(147 days)
The Capiox® FX Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.
The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures.
The Capiox® FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir (both 3-liter and 4-liter) is for use with patients when the required blood flow rate will not exceed 5.0 L/min.
The Capiox® FX25 Advance is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox® FX Advance Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
The Capiox® FX15 Advance devices each contain an integrated heat exchanger system and an integrated arterial filter. and a detachable hardshell reservoir. The oxygentor/arterial filter module can be used independent of the hardshell reservoir since the performance of the oxygenator/arterial filter is not dependent upon the use of a Terumo reservoir. The design provides an integrated system for ease of use and offers options to the user-perfusionist.
The Capiox® FX15 Advance devices are membrane-type oxygenators that consists of microporous hollow polypropylene fibers. When in use, blood flows around the outside of fibers while gas flows through the inside of the fibers. Because the fibers are micro-porous, gas exchange can occur through the fiber walls by way of diffusion. The Capiox® FX15 Advance Oxygenator module is comprised of a wound fiber design whereby continuous strands of fiber are wound around a core support structure. The total amount of fiber that is exposed to blood and gas is approximately 1.5 m2 for the FX15 models.
The screen mesh material that comprises the Arterial Filter is made of polyethylene terephthalate (PET) -and is wrapped around the outside of the hollow fiber membrane. This 32 micron mesh is responsible for the filtration of particulates from the blood stream, and also facilitates air removal from the blood.
The integrated heat exchanger contains a stainless steel bellows that facilitates the transfer of heat. The heat exchanger has a water inlet port and a water outlet port to allow water (from an external water bath) to enter and flow to the inside of steel bellows to effectively control the temperature of the blood that flows on the outside of the steel bellows.
The Capiox® FX15 Advance Oxygenator may be used with a 3-liter or 4-liter hardshell blood reservoir. The reservoir includes a positive pressure relief valve that is incorporated into the lid of the reservoir. The relief valve permits the release of positive pressure within the reservoir. . ,
This is an FDA 510(k) premarket notification for the Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir. The document focuses on demonstrating substantial equivalence to a predicate device (Terumo Capiox FX Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir - K140774), rather than providing a detailed study description with acceptance criteria and device performance results in the format requested.
Therefore, much of the requested information, particularly quantitative acceptance criteria, specific device performance numbers, and details on ground truth establishment, sample sizes for training/test sets, expert qualifications, and adjudication methods for AI/ML studies, is not present in this document. The device is a physical medical device, not an AI/ML diagnostic tool, which further explains the absence of certain requested AI/ML specific information.
Here's what can be extracted and inferred based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table with explicit numerical acceptance criteria and reported device performance for each parameter. Instead, it states that "Performance evaluations have demonstrated equivalence between the varying designs" and "The subject Capiox® FX15 Advance devices exhibit equivalent performance to the predicate devices."
The types of performance evaluations conducted for the reservoir are listed as:
- Verification Testing of Curved Inlet Reservoir Connections
- Verification Testing of Pressure Drop
- Verification Testing of Hemolysis
- Verification Testing of Reservoir Venous Filter Defoaming
- Verification Testing of Clotting Performance
- Air Handling (Worst Case challenge with 4 Liter Reservoir at hi flow rate)
- Flow Dynamics of Curved Inlet Port
For each of these, the implicit acceptance criterion is "equivalence to the predicate device" or "meeting specifications" without providing specific thresholds or numerical results.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The evaluations are described as "simulated use performance evaluations on the reservoir." This suggests laboratory testing on multiple units or configurations, but the exact number of units or test runs is not provided.
- Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective) as these are non-clinical, simulated-use engineering performance tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This document describes performance testing of a physical medical device, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for these performance tests would be established by the physical and chemical properties of blood and the device, measured by calibrated instruments and standard protocols.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
- No. This is not an algorithm. The performance tests are for the physical device itself.
7. The Type of Ground Truth Used:
- For the performance evaluations, the "ground truth" implicitly refers to objective measurements of physical properties and chemical interactions (e.g., pressure drop, hemolysis rates, de-foaming efficiency, clotting time) using established scientific and engineering methodologies, often compared against predefined specifications or the performance of the predicate device.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”