(68 days)
The ATS Suction Line is a suction line to aspirate and anticoagulate blood from the surgical field into an autotransfusion reservoir with ¼" suction port connected to a vacuum source.
The ATY Y-Adapter is a Y-Adapter to connect two autotransfusion reservoirs with 1/4´´ female outlet connector to an autotransfusion device.
The ATO Oxygenator Line is a tubing system to connect an oxygenator with 1/4´´ male connector to an autotransfusion device: - via a Y-adapter connected to an autotransfusion reservoir; or
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directly to the autotransfusion device accepting a 1/4´´ female connector; or
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via an autotransfusion reservoir.
The ATS Suction Line consists of a double lumen tubing set for collection and anticoagulation of shed blood in surgery or trauma. The large tubing is used for aspiration of the shed blood. The small tubing welded to the large tubing provides anticoagulation. The large suction tube and small anticoagulation tube meet at the Yankauer adapter, to provide anticoagulation immediately after collection of blood. The suction line is connected to the appropriate collection reservoir by a ¼´´ female connector. The anticoagulant line is spiked to a anticoagulant container. Anticoagulant dosage is controlled by a roller clamp and regulates the drip rate of the anticoagulant into the drip chamber. The Yankauer adapter is designed to adapt to suction tips from 6.5 to 9.5 mm outer diameters.
The ATY Y-Adapter is a disposable tubing set used to connect two autotransfusion reservoirs to an autotransfusion disposable set prior to processing. Each branch of the Y-Adapter may be attached to the blood outlet port of two reservoirs by 2 stepped ¼´´ adapters. Each branch connecting to the reservoirs has a pinch clamp to control flow to the autotransfusion device. The Y-Adapter outlet line has a universal adapter fitting for ¼´ male connectors or 3/8´´ female connectors. Alternatively, the ATY Y-Adapter can be used to connect one autotransfusion reservoir and one oxygenator line to an autotransfusion device.
The ATO oxygenator line is a disposable tubing set for the collection or transfer of shed blood from the extracorporeal circulation (ECC) in cardiac surgery to an autotransfusion reservoir or to an autotransfusion device prior to processing. The is connected to the coronary perfusion port of an oxygenator prior to priming ECC. After conclusion of ECC, it may be connected to the free branch of a Y-adapter attached to an autotransfusion reservoir outlet, or directly to the blood inlet line of an autotransfusion device for direct processing. Alternatively it may be connected to a ¼" inlet connector of an autotransfusion reservoir to empty the oxygenator content into the reservoir prior to processing.
All three devices are for single patient use, sterilized using ethylene oxide gas, and the fluid paths are non-pyrogenic.
Acceptance Criteria and Device Performance Study for Fresenius C.A.T.S Autotransfusion Accessories
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Compliance with applicable standards for: | Demonstrated compliance |
| - Cytotoxicity | Performed and compliant | |
| - Sensitization | Performed and compliant | |
| - Intracutaneous toxicity | Performed and compliant | |
| - Systemic toxicity | Performed and compliant | |
| - Hemocompatibility (hemolysis) | Performed and compliant | |
| - Genotoxicity | Performed and compliant | |
| - Pyrogenicity | Performed and compliant | |
| Structural Integrity | Withstand twice the flow capacity associated with use of autotransfusion devices. | Demonstrated compliance |
| Withstand twice the negative pressures associated with use of autotransfusion devices. | Demonstrated compliance | |
| Withstand twice the positive pressures associated with use of autotransfusion devices. | Demonstrated compliance | |
| Packaging & Sterility | Adequacy of packaging systems to protect devices. | Demonstrated compliance |
| Adequacy of packaging systems to maintain sterility for indicated shelf-life. | Demonstrated compliance | |
| Shelf-life of 1 year maintained. | Demonstrated compliance | |
| Overall Suitability | Satisfy requirements of AAMI/ANSI standards for autotransfusion devices. | Demonstrated compliance |
| Materials used are suitable for the intended use. | Demonstrated compliance | |
| Biocompatibility, structural integrity, packaging integrity, and sterility maintained for labeled shelf-life. | Demonstrated compliance |
2. Sample Size and Data Provenance:
The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of devices tested for structural integrity or biocompatibility). However, it implies testing was conducted on a sufficient number of devices to demonstrate compliance.
The data provenance is not explicitly stated in terms of country of origin. The studies appear to be retrospective in the sense that they were performed on manufactured devices to validate their properties and then submitted for regulatory approval.
3. Number of Experts and Qualifications for Ground Truth:
This document does not describe a study involving human experts to establish ground truth in the way one might for diagnostic imaging devices. The "ground truth" here is compliance with established engineering and biocompatibility standards. The experts involved would have been the internal Fresenius Hemotechnology, Inc. engineers, scientists, and regulatory affairs personnel responsible for designing, testing, and validating the devices against these predefined standards. Their qualifications would likely include expertise in biomaterials, medical device design, manufacturing, and regulatory compliance.
4. Adjudication Method:
Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or evaluations where human readers interpret data to establish ground truth (e.g., radiologists reading images). This type of adjudication is not applicable to the technical and performance testing described in this document for the autotransfusion accessories. The compliance was determined by direct measurement and analysis against predefined technical specifications and standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for these autotransfusion accessories as they are not AI-powered diagnostic or assistive devices requiring human interpretation.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the sense that the devices themselves were tested against technical specifications and standards (e.g., biocompatibility testing, structural integrity testing, shelf-life studies). This testing focused solely on the inherent performance characteristics of the devices without human interaction other than setting up and operating the testing equipment. The goal was to prove the devices' ability to function as intended and safely under specified conditions.
7. Type of Ground Truth Used:
The ground truth used was based on established industry standards and regulatory requirements. Specifically:
- Biocompatibility: Applicable standards for cytotoxicity, sensitization, intracutaneous toxicity, systemic toxicity, hemocompatibility (hemolysis), genotoxicity, and pyrogenicity.
- Structural Integrity: Requirements to withstand twice the flow capacity and negative/positive pressures associated with autotransfusion device use.
- Packaging and Sterility: Requirements for protecting devices, maintaining sterility, and demonstrating a one-year shelf-life.
- Overall Suitability: Compliance with AAMI/ANSI standards for autotransfusion devices.
8. Sample Size for the Training Set:
This question is not applicable. These are medical devices (tubing sets, adapters) and not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" in this context refers to the design and refinement process of the physical device, which typically involves iterations of prototypes and bench testing, but not a formally defined "training set" like in AI development.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for these physical medical devices. The design and manufacturing process would be guided by engineering principles, material science, and regulatory requirements, with validation against the "ground truth" of established standards as described in point 7.
§ 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).