(35 days)
Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.
The flexible luer lock adapters are single use only devices that consist of a flexible tubing segment with an inner diameter of 0.32 cm (0.125 in) with a male luer adapter on one end and a female luer adapter on the other end. This device is currently packaged with the Affinity Pixie Cardiotomy/Venous Reservoir device. It is also available as a standalone device (subject of this submission).
The provided text describes a 510(k) submission for the Medtronic Affinity® Flexible Luer Lock Adapters. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing of the updated packaging for a device that was previously an accessory.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Details/Context |
|---|---|---|---|
| Packaging Integrity | Compliance with ISO 11607-1 and 11607-2, 2006 | Packaging was visually inspected, subjected to dye penetration test, and peel test. | Packaged samples were sterilized twice and subjected to climactic conditioning prior to distribution simulation (ASTM D4169-08) and testing. The tests ensure integrity of seals and proper adherence between Tyvek lid and blister tray. The conclusion states compliance was demonstrated. |
| Sterility Maintenance | Maintenance of sterility after processing and distribution | Packaged samples were sterilized twice and subjected to climactic conditioning. (Implies sterility was maintained after these processes as part of overall packaging integrity.) | Sterilization was a pre-step for packaging integrity testing, demonstrating packaging's ability to maintain sterility after multiple cycles and environmental stresses. |
Note: The core product (the luer lock adapter itself) is stated to be identical to the predicate device in terms of design, materials, intended use, and principles of operation. Therefore, there are no specific performance criteria for the adapter's function (e.g., fluid flow, connection strength) in this submission, as those were already established for the predicate device. The focus is solely on the new packaging configuration.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of samples used for the packaging tests (e.g., how many blister trays were tested for dye penetration or peel strength). It refers to "packaged samples."
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in the sense that the device itself largely pre-exists as part of another product, and the study is for demonstrating the adequacy of the new packaging for standalone distribution. It's a lab-based performance study, not a clinical trial involving human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable (N/A). This study is a physical and mechanical performance test of packaging, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for packaging integrity is defined by compliance with ISO and ASTM standards and visual/mechanical tests (dye penetration, peel strength).
4. Adjudication Method for the Test Set
- Not applicable (N/A). As this is a physical performance study, there is no need for expert adjudication in the traditional sense. The results are objectively measured against established criteria (e.g., successful dye penetration vs. no penetration, peel strength within a range).
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
- No. This is not an AI/imaging device. It's a medical device accessory whose performance evaluation focuses on packaging integrity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A). This is not an AI/algorithm-based device. The device itself (the luer lock adapter) is a standalone accessory, but its performance in this submission relates to its packaging.
7. The type of ground truth used
- Defined by International Standards and Objective Physical Measurements: The "ground truth" for the packaging performance is compliance with ISO 11607-1 and 11607-2, 2006, and ASTM D4169-08. Performance is assessed through objective measurements like visual inspection, dye penetration, and peel tests.
8. The Sample Size for the Training Set
- Not applicable (N/A). There is no "training set" as this is not an AI or machine learning product.
9. How the Ground Truth for the Training Set was Established
- Not applicable (N/A). There is no training set or associated ground truth for this type of device submission.
§ 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.