(36 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, Backup Battery Module, and Cart 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.
Here's the information regarding the acceptance criteria and study proving the device meets them, based on the provided text:
Device Name: Anivia SG1000 Pump Console (K230698)
Regulation Name: Cardiopulmonary Bypass Pump Speed Control
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list "acceptance criteria" in a quantitative performance table format. Instead, it describes various non-clinical tests conducted and states that "All testing met predetermined acceptance criteria." The table below summarizes the types of tests performed and the general outcome.
| Acceptance Criteria Category | Reported Device Performance / Outcome |
|---|---|
| Software Performance | Software verification and validation testing met predetermined acceptance criteria. |
| Functional Design | Functional design verification and validation testing met predetermined acceptance criteria. |
| Electrical Safety | Electrical safety testing met predetermined acceptance criteria and the IEC 60601-1:2005/AMD1:2012 standard. |
| Electromagnetic Compatibility (EMI/EMC) | Electromagnetic interference and compatibility (EMI/EMC) testing met predetermined acceptance criteria and the IEC 60601-1-2:2014 standard. |
| Interoperability | Interoperability evaluation with specified accessories met predetermined acceptance criteria. |
| Reliability | Reliability testing met predetermined acceptance criteria. |
| Simulated Use | Simulated use testing met predetermined acceptance criteria. |
| Cleaning Validation | Cleaning validation met predetermined acceptance criteria and the ISO 17664-2:2021 standard. |
| Battery Performance | Backup Battery Module (LiFePO4) provides a minimum of 1 hour and up to 3 hours of backup power depending on speed and flow. Certified to IEC 62133-2:2017/AMD1:2021 and UN38.3. |
| Packaging & Shipping | Packaging and ship testing met predetermined acceptance criteria and the ASTM D4169:2022, DC13, Level I standard. |
| Risk Management | Complies with ISO 14971:2019. |
| Usability | Usability testing was conducted. (Outcome: met predetermined acceptance criteria, implied by "All testing met predetermined acceptance criteria.") |
| Alarms | Visual and auditory alarms are present for abnormal conditions (Speed, Flow Rate, Back Flow, Bubble, Pressure, Temperature). |
| Pump Speed | Varies by pump driver module, e.g., 0-4500 RPM (Medtronic BPX-80 compatible), 0-5000 RPM (Maquet Rotaflow® RF-32 compatible), 0-4000 RPM (Medtronic Affinity CP compatible), 0-3500 RPM (LivaNova Revolution® compatible). |
| Blood Flow Rate | Dependent on external circuit, up to 0 – 9.9 L/min. |
| External Standards Compliance | Certified to various IEC, ISO, UL, UN, and ASTM standards (listed in detail in section 9.3). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of number of patient cases or images, as this is a device for regulating pump speed in cardiopulmonary bypass, not an AI/imaging diagnostic device. The testing involved various engineering and systems-level tests.
- Data Provenance: Not applicable in the context of typical AI/imaging studies. The testing described is performance testing of the device itself (hardware, software, electrical, mechanical, reliability) against engineering standards and internal criteria. There is no mention of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is a cardiopulmonary bypass pump console, not a diagnostic tool requiring expert interpretation of medical data (like images or clinical reports) to establish ground truth for a test set. The "ground truth" here is adherence to engineering specifications and performance standards, validated through bench testing, not expert consensus on clinical cases.
4. Adjudication method for the test set:
Not applicable, as there is no "test set" in the context of clinical interpretation subject to adjudication. The performance was assessed against predetermined engineering and functional criteria.
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, which is an electromechanical medical device, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI algorithm. The device operates with human involvement (physicians, perfusionists, etc.) for setup, monitoring, and control during cardiopulmonary bypass procedures. The "standalone" performance refers to the device's functional integrity as a machine.
7. The type of ground truth used:
The "ground truth" for this device's performance is established by:
- Engineering specifications and design requirements.
- International consensus standards (e.g., IEC 60601 series, ISO 14971).
- Internal predetermined acceptance criteria for functional, electrical, mechanical, software, reliability, and safety tests.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It's an electromechanical medical device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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).