(63 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.
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 and the removal of particulates/emboli from suctioned blood entering the reservoir.
The provided document describes a 510(k) premarket notification for the CAPIOX® SX Hardshell Reservoir, asserting its substantial equivalence to the predicate device, Maxima Forte (Medtronic, K961836). The acceptance criteria and "study" proving its compliance are based on a comparison to this predicate device rather than a standalone clinical study with detailed performance metrics against predefined criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are implicitly defined by the specifications and performance of the Maxima Forte predicate device. The "reported device performance" is the CAPIOX® SX Hardshell Reservoir's specifications, demonstrating substantial equivalence.
| Item | Acceptance Criteria (Predicate: Maxima Forte) | Reported Device Performance (CAPIOX® SX Reservoir) |
|---|---|---|
| Reservoir maximum volume | 4,000 mL | 4,000 mL |
| Minimum operating volume | 500 mL | 200 mL |
| Cardiotomy inlet flow rate | 1-5 LPM | 0.5-5 LPM |
| Venous flow rate | 1-7 LPM | 0.5-7 LPM |
| Cardiotomy Filtration Efficiency | 95% efficient for particles ≥20u | Greater than 90% efficiency for particles ≥20u |
| Sterility Assurance Level | Not explicitly stated but implied to be validated for marketed device | 10^-6 |
| Biocompatibility (Blood Contacting Materials) | Not explicitly stated but implied to be compliant for marketed device | Tested in accordance with FDA GPM #G95-1 / ISO-10993 |
Note: The document explicitly states, "The specifications of the CAPIOX SX Hardshell Reservoir and the Maxima Forte are substantially equivalent." Also, for the filtration efficiency, it states, "This difference in filter material does not have a significant clinical impact."
2. Sample Size Used for the Test Set and Data Provenance
No information is provided regarding a "test set" in the context of clinical or performance data for comparing the CAPIOX® SX Hardshell Reservoir directly against the predicate. The "study" is a comparison of specifications and design features for substantial equivalence. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective). The assessment is based on product specifications and engineering design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert consensus or image interpretation. The ground truth for this submission is the established performance and specifications of the legally marketed predicate device (Maxima Forte) and the design/material specifications of the new device.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring expert adjudication. The comparison is based on documented specifications and design.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe an MRMC comparative effectiveness study. The submission relies on establishing substantial equivalence to a predicate device based on design, materials, technology, and performance specifications, not on clinical effectiveness studies or human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device (a hardshell reservoir) is not an algorithm or an AI device.
7. The Type of Ground Truth Used
The "ground truth" for the substantial equivalence determination is the established specifications and performance of the predicate device (Maxima Forte) and the verified design, material, and manufacturing standards of the CAPIOX® SX Hardshell Reservoir. This includes:
- Engineering specifications (e.g., volume, flow rates, filtration efficiency).
- Material composition and biocompatibility testing (in accordance with GPM #G95-1 / ISO-10993).
- Sterility validation.
- Pyrogenicity testing.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as explained in point 8.
§ 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.