact on safety and effectiveness.") |
| Dimensions/Weight: Varied. | Met: Dimensional and weight differences in Display & Control Module (smaller/lighter than predicate) are stated to have "no impact on safety and effectiveness" due to newer technology. |
| Non-Clinical Tests: Software verification, functional design, electrical safety, EMI/EMC, interoperability, reliability, simulated use, cleaning validation, packaging, shipping. | Met: All listed tests were conducted and "All testing met predetermined acceptance criteria." Compliance with numerous consensus standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, IEC 62366, UL 2054, etc.) was also achieved. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance, as this device does not involve AI or machine learning that would typically use such a test set. The non-clinical tests involved "system bench testing, mechanical testing, electrical safety and electromagnetic interference and compatibility testing, software testing, reliability, and usability testing." The sample size for these engineering and performance tests is not quantified (e.g., number of devices tested, number of test runs).
Data provenance is not applicable since no clinical data or patient data was used to assess the device's performance in this 510(k) submission. All tests mentioned are non-clinical, benchtop, or simulated use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device does not involve a "ground truth" derived from expert review or clinical annotations for an algorithm. The evaluation relies on engineering tests and compliance with recognized standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as there is no "test set" in the context of human-reviewed data where adjudication would be necessary.
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 device is a cardiopulmonary bypass pump console, not an AI/ML-driven diagnostic or interpretative tool that would involve human readers or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is electro-mechanical hardware with software controls, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of medical device (a pump console), "ground truth" is established through engineering specifications, validated test methods (e.g., measuring pump speed, flow rate, alarm accuracy), and compliance with international consensus standards. There is no biological or imaging "ground truth" involved.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set." The software embedded in the device undergoes traditional software verification and validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).