(181 days)
Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.
The subject device is a tamper evident female luer lock cap intended for use with male luer ports on syringes. Covering luer fittings on syringes helps reduce the risk of touch contamination and medication leakage. The user group consists of those involved in pharmacy compounding as well as health care professionals. The subject device's clear outer shell/housing provides tamper evidence if the cap or the contents of the container is tampered with prior to clinical administration. Once removed, the shell/housing cannot be replaced back onto the luer cap, thus making it obvious if someone has previously attempted to remove the cap and/or attempted to tamper with the contents of the syringe. The subject TrueCare Biomedix Tamper Evident Cap is packaged in a bulk pharmacy tray with 25 caps per tray and is provided sterile via ethylene oxide sterilization.
This document is a 510(k) premarket notification for a medical device, which is a submission to the FDA for review of a new device to determine if it is "substantially equivalent" to an already legally marketed device (predicate device). It is not a study report that directly provides acceptance criteria and performance data in the format requested.
Therefore, the requested information elements (1-9) cannot be fully extracted and formatted as a direct study report from the provided text. The document primarily focuses on establishing substantial equivalence based on indications for use, technological characteristics, and a summary of non-clinical tests to demonstrate safety and performance without providing specific acceptance criteria and detailed study results for each.
However, I can extract the relevant information regarding the tests performed to support the substantial equivalence claim.
Here's an interpretation of the available information in the context of your request:
Device: TrueCare Biomedix Tamper Evident Cap
Predicate Device: International Medical Industries Prep-Lock Tamper Evident Cap (K193192)
Indication for Use: Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.
Summary of Device Performance and Testing (Not a Direct Acceptance Criteria Table):
The document states that the subject device (TrueCare Biomedix Tamper Evident Cap) was tested and demonstrated to be in conformance with certain standards and internal methods. It does not provide specific numerical acceptance criteria alongside performance reports for each test, but rather mentions the standards or types of tests performed to deem the device safe and effective and substantially equivalent to the predicate.
Here's a breakdown of the testing mentioned:
1. Performance Testing:
- Standard Conformance: ISO 80369-7:2016 (Small-bore connectors for liquids and gases in healthcare applications - Part 7 Connectors for intravascular or hypodermic application).
- Specific Functional Tests (Internal Methods):
- Pull-off force testing
- Tamper evidence functional testing ("to demonstrate that if the housing feature has been removed or tampered with, that it is obvious to the user.")
2. Biocompatibility Testing (In accordance with ISO 10993-1):
- Classification: Limited duration, externally communicating device, Blood Path Indirect (
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).