(150 days)
Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
Our Vertical Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a tabs down, leakresistant, polypropylene lid. The lid has a chimney-type opening into which the sharps are dropped vertically.
The provided text describes a 510(k) submission for a "Vertical Entry Sharps Container." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a full-fledged study with detailed metrics like accuracy or sensitivity.
Therefore, the information requested in the prompt (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable or not present in this document. The 510(k) process for this device type primarily relies on comparing design, materials, and intended use to existing devices, and ensuring compliance with general controls (like Good Manufacturing Practices).
Here's a breakdown of why each section of your request cannot be fulfilled from the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document does not describe specific quantitative acceptance criteria or performance metrics for this device beyond its intended function as a receptacle for sharps and its puncture-resistant property. The primary "performance" assessed is its substantial equivalence to predicate devices, implying it functions similarly and safely.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No specific test set or data from performance testing is mentioned. The submission is a comparison to predicate devices, not a study involving a test set of data.
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)
- Not Applicable. As there is no "test set" and no "ground truth" to establish in the context of a diagnostic or interpretive device, experts for this purpose were not involved and are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 passive medical device (a sharps container), not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. As this device collects sharps, there is no "ground truth" in the diagnostic sense. The "ground truth" for a sharps container would be its ability to safely contain sharps, which is often assessed through design verification, material testing, and compliance with standards, not diagnostic ground truth.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Device Information Provided:
- Device Name: Vertical Entry Sharps Container
- Manufacturer: Custom Medical Plastics, Inc.
- Intended Use: Provides a receptacle for used, contaminated medical sharps and for enclosure during transport to ultimate disposal.
- Material: Injection-molded polypropylene container and lid.
- Key Feature: Chimney-type opening for vertical sharps drop, designed to better protect user's fingers.
- Safety Statement: Puncture-resistant, but not entirely puncture-proof; warns against overfilling, inspect before handling, and handle with care.
- Disposal: Incineration in compliant medical waste incinerators.
- Regulatory Class: Class II accessory to a hypodermic needle (21 CFR Section 880.5570); Panel 80 FMI.
- Substantial Equivalence Claim: To Vertical Entry Sharps Containers manufactured by Sage Products Inc. and Sherwood Medical, based on similar materials (polypropylene), manufacturing process (injection molding), and design (chimney-type opening).
- Date of Submission: December 24, 1996 (Amended April 4, 1997)
- FDA Decision: Substantially Equivalent (July 3, 1997)
The 510(k) process for this device type primarily relies on comparing the device's design, materials, and intended use to existing legally marketed predicate devices, not on generating novel performance data against specific acceptance criteria.
§ 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).