(143 days)
The Point of Use II Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc. The Point Of Use II Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.
Devon's Point of Use II Sharps-A-Gator" wil: be used as a single use only container . for sharps collection/disposal. The Point of Use II Sharps-A-Gator® comes in 2 3 -7- 5 gallon and 2.8 +/- 5 gallon . containers. Both container buckets are available in clear. translucent and opaque color versions. The top housing assembly and base are made of polypropylene plastic material and processed through injection molding. The top cover includes the top cover housing, moving tortuous path with an actuator, a flapper and a lid. These components are assembled during the manufacturing process. The base is joined with the top cover assembly by the end user. The assembled container can be secured to a locking bracket or into a cabinet, or used as a free standing unit. The Point of Use II Sharps-A-Gator" has a horizontal top load opening and a moving tortuous path with an actuator that enable the user to "flush" sharps that lodge in the tortuous path without reaching into the container. The Point of Use II Sharps-A-Gator® moving tortuous path restricts hand entry. The Point of Use II Sharps-A-Gator" is made with heavy metal free materials that . are safe to incinerate and autoclave.
The provided text describes the Point of Use II Sharps-A-Gator™ device, a sharps collection and disposal system. The information is from a 510(K) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results for acceptance criteria.
Therefore, the requested information regarding acceptance criteria and performance study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth establishment, training set size) is largely absent from the provided text.
However, I can extract the stated acceptance criteria and the general claim of compliance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Puncture Resistance per ASTM Draft #17 | Complies with all acceptance criteria listed above |
| Functional Drop test based on ECRI's guidelines | Complies with all acceptance criteria listed above |
| Leak Resistance and Stability based on OSHA 1910.1030 Blood Pathogens Standards requirement | Complies with all acceptance criteria listed above |
| In-house assembly and wall thickness verification tests during manufacturing | Complies with all acceptance criteria listed above |
| Functional tests during manufacturing | Complies with all acceptance criteria listed above |
| Qualifying tests for moving tortuous path | Complies with all acceptance criteria listed above |
Missing Information (Not available in the provided text):
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests mentioned (ASTM, ECRI, OSHA) are standards, but the specific testing data provenance is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The performance tests appear to be physical/mechanical tests against established standards, not requiring expert ground truth establishment in the diagnostic sense.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in subjective assessments (e.g., image interpretation), which is not the nature of these engineering and safety tests.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- Not applicable. This device is a physical sharps container, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- For the physical performance tests, the "ground truth" would be the successful completion of the test criteria outlined by the respective standards (ASTM Draft #17 for puncture resistance, ECRI for functional drop, OSHA for leak resistance).
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).