(33 days)
The Capiox® Advance 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 blood to the patient for blood volume replacement.
The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.
The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.
The device may be used for procedures lasting up to 6 hours.
The Capiox® Advance Hardshell Reservoir device and the predicate Capiox® RX Hardshell Reservoir device are both used as a blood storage devices during and after cardiopulmonary bypass procedures. Venous blood enters the reservoir via gravity, or by way of external vacuum that may be applied to the reservoir.
Venous blood that is drawn from the patient enters the device via the venous blood inlet port. The blood passes through a defoamer to remove air bubbles from the blood and through a filter to remove particulates from the blood.
Blood may also be suctioned into the reservoir from the cardiotomy field. This blood enters the device through the cardiotomy blood suction ports. The blood passes through a defoamer to remove air bubbles from the blood and through a filter to remove particulates from the blood.
Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.
The design of the Capiox® Advance Hardshell Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. It contains a rotatable venous blood inlet port. The total capacity of the reservoir is 4000mL.
The venous section of the reservoir contains a filter for particulate matter removal and a defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter for particulate matter removal and a defoamer to facilitate air bubble removal.
The provided text describes a 510(k) premarket notification for the Capiox® Advance Hardshell Reservoir (K153143). This is an administrative document for a medical device and, as such, it does not contain the detailed data from clinical studies with acceptance criteria, sample sizes, or ground truth establishment that would be present in a research paper.
However, I can extract the relevant information that is available about the performance evaluations and what they aim to show for the device:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Performance Evaluations" that were conducted to establish substantial equivalence to a predicate device (Capiox® RX Hardshell Reservoir; K130359). However, it does not provide specific numerical acceptance criteria or the reported device performance for each evaluation. It simply lists the types of tests performed.
| Performance Evaluation Type | Acceptance Criteria (Not provided in source) | Reported Device Performance (Not provided in source) |
|---|---|---|
| Air Handling Performance | Not specified | Not specified |
| Hemolysis | Not specified | Not specified |
| Venous Filter Dynamic Hold Up and/or Pressure Drop | Not specified | Not specified |
| Vacuum Testing (Product Integrity, Large Venous Port-O-Ring Seal) | Not specified | Not specified |
| Burst, Leak, Circulation, and/or Pull Testing to Evaluate Venous Port and Tubing Connection Integrity | Not specified | Not specified |
| Pre-Connect Evaluation | Not specified | Not specified |
| Package Testing | Not specified | Not specified |
The document states that "Clinical studies involving patients are not necessary to demonstrate substantial equivalence... Substantial equivalence is demonstrated with the following in-vitro performance evaluations." This indicates that the evaluations listed above are the studies that demonstrate the device meets the necessary criteria for substantial equivalence, implying their results were favorable and met internal company-defined specifications, even if those are not explicitly detailed here.
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the Capiox® Advance Hardshell Reservoir to the predicate device." Therefore, there was no test set with human patient data used for this 510(k) submission.
The provenance of the data for the in-vitro performance evaluations is not specified, but it would typically be internal laboratory testing conducted by Terumo Cardiovascular Systems Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical studies with human patient data were conducted that would require expert-established ground truth. The evaluations were in-vitro tests, likely with predefined physical or chemical standards.
4. Adjudication method for the test set
Not applicable, as no test set with human patient data was used.
5. 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 device is a cardiopulmonary bypass hard-shell reservoir, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the in-vitro performance evaluations would be the established scientific and engineering standards and specifications for devices of this type, as well as the performance of the predicate device. For example:
- Air Handling Performance: Likely measured against predefined thresholds for air bubble removal efficiency.
- Hemolysis: Measured against acceptable levels of blood cell damage according to ISO standards or industry best practices.
- Venous Filter Dynamic Hold Up and/or Pressure Drop: Measured against specifications ensuring adequate blood flow and minimal retention.
- Product Integrity/Seal, Burst, Leak, Circulation, Pull Testing: Measured against engineering specifications for mechanical strength and leak resistance.
- Pre-Connect Evaluation: Likely assessed for ease of connection and secure fit.
- Package Testing: Assessed against standards for maintaining sterility and integrity during shipping and storage.
These "ground truths" are based on engineering principles, industry standards (e.g., ISO), and the performance characteristics of the legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary:
The provided document describes a 510(k) premarket notification for a Class II medical device, the Capiox® Advance Hardshell Reservoir. The submission relies on demonstrating "substantial equivalence" to a predicate device through in-vitro performance evaluations rather than clinical studies with human patients. As such, information typically found in detailed studies evaluating diagnostic algorithms (like acceptance criteria, sample sizes for human readers/patients, ground truth establishment by experts, or AI-specific studies) is not present. The "studies" in this context are a series of laboratory-based engineering and performance tests designed to confirm that the modified device functions comparably and safely to its predicate.
§ 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.