(143 days)
The MED-RX® Patient Delivery Set is to be used in the injection of contrast agents and flushing solutions for the purpose of enhancing diagnostic images.
The MED-RX® Patient Delivery Sets each consist of a male luer lock, two female luer locks, 3 tubing pieces, and either a dual check valve, a single check valve, or a Y-connector. The tube is made of polyvinyl chloride (PVC). The total length of the sets varies from 18″ to 86″ and is also available in a coiled configuration. The MED-RX® Patient Delivery Sets are provided sterile and are not to be resterilized.
This document describes the design and testing of a medical device, the MED-RX® Patient Delivery Set, but does not describe an AI/ML device. The information requested, particularly regarding acceptance criteria and studies proving the device meets those criteria, is typically provided for AI/ML devices to demonstrate their performance against defined metrics and ground truth.
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study that proves the device meets those criteria from the provided text, as it pertains to a physical medical device and not an AI/ML system.
However, I can extract the non-clinical test summary which details performance tests:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Test Summary)
| Test | Standard | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|---|
| Tensile Strength | ISO 8536-4:2010 | Withstand 15 N for 15 Seconds | Withstand 15 N for 15 Seconds, Pass |
| Resistance to Leakage | As per Benlan internal requirements | (Not specified, but implied "Pass") | Pass |
| Particulate Contamination | ISO 8536-4:2010 | Meet contamination index limit | Samples met contamination index limit |
| Chemical Requirements | ISO 8536-4:2007 PER Clause 5 & 7 | (Not specified, but implied "Pass") | Pass |
| Natural Rubber Latex Content | Modified Lowry Method | Not contain natural rubber latex | Device does not contain natural rubber latex |
| Method of Validation (Sterilization) | ANSI/AAMI/ISO 11135-1: 2007 | Achieve 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 | (Not specified, but implied "Pass") | Pass |
| Bacterial Endotoxins | Current edition of ANSI/AAMI ST72 | (Not specified, but implied "Pass") | Pass |
| Hemolysis Assay | ASTM F-756-00 | Non-hemolytic | Product code 10-1254T is considered non-hemolytic and passes the test. |
| Acute Systemic Injection Test | ISO 10993-11 | Meet ISO Acute Systemic Injection Test requirements | The findings indicate that the requirements of the ISO Acute Systemic Injection Test have been met. |
| Rabbit Pyrogen Test | USP 32:2009 | Non-pyrogenic | Product code 10-1254T was considered non-pyrogenic. |
| Intracutaneous Reactivity Test | ISO 10993-10:2002 | Meet ISO Intracutaneous Reactivity Test requirements | The requirements of the ISO Intracutaneous Reactivity Test have been met. |
| Guinea Pig Maximization Sensitization Test | ISO 10993-10:2002 | No sensitization response | Product code 10-1254T did not elicit a sensitization response. |
| Cytotoxicity | ISO 10993-5: 2009 ISO MEM Elution with L-929 Mouse Fibroblast Cells | Non-cytotoxic | Product code 10-1254T is considered non-cytotoxic. |
Regarding the specific questions about AI/ML device studies:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This is not an AI/ML device; therefore, no test set of data (e.g., images, patient records) is described. The "samples" referred to in the non-clinical tests are physical units of the device.
3. 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/ML device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/ML device.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the physical device, the "ground truth" is established by compliance with the specified international and internal standards (e.g., ISO, ASTM, USP) for physical and biological characteristics.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.
§ 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.