(126 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/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative 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 Cell Saver Elite/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative 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 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/Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.
The subject of this Special 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System software and hardware to enable use of wired and wireless connectivity.
This document describes the regulatory approval (K162423) for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System with added wired and wireless connectivity features. The approval is based on demonstrating substantial equivalence to a predicate device (K160197).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on the safety and performance of the added connectivity features and modifications to the user interface hardware. The acceptance criteria essentially revolve around demonstrating that these changes do not compromise the existing performance requirements of the autotransfusion system and comply with relevant standards.
| Acceptance Criteria (What was measured/verified) | Reported Device Performance (Result) |
|---|---|
| Electromagnetic Compatibility (EMC) compliance (per IEC 60601-1-2) | Pass |
| Electrical Safety compliance (per IEC 60601-1) | Pass |
| Wireless Coexistence of the Cell Saver Elite/Elite+ with potential interference appliances | Pass |
| Software Validation of Version AN of the CS Elite/Elite+ Software to ensure correct functionality and communication capabilities | Pass |
| Maintenance of previous performance requirements despite UI hardware and software changes (implied) | Subject device met all performance requirements, demonstrating substantial equivalence to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size" in terms of number of devices or number of test cases run for each test. The non-clinical testing summary simply lists the tests conducted.
The data provenance is from non-clinical testing performed by the manufacturer, Haemonetics Corporation, as part of their 510(k) submission. This is internal testing, not patient data, and is thus prospective in the sense that it was performed specifically for this submission. The country of origin for the data generation would be where Haemonetics conducted their internal R&D and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission for device modifications. No "ground truth" based on expert medical opinion (like clinical diagnosis) was established or used for the technical performance tests (EMC, electrical safety, wireless coexistence, software validation). These tests rely on engineering standards and functional verification.
4. Adjudication Method for the Test Set
This is not applicable. The tests performed (EMC, electrical safety, wireless coexistence, software validation) are objective engineering and software verification tests, not subjective interpretations requiring 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
This is not applicable. This submission is for modifications to an autotransfusion system, a medical device that processes blood. It does not involve "human readers" or "AI assistance" in the context of interpreting medical images or making diagnostic decisions, which is typically where MRMC studies are conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an autotransfusion system, not an algorithm performing a standalone diagnostic or interpretive function. The "software validation" was for the embedded software controlling the device's functionality and connectivity, which operates as part of the overall system with human operators.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was based on engineering specifications, regulatory standards (e.g., IEC 60601-1-2, IEC 60601-1), and the defined functional requirements of the device. For example, for EMC, the ground truth is compliance with the specified limits in the standard. For wireless coexistence, the ground truth is the device operating without unacceptable interference. For software, the ground truth is the software performing as designed according to its requirements.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI/ML system that undergoes a "training phase" with a training set of data in the typical sense (e.g., for image recognition or predictive models). The software validation refers to the testing of the developed software against its requirements.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8. The device's software is developed through standard software engineering practices and validated against pre-defined functional and performance requirements.
§ 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).