(116 days)
The Tamper Evident Cap with Male Luer Lock is indicated for use as a cap for female Luer ports on medical devices such as manifolds, stopcocks or set.
The Tamper Evident Cap with Male Luer Lock (MTEC) is a sterile, single use device which will be used to cover female Luer ports on medical devices and provide evidence of access. MTEC is provided in two packaging configurations; a 10-up tray and single unit blisters. Both configurations are offered in multiple colors and all the components used in the manufacture of MTEC are comprised of polystyrene and polypropylene resin.
Here's a breakdown of the acceptance criteria and study information based on the provided text, while noting limitations in detail for device performance and several other categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 80369-7:2016 (Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications) | The MTEC device meets the bench testing requirements of ISO 80369-7:2016. Specifically, it meets requirements for: |
- Separation Force
- Unscrewing torque
- Ease of assembly
- Stress cracking
- Liquid leakage test
- Resistance to overriding |
| Shelf Life Evaluation | Design verification of the shelf life was conducted and implied to meet criteria. The document states "All test results meet the acceptance criteria." |
| Sterilization Product Adoption (AAMI TIR 28:2009/(R)2013) | Implied to meet criteria: "All test results meet the acceptance criteria." |
| Packaging (ISO 11607-1:2006) | Implied to meet criteria: "All test results meet the acceptance criteria." |
| Sterility (ISO 11135:2014) | Implied to meet criteria: "All test results meet the acceptance criteria." |
| Residuals (ISO 10993-7:2008) | Implied to meet criteria: "All test results meet the acceptance criteria." |
| Biocompatibility (ISO 10993-1, relevant FDA Guidance) | Biocompatibility testing was conducted according to the cited guidance and standards for an External Communicating Device, Blood Path, Indirect Contact, Limited Duration, and implied to meet criteria: "All test results meet the acceptance criteria." |
| Tamper Evident Design Feature | The MTEC device's tamper evident design feature was tested and successfully passed all internal specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used for any of the bench tests (e.g., ISO 80369-7:2016, tamper evident feature testing).
The data provenance is from non-clinical bench testing performed by International Medical Industries, Inc. (the manufacturer). The country of origin for the data is not explicitly stated but implies testing was done internally by the manufacturer. The data is prospective in the sense that it was generated specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are non-clinical bench tests comparing device performance to established international standards and internal specifications, not studies involving human interpretation or ground truth establishment by experts in a clinical context.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical bench tests against objective criteria, not studies requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (tamper evident cap) and relies on non-clinical bench testing for substantial equivalence, not clinical effectiveness studies with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical component, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical bench tests is established by:
- International Standards: e.g., ISO 80369-7:2016, ISO 11607-1:2006, ISO 11135:2014, ISO 10993-7:2008.
- Internal Specifications: For the tamper-evident design feature.
- FDA Recognized Guidance Documents: For biocompatibility testing (e.g., ISO 10993-1 and specific FDA guidance for intravascular administration sets).
These are objective, quantitative criteria rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical component, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical component, not an AI/ML algorithm.
§ 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.