(85 days)
The Haemonetics Cell Saver® Elite™ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.
The Cell Saver Elite Autotransfusion System is an evolution of the previously cleared Haemonetics Cell Saver Elite Autotransfusion System. The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion. The changes from the previously cleared Cell Saver Elite to the subject Cell Saver Elite system include a software change and a mechanical change to the pinch valve disposable sensor detection system.
The Haemonetics Cell Saver Elite Autotransfusion System is an autotransfusion apparatus. The data provided includes non-clinical performance testing which focuses on processing efficiency and product characteristics of blood products.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Final product hematocrit | 40-60% | Data met Acceptance Criteria |
| Heparin Washout | ≥95% | Data met Acceptance Criteria |
| Free Hemoglobin Washout | ≥95% | Data met Acceptance Criteria |
| Red Blood Cell Recovery | ≥80% | Data met Acceptance Criteria |
| Platelet Rich Plasma (PRP) product | N/A (characterization only) | Meets threshold of 3x incoming platelet count |
| RBC recovery (without Lysate) | ≥80% | Exceeded acceptance criteria, ~12% higher than procedures with high free hemoglobin |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of tests or units of blood) used for each in-house laboratory evaluation. It states "Test data demonstrates that the device and resultant blood products met all clinical and performance requirements". The data provenance is "In-house Laboratory Evaluation," implying the data was generated within Haemonetics Corporation and is retrospective for the purpose of this 510(k) submission, as it refers to testing submitted with a previous 510(k) in 2010.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the non-clinical performance studies described. The ground truth for these studies relies on instrumental measurements and validated laboratory protocols for determining blood product characteristics (e.g., hematocrit, concentration of substances, cell recovery). There is no mention of human expert evaluation for establishing ground truth in these technical performance tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is based on laboratory measurements and established performance criteria, not on expert consensus or adjudication.
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 an autotransfusion system, a medical device that processes blood. It is not an AI-powered diagnostic or imaging device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance studies described ("In-house Laboratory Evaluation") are essentially standalone performance evaluations of the device's ability to process blood and achieve specific product characteristics. The device operates automatically based on programmed protocols.
7. The Type of Ground Truth Used
The ground truth for the performance studies was established through:
- Laboratory Measurements: Quantifiable parameters like hematocrit, heparin concentration, free hemoglobin concentration, and red blood cell recovery.
- Established Performance Criteria/Thresholds: Pre-defined numerical targets or ranges (e.g., hematocrit 40-60%, washout ≥95%) that the device's output should achieve.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical device (autotransfusion system) rather than an algorithm or AI model that requires a training set in the conventional sense. Its performance is based on engineering design and validated physical/chemical processes.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device. The "ground truth" for its operation is the set of physical and biochemical principles it utilizes for blood processing.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).