(126 days)
The Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs into the body.
The Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in 30G, 32G and 33G sizes. The distal end of the needle cap, which protects the needle prior to use.
This document is a 510(k) Premarket Notification for the "Mini Needle" device and focuses on establishing substantial equivalence to a predicate device rather than a comprehensive study proving novel acceptance criteria for a new type of device. Therefore, some of the requested information (like effect size of MRMC studies, number of experts for ground truth, or training set details) is not applicable or not provided in the document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mini Needle are primarily based on demonstrating substantial equivalence to a predicate device (TSK Hypodermic Needle) and meeting relevant ISO standards for medical needles. The device performance is reported as meeting these specified criteria.
| Acceptance Criteria (Based on ISO Standards & Predicate Device Equivalence) | Reported Device Performance |
|---|---|
| Dimensional and Physical Properties Verification (ISO 594-1/-2) | Met all specified criteria |
| Bond and Material Strength Verification (ISO 594-1/-2) | Met all specified criteria |
| Biocompatibility Testing (ISO 10993) | Met all specified criteria |
| Sterilization Validation (ISO 11137-1/2) | Met all specified criteria |
| Packaging Validation | Met all specified criteria |
| Intended Use Equivalence | Substantially equivalent |
| Principle of Operation Equivalence | Substantially equivalent |
| Technological Characteristics Equivalence | Substantially equivalent |
| Absence of New Safety or Performance Questions | Did not raise new questions |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size used for each of the listed tests (Dimensional, Bond/Material Strength, Biocompatibility, Sterilization, Packaging).
Data Provenance: The data appears to be from prospective testing conducted by the manufacturer, OcuJect, LLC, on their Mini Needle devices. There is no mention of country of origin for the data beyond the manufacturer's location in Newport Beach, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission. For mechanical devices like needles, "ground truth" is typically established through adherence to engineering specifications and ISO standards, not expert consensus on medical images or diagnoses. The testing involves physical and chemical evaluations by qualified personnel in laboratories, not medical experts establishing a "ground truth" for a diagnostic outcome.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert opinions might differ on a diagnostic outcome (e.g., classifying an image). For mechanical and physical testing of a needle, the results are objective measurements against defined criteria.
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 is not applicable. The Mini Needle is a physical medical device (a hypodermic needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The Mini Needle is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurements against established engineering specifications and international standards (ISO standards) for hypodermic needles. These standards detail acceptable dimensional tolerances, material properties, strength, sterility, and biocompatibility.
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device, the Mini Needle does not involve a "training set" in the context of machine learning or AI development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as above.
§ 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).