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510(k) Data Aggregation
(76 days)
The COBE® Sentry® SMAR T™ 43 Micron Arterial Filter with PrimeGard® is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours.
The COBE® Sentry® SMAR T™ 43 Micron Arterial Filter with PrimeGard® is a sterile device with a nonpvrogenic fluid pathway. It is for single use only and is not to be resterlized by the user. The device is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours. It is designed to filter out micro-particles intrough the arterial line of a cardiopulmonary bypass circuit.
The Sentry® SMAR,T™ Arterial Filter consists of a transparent cap and casing with 3/8" barbed inlet and outlet ports. The cap has an integral luer lock vent/purge port. The filter cartridge consists of a 43 micron screen filter media, fan-folded with support netting. The filter cartridge is attached to an internal support which minimizes the blood volume within the device and directs blood flow. Blood coming into the device contacts the flow director plate of the support, which slows the blood flow to facilitate removal of air. The PrimeGard® heparin coating enhances air removal during priming. The Sentry® SMAR,T™ Arterial Filter contains surface-modifying additives that improve the blood compatibility of the device.
The provided text describes a 510(k) pre-market notification for a medical device, the COBE® Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard®. This submission is for a new version of an existing device, primarily adding surface-modifying additives to improve blood compatibility.
Based on the information provided, here's an analysis of the acceptance criteria and study as requested, with a significant caveat that specific acceptance thresholds are not explicitly stated in this document. The document focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance targets against a predefined standard.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not provide a table with explicit numerical acceptance criteria. Instead, the "acceptance criteria" are implied to be that the new device performs similarly or better than the predicate device across various performance aspects, and that the addition of new materials does not negatively affect safety and effectiveness. The reported performance is a statement of substantial equivalence across these performance areas.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Demonstrated similar or better mechanical integrity than predicate. | Performance tests were performed to demonstrate substantial equivalence to the currently marketed COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®. (Implies satisfactory mechanical integrity). |
| Air Challenge | Demonstrated similar or better air removal capability than predicate. | Performance tests were performed to demonstrate substantial equivalence... (Implies satisfactory air challenge performance). |
| Pressure Drop | Demonstrated similar or acceptable pressure drop compared to predicate. | Performance tests were performed to demonstrate substantial equivalence... (Implies acceptable pressure drop). |
| Blood Trauma | Demonstrated similar or less blood trauma (platelet reduction, WBC reduction, plasma free hemoglobin) than predicate. | Performance tests were performed to demonstrate substantial equivalence... (Implies acceptable levels of blood trauma, or an improvement). In-vitro testing also performed to demonstrate improved blood compatibility. |
| Filtration Efficiency | Demonstrated similar or better filtration efficiency than predicate. | Performance tests were performed to demonstrate substantial equivalence... (Implies satisfactory filtration efficiency). |
| Ease of Prime | Demonstrated similar or improved ease of priming compared to predicate. | Performance tests were performed to demonstrate substantial equivalence... (Implies satisfactory ease of prime, potentially enhanced by PrimeGard®). |
| Priming Volume | Demonstrated similar or acceptable priming volume compared to predicate. | Performance tests were performed to demonstrate substantial equivalence... (Implies acceptable priming volume compared to predicate, and that the new material did not adversely impact it). |
| Biocompatibility | Demonstrated equivalent or improved biocompatibility. | Biocompatibility tests were performed to demonstrate substantial equivalence. In-vitro testing was also performed to demonstrate improved blood compatibility of the materials containing the surface modifying additives. (This is a key improvement over the predicate device). |
2. Sample Size for Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance or biocompatibility tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective). This level of detail is typically found in the full study reports, which are not included in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The assessment appears to be based on objective performance measurements rather than subjective expert ratings.
4. Adjudication Method
This information is not provided. Given the nature of the performance tests (e.g., mechanical integrity, blood trauma), an adjudication method as typically described for diagnostic imaging studies (e.g., 2+1 radiologist consensus) would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret outputs, not for a filtering device like this arterial filter.
6. Standalone Performance Study
The document describes performance tests for the device itself (e.g., mechanical integrity, filtration efficiency, blood trauma). This can be considered a form of standalone performance study as it evaluates the algorithm/device's performance without a human-in-the-loop for interpretation. The "algorithm" in this case is the physical design and material properties of the filter.
7. Type of Ground Truth Used
The "ground truth" for the tests described would be based on objective measurements and laboratory standards. For example:
- Mechanical Integrity: Measured against engineering specifications and industry standards for filter strength and durability.
- Air Challenge: Measured air removal efficiency.
- Pressure Drop: Measured pressure differential across the filter at specified flow rates.
- Blood Trauma: Measured reductions in platelet and white blood cell counts, and quantification of plasma free hemoglobin using laboratory assays.
- Filtration Efficiency: Measured particle removal efficiency.
- Biocompatibility: Assessed using standardized in-vitro tests for compatibility with blood and tissues (e.g., cytotoxicity, hemolysis, complement activation, thrombogenicity).
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a physical medical device, not an AI or machine learning algorithm that requires a training set of data.
9. How Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, this information is not relevant.
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