(115 days)
Oak Ridge Products Sharps containers are a single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals.
The containers 0330-150S and 0370-1500 are intended to be used in areas where there is no unsupervised patient access.
The 0330-150M container with the counterbalanced closure is intended to be used in areas that have unsupervised patient access.
The Oak Ridge Products Sharps Containers are of injection molded polypropylene plastic, designed for a single-use by health care professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant. leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of a similar chemical formula as the comparable predicate devices and many of the sharps objects that will be placed within the container such as plastic syringe bodies. These containers are suitable for a terminal disposal by incineration and all materials used are fully consumable during incineration.
The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. The lid and closure come preassembled with the base not attached. Parts are nested to together to reduce storage and shipping requirements. The health care facility performs the final assembly on-site by snapping the lid to the base.
This document describes the Oak Ridge Products Multi-Purpose Sharps Container and its substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Standard | Reported Device Performance |
|---|---|
| Puncture Resistance: ASTM F2132-01 (reapproved 2008) | Passed |
| Leak Resistance (bottom and sides): Based on OSHA Specification 29CFR 1910:1030 | Passed |
| Overfill Detection and Capacity: Based on relevant standards (not explicitly stated for this, but implied by "Passed" for this criterion in general) | Passed |
| Needle Unwinder and Recapper: (Only present on the large model) | Passed |
| Impact Resistance and Safe Handling: Based on ISO 23907:2012 | Passed |
| Sharps Access, Closure, and Minimization of Aerosolization: Based on ISO 23907:2012 | Passed |
| Stability: Based on ISO 23907:2012 | Passed |
| Mounting Brackets Usability and Stability: (Applies only to Medium sharps container) | Passed |
| Handle Strength: Based on ISO 23907:2012 | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. It mentions that testing was performed by an independent materials testing lab (for Puncture Resistance). The data provenance is not specified beyond being "Product Testing" performed in the context of a 510(k) submission, implying it's prospective testing for this specific device model. No information is given about country of origin of data or whether it's retrospective or prospective for the actual test sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a physical sharps container, and its performance is evaluated against engineering and safety standards, not against "ground truth" established by human experts in the context of medical imaging or diagnostic algorithms. The "ground truth" for these tests are the objective pass/fail criteria defined by the standards (e.g., no needle puncture, no leaks).
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., medical image reading) where there might be disagreements in initial assessments. For physical product performance tests against objective standards, the outcomes are typically definitive (pass/fail).
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 information is not applicable. This device is a physical medical waste container, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and analysis of AI assistance effect size are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests are the objective measurement criteria and pass/fail thresholds defined by recognized consensus standards such as ASTM F2132-01, ISO 23907:2012, and OSHA Specification 29CFR 1910:1030. These standards provide quantifiable metrics (e.g., puncture depth, leakage volume, stability under load) to determine if the device meets the safety and performance requirements.
8. The sample size for the training set
This information is not applicable. This is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As explained above, there is no training set for a physical product.
§ 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).