(267 days)
The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.
The GRP Sharps Container is a blow molded HDPE bottle with a spun-weld iris at the opening. The iris acts as an aperture, allowing a vertical sharps drop. The device has a yellow safety ring which prevents the cap from locking closed during use. The device has a white 2.5″ cap which contains a sealing gasket. Once the GRP Sharps Container is full, the safety ring is removed prior to pacing the cap on. When the safety ring has been removed, the cap locks down for a tight seal. The device is available in four sizes: 1.5 quart, 1 gallon, 2 gallon and 3 gallon. The containers are identical except for capacity.
The provided text describes a 510(k) premarket submission for a medical device: GRP Sharps Container. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria, ground truth, and expert adjudication in the way an AI/ML device would.
Therefore, many of the requested categories (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this submission, as it is for a physical device (sharps container) and not an AI/ML diagnostic or prognostic tool.
However, I can extract the acceptance criteria based on compliance with standards and the reported performance as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards/guidance) | Reported Device Performance |
|---|---|
| Puncture Resistance: Complies with ASTM F 2132-01 (reapproved 2008), "Standard Specification for Puncture Resistance of Materials used in Collectors for Discarded Medical Needles and other Sharps" | Complies with ASTM F 2132-01 (reapproved 2008) |
| Impact Resistance: (Likely BSI 7320:1994.4 Impact Resistance based on listed tests) | BSI 7320:1994.4 Impact Resistance (Testing conducted in accordance with) |
| Leak Resistance: Conforms to CSA Z316.6-95, 3.9.2.1 -- "Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste - Leak Resistance" (Also references OSHA 29CFR for Leakage) | Conforms to CSA Z316.6-95 Leak Resistance |
| Complies with CSA CZ316.5-95 and OSHA 29CFR (for Leakage) | |
| Container Stability/Topple Resistance: Conforms to CSA Z316.6-07 "Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste - Container Stability" | Conforms to CZA Z316.6-07 Topple resistance |
| Handle Strength and Fill Capacity: (Likely CSA Z316.6-07 based on listed tests) | CSA Z316.6-07 Handle Strength and Fill Capacity (Testing conducted in accordance with) |
| Sharps Injury Protection: ISO 23907 First edition 2012-09-01 "Sharps injury protection - Requirements and test methods - Sharps containers" | ISO 23907 First edition 2012-09-01 Sharps injury protection - Requirements and test methods - Sharps containers (Testing conducted in accordance with) |
| Guidance Document Compliance: "Guidance on the Content and Format of Premarket Notification (510(k)) submissions for Sharps, dated October 1993" | FDA Guidance Document "Guidance on the Content and Format of Premarket Notification (510(k)) submissions for Sharps, dated October 1993, was used to help identify applicable physical and mechanical features." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of typical AI/ML studies. The testing would have involved a sufficient number of physical GRP Sharps Container units to ensure compliance with the specified standards for each model size.
- Data Provenance: The tests conducted are non-clinical, laboratory-based physical and mechanical performance tests on the manufactured device itself, rather than data from human subjects or clinical settings. The provenance is from these specific laboratory tests against recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission is for a physical medical device (sharps container) and not an AI/ML algorithm that requires expert-established ground truth from data for diagnostic or prognostic purposes. Compliance is determined by objective physical testing against established international and national standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3. Ground truth is derived from objective performance against engineering standards.
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 is a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Objective performance against established engineering standards and regulatory requirements. For example, puncture resistance is directly measured against the criteria specified in ASTM F 2132-01. Leak resistance is measured against CSA Z316.6-95.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).