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510(k) Data Aggregation
(151 days)
The Sol-M Exchangeable Needles are sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
The Sol-M Exchangeable Needles are a sterile, single use, standard hypodermic needle. The device is available in 16 to 31 gauge and in lengths from 5/16" to 1-1/2". In addition, the needle tip is available in a regular or short bevel. Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle cap/shield. The Sol-M Exchangeable Needles are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
The Sol-M Exchangeable Needles are intended for injecting fluids into or withdrawing fluids from parts of the body below the skin's surface.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Sterile Hypodermic Needles for Single Use (ISO 7864) | Met appropriate requirements |
| Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment (ISO 594) | Met appropriate requirements |
| Stainless Steel Needle Tubing for Manufacture of Medical Devices (ISO 9626) | Met appropriate requirements |
| Hypodermic Needles for Single Use Colour Coding for Identification (ISO 6009) | Met appropriate requirements |
| Physical, mechanical, and biological specifications | Substantially equivalent to the predicate device (DuoPross Needles) |
| Accelerated aging to verify performance over device life | Performance verified |
| Product specifications and requirements | Met all product specifications and requirements |
2. Sample size used for the test set and the data provenance:
The document does not specify a separate test set sample size or its provenance. The testing appears to have been conducted based on meeting international standards and comparing to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth was established through adherence to international standards and direct comparison of physical, mechanical, and biological specifications. This type of device does not typically involve expert clinical judgment for ground truth establishment in this regulatory context.
4. Adjudication method for the test set:
Not applicable. The evaluation was based on compliance with established engineering and medical device standards.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
No MRMC comparative effectiveness study was conducted. The submission focused on demonstrating substantial equivalence to a predicate device through technical and performance comparisons rather than clinical efficacy against human readers.
6. Standalone (algorithm only without human-in-the-loop performance) study:
Not applicable. This is a physical medical device (hypodermic needle), not an algorithm or AI.
7. Type of ground truth used:
The ground truth was based on:
- Compliance with international standards: ISO 7864, ISO 594, ISO 9626, and ISO 6009 define the acceptable performance characteristics for hypodermic needles.
- Comparison to a predicate device's specifications: The DuoPross Needles (K052445) served as the benchmark for physical, mechanical, and biological equivalence.
- Verification of product specifications and requirements: Internal testing ensured the device met its own defined design and performance criteria.
8. Sample size for the training set:
Not applicable. This is a physical medical device, not an AI or machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical device.
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