(190 days)
HumaPen Ergo II is a reusable insulin Pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
The HumaPen Ergo II is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.
The provided document is a 510(k) summary for the HumaPen Ergo II, a reusable insulin pen. It focuses on demonstrating substantial equivalence to a predicate device (HumaPen Luxura) based on non-clinical performance data.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The device (HumaPen Ergo II) meets the requirements of ISO 11608-1:2014 Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems. The document specifically outlines that the device passed dose accuracy requirements after preconditioning under various conditions defined in this standard.
| Acceptance Criteria (from ISO 11608-1:2014) | Reported Device Performance (HumaPen Ergo II) |
|---|---|
| Dose Accuracy (Standard Atmosphere) | Passed dose accuracy requirements |
| Dose Accuracy (Cool Atmosphere) | Passed dose accuracy requirements |
| Dose Accuracy (Warm Atmosphere) | Passed dose accuracy requirements |
| Last-dose Accuracy | Passed dose accuracy requirements |
| Dry Heat | Passed dose accuracy requirements |
| Cold Storage | Passed dose accuracy requirements |
| Free Fall | Passed test |
| Vibration | Passed test |
| Damp Heat | Passed test |
| Temperature cycling (Cyclical) | Passed test |
| Life-cycle test | Devices were operated for the number of actuations expected for 4.5 years of operation (to support 3-year in-use life) prior to performing dose accuracy testing. Passed. |
| Biocompatibility (ISO 10993-1:2009) | Exterior materials evaluated for in vitro cytotoxicity, skin irritation, and sensitization; met biocompatibility standard. |
| Human Factors | Demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Dose Accuracy & Environmental Testing: The document does not specify the exact sample size for the dose accuracy and environmental tests conducted according to ISO 11608-1:2014. The standard itself would dictate minimum sample sizes for such tests.
- Biocompatibility Testing: The document states that the exterior materials were "evaluated," but does not explicitly state the sample sizes of materials or animal subjects (if applicable) used.
- Human Factors Testing: The document does not specify the sample size for human factors testing.
- Data Provenance: The studies are non-clinical (laboratory/bench testing, material testing, human factors testing, presumably conducted by the manufacturer or contracted labs). The country of origin of the data is not specified, but given the submission to the US FDA by Eli Lilly and Company, Inc., it is reasonable to assume the studies were conducted to international standards accepted by the FDA. The data is prospective in the sense that the new device was tested against established standards to demonstrate performance.
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. The "ground truth" for non-clinical performance and biocompatibility is established by adherence to recognized international standards (ISO 11608-1:2014 and ISO 10993-1:2009) and the objective measurements derived from applying the test methods specified in these standards. Expert consensus would apply to clinical trials or diagnostic accuracy studies, which were not performed here.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical studies or image-based diagnostic assessments. The tests described are objective, quantitative measurements against specific criteria outlined in ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is an insulin pen, not an AI-powered diagnostic device or a system requiring human interpretation of medical images. No MRMC study or AI-assistance study was performed or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a mechanical pen-injector. There is no algorithm or AI component to evaluate in a standalone manner. The "standalone" performance here relates to the device's ability to precisely deliver insulin, which is covered by the dose accuracy testing per ISO 11608-1.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is based on:
- Objective measurements against established international standards: Specifically, the requirements and test methods detailed in ISO 11608-1:2014 for needle-based injection systems (for dose accuracy, life-cycle, environmental stability, etc.).
- Biocompatibility standards: ISO 10993-1:2009, which defines methods and criteria for evaluating biological responses to medical device materials.
These are considered objective, verifiable criteria rather than subjective expert consensus, pathology, or outcomes data in the traditional sense, as this is a non-clinical evaluation.
8. The Sample Size for the Training Set
This is not applicable. The HumaPen Ergo II is a mechanical device, not an AI/machine learning model. Therefore, there is no "training set" in the context of algorithmic development. The design and manufacturing process would involve internal testing and validation, but not a training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/machine learning model. The "ground truth" for the device's design and manufacturing is established by engineering specifications, design verification, and validation against the relevant ISO standards to ensure the device performs as intended.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).