(89 days)
The RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.
The RDI Suction Safety Device is a three function assembly that is positioned in a suction line. The Suction Safety Device contains to valves. The first valve is a check valve that insures unidirectional flow. The second valve is a combination valve that relieves excess pressure and relieves excess vacuum.
Here's an analysis of the provided information regarding the RDI Suction Safety Device, focusing on acceptance criteria and supporting studies, formatted as requested.
RDI SUCTION SAFETY DEVICE - K960937
This device is not an AI/ML powered device, therefore some of the requested information (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, etc.) is not applicable. The documentation primarily focuses on demonstrating substantial equivalence to a predicate device and basic functional and safety testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Fluid contact materials comply with Tripartite Biocompatibility Guidance for external devices, blood path direct, short term use. | Complies |
| Sterilization | Validated AAMI/ISO Method 1 validation for Gamma radiation sterilization. | Validated |
| Pyrogenicity | Non-pyrogenic. | Non-pyrogenic |
| Functional - Pressure Relief | "Similar to predicate" (Delta Vacuum Relief Valve 510(k) 760894 performance). | Found to be similar to predicate |
| Functional - One-Way Flow | "Similar to predicate" (Delta Vacuum Relief Valve 510(k) 760894 performance). | Found to be similar to predicate |
| Functional - Vacuum Relief | "Similar to predicate" (Delta Vacuum Relief Valve 510(k) 760894 performance). | Found to be similar to predicate |
| Package Integrity | Pass in accordance with ASTM F1140-88. | Passed in accordance with ASTM F1140-88 |
| Shipping/Distribution Integrity | Pass in accordance with NSTA Project 1A vibration/drop tests. | Passed in accordance with NSTA Project 1A vibration/drop tests |
| Shelf Life/Accelerated Aging | Establish a two-year shelf life. | Successful two year shelf life |
| Substantial Equivalence | Demonstrated substantial equivalence to the Delta Vacuum Relief Valve (K760894). | Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary for the functional, material, or packaging tests. As this is not an AI/ML device, the concept of a "test set" in the context of clinical data or image analysis is not relevant. The testing described is laboratory-based functional and physical testing of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided. The "ground truth" for this device's performance is established through direct physical and functional testing against defined standards and specifications, or by direct comparison to a predicate device's measured performance, rather than through expert review of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods are typically associated with clinical studies or expert review processes, which are not described for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially with and without AI assistance. The RDI Suction Safety Device is a physical medical device, not a diagnostic tool utilizing AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI component.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation relies on:
- Standardized Test Methods: Adherence to established industry standards like ASTM F1140-88, NSTA Project 1A, AAMI/ISO for sterilization, and Tripartite Biocompatibility Guidance.
- Predicate Device Performance: Direct comparison of observed performance (pressure relief, one-way flow, vacuum relief) to the measured functional characteristics of the Delta Vacuum Relief Valve (K760894). The predicate device's performance serves as the benchmark.
8. The Sample Size for the Training Set
Not applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set" in that context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.