(47 days)
The Capiox FX Hollow Fiber Oxygenator and Arterial Filter 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 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.
The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
The Capiox FX device is a modification of the Capiox RX device that has an arterial filter integrated into the design. The design of the oxygenator device is such that it utilizes an integrated oxygenator/heat exchanger module that provides for gas transfer (blood oxygenation and carbon dioxide removal) and for blood temperature control. The RX Oxygenator/Arterial Filter device also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The filter contained within the oxygenator module is comprised of 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator fiber bundle. This design permits the oxygenation of blood and removal of carbon dioxide as blood passes through the fiber bundle and also facilitates blood filtration after the blood has been oxygenated. Air removal is accomplished by entrapment followed by permeation of the air into the hollow fibers of the oxygenator bundle - and subsequently is exhausted (along with carbon dioxide) via the gas outlet port. The materials used include polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.
Acceptance Criteria and Device Performance for TERUMO CAPIOX® FX Hollow Fiber Oxygenator
The TERUMO CAPIOX® FX Hollow Fiber Oxygenator with Integrated Arterial Filter (K071494) was evaluated through a series of in-vitro performance tests to demonstrate substantial equivalence to predicate devices (Terumo's Capiox® RX15 Oxygenator/Reservoir K051997, Terumo's Capiox® RX25 Oxygenator/Reservoir K040210, and Terumo's Capiox® AF125X Arterial Filter K052205). Clinical studies were not deemed necessary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for each test. Instead, it states that the device "exhibited performance that is deemed to be substantially equivalent to the performance of the predicate devices" based on the evaluations. The tests conducted and the general performance statements are summarized below:
| Performance Evaluation Category | Reported Device Performance |
|---|---|
| Gas Transfer | Deemed substantially equivalent to predicate devices. |
| Effects on Blood Components (Hemolysis) | Deemed substantially equivalent to predicate devices. |
| Pressure Drop | Deemed substantially equivalent to predicate devices. |
| Mechanical Integrity | Deemed substantially equivalent to predicate devices. |
| Static Priming Volume | Deemed substantially equivalent to predicate devices. |
| Heat Exchanger Performance | Deemed substantially equivalent to predicate devices. |
| Filtration Efficiency | Deemed substantially equivalent to predicate devices. |
| Air Handling | Deemed substantially equivalent to predicate devices. |
| Tubing Connection Strength | Deemed substantially equivalent to predicate devices. |
| Sterilization Conditions | Validated in accordance with AAMI guidelines to provide a SAL of 10-6. Ethylene oxide residues will not exceed maximum limits. |
| Biocompatibility | Blood contacting materials found to be biocompatible as per ISO 10993. |
| Polymer Coating (PMEA) | Evaluated in an in-vivo animal study; no adverse conditions noted. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for the independent performance evaluation tests (test set). The studies were in-vitro evaluations.
- Data Provenance: The studies were internal in-vitro performance evaluations conducted by Terumo Corporation (Ashitaka Factory), Fujinomiya City, Shizuoka Pref., Japan. The specific country of origin for the data generation is Japan. The studies are prospective in nature, as they were conducted to support the 510(k) submission for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable. The ground truth for the in-vitro physical and biological performance tests would be established by standard engineering and biocompatibility testing methodologies, not by expert consensus in the typical sense of diagnostic accuracy studies. The equivalence is drawn against established predicate devices, implying that their performance serves as a benchmark for "ground truth" or acceptable performance in these technical domains.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation. For in-vitro engineering and biological performance tests, the results are quantitative or qualitative assessments against defined standards or predicate device performance, not subject to subjective adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not pertinent to the in-vitro performance evaluation of this medical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was conducted. The performance evaluations listed (Gas Transfer, Hemolysis, Pressure Drop, etc.) are all conducted on the device itself, without human intervention for direct performance measurement. These are in-vitro tests designed to assess the device's inherent functional characteristics and safety.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluations was based on:
- Engineering Standards and Specifications: For tests like Pressure Drop, Mechanical Integrity, Static Priming Volume, and Tubing Connection Strength.
- Biological Performance Benchmarks: For tests like Gas Transfer, Effects on Blood Components (Hemolysis), Filtration Efficiency, and Air Handling, the "ground truth" or acceptable performance was defined by demonstrating substantial equivalence to the performance of legally marketed predicate devices, and adherence to accepted medical device performance expectations for cardiopulmonary bypass equipment.
- Regulatory Guidelines and Recognized Standards: For Sterilization (AAMI guidelines), Biocompatibility (ISO 10993), and the safety of the PMEA coating (demonstrated through prior FDA clearances and an in-vivo animal study).
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of this device's performance evaluation. The device is not an AI/ML algorithm that learns from data. Its performance is inherent to its design and materials, and it is validated through direct testing.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #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.”