(22 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 may also be used with vacuum-assisted venous return procedures during cardiopulmonary bypass procedures lasting up to 6 hours.
The design of the CAPIOX® SX10 Reservoir consists of a hard casing reservoir containing blood filters. It has a rotatable venous blood inlet port that permits minimizing tubing lengths, which could result in lower circuit priming volumes. The total capacity of the reservoir is 3000 mL.
The CAPIOX® SX10 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, thus permitting blood to reside in the lower-section of the reservoir.
The cardiotomy section of the SX10 Reservoir contains a defoamer and a "sock-like" filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.
The generic materials used in the CAPIOX® RX Hardshell Reservoir are polycarbonate. polypropylene, polyethylene terephthalate, silicone, polyvinyl chloride, polyurethane, nylon, stainless steel, ceramic, and polymer coating solutions.
Here's a breakdown of the acceptance criteria and study information for the CAPIOX® SX10 Hardshell Reservoir, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied/Compared To Predicate) | Reported Device Performance |
|---|---|---|
| Filter Defoaming | Substantially equivalent to predicate device (K991973) | Performance comparison studies demonstrated no clinically significant differences, indicating similar defoaming capabilities. |
| Pressure Drop | Substantially equivalent to predicate device (K991973) | Performance comparison studies demonstrated no clinically significant differences, implying similar pressure drop profiles. |
| Filtration Efficiency | Substantially equivalent to predicate device (K991973) | Performance comparison studies demonstrated no clinically significant differences, suggesting equivalent particulate removal. |
| Effects Upon Cellular Blood Components | Substantially equivalent to predicate device (K991973), maintaining similar blood compatibility. | Performance comparison studies demonstrated no clinically significant differences. Additionally, biocompatibility studies (ISO 10993) on blood-contacting materials found them to be biocompatible, and an in-vivo animal study of the polymer coating noted no adverse conditions, implying no adverse effects on cellular blood components. |
| Pressure Integrity Testing | Substantially equivalent to predicate device (K991973) | Performance comparison studies demonstrated no clinically significant differences, implying equivalent structural integrity under pressure. |
| Fluid Breakthrough Time | Substantially equivalent to predicate device (K991973) | Performance comparison studies demonstrated no clinically significant differences, indicating similar performance in preventing fluid breakthrough. |
| Sterilization Conditions | AAMI guidelines, Sterility Assurance Level (SAL) of 10-6 | Validated in accordance with AAMI guidelines to provide a SAL of 10-6. |
| Ethylene Oxide Residues | Not to exceed maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended). | Will not exceed the maximum residue limits. |
| Biocompatibility | Recommended by FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration]. | Blood contacting materials were found to be biocompatible. |
| Material Stability | Stable over the expiry of the product. | Material characterization studies (physico-chemical profiles of aged and non-aged devices) demonstrated stability of the materials over the product's expiry. |
| Polymer Coating Safety | No adverse conditions in-vivo. | Evaluated in an in-vivo animal study; no adverse conditions were noted. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the performance comparison tests (Filter Defoaming, Pressure Drop, Filtration Efficiency, Effects Upon Cellular Blood Components, Pressure Integrity Testing, Fluid Breakthrough Time). It generically refers to "comparison studies of the performance."
The data provenance is not specified. It can be inferred that the testing was conducted by Terumo Corporation, likely at their Ashitaka Factory in Japan, as this is the submitter's location. The studies are retrospective in the sense that they are comparing a new device against an existing, cleared predicate device, but the tests themselves were performed anew for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The performance tests are laboratory or bench tests, not clinical studies involving expert interpretation of medical images or data. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not applicable here. The "ground truth" for these tests would be the established scientific or engineering methods for measuring the stated parameters (e.g., standard methods for measuring pressure drop or filtration efficiency).
4. Adjudication Method for the Test Set
This information is not applicable as the studies are technical performance tests, not studies requiring human adjudication of clinical outcomes or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a blood reservoir for cardiopulmonary bypass, and its evaluation focuses on physical and biological performance characteristics rather than diagnostic accuracy or human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations (Filter Defoaming, Pressure Drop, etc.) would be established through scientific and engineering measurements performed using standardized laboratory protocols. For biocompatibility, the ground truth relies on established international standards (ISO 10993) and in-vivo animal study observations. For sterilization and ethylene oxide residues, the ground truth is based on regulatory guidelines (AAMI, FDA regulations).
8. The Sample Size for the Training Set
This question is not applicable as this is a physical medical device and not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of device submission.
§ 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.