(72 days)
The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
The CellTrans 10 device consists of a sterile, double wrapped package, containing two needle and drain assemblies, a blood collection assembly with patient drain connection line and a compressible bellows collection vessel with twin outlet ports, and two blood Transfer bags. The patient and transfer bag lines are fitted with pinch clamps, and in addition the transfer bag connection luers are fitted with sealing caps, for use after a filled bag is removed from the collection vessel. The collection bellows and transfer bags are fitted with non-return valves to prevent backflow of exudate to the patient.
The drains are placed in the patient, and connected to the collection system via the twin drain Y-connector. The transfer bags are fitted to the collection vessel outlet ports. Blood collection is initiated by compressing the bellows to apply a low vacuum to the wound, the collected blood then transferring into one of the transfer bags, via the gross filter. When the baq is full, or in accordance with the American Association of Blood Banks Guidelines for Blood Recovery and Reinfusion in Surgery (AABB), the bag can be removed from the collection system, and transferred for reinfusion to the patient. Blood collection can continue with the second transfer bag.
Following use of the second bag, the device can be used as a wound drainage device if this is clinically desirable, by draining into a standard wound drainage bag.
This document describes the Summit Medical CellTrans™ Postoperative Autotransfusion System, a device for collecting and reinfusing a patient's own blood following surgery. The information provided outlines the safety and effectiveness testing conducted to demonstrate its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Functional Performance | Vacuum testing | Device meets criteria; specific values not provided. |
| Pressure leak decay tests | Device meets criteria; specific values not provided. | |
| Functional testing (water and time-expired blood) | Performs in accordance with design specifications. | |
| Mechanical Integrity | Mechanical testing of bonded joints | Device meets criteria; specific values not provided. |
| Sterilization | Microbiological bioburden validation | Validated. |
| Endotoxin validation | Validated. | |
| Gamma sterilization (ISO 11137, EN552) | Validated. | |
| Biocompatibility | Cytotoxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. |
| Sensitization (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Irritation or Intracutaneous Reactivity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Acute Systemic Toxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Subchronic Toxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Hemocompatibility | Hemocompatibility testing (ISO 10993-4) | Detailed evaluation of blood cell parameters demonstrated device meets applicable standards. |
2. Sample Size for Test Set and Data Provenance:
The provided document describes performance testing, sterilization validation, and biocompatibility testing, not a clinical study involving a "test set" of patient data in the typical sense for an AI/diagnostic device. For the hemocompatibility testing (ISO 10993-4), which involved comparing blood passed through the CellTrans™ system with homologous (banked) blood, the sample size for the blood cell parameter evaluation is not specified.
The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is based in the UK (Summit Medical Ltd, Gloucestershire, UK). The nature of the testing suggests laboratory-based evaluations rather than retrospective or prospective clinical data collection from a patient population.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
Not applicable. The "test set" here refers to laboratory samples (e.g., blood cell parameters, materials for biocompatibility) and engineering tests, not a set of clinical cases requiring expert consensus or ground truth establishment by clinical experts.
4. Adjudication Method (Test Set):
Not applicable. This was not a clinical study requiring adjudication of expert interpretations. The results were likely evaluated against pre-defined engineering and biological specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is an autotransfusion system, not a diagnostic imaging or AI-assisted diagnostic device, and therefore this type of study is not relevant to its evaluation.
6. Standalone Performance Study:
Yes, the studies described are essentially standalone performance studies of the device itself. The performance testing (vacuum, pressure, functional, mechanical) evaluates the device's intrinsic capabilities. The sterilization validation ensures the device's sterility. The biocompatibility and hemocompatibility testing assesses the device's interaction with biological systems in a standalone manner, without human intervention as part of the primary performance metric.
7. Type of Ground Truth Used:
For the performance and validation tests, the "ground truth" was established by predetermined engineering specifications, international standards (e.g., ISO 11137, EN552, ISO 10993, ISO 10993-4), and regulatory guidance (FDA Blue Book Memo G95-1). For example, for hemocompatibility, the "ground truth" was the characteristics of homologous (banked) blood, against which the blood processed by the device was compared.
8. Sample Size for Training Set:
Not applicable. This device is not an AI/machine learning device that requires a "training set" for model development.
9. How Ground Truth for Training Set Was Established:
Not applicable, as no training set was used.
§ 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).