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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 System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intraoperative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite Autotransfusion System fat washing protocol and modified 70mL bowl algorithm.

The Cell Saver Elite System consists of a single use disposable set and reusable 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 using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

Here's a breakdown of the acceptance criteria and study information for the Haemonetics Cell Saver Elite Autotransfusion System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (for Fat Washing Protocol):

Note: (**) refers to data from the reference device Sorin Xtra, cited as "Fat removal during cell salvage - An optimized program in the XTRA® autotransfusion device" by Timo Seyfried, MD, Michael Gruber, MD; Lilith Haas; Emil Hansen, PhD, MD 13th ECOPEAT Vienna - Austria 2013.*
Note: () for the subject device indicates "depending on bowl size used".*

2. Sample Size and Data Provenance for the Test Set:

• Sample Size: The document does not explicitly state the sample size used for the performance tests (functional testing and software validation). It lists several test reports by number (e.g., TR-SOF-100562, TR-OTH-100649), but these reports themselves are not included in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "non-clinical performance testing was submitted."

3. Number of Experts and Qualifications for Ground Truth:

• This information is not provided in the document. The testing described appears to be primarily technical and functional validation against predefined performance metrics for a medical device rather than studies requiring expert human interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

• This information is not applicable and not provided. The testing described is against established performance requirements and is not a clinical study requiring adjudication of expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study is mentioned. The submission is for a modification to an existing autotransfusion system, focused on technical performance improvements rather than reader interpretation.

6. Standalone Performance Study (Algorithm Only):

• The document implies standalone performance studies were conducted for the device's functionality. Table 1 "Summary of Performance Studies" lists "Software Validation" and "Functional Testing" with corresponding report numbers and "Test Intent" that demonstrate the device (or its software components and new features like fat washing protocol and modified 70mL bowl algorithm) met performance requirements. The results are simply "Passed," indicating the algorithm's performance in achieving the specified criteria.

7. Type of Ground Truth Used:

• The ground truth used for the performance studies appears to be based on objective, quantitative measurements related to blood processing parameters. For example:
  • Hematocrit (HCT%)
  • Red Blood Cell (RBC) Recovery
  • Plasma Hemoglobin (HgB) Washout
  • Heparin Washout
  • Albumin Washout
  • Fat Removal
• These are physical and chemical properties of blood that can be measured directly by laboratory methods, establishing a clear objective ground truth for the device's performance in processing blood.

8. Sample Size for the Training Set:

• The document does not provide details about a "training set" as this device is not an AI/ML algorithm that typically requires a large training dataset in the same way. The mentioned "Software Validation" and "Functional Testing" refer to verification and validation activities for the device's software and hardware, where "training" in the context of machine learning is not directly applicable.

9. How Ground Truth for the Training Set Was Established:

• As mentioned above, the concept of a "training set" and its associated ground truth establishment is not relevant to this type of device submission based on the provided information. The validation focuses on ensuring the device meets pre-defined performance specifications for blood processing.

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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 Haemonetics Cell Saver 5 Autologous Blood Recovery 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 centrifygal 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 Cell Saver Elite system is designed to perform the same types of procedures as the Cell Saver 5 system, utilizing very similar disposable sets. The primary changes from the Cell Saver 5 to the Cell Saver Elite systems include a modernized graphical user interface with a touch screen display, barcode data capture capability to simplify data entry, and the integration of an onboard vacuum system to provide regulated vacuum to the collection reservoir.

Here's an analysis of the acceptance criteria and supporting studies for the Haemonetics Cell Saver Elite Autotransfusion System, based on the provided document:

Acceptance Criteria and Device Performance Study for Haemonetics Cell Saver Elite Autotransfusion System

1. Table of Acceptance Criteria and Reported Device Performance

• Heparin Washout ≥95%
• Free Hemoglobin Washout ≥95%
• Red Blood Cell Recovery ≥80% | Conclusion: Data met Acceptance Criteria |
  | In-house Laboratory Validation of Platelet Sequestration Protocol Using the Cell Saver Elite
  (Protocol TR-CLN-100201) | No formal acceptance criteria; characterization of the product. | Conclusion: The platelet rich plasma that is produced meets the threshold of three (3) times the incoming platelet count of the whole blood. |
  | In-house Laboratory Evaluation of Processing Efficiency and Product Characteristics using Pools without Lysate
  (Protocol TR-CLN-100049) | - Final product hematocrit of 40-60%
• Heparin Washout ≥95%
• Free Hemoglobin Washout ≥95%
• Red Blood Cell Recovery ≥80% | Conclusion: Data met Acceptance Criteria. The data above indicate the processed RBC product data from all three bowl types exceeded the acceptance criteria in terms of Hematocrit, RBC Recovery and Washout. The RBC recovery data was, on average 12% higher than the RBC Recovery derived from procedures using pools with high levels of free hemoglobin. |

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample sizes used for the test sets in the non-clinical laboratory studies (TR-CLN-100177, TR-CLN-100201, TR-CLN-100049).

The data provenance is internal in-house laboratory evaluations. There is no information regarding the country of origin of the data beyond "in-house laboratory" or whether it was retrospective or prospective. Given it is laboratory testing for performance characterization, it would typically be prospective testing conducted for the purpose of the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The studies are described as "in-house laboratory evaluations" characterizing device performance, not assessments based on expert-derived ground truth from a clinical data set. The ground truth for these tests would be the measured properties of the processed blood products (e.g., hematocrit, washout percentages), which are quantifiable laboratory values.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective expert assessment is used to establish ground truth or evaluate a device's diagnostic output. Since these are laboratory performance studies measuring objective parameters of blood processing, an adjudication method is not applicable and therefore not mentioned. The "ground truth" for these studies is the direct measurement of the physical and chemical properties of the blood components.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document describes non-clinical laboratory performance testing of the device itself and a comparison of its characteristics to a predicate device. It does not involve human readers evaluating output or comparing human performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The studies described are standalone performance studies of the device (Haemonetics Cell Saver Elite system) itself, focusing on its ability to process blood and produce a specific output (e.g., washed red blood cells, platelet-rich plasma). The device itself operates autonomously in its processing functions, so its performance is inherently "algorithm only" or "device only" in terms of its processing capabilities. There is no human interaction during the blood processing and characterization that would alter the device's fundamental performance metrics.

7. Type of Ground Truth Used

The ground truth used for these performance studies is objective, quantitative laboratory measurements of the processed blood products. This includes:

• Final product hematocrit
• Heparin Washout percentage
• Free Hemoglobin Washout percentage
• Red Blood Cell Recovery percentage
• Platelet count in platelet-rich plasma

These are direct physical and chemical measurements rather than subjective expert consensus, pathology reports, or patient outcomes.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The Haemonetics Cell Saver Elite Autotransfusion System is a medical device that performs physical blood processing through centrifugation and washing. It is not an AI/ML-based diagnostic or prognostic algorithm that requires a "training set" in the computational sense. Its design and performance are established through engineering, physics, and validation testing, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As stated above, the device does not use a training set as it is not an AI/ML system. Its "ground truth" for development and validation is based on established principles of blood processing, and performance is verified through rigorous laboratory testing against predefined specifications.

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