(61 days)
The Dideco D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for 6 hours or less.
The D 905 EOS Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservoir (hereafter referred to as the D 905 EOS) is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir. The device is a modified version of the currently marketed D 903 Avant 2 Ph.I.S.I.O (K033323) predicate device (hereafter referred to as the Avant Ph.1.S.I.O.). The modification is limited to an overall reduction in the size of the device. The reduction in size enables the device to be better suited for the pediatric and small adult patient population.
Here's an analysis of the provided text regarding the D 905 EOS Oxygenator, extracting information relevant to acceptance criteria and the study proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a dedicated table. Instead, it states that the test results "met established specifications" and that the device is "substantially equivalent" to predicate devices. The performance is reported in relation to these comparisons.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:1995 and FDA guidelines; Sterility; Non-pyrogenicity; ETO residuals; Package Integrity | Met established specifications for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity, Mutagenicity, Sterility, Pyrogenicity, ETO residuals, and Package Integrity. |
| Gas Transfer Characteristics | Comparable to predicate devices (Avant Ph.I.S.I.O. and Cobe Optimin) | Showed substantial equivalence to Cobe Optimin and comparable to Avant Ph.I.S.I.O. |
| Pressure Drop | Comparable to predicate devices | Showed substantial equivalence to Cobe Optimin and comparable to Avant Ph.I.S.I.O. |
| Plasma Leakage Data | Met established specifications | Met established specifications. |
| Operating Blood Volumes | Met established specifications | Met established specifications. |
| Heat Exchanger Performance | Met established specifications | Met established specifications. |
| Hemolysis/Cell Depletion | Met established specifications | Met established specifications. |
| Mechanical Integrity | Met established specifications | Met established specifications. |
| Venous Cardiotomy Reservoir Characterization | Comparable to predicate devices (Avant Ph.I.S.I.O.) and met established specifications for various parameters. | Showed substantial equivalence to Avant Ph.I.S.I.O. for breakthrough times, volumes, graduated scale accuracy, residual blood volume, defoaming capacity, filtration efficiency, and reservoir housing integrity. |
| Leaching Studies | Met established specifications | Met established specifications. |
| Clinical Performance (Post-Market) | No reports of adverse events due to malfunctioning. | In commercial distribution in Europe since March 2003 with no reported adverse events. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size for each performance characteristic. Instead, it refers to in-vitro testing performed on the "D 905 EOS" (the device itself) and, "for comparative purposes," on the "D 903 Avant 2 Ph.I.S.I.O." and the "Cobe Optimin predicate device."
- Sample Size: Not explicitly stated as a number of devices or data points for the in-vitro tests. It refers to testing the device and predicate devices.
- Data Provenance: Retrospective for the predicate devices as they are "legally marketed." Prospective for the D 905 EOS, as the testing was conducted to support its 510(k) submission. There is no mention of country of origin for the data collection, but the submitter is Italian (Dideco S.r.l.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are in-vitro tests, which typically rely on standardized laboratory measurements and comparison to objective specifications and predicate device performance, rather than expert judgment for "ground truth."
4. Adjudication Method for the Test Set
Not applicable. As described above, the studies are in-vitro tests with objective measurements, not studies requiring expert adjudication.
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 medical oxygenator, not an AI-based diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the context of imaging or similar interpretation tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device itself is a standalone medical device. The "standalone" concept typically applies to software or AI algorithms operating independently of human intervention. Here, the device's performance was evaluated in various standalone in-vitro tests.
7. The Type of Ground Truth Used
The "ground truth" for the in-vitro performance characteristics was established by:
- Established Specifications: These would be pre-defined numerical or qualitative criteria based on regulatory guidelines, engineering principles, and clinical requirements for oxygenators.
- Predicate Device Performance: The functional parameters of the D 903 Avant 2 Ph.I.S.I.O. and Cobe Optimin served as benchmarks for demonstrating substantial equivalence.
There is no mention of pathology, outcomes data, or expert consensus (in the context of clinical interpretation) as ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a software algorithm that would require a "training set" in the context of machine learning. The term "training set" refers to data used to train an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as point 8.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”