(150 days)
Our Horizontal Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
Our Horizontal Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a snap-on, leakresistant, poly-propylene lid. The lid has a "mail-box" style raised opening into which the sharps are dropped horizontally. When the container is full, a unique butterfly closure system closes to prevent over-filling and to prevent access to the sharps inside.
This document describes a 510(k) submission for a Horizontal Entry Sharps Container, focusing on its substantial equivalence to existing devices rather than a detailed study proving performance against acceptance criteria. There is no information in the provided text that describes the actual acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in your prompt.
The 510(k) summary (Attachment 5, Rev. 1) and the FDA letter explicitly state that the device is being submitted for "substantially equivalent" status. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device, rather than providing new clinical or non-clinical study data to prove novel performance claims against specific acceptance criteria.
Therefore, I cannot populate the table or answer most of the questions you've posed based on the provided text.
Here's what can be inferred from the document regarding the device's intended claims and comparison:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance are provided in the document. The submission is based on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or data provenance from a performance study is mentioned.
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. No ground truth determination or expert involvement for a study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication is mentioned.
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 not an AI/imaging device, and no MRMC study is mentioned.
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 (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for a study is mentioned.
8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is mentioned.
Summary of Device and 510(k) Submission:
- Device Name: Horizontal 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.
- Classification: Class II accessory to a hypodermic needle (21 CFR Section 880.5570), Product Code: FMI.
- Basis for Marketing: Substantial equivalence to Horizontal Entry Sharps Containers manufactured by Sage Products Inc. and Sherwood Medical.
- Key Features (described in 510(k) summary):
- Injection-molded polypropylene container with a snap-on, leak-resistant polypropylene lid.
- "Mail-box" style raised opening for horizontal sharps insertion.
- Unique butterfly closure system to prevent over-filling and access once full.
- Wall mount bracket and locking mechanism (similar to predicates).
- Key Claim: "Our Horizontal Entry Sharps Container will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use." (This is a general quality statement, not a specific performance metric).
- Cautionary Statement: "container is puncture resistant, but not entirely puncture-proof. To avoid the possibility of accidental sticks, do not overfill, inspect unit before handling and handle with care."
The provided text focuses on the description of the device and the justification for substantial equivalence to existing devices, which is the core of a 510(k) submission. It does not contain the specifics of a detailed performance study as you've outlined. For physical devices like this, manufacturing specifications, material testing, and design validation (often demonstrated through comparison with predicate devices and adherence to relevant standards, though not explicitly detailed here) would form the basis of safety and effectiveness, rather than clinical study-style 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).