(67 days)
The CAPIOX® Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. The device may be used for procedures lasting up to 6 hours.
The design of the CAPIOX® Cardiotomy 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. The total capacity of the reservoir is 1000 mL. The cardiotomy section of the CAPIOX® Cardiotomy Reservoir contains a defoamer and a filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.
Here's a breakdown of the acceptance criteria and the study information for the CAPIOX® Cardiotomy Reservoir, based on the provided text:
Summary of Acceptance Criteria and Device Performance
The device's acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to predicate devices. This means that its performance must be comparable to, and not raise new questions of safety or effectiveness compared to, established devices already on the market. The study aims to prove this equivalence.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The CAPIOX® Cardiotomy Reservoir and the predicate CAPIOX® RX05 Hardshell Reservoir share the same intended uses: facilitating removal of particulate matter and micro air bubbles from aspirated blood, and storing it during extracorporeal circulation for procedures up to 6 hours. |
| Principles of Operation/Technology Equivalence | Both the CAPIOX® Cardiotomy Reservoir and the predicate CAPIOX® RX05 Hardshell Reservoir utilize the exact same technology: blood enters via inlet/suction ports, passes through a defoamer and filter, and exits via gravity. |
| Design and Materials Equivalence | The CAPIOX® Cardiotomy Reservoir's design and materials are identical to the predicate CAPIOX® RX05 Hardshell Reservoir, with the only difference being the absence of a venous filter in the proposed device. No new materials are used. |
| Performance Equivalence | The cardiotomy section of the CAPIOX® Cardiotomy Reservoir is exactly the same as the cardiotomy section of the predicate CAPIOX® RX05 Hardshell Reservoir. Therefore, there are no performance differences between their cardiotomy sections. Comparative studies with the Medtronic Minimax Reservoir further demonstrated substantial equivalence for select performance evaluations. |
| Sterilization Assurance Level (SAL) | Sterilization conditions validated in accordance with AAMI guidelines to provide an SAL of 10^-6. |
| Biocompatibility | Biocompatibility studies conducted on the CAPIOX® RX25 Hardshell Reservoir (constructed of the same materials) were referenced. Blood-contacting materials satisfied all biocompatibility test specifications as per ISO 10993 for External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours). |
| Specific Performance Tests | - Filter Defoaming Cardiotomy Section: |
- Pressure Drop Cardiotomy Section:
- Filtration Efficiency Cardiotomy Section:
- Effects Upon Cellular Blood Components:
- Pressure Integrity Testing:
- Tubing Connection Strength:
- Filter Breakthrough Time:
(Detailed results for these specific tests are not provided in the text, only that the tests were conducted.) |
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "comparative studies" and "tests were conducted" without providing specific numbers of devices or test runs. Given the nature of medical device testing (e.g., sterilization, biocompatibility, mechanical performance), it would involve a sufficient number of units to ensure statistical validity and representativeness, but the exact count is not given.
- Data Provenance: Not explicitly stated. However, given that Terumo Cardiovascular Systems (a US-based company) is submitting a 510(k) to the FDA, it is highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The testing appears to be prospective in nature, as it was conducted specifically to demonstrate equivalence for this new device submission.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of device (a cardiotomy reservoir) does not typically involve expert consensus for "ground truth" in the way a diagnostic AI algorithm might. The "ground truth" for its performance is established through objective engineering and biological tests (e.g., measuring filtration efficiency, pressure drop, cellular damage, sterility, biocompatibility) against predetermined specifications or established predicate device performance.
- Therefore, no information on the number or qualifications of experts establishing "ground truth" in this context is provided or relevant. The "ground truth" comes from the physical and chemical properties of the device and its interaction with blood.
-
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading by radiologists) used to establish ground truth for AI algorithms. For medical devices like this, the performance is measured objectively through assays and tests, not subjective expert judgment.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The CAPIOX® Cardiotomy Reservoir is mechanical blood processing device, and its evaluation does not involve human "readers" or diagnostic tasks that would benefit from such a study.
-
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Not applicable. This device is not an algorithm or AI system. Its performance is inherently standalone in the sense that it functions physically and biologically without human "input" for its core operation (processing blood). The "standalone performance" is what the various engineering and biological tests were designed to assess.
-
Type of Ground Truth Used:
- The "ground truth" is based on objective measurements, laboratory test results, and established standards. This includes:
- Biocompatibility test results: Against ISO 10993 standards.
- Sterilization validation: Against AAMI guidelines for SAL.
- Physical performance measurements: Such as filtration efficiency, pressure drop, pressure integrity, tubing connection strength, and filter breakthrough time, benchmarked against predicate devices.
- Cellular effects: Assessment of impact on blood components.
- The "ground truth" is based on objective measurements, laboratory test results, and established standards. This includes:
-
Sample Size for the Training Set:
- Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set." The device itself is manufactured, and its performance is evaluated, not "trained."
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for a mechanical medical device like this.
§ 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.