(93 days)
Recap-1 is used following OSHA guidelines to safely recap conventional needles prior to transport to an authorized sharps container in order to minimize the possibility of accidental needlesticks from occurring, after the injection procedure has been completed.
The device would be used in all healthcare environments to protect healthcare workers and patients from needlesticks after the injection process has taken place.
Recap-1 is 3"x4"x4.5" made of red pigmented ABS plastic weighing 6.5 ounces. The faceplate has 5 precise apertures to accommodate a majority of needles and their corresponding caps that are in the healthcare market today. It is labeled Recap-1, onehanded needle recapper. The five apertures identify by name the different types of needles that can be resheathed. Below the apertures it is stated "Do Not Use 2 Hands" thus conforming with OSHA guidelines and 29 CFR Part 1910.1030.
The provided text describes a 510(k) summary for the Recap-1 device, a one-handed needle recapper. The document focuses on demonstrating substantial equivalence to a predicate device, Needlesafe II, and ensuring compliance with OSHA guidelines regarding needle recapping.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided Bench Testing section, the acceptance criteria are implicitly related to the absence of problems during the recapping and removal process.
| Acceptance Criteria | Reported Device Performance (Recap-1) |
|---|---|
| No cap sticking in the device during one-handed needle recapping procedure. | None reported for any of the 8 tested cap sizes. |
| No problem removing the recapped needle from the device. | None reported for any of the 8 tested cap sizes. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: "10 needles of each cap size as defined in the enclosed Needle Cap Fit Guide." There are 8 distinct cap sizes listed in the table, meaning a total of 80 needles were tested (10 needles * 8 cap sizes).
- Data Provenance: Not explicitly stated. The tests were "Bench Testing," suggesting they were conducted in a laboratory or controlled environment by the manufacturer (MedScience, Inc. in Cleveland, Ohio). It is a prospective test designed to evaluate the new device. No country of origin for the data is specified beyond the manufacturer's location.
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)
- The document does not mention the use of experts to establish ground truth for this bench testing. The evaluation criteria ("Cap Sticking in Device" and "Problem Removing Recapped Needle") seem to be objective and directly observable from the device's mechanical function.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- None specified. The testing appears to be a direct observation of device function against a simple pass/fail criterion (presence or absence of sticking/problems). There is no indication of multiple reviewers or an adjudication process.
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
- No, an MRMC comparative effectiveness study was not done. This document describes a mechanical device for recapping needles, not an AI-assisted diagnostic or interpretative tool. The study focuses on the device's physical function rather than human interpretation or performance with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance test was done. The "Bench Testing of Recap-1" evaluates the device's functional performance (recapping and removal) independently. There is no human interaction that influences the core mechanical performance being measured. The human operator is simply using the device as intended.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth used is based on direct observation of functional performance during bench testing. For "Cap Sticking in Device," the ground truth is simply whether the cap physically stuck or not. For "Problem Removing Recapped Needle," it's whether the recapped needle could be freely removed or not. These are objective, observable physical events.
8. The sample size for the training set
- The document does not mention a training set. This is a physical device, and the testing described is a functional validation, not a machine learning model that requires training data.
9. How the ground truth for the training set was established
- Not applicable, as no training set is mentioned 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).