(461 days)
The Optima XP™ is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
The Optima XP™ is a hollow fiber membrane oxygenator with integral heat exchanger. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's gas exchange and body temperature regulation requirements during surgical procedures,
The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.
Here's an analysis of the provided text regarding the Optima XP device, structured according to your request:
Acceptance Criteria and Device Performance Study for Optima XP
The Optima XP is a hollow fiber membrane oxygenator with an integral heat exchanger, intended for adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The key modification from its predicate device, the Optima, is an increase in membrane surface area achieved by decreasing fiber diameter and increasing fiber count.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are implicitly defined by the goal of the device modification and comparisons to its PREDICATE DEVICE (COBE® Optima TM Hollow Fiber Membrane Oxygenator).
| Acceptance Criteria Category | Specific Criteria/Performance Aspect | Reported Device Performance (Optima XP vs. Optima) |
|---|---|---|
| Oxygen Transfer Rate | Increased oxygen transfer compared to the Optima | Increased oxygen transfer rate |
| Operating Volume | Corresponding increase in operating volume is acceptable | Higher operating volume (deemed acceptable) |
| Gas Side Pressure Drop | Corresponding increase in gas side pressure drop is acceptable | Higher gas side pressure drop (deemed acceptable) |
| Carbon Dioxide Transfer | No significant difference compared to the Optima | Not significantly different |
| Blood Pathway Pressure | No significant difference compared to the Optima | Not significantly different |
| Unrecoverable Volume | No significant difference compared to the Optima | Not significantly different |
| Blood Trauma | No significant difference compared to the Optima | Not significantly different |
| Heat Exchanger | Identical design, manufacture, and installation to predicate | Identical; not evaluated for this 510(k) as there are no changes |
| Safety & Effectiveness | As safe and effective as, and performs as well as or better than, Optima | Concluded to be as safe and effective and performs as well as or better than the Optima based on in vitro testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The study involved "in vitro testing", suggesting lab-based experiments rather than patient data.
- Data Provenance: The study was conducted as "in vitro testing." No information on country of origin is provided. It is considered retrospective in the sense that it evaluates a modified device against a pre-existing device in a controlled lab environment. No human data was collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for performance measures like oxygen transfer rate, CO2 transfer rate, pressure drops, etc., is established through direct physical measurements using standardized laboratory methods, not expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The testing relies on quantifiable physical measurements rather than subjective assessment requiring 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
- MRMC Study: No, an MRMC study was not done. This device is an oxygenator, not a diagnostic imaging device, and does not involve human readers interpreting data or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (an oxygenator), not an algorithm or AI system. Its performance is inherent to its design and material properties.
7. The type of ground truth used
- Type of Ground Truth: The ground truth was based on direct, quantitative physical measurements of various performance characteristics (e.g., oxygen transfer rate, CO2 transfer rate, blood pathway pressure drop, operating volume) obtained through in vitro testing. These measurements were then compared to those of the predicate device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the conventional sense. The device's design and performance are a result of engineering and manufacturing processes, not data-driven training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set. The "ground truth" in terms of validating the device's design and manufacturing likely involved engineering specifications, material testing, and internal quality control, rather than data-driven establishment.
§ 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.”