(87 days)
The MED-RX Extension Set with T-Connector is intended to be used for administration or withdrawal of fluids to or from a neonatal patient as directed by a physician.
The MED-RX Extension Set with T-Connector is offered in two configurations, identical except for the tubing length. The proximal end of the MED-RX Extension Set with T-Connector features a T-Connector with an injection port and an integral rotating male luer lock. The distal end has a female luer lock fitting. The inner and outer diameter of both devices is consistent at 0.040" and 0.095" respectively, while the lengths available are either 4" or 38". Each of the luer fittings (distal female luer lock and proximal rotating male luer lock) are provided with protective caps. The MED-RX Extension Set with T-Connector is provided sterile and is single use.
This document describes the premarket notification for the "MED-RX Extension Set with T-Connector." The provided text focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or algorithms, human readers, or image analysis. Therefore, many of the requested categories related to AI performance are not applicable.
Here's an analysis of the provided information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Standard | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|
| Tensile Strength - Tubing/T-Connector | ISO 8536-4:2007 | Pass | Pass |
| Tensile Strength - Tubing/Female Luer Lock | ISO 8536-4:2007 | Pass | Pass |
| Leakage under Pressure | ISO 8536-4:2007 | Pass | Pass |
| Liquid Leakage | ISO 8536-4:2007 | Pass | Pass |
| Particulate Contamination | ISO 8536-4:2007 | Samples meet contamination index limit | Samples met contamination index limit |
| Chemical Requirements | ISO 8536-4:2007 (Clauses 5 & 7) | Pass | Pass |
| Natural Rubber Latex Content | Modified Lowry Method | Device does not contain natural rubber latex | Device does not contain natural rubber latex |
| Sterilization Method of Validation | ANSI/AMMI/ISO 11135-1: 2007 | Validated to a Sterility Assurance Level of 1 x 10^-6 | Validated to a Sterility Assurance Level of 1 x 10^-6 |
| EO Sterilization Residuals | ISO 10993-7: 2008 | Pass | Pass |
| Bacterial Endotoxins | ANSI/AAMI ST72: 2002 | Pass | Pass |
| ISO MEM Elution with L-929 Mouse Fibroblast Cells (Cytotoxicity) | ISO 10993-5: 2009 | Considered non-toxic | Product code 10-1053XLU is considered non-toxic. |
| ISO Guinea Pig Maximization Sensitization Test | ISO 10993-10:2002 | Did not elicit a sensitization response | Product code 10-1053XLU did not elicit a sensitization response. |
| ISO Intracutaneous Reactivity Test | ISO 10993-10:2002 | Considered a non-irritant | Product code 10-1053XLU would be considered a non-irritant. |
| ISO Acute Systemic Injection Test | ISO 10993-11: 2006 | Requirements of the test met | The findings indicate that the requirements of the ISO Acute Systemic Injection Test have been met. |
| ASTM Hemolysis Assay - Extract Method | ASTM F-756-00 | Considered non-hemolytic and passes | Product code 10-1053XLU is considered non-hemolytic and passes the test. |
| Materials Mediated Rabbit Pyrogen Test | USP 32: 2009 | Determined to be non-pyrogenic | Product code 10-1053XLU is determined to be non-pyrogenic. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units) used for each non-clinical test. The data provenance is internal testing performed by Benlan Inc., as part of their 510(k) submission to the FDA. This is likely retrospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device in vitro testing, not an AI or diagnostic tool requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation or AI output that would require adjudication.
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
Not applicable. This is a medical device (extension set) that does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (extension set) and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests is established by the specified ISO, ANSI/AAMI, ASTM, and USP standards. These standards define the acceptable physical, chemical, and biological properties of the device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/machine learning model, no ground truth was established for it.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.