(78 days)
The CAPIOX SX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement
The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.
CAPIOX® SX hardshell reservoir has a rotatable venous blood inlet port to permit minimizing tubing lengths which could result in lower circuit priming volumes.
The Hardshell reservoir contains a defoamer and a screen filter in the venous blood inlet section. The defoamer resides in the upper part of the reservoir permitting blood to reside in the lower section of the reservoir while not in constant contact with the defoamer. The total capacity of the reservoir is 4,000 mL.
The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal of particulates/emboli from suctioned blood entering the reservoir.
The provided text describes the acceptance criteria for the CAPIOX® SX Hardshell Reservoir and states that the device meets these criteria through substantial equivalence to predicate devices, rather than through a direct study.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the CAPIOX® SX Hardshell Reservoir are established by demonstrating substantial equivalence to the Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir. The device's performance aligns with these criteria through direct comparison of specifications and operational principles.
| Item | Acceptance Criteria (Predicate Devices: Bentley HSR4000/BMR) | Reported Device Performance (CAPIOX SX Hardshell Reservoir) |
|---|---|---|
| Reservoir volume | ||
| Maximum | 4,500 mL | 4,000 mL |
| Minimum operating volume | 300 mL | 200 mL |
| Blood flow rate during CPB | ||
| Cardiotomy inlet | 1-5 LPM | 0.5-5 LPM |
| Venous flow | 1-7 LPM | 0.5-7 LPM |
| Cardiotomy Filtration Efficiency | 80% efficiency for particles > 20u | Greater than 90% efficiency for particles ≥20u |
| Intended Use | Blood storage during extracorporeal circulation, post-operative chest drainage/autotransfusion, vacuum assisted venous return (for BMR) | Blood storage during extracorporeal circulation, post-operative chest drainage/autotransfusion, vacuum assisted venous return |
| Design | Clear plastic casing, filter and defoamer elements | Clear plastic casing, filter and defoamer elements |
| Technology/Principles of Operation | Gravity and/or external vacuum for blood collection, air removal via defoamers, particulate removal via filters | Gravity and/or external vacuum for blood collection, air removal via defoamers, particulate removal via filters |
Study Details
The provided document does not describe an independent study to prove the device meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. Therefore, many of the requested study details are not applicable.
- Sample size used for the test set and the data provenance: Not applicable, as a direct performance study with a test set is not described. The device's equivalence is based on comparing specifications and design.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set with ground truth established by experts is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. The device is a medical reservoir, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical reservoir, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for substantial equivalence is the established performance and safety profile of the predicate devices, inferred from their regulatory clearance.
- The sample size for the training set: Not applicable, as no machine learning model or training set is described.
- How the ground truth for the training set was established: Not applicable.
Additional Safety Information (As per the document, not a "study")
The document does include additional safety information, which are compliance statements rather than a performance study:
- Pyrogen Testing: Indicated as performed.
- Sterilization conditions: Validated to provide a Sterility Assurance Level (SAL) of 10^-6.
- Ethylene oxide residuals: Will not exceed maximum residue limits.
- Manufacturing control testing: Performed.
- Blood contacting materials: Tested in accordance with FDA General Program Memorandum #G95-1 (ISO-10993 for external communicating devices/circulating blood/limited contact duration).
Conclusion: The CAPIOX® SX Hardshell Reservoir was determined to meet acceptance criteria by demonstrating "substantial equivalence" to predicate devices (Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir) based on intended use, design, technology/principles of operation, and specifications. No direct performance study with a test set as typically understood for diagnostic devices was conducted or described in this summary.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.