(154 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 the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, plasma product for reinfusion to the same patient within the recommended time of the American Association of Blood Banks (AABB), 9th Edition.
The subject of this Traditional 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System 7.3 (AQ) software update which allows users the ability to manually control the cell salvage procedure through manual mode, quick transfer and decreased minimum wash volume. The Cell Saver Elite/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/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.
The provided text is a 510(k) Summary for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) software update. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain information about the acceptance criteria and study design for proving the device meets those criteria from an AI/ML perspective.
The changes in this 510(k) are related to a software update (version 7.3 AQ) for an autotransfusion system, specifically adding "manual mode, quick transfer and decreased minimum wash volume" features. This device processes blood (concentrating and washing red blood cells) rather than interpreting medical images or data using AI/ML algorithms.
Therefore, many of the requested items (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, how ground truth for training set was established) are not applicable to this type of device and submission.
The document focuses on:
- Software Verification: To verify the new software revision.
- Functional Testing: To validate washout performance (a physical function of the blood processing).
- Usability Testing: To validate operational needs and usability.
These tests are standard for a medical device software update and functional changes, but they do not involve AI/ML performance evaluation as typically understood in the context of diagnostic or prognostic AI systems that require ground truth, expert readers, and rigorous statistical analysis of AI model performance.
In summary, this document is for a medical device software update, not an AI/ML device. Therefore, it does not provide the information requested about AI/ML acceptance criteria and study paradigms.
§ 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).