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510(k) Data Aggregation
(355 days)
The COBE Optima™ and CML Duo™ are 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 COBE Optima™ is a hollow fiber membrane oxygenator with integral heat exchanger. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy the patient's gas exchange and body temperature regulation requirements.
The CML Duo™ is a flat sheet membrane oxygenator with integral heat exchanger. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy the patient's gas exchange and body temperature regulation requirements.
The products are sterilized by ethylene oxide gas and have nonpyrogenic fluid pathways.
Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study proving the device meets them, presented in the requested format:
Acceptance Criteria and Device Performance Study for COBE® Optima™ and CML Duo™ Membrane Oxygenators with Seal Modifications
This 510(k) submission (K964043) covers modifications to the COBE Optima™ end cap-to-core joint and the COBE Optima™ and CML Duo™ heat exchanger seals. The core assertion is that these modifications do not significantly change the specifications or performance of the devices. Therefore, the acceptance criteria are based on demonstrating that the modified devices perform equivalently to the predicate devices in critical areas.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Performance | Blood pathway pressure drop for the modified COBE Optima oxygenator should not significantly change from the predicate device. | "Blood pathway pressure drop... for the COBE Optima oxygenator with modified seals were tested and did not significantly change from the predicate device." |
| Blood pathway integrity for the modified COBE Optima oxygenator should not significantly change from the predicate device. | "Blood pathway integrity for the COBE Optima oxygenator with modified seals were tested and did not significantly change from the predicate device." | |
| Blood pathway pressure drop for the modified CML Duo oxygenator should not significantly change from the predicate device. | "Blood pathway pressure drop... for the CML Duo oxygenator with modified seals were tested and did not significantly change from the predicate device." | |
| Blood pathway integrity for the modified CML Duo oxygenator should not significantly change from the predicate device. | "Blood pathway integrity for the CML Duo oxygenator with modified seals were tested and did not significantly change from the predicate device." | |
| Biocompatibility | Raw materials used for the modifications must be safe for use in the COBE Optima and COBE CML Duo. | "Biocompatibility tests of the raw materials used for these modifications indicate that they are safe for use in the COBE Optima and the COBE CML Duo." |
| Manufacturing/Sterilization | Modifications should not lead to significant changes in manufacturing processes or sterilization methods. (Implied acceptance by the FDA's "no significant changes" statement) | "There are no significant changes being made to the processes used to manufacture or sterilize the devices." (This statement is a declaration by the manufacturer, implicitly accepted by the FDA's clearance). |
| Labeling | Modifications should not result in any labeling changes. (Implied acceptance by the FDA's "no labeling changes" statement) | "These modifications will not result in any labeling changes for the devices..." (This statement is a declaration by the manufacturer, implicitly accepted by the FDA's clearance, as the FDA explicitly mentions "for the indications for use stated in the enclosure" without requiring new labeling for performance changes). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Blood pathway pressure drop and blood pathway integrity... were tested" but does not provide specific numbers of devices tested or the number of measurements taken.
- Data Provenance: The testing was "in vitro." This implies laboratory testing, likely conducted by the manufacturer (COBE Cardiovascular, Inc.) to compare the modified devices to the predicate devices. The country of origin of the data is not specified, but given the manufacturer's location (Arvada, CO, USA), it's highly probable the testing occurred in the USA. The testing is prospective in the sense that it was conducted on the modified devices before market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for a medical device modification and relies on in vitro engineering and materials testing, not a clinical study involving human patients or expert interpretation of diagnostic images/data to establish ground truth. The "ground truth" for these tests is based on established engineering principles and measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was in vitro testing. There was no need for human adjudication of results in the way it would be applied in a clinical trial or diagnostic performance study. The evaluation likely involved direct measurement and comparison to predefined engineering specifications or performance ranges derived from the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). The current submission pertains to the physical and functional performance of a blood-oxygenating device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device. The in vitro testing can be considered "standalone" in the sense that it evaluates the device's intrinsic performance characteristics without human involvement beyond operating the testing equipment.
7. The Type of Ground Truth Used
The ground truth for this in vitro testing was based on:
- Functional Performance Metrics: Direct measurements of physical attributes like blood pathway pressure drop and blood pathway integrity, compared to the established performance of the legally marketed predicate devices.
- Biocompatibility Standards: Results of biocompatibility tests on raw materials, likely conforming to ISO or other recognized standards for medical device materials, demonstrating safety for patient contact.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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