(173 days)
COBE® SMAR T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.
The COBE® SMAR, T™ Tubing and Connectors are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices are used in connecting oxygenators, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support. The tubing may also be used in roller-type cardiopulmonary bypass blood pumps. In particular, tubing sizes with a 3/32 inch wall thickness are used in the pump head of a roller-type cardiopulmonary bypass blood pump, where the tubing is cyclically compressed by the pump to cause blood to flow through the cardiopulmonary bypass circuit.
COBE® SMAR.T™ Tubing is polyvinyl chloride (PVC) tubing ranging in size from 0.075" ID x 0.020" wall to 5/8" ID x 1/8" wall. COBE® SMAR, T™ Connectors are of the following generic types: straight with or without luer port, reducer with or without luer port, Y with or without luer port, male or female luer locks, and saturation/hematocrit monitor connectors.
The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance thresholds in a clinical or analytical setting. Instead, it describes a 510(k) submission for a medical device (COBE® SMARxT™ Tubing and Connectors) and outlines the testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or reported device performance values against those criteria. It lists the types of performance tests conducted but does not specify the pass/fail thresholds or the measured outcomes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified quantitatively in the provided text) | Performance testing consisted of: |
- Bond Strength
- Static Leak Test
- Rated Pressure
- Kink Resistance
- Tubing Pump Life
- Tubing Spallation
- Saturation/Hematocrit Connector Testing
In-vitro testing was performed to demonstrate:
- Improved blood compatibility of the materials containing the surface modifying additive. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for any of the performance or biocompatibility tests. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The tests described appear to be in vitro and potentially laboratory-based rather than clinical studies with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided. The testing described is technical performance and biocompatibility testing of a medical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the tests described are objective engineering and material property assessments, not subjective assessments 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
This is not applicable. The device is tubing and connectors for cardiopulmonary bypass circuits, not an AI-assisted diagnostic or decision-support system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical component, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be the established engineering specifications and material properties for similar medical-grade tubing and connectors, along with standards for biocompatibility. For example:
- Bond Strength: Meeting a minimum force required to separate bonded components.
- Static Leak Test: No leakage observed under a specified pressure.
- Rated Pressure: Withstanding a maximum specified pressure without failure.
- Kink Resistance: Maintaining patency under specified bending conditions.
- Tubing Pump Life: Enduring a minimum number of pump cycles without failure or significant degradation.
- Tubing Spallation: Exhibiting an acceptable level of particulate generation during pumping.
- Biocompatibility: Meeting ISO 10993 standards and showing no adverse biological reactions in vitro.
The predicate device (COBE® Tubing and Connectors) likely served as the benchmark against which the new device demonstrated "substantial equivalence."
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
Summary of the Study:
The study performed was a series of in-vitro performance and biocompatibility tests designed to demonstrate that the COBE® SMARxT™ Tubing and Connectors are substantially equivalent to the legally marketed predicate device (COBE® Tubing and Connectors). The primary difference in the new device is the addition of a non-leaching, surface-modifying additive to improve blood compatibility. The tests aimed to prove that this additive does not negatively impact the safety and effectiveness of the device's core mechanical and fluid-handling functions, and in fact, provides an improved characteristic (blood compatibility). The specific quantitative results and acceptance criteria for these tests are not provided in the summary.
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).