(272 days)
The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is metallic canister fitted with thermal plastic top and has a orange-red biohazard label adhered to the containers with fill line printed on the front. The BWCSH-1 device is for single use, disposable and is not a secondary container. The BWCSH-1 sharps container dimensions are 10.5 inches in width at the top, 4.75 inches deep and 8.25 inches in height. BWCSH-1 sharps container weighs 1.075 pounds when empty.
The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is stable, puncture resistant, impact and shatter resistant, and leak-proof on the sides and bottom. The BWCSH-1 container is fitted with a rotating top, allowing safe one-handed disposal of used sharps. The container has a locking tamper resistant plastic lid that once snapped in place, cannot be manually removed. Labels are orange-red with black text and a black biohazard symbol printed on a white background. Labels are adhered to the containers at the time of manufacture with the fill line printed. The BWCSH-1 device is for single use, disposable and is not a secondary container.
The BWCSH-1 sharps container three main components are nested together to reduce storage and shipping requirements. The rotating top is made with uncolored translucent material. The translucent nature of the product allows for a visual determination of content level. The bottom of the rotating top's internal chute matches the fill line to physically prevent over filling.
The provided text describes a 510(k) submission for a sharps container (BWCSH-1), which is a Class II medical device. As such, the submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a comparative effectiveness study or a standalone algorithm performance study, which are more common for AI/ML-driven devices.
Here's an analysis of the provided information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| Puncture Resistance (ASTM F2132-01(2008)) | Passed |
| Leak-Proof (29 CFR 1910.1030(d)(2)(viii)(c)) | Passed |
| Impact and Shatter Resistance (ISO 23907:2012) | Passed |
| Stability (29 CFR 1910.1030(d)(4)(iii)(A)(2)(ii)) | Passed |
| No features to bend, break, or shear needle. | No Feature Present |
| Labeling: "Single Use" | Labeling is "Single Use" |
| Overfill Indication: Labeled "Do Not Fill Above This Line" | Labeled "Do Not Fill Above This Line" |
| Clarity: Minimum of one translucent component (base or top) | Each Container has a minimum of one translucent component, either base or top |
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 size for each performance test (e.g., how many sharps containers were tested for puncture resistance). It only states that performance testing was performed. The data provenance is not specified, but it's implied to be from a materials testing lab for the puncture resistance test.
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 type of information is not applicable to this device. The "ground truth" for a sharps container's performance is objective physical testing against established international standards and regulations, not expert consensus or interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to this device. Adjudication methods like 2+1 or 3+1 typically apply to studies where human experts are making judgments that need to be resolved. For physical performance tests, the results against the standard are generally definitive.
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
This is not applicable. The device is a physical sharps container, not an AI/ML-driven diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests of the sharps container is based on objective measurements against established performance standards and regulations. These include:
- ASTM F2132-01(2008) for Puncture Resistance
- 29 CFR 1910.1030(d)(2)(viii)(c) for Leak-Proof
- ISO 23907:2012 for Impact and Shatter Resistance
- 29 CFR 1910.1030(d)(4)(iii)(A)(2)(ii) for Stability
8. The sample size for the training set
This is not applicable. The device is a physical product and does not involve a training set as would be used for AI/ML models.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this device.
§ 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).