(100 days)
The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.
The Medifine Pen Needle consists of a needle with hub, and shield assembly. The needle shield is intended to provide physical protection to the needle with the hub. Blister paper covers the primary container maintains sterility of the needle covering the hub and the shield with the blister paper. The needle hub can be connected onto the pen injector device for the subcutaneous injection of insulin. The device offers two compatible types of needle (patient contact point) as below. The user can choose the needle as per their preference.
The provided text describes a 510(k) premarket notification for the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices, specifically the Medifine Pen Needle 3 Bevel & Medifine Pen Needle Quinta 5 Bevel (K171144) and the CareFine Pen Needle by Facet Technologies, LLC (K140568) for an Over-the-Counter (OTC) claim.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Medifine Pen Needles are based on compliance with various ISO and ASTM standards. The document states that the "test results show that the subject device is substantially equivalent to the predicate devices in the market," implying the device performance met these criteria. However, specific numerical performance results for each test item are not provided in this document. The table below lists the test items and the relevant standards used as acceptance criteria.
| No | Test Item | Test Method / Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|---|
| 1 | Dimensions | ISO 11608-2:2012 Clause 4.2.1 General; ISO 9626 1991_Amd2001, clause 8 | Met substantial equivalence (specific data not provided) |
| 2 | Dimensions for needles | ISO 11608-2:2012 Clause 4.2.2 Dimensions for needles | Met substantial equivalence (specific data not provided) |
| 3 | Determination of flow rate through the needle | ISO 11608-2:2012 Clause 4.3 Determination of flow rate through the needle | Met substantial equivalence (specific data not provided) |
| 4 | Bond between hub and needle tube | ISO 11608-2:2012 Clause 4.4 Bond between hub and needle tube; ISO 7864 Clause 13.1 | Met substantial equivalence (specific data not provided) |
| 5 | Needle points | ISO 11608-2:2012 Clause 4.5 Needle point | Met substantial equivalence (specific data not provided) |
| 6 | Freedom from defects | ISO 11608-2:2012 Clause 4.6 Freedom from defects; ISO 7864 Clause 11.3 | Met substantial equivalence (specific data not provided) |
| 7 | Lubrication | ISO 11608-2:2012 Clause 4.7 Lubrication | Met substantial equivalence (specific data not provided) |
| 8 | Dislocation of measuring point at patient end | ISO 11608-2:2012 Clause 4.8 Dislocation of measuring point at patient end | Met substantial equivalence (specific data not provided) |
| 9 | Determination of functional compatibility with needle-based injection systems | ISO 11608-2:2012 Clause 4.9; Test Method - Clause 11. | Met substantial equivalence (specific data not provided) |
| 10 | Ease of assembly and disassembly | ISO 11608-2:2012 Clause 4.10; Test Method - Clause 11 | Met substantial equivalence (specific data not provided) |
| 11 | Compatibility of Needles and Injector systems | ISO 11608-2:2012 Clause 11; Test Method - Clause 11 | Met substantial equivalence (specific data not provided) |
| 12 | Cannula Test | ISO 9626 Clause 4, 5, 6, 7, 8, 9, 10, 11 | Met substantial equivalence (specific data not provided) |
| 13 | Extraction Test | ISO 7864 Clause 6 | Met substantial equivalence (specific data not provided) |
| 14 | Corrosion Test | ISO 9626 Clause 11 | Met substantial equivalence (specific data not provided) |
| 15 | Sterility Test | ISO 11737-2 | Met substantial equivalence (specific data not provided) |
| 16 | Packaging/Aging Test | ASTM D4169-09, ISO 11608-2, ASTM F1929, ISO 11608-2 | Met substantial equivalence (specific data not provided) |
| 17 | Biocompatibility | Same raw material, manufacturing processes, and sterilization method as predicate device (K171144) | Met substantial equivalence (specific data not provided) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each test item. It only states that "The following tests were performed on the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel." The data provenance is not explicitly mentioned (e.g., country of origin or retrospective/prospective). However, the testing is performed to satisfy international standards (ISO, ASTM), implying a standardized testing environment rather than a clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes a submission for a medical device (pen needles) based on engineering performance testing and substantial equivalence to existing devices, not on diagnostic accuracy requiring expert interpretation of medical images or data. Therefore, the concept of "ground truth" and "experts" in the context of clinical interpretation, as typically applied to AI/ML medical devices, is not applicable to this type of submission. The ground truth for the performance tests would be defined by the specifications and measurement techniques within the cited ISO and ASTM standards.
4. Adjudication Method for the Test Set
As explained above, this submission is for a medical device that relies on engineering and material performance criteria. Therefore, an adjudication method for a test set, in the sense of resolving discrepancies between expert interpretations, is not applicable. The results of the performance tests would be objective measurements against predefined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically conducted for AI/ML diagnostic or prognostic devices to assess the impact of AI assistance on human reader performance. The Medifine Pen Needle is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This document describes the performance testing of a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance criteria and performance testing of the Medifine Pen Needle is based on established engineering and safety standards (ISO, ASTM). These standards define acceptable dimensions, flow rates, bond strengths, material properties, sterility, and other physical and safety features. It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data.
8. The Sample Size for the Training Set
This document describes a 510(k) submission for a physical medical device. It does not involve any artificial intelligence or machine learning algorithms that would require a "training set." Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm involved in this device, the question of how its ground truth was established 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).