(84 days)
The CAPIOX® SX10 Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line during cardiopulmonary bypass procedures lasting up to 6 hours. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used in the vacuum-assisted venous return technique during cardiopulmonary bypass procedures lasting up to 6 hours.
CAPIOX® SX10 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 contact with the defoamer. The total capacity of the reservoir is 3000 mL. The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal and the removal of particulates/emboli from suctioned blood entering the reservoir.
There is no study described that proves the device meets specific acceptance criteria in the provided document. The document is primarily a 510(k) submission for substantial equivalence. It compares a new device (CAPIOX® SX10 Hardshell Reservoir) to a predicate device (CAPIOX® SX Hardshell Reservoir), asserting substantial equivalence rather than presenting an effectiveness study with acceptance criteria.
The document lists "Specifications" for both devices, which could be interpreted as performance criteria for the device itself rather than acceptance criteria for a study.
Here's the information as requested, based on the provided text, with many fields noted as "Not Applicable" or "Not Provided" because the document is a 510(k) submission for substantial equivalence, not a clinical or performance study report.
Acceptance Criteria and Device Performance (from Specifications Table)
| Item | Acceptance Criteria (from Predicate Device) | Reported Device Performance (CAPIOX® SX10) |
|---|---|---|
| Reservoir Volume | ||
| Maximum Volume | 3000 mL | Not explicitly stated (implied 3000 mL based on predicate) |
| Minimum Volume | 100 mL | Not explicitly stated (implied 100 mL based on predicate) |
| Blood Flow Rate During Cardiopulmonary Bypass | ||
| Cardiotomy Inlet Maximum | 0.5-5 L/min | 4.0 L/min Max. |
| Venous Flow Minimum | 0.5 L/min | 0.5 L/min Min. |
| Venous Flow Maximum | 7.0 L/min | 4.0 L/min Max. |
| Cardiotomy Filtration Efficiency | Greater than 90% efficiency for particles ≥ 20u | Greater than 90% efficiency for particles ≥ 20u |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. The document does not describe a performance or clinical study with a test set. It's a submission for substantial equivalence based on design, technology, and specifications comparison to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment by experts is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set is described.
- 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. This document pertains to a medical device (hardshell reservoir) and does not involve AI, human readers, or image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established as there is no performance study or data acquisition described. The "ground truth" for the submission is the existence and established safety/effectiveness of the predicate device.
- The sample size for the training set: Not applicable. No training set is described as this is not a machine learning or data-driven study.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is described.
Summary of the document's approach to "proof":
The document argues for substantial equivalence by demonstrating that the CAPIOX® SX10 Hardshell Reservoir has:
- The same intended use.
- Similar design and materials.
- Equivalent technology and principles of operation.
- Specifications that are either identical or whose differences "do not raise new issues of safety and effectiveness" (e.g., maximum flow rates, which are within acceptable ranges).
Safety information provided (pyrogen testing, sterilization, EO residuals, manufacturing control, biocompatibility testing via ISO-10993) addresses general device safety rather than specific performance as measured in a comparative study.
Therefore, the "proof" that the device meets "acceptance criteria" is primarily an assertion of substantial equivalence to a legally marketed predicate device, rather than data from a direct performance study establishing novel acceptance criteria. The acceptance criteria used are implicitly the performance characteristics and safety profile of the predicate device.
§ 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.