(202 days)
The Unifine SafeControl™ range of pen needles are intended for use with multi-dose injection devices for the subcutaneous injection of FDA approved drugs, including insulin.
The Unifine SafeControl™ safety pen needle is a sterile, single-use, disposable device intended for use with multi-dose Injector devices for the subcutaneous injection of FDA approved drugs, including insulin. The device is designed for prescription and over-the-counter use and to be used by self-administering patients, care-givers and healthcare professionals. The safety pen needle is a 30-gauge needle available in sizes between 5mm and 8mm lengths. The pen needle assembly consists of a cannula attached to a needle carrier assembled into a plastic moulded needle hub and safety guard, a primary container that houses the entire assembly and a sterility seal that covers the assembly inside the primary container. The entire device is packaged and labeled as a sterile single-use device.
This document is a 510(k) Premarket Notification for the Unifine SafeControl™ safety pen needle. It describes the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving the device meets them:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "Meets standard" for each test listed, implying compliance with the specified ISO or ASTM standards. The reported device performance uniformly states "Meets standard" for all listed tests.
| Test | Standard/Requirement | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Visual Inspection | ISO 11608-2:2012 Section 12.2.2 | Meets standard | Meets standard |
| Torque to attach to pen | ISO 11608-2:2012 Section 11.4.1.5 | Meets standard | Meets standard |
| Torque to remove from pen | ISO 11608-2:2012 Section 11.4.3 | Meets standard | Meets standard |
| Dose accuracy | ISO 11608-2:2012 Section 11.4.2 | Meets standard | Meets standard |
| Flow Rate | ISO 11608-2:2012 Section 4.3 | Meets standard | Meets standard |
| Force to over-ride safety feature | ISO 11608-5:2012 Section 5.1.11.2 | Meets standard | Meets standard |
| Needle Retention | ISO 11608-2:2012 Section 9 | Meets standard | Meets standard |
| Needle Dislocation | ISO 11608-2:2012 Section 4.8 | Meets standard | Meets standard |
| Sterility - Seal integrity | ISO 11607-1:2007 Section 6.3 | Meets standard | Meets standard |
| Internal pressure test (Burst Testing) | ASTM-F-1140-07:2007, ASTM 4169 2016 Section 16.2 | Meets standard | Meets standard |
| NIS Compatibility | ISO 11608-2:2012 Section 4.9 | Meets standard | Meets standard |
| Simulated Clinical use testing (sharps safety testing) | ISO 23908:2011 & Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features | Meets standard | Meets standard |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Pyrogenicity) | ISO 10993-1, ISO 10993-11 Annex F | Materials are biocompatible | Materials are biocompatible |
| Sterilization (Dose mapping) | ISO 11137: "Sterilization of Healthcare Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices." | Achieves SAL 10-6 | Achieves SAL 10-6 |
| Shelf life | ISO 11608-2, ISO 23908, and ASTM F1980-16 | 2-year initial, 5-year upon studies completed | 2-year initial, studies for 5-year ongoing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the bench tests. It mentions that "Written protocols specified the scope, objectives, specifications, test equipment, test methods and acceptance criteria," which would typically include sample sizes, but these details are not provided in the summary.
The data provenance is not explicitly stated as retrospective or prospective clinical data. Given that it's a 510(k) summary focusing on bench testing, the data is primarily from non-clinical performance testing conducted by the manufacturer, Owen Mumford Ltd., which is based in the United Kingdom.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The "ground truth" for these tests relates to meeting objective engineering and material standards (e.g., specific force measurements, flow rates, sterility assurance levels), not a clinical diagnosis or interpretation by human experts.
For biocompatibility, it states that "Full device evaluation includes a review of all the materials, consumables, manufacturing processes and environments by an expert toxicologist." The number of toxicologists and their specific qualifications are not provided, but the expert's role here is to review and ensure compliance with biocompatibility standards based on material properties and testing results, not to establish a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
This is not applicable as the tests are objective bench tests based on measurable physical properties and adherence to established standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic devices where human readers' performance is compared with and without AI assistance. The Unifine SafeControl™ is a physical medical device (pen needle) and its effectiveness is determined by its physical and material properties, not through AI-assisted human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm-only performance study was not done. This concept is relevant for AI/ML-driven diagnostic software. The Unifine SafeControl™ is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established through compliance with recognized industry standards and specifications. This includes:
- Engineering specifications: For physical properties like torque, force, flow rate, needle retention, etc. (e.g., ISO 11608-2, ISO 11608-5).
- Material and safety standards: For sterility assurance and biocompatibility (e.g., ISO 11607-1, ASTM F1980-16, ISO 10993 series, ISO 11137).
- Sharps safety guidelines: For the safety feature (e.g., ISO 23908:2011 & FDA Guidance).
Essentially, the ground truth is that the device performs as expected and safely according to these predefined, objective standards.
8. The Sample Size for the Training Set
There is no training set as this is a physical medical device (a pen needle) and not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this question is not applicable.
§ 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).