(73 days)
Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.
The Tamper Evident Cap (TEC) is a sterile, single use device which will be used to cover male luer ports on medical devices and provide evidence of access. TEC is offered in multiple colors and all the components used in the device are comprised of polystyrene and polypropylene resin. The TEC device is marketed as a stand-alone device and packaged in bulk.
This document is a 510(k) summary for the Prep-Lock™ Tamper Evident Cap for IV Syringes (K193192). It focuses on demonstrating substantial equivalence to a predicate device (K861276), primarily due to a change in packaging configuration.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document lists various non-clinical bench tests performed to assess the new packaging configuration of the Tamper Evident Cap. It states that "All pre-determined acceptance criteria were met." However, it does not explicitly define the specific acceptance criteria for each test in a quantitative manner, nor does it provide detailed numerical results for the reported device performance. It only states that the device "conforms to the same functional and sterility specifications as the predicate device."
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterility Assurance 10-6 SAL | Sterilization per ANSI/AAMI/ISO 11737-2:2009/(R)2014 achieved 10-6 SAL. | Meets established sterility assurance level. |
| Sterilization Product Adoption | Conformance to AAMI TIR 28 for ethylene oxide sterilization. | Conforms to AAMI TIR 28. |
| Shelf Life | Conformance to ASTM F1980-16 for accelerated aging. | Maintains 3-year shelf life. |
| EO/ECH Residuals | Conformance to ISO 10993-1 and relevant guidance for residuals. | Meets requirements for EO/ECH residuals. |
| Device Function (HE75, ISO 80369-7, IMI Internal Tests) | Design per AAMI ANSI HE75, connectors per ISO 80369-7, and satisfactory internal tests for tamper evident break force, simulated use, and weld strength. | Meets functional specifications. |
| Packaging Integrity (ASTM F 1886, ASTM F 88) | Integrity of seals per ASTM F 1886, minimum peel strength per ASTM F 88. | Packaging maintains integrity. |
| Transportation (ISTA 3B, ASTM F1886, F1929) | Packaging withstands ISTA 3B test, visual seal inspection per ASTM F1886, and dye penetration per F1929. | Withstands transportation challenges. |
| Product Validation (Human factors) | Usability assessment of packaging use. | Packaging deemed usable. |
| Biocompatibility Testing | Conformance to ISO 10993-1 and FDA guidance for indirect blood contact, limited duration. | Device is biocompatible. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the described non-clinical bench tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of bench testing for a device modification (packaging), these would typically be conducted prospectively by the manufacturer (International Medical Industries, Inc., Pompano Beach, Florida, USA).
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)
This is not applicable to the provided document. The study described is a non-clinical bench testing for a physical medical device (tamper evident cap) and its packaging, not an AI/diagnostic device that would require expert-driven ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is non-clinical bench testing. Human adjudication methods like 2+1 are typically used for clinical studies involving interpretation of medical images or patient outcomes.
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 device is not an AI-powered diagnostic tool, and therefore, no MRMC comparative effectiveness study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench tests, the "ground truth" is implied by the standards and internal specifications that the device and its packaging must meet (e.g., ANSI/AAMI/ISO 11737-2 for sterility, ASTM F1980-16 for shelf life, ISO 10993-1 for biocompatibility). The tests directly measure whether the physical properties and performance characteristics of the device and its packaging conform to these established benchmarks.
8. The sample size for the training set
Not applicable. This document describes the testing of a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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).