(22 days)
The SAFE MAXI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and to defoam and filter intra-thoracic suction blood prior to returning it to the extracorporeal circuit.
SAFE MAXI venous/cardiotomy reservoir is a hard shell reservoir with separate venous and cardiotomy inlets. The venous inlet with 175 micron venous filter is placed at the bottom of the reservoir, which provides a bottom to top venous blood flow. Returning suction blood enters the large surface area 20 micron depth filter at the top of the reservoir. The SAFE MAXI venous/cardiotomy reservoir is single-use, disposable, sterile and non-pyrogenic. The reservoir is a sealed type for vacuum applications. The maximum capacity of the reservoir is 4000 ml.
This 510(k) summary describes a medical device, the SAFE MAXI venous/cardiotomy reservoir, and its claim of substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving the device meets them through a dedicated study with defined metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted directly from this document.
However, based on the provided text, here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating similar characteristics and comparable performance to predicate devices to establish substantial equivalence.
| Characteristic / Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biocompatible and non-toxic | Determined to be biocompatible and nontoxic, based on testing of the predicate SAFE MINI reservoir due to similar design and material content. |
| Blood Cell Damage | Comparable to predicate device | Performed using the same blood pool as the Gish Biomedical reservoir, implying comparable performance. (Specific metrics of "damage" are not provided). |
| Effectiveness/Operational Characteristics | Functional as intended | Function determined by evaluating operational characteristics. (Specific metrics are not provided). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical or performance study with a defined sample size. The evaluation appears to be based on:
- Biocompatibility: Likely laboratory testing, potentially on material samples or the predicate device.
- Blood Cell Damage Test: This was performed using a "same blood pool" setup, suggesting a comparative in vitro or ex vivo experiment. The number of samples or runs is not specified.
- Effectiveness Testing: "Evaluating its operational characteristics" suggests various engineering or bench tests.
Data Provenance: Not explicitly stated, but given the manufacturer (POLYSTAN A/S, Denmark), the testing would likely have taken place in a laboratory setting, possibly in Denmark or the US. The nature of these tests (e.g., in vitro, bench testing) means they are not "retrospective" or "prospective" in the clinical trial sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of device evaluation (substantial equivalence to predicates for a physical component) does not involve expert consensus on "ground truth" derived from clinical cases, as would be common for diagnostic algorithms or imaging devices.
4. Adjudication Method for the Test Set
Not applicable. As above, this isn't a study design that involves expert adjudication of findings.
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 passive medical component (blood reservoir) and does not involve AI or human "readers."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical component, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices. The device's substantial equivalence is established by demonstrating (through laboratory/bench testing) that its performance and safety characteristics are comparable.
- Biocompatibility: Chemical and biological testing standards (e.g., ISO 10993).
- Blood Cell Damage: Measured parameters (e.g., free hemoglobin, platelet activation) in an in vitro setup.
- Effectiveness: Engineering performance metrics (e.g., flow rates, defoaming efficiency, filtration efficacy, volume capacity).
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.