(146 days)
The Terumo Luer Lock Adapters are single use, disposable components, intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. The devices may be used in procedures lasting up to 6 hours in duration.
The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. For use up to six hours. One end of the luer lock adapter has a male or female luer lock connection which may be connected to any opposite luer fitting within the tubing pack. The opposite side of the luer lock adapter has a tubing connection point which is barbed for the 1/8", 3/16" and 1/4" male and female adapters. The Pressure line luer adapters have an internal slip fit connection point for tubing. The tubing connection points are generally bonded to tubing with the appropriate inner diameter (1/8", 3/16", %") or pressure line tubing using cyclohexaprope. In some cases, a tie-band is attached to the outside of the tubing connection to the luer lock adapter. The luer fitting may be pre-connected to an opposite luer fitting within the cardiopulmonary bypass circuit by Terumo Cardiovascular Systems. The luer fitting may be connected by the end-user to either another opposite " 110 160 within the cardiopulmonary bypass circuit or to an external luer fitting. The luer lock adapters provide a leak proof connection point between components and various lines within the circuit, with the ability for a user to easily disconnect and re-connect the adapters as needed to any other opposite standard luer fitting, The luer lock adapters can be disconnected and re-connected by hand.
The provided documentation describes the Terumo Luer Lock Adapters and the performance testing conducted to demonstrate their substantial equivalence to predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional Stability | Intended to ensure the device maintains its specified dimensions post-manufacturing and during use. | Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed). |
| Pre-connection | Intended to ensure proper assembly and interface with other components before clinical use. | Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed). |
| Connection Strength | Intended to ensure the luer lock adapters maintain a secure connection under expected forces and prevent accidental disconnections during use, providing a leak-proof connection as stated in the device description. | Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed). The device description explicitly states: "The luer lock adapters provide a leak proof connection point between components and various lines within the circuit, with the ability for a user to easily disconnect and re-connect the adapters as needed to any other opposite standard luer fitting." |
| Circulation Test | Intended to simulate blood flow conditions and ensure device integrity and functionality (e.g., no leaks, no material degradation, no interference with flow). | Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed). |
| Pressure Test | Intended to ensure the luer lock adapters can withstand the expected pressure within the cardiopulmonary bypass circuit without leaking or failure. | Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed). |
| Sterility Assurance Level (SAL) | SAL of 10⁻⁶ (meaning no more than 1 in a million units are non-sterile). | Validated to provide a SAL of 10⁻⁶. |
| Ethylene Oxide Residues | Not to exceed stated or implied maximum residue limits at the time of product distribution. | Terumo asserts that ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution. |
| Biocompatibility | Meets requirements of ISO 10993 for external communicating devices, circulating blood, limited exposure (≤ 24 hours). | Biocompatibility studies conducted; blood contacting materials found to be biocompatible. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is an internal "Performance Testing" conducted by Terumo Cardiovascular Systems Corporation. The documentation states: "The following tests were conducted in order to demonstrate the Terumo Luer Lock Adapters are substantially equivalent to the predicate devices." The successful completion of these tests, along with the biocompatibility studies and sterility validation, formed the basis for the FDA's determination of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The specific sample sizes for each of the performance tests (Dimensional Stability, Pre-connection, Connection Strength, Circulation Test, Pressure Test) are not detailed in the provided summary.
- Data Provenance: The data provenance is internal to Terumo Cardiovascular Systems Corporation. The tests were conducted by the submitter of the 510(k). The country of origin of the data is implied to be the United States, where Terumo Cardiovascular Systems Corporation is located (Elkton, MD). The study is retrospective in the sense that the testing was performed to support a premarket notification for an existing device design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The performance testing described is laboratory-based and involves objective measurements of device characteristics (e.g., strength, dimensions, leak integrity), not subjective interpretation by human experts. Therefore, there is no "ground truth" established by experts in the context of the described tests.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As the testing is objective and quantitative, there is no need for an adjudication method.
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
There was no MRMC comparative effectiveness study done. This device is a passive medical component (luer lock adapter) and does not involve AI or human readers for interpretation. The study focused on the physical and functional performance of the device itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. This device is a passive medical component and does not utilize an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective engineering and laboratory measurements against predefined specifications and industry standards. For example:
- Dimensional Stability: Ground truth is the device's measured dimensions compared to engineering drawings/specifications.
- Connection Strength: Ground truth is the force at which the connection fails or leaks, compared to a minimum acceptable strength.
- Sterility: Ground truth is the result of microbiological testing (e.g., bioburden and sterility tests) to confirm the SAL.
- Biocompatibility: Ground truth is the results of biological assays confirming the absence of adverse biological reactions as per ISO 10993 standards.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a passive medical component and does not involve machine learning or a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As there is no training set for this type of device, no ground truth was established for it.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.