(244 days)
The Medline Reinforced Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 22lbs. (10kg), for a duration of use up to 72 hours.
The Medline Reinforced Epidural Catheter is a single use device made of flexible polyurethane elastomer tubing. The subject device is sold sterile, and will be packaged inside of a convenience kit alongside a variety of other components that are outside the scope of this 510(k) submission. The proposed epidural catheter is designed as a closed tip device with two eyelets to provide for the dispersion of anesthetic agents. The catheter features a 19G design and is 913 millimeters (mm) long. The catheter has a marked tip, with 10mm increments up the length of the device (up to 913mm). The 100mm mark is indicated by two marks, 150mm by three marks, 200mm by 4 marks, and 250mm by 5 marks. In addition, the Medline Reinforced Epidural Catheter has an internal radiopaque inner spring that is evenly distributed inside the device, terminating 2+/-0.05mm from the liquid outlet end. As an added safety feature, a solid wide warning mark is featured on the proposed device to indicate exit of the catheter from a needle when used in conjunction with an epidural needle.
This document is a 510(k) premarket notification for a medical device (Medline Reinforced Epidural Catheter) and as such focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information typical of a study that would define acceptance criteria for AI/Algorithm-based device performance and then prove the device meets those criteria using clinical data and expert input.
Therefore, many of the requested elements (1-9) regarding acceptance criteria, reported performance, sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/algorithm performance are not applicable or not present in this document.
However, I can extract the information provided regarding the non-clinical testing and the company's conclusion of substantial equivalence.
Summary of Non-Clinical Testing and Conclusion of Substantial Equivalence:
The Medline Reinforced Epidural Catheter is seeking 510(k) clearance based on substantial equivalence to the ARROW® FlexTip Plus® Epidural Catheter (K140110). Instead of defining acceptance criteria for algorithmic performance, the submission focuses on demonstrating safety, performance, and functionality through various non-clinical tests.
No information provided in the document refers to an AI/algorithm-based device, nor does it contain data on acceptance criteria, reported device performance (in the context of AI), sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/algorithm evaluation.
The document describes non-clinical testing for a physical medical device. Here's a summary of the non-clinical tests conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not define quantitative acceptance criteria for algorithm performance or report such performance metrics. Instead, it lists various non-clinical tests conducted to demonstrate the safety and functionality of the physical catheter. The "reported device performance" is implied by the successful completion of these tests in accordance with relevant standards.
| Test Category | Specific Test | Acceptance Standard/Method | Reported Performance |
|---|---|---|---|
| Chemical Safety | Particulate Matter Testing | USP Particulate Matter Injections | Results demonstrated overall safety and effectiveness (as stated in the submission). Specific particle counts or thresholds are not provided in this summary. |
| Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing | USP Bacterial Endotoxin Testing | Results demonstrated overall safety and effectiveness. Specific endotoxin levels or thresholds are not provided. | |
| Functional Performance | Kink Testing | Not explicitly stated (implied internal protocol or recognized standard) | Results demonstrated overall safety and effectiveness, supporting substantial equivalence. Specific kink resistance values or criteria are not provided. |
| Dimensional Analysis | Not explicitly stated (implied internal protocol) | Results demonstrated overall safety and effectiveness. Specific dimensional measurements or tolerances are not provided. | |
| Simulated Distribution Testing | ISTA 3A-2018 General Simulation Performance Test Procedure for Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less | Results demonstrated the ability to maintain functionality upon distribution. Specific test outcomes (e.g., integrity after simulation) are not detailed here beyond a general statement of effectiveness. | |
| Transportation Testing | ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems | Results demonstrated the ability to maintain functionality during transportation. Specific test outcomes are not detailed here. | |
| Visual Appearance Testing | Not explicitly stated (implied internal protocol) | Results demonstrated overall safety and effectiveness, presumably meeting visual inspection criteria. | |
| Ink Adherence Testing | Not explicitly stated (implied internal protocol) | Results demonstrated overall safety and effectiveness, indicating the markings adhere properly. | |
| Tensile Strength Testing | ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension | Results demonstrated overall safety and effectiveness. Specific tensile strength values are not provided. | |
| Flow Rate Testing | ASTM F623-99 Standard Performance Specification for Foley Catheter (Flow Rate) Note: While a Foley catheter standard is cited, it's used for flow rate testing of an epidural catheter, presumably for catheter-specific flow requirements. | Results demonstrated overall safety and effectiveness. Specific flow rates or thresholds are not provided. | |
| Connector Pull Out Testing | Not explicitly stated (implied internal protocol) | Results demonstrated overall safety and effectiveness. Specific pull-out forces are not provided. | |
| Leakage Testing | ISO 80369-6 Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications | Results demonstrated overall safety and effectiveness. Specific leakage rates or criteria are not provided. | |
| Packaging Integrity Testing | ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Results demonstrated overall safety and effectiveness, indicating packaging integrity. | |
| Seal Strength Testing | ASTM F88-16 Standard Test Method for Seal Strength of Flexible Barrier Materials | Results demonstrated overall safety and effectiveness, indicating appropriate seal strength. | |
| X-Ray Opaque Detection Testing | Not explicitly stated (implied internal protocol) | Results demonstrated overall safety and effectiveness, presumably confirming the radiopaque properties for visibility under X-ray. | |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemolysis, Subacute Systemic Toxicity, Chemical Characterization | ANSI/AAMI/ISO 10993-1:2009 & specific sub-parts of ISO 10993 (e.g., -5, -10, -11, -4, -18) and USP | The tests were conducted and the protocols/reports are available for FDA review (Appendix E). The overall conclusion is that the device's biocompatibility supports substantial equivalence. Specific results or pass/fail criteria from these tests are not |
| detailed in this summary document. | |||
| Sterilization | Sterilization Validation | ISO 11135:2014 Sterilization of Health Care Products - Ethylene Oxide... | Demonstrated a Sterility Assurance Level (SAL) of 1 x 10^-6. |
| EO and ECH Residuals | ISO 10993-7:2008(R)2012 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals | The device was evaluated, and presumably, residuals were within acceptable limits as part of the overall safety determination. Specific residual levels are not provided. | |
| Shelf Life | Accelerated Aging Studies | ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Verified a one-year shelf life, ensuring functionality and sterility are maintained. |
Regarding your specific questions:
- A table of acceptance criteria and the reported device performance: See the table above. Note that these are for a physical device, not an AI/algorithm.
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for an AI/algorithm. For the non-clinical tests, sample sizes would be defined by the selected standards and internal protocols, but are not specified in this summary. Data provenance is not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable as this is not an AI/algorithm study requiring ground truth derived from expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing of a physical device.
- 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/algorithm device submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/algorithm device submission.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as this is not an AI/algorithm study. The "ground truth" for a physical device is its ability to meet engineering specifications and safety standards through physical and chemical testing.
- The sample size for the training set: Not applicable; there is no training set mentioned, as this is not an AI/algorithm device.
- How the ground truth for the training set was established: Not applicable; there is no training set mentioned, as this is not an AI/algorithm device.
Conclusion stated in the document:
Based on the non-clinical testing, Medline Industries, Inc. concludes that the Medline Reinforced Epidural Catheter is substantially equivalent to the predicate device, ARROW® FlexTip Plus® Epidural Catheters (K140110).
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).