(90 days)
Conduit tubing to deliver fluids from an electronic or manual injector; connector tubing to provide a sterile fluid pathway between two devices.
The High Pressure Line is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. The device consists of plastic tubing with plastic luer lock connector hubs at each end. The luer lock connector hubs are a female/male combination or a female/rotating male combination. The device is available in lengths of 10 to 48 inches and supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits,trays, or packs.
The provided 510(k) summary for the "High Pressure Injection Line" (K963749) does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria, as typically seen for AI/ML or diagnostic devices. This is because K963749 is for a medical device (tubing) and not an AI-powered diagnostic tool. The regulatory requirements and testing methodologies are fundamentally different.
However, I can extract the information that is present and highlight the differences:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | Cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and hemocompatibility tests passed. |
| Material Safety/Physicochemical Properties: | Meets requirements of USP XXIII physicochemical tests for plastics. |
| Functional Equivalence to Predicate Device: | Results of simulated use tests, pull tests, and static pressure tests indicate equivalent or better performance than the predicate device (Advance High Pressure Lines; K911884). |
Explanation of "Implied" Criteria: The 510(k) process for this type of device relies heavily on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implicitly tied to the predicate device's established safety and performance, and demonstrating that the new device meets or exceeds those attributes.
Regarding the other requested information, the 510(k) summary for K963749 does not contain the following details, as they are largely irrelevant for a non-AI/ML medical device like a high-pressure injection line:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to the physical units of the device tested, not a dataset for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context would generally be objective measurements of material properties and performance, not expert interpretations.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. MRMC studies are for evaluating diagnostic accuracy with human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used: For this device, "ground truth" would be established by validated laboratory equipment and standardized testing protocols (e.g., measuring burst pressure, tensile strength, biocompatibility assays).
- The sample size for the training set: Not applicable. There is no training set as it's not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (Implied):
The "study" referenced in the 510(k) to prove the device meets acceptance criteria is a series of bench tests and biocompatibility assessments designed to demonstrate that the Maxxim Medical High Pressure Injection Line is substantially equivalent to its predicate device (Advance High Pressure Lines; K911884).
Specifically, the document states:
- "Biocompatibility of the device has been established by cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompa-tibility tests."
- "The device meets the requirements of the USP XXIII physico-chemical tests for plastics."
- "Results of simulated use tests, pull tests and static pressure tests indicate that the High Pressure Injection Line has performance characteristics equivalent to or better than those of the predicate device."
These tests are the "proof" that the device is safe and effective for its intended use, by demonstrating it performs comparably or better than an already legally marketed device with a similar design and function. The 510(k) process for such devices focuses on demonstrating this substantial equivalence rather than establishing novel clinical efficacy.
§ 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.