(270 days)
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
The HumaPen Luxura is a reusable mechanical pen-injector designed for use for the selfinjection 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.
Here's an analysis of the provided text regarding the HumaPen Luxura device, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Premarket Notification from the FDA for the HumaPen Luxura, a reusable insulin pen. It primarily demonstrates substantial equivalence to a predicate device (HumaPen Luxura HD) rather than presenting a comprehensive study of a novel AI-powered device. Therefore, many of the requested categories for AI-specific studies and performance metrics are not applicable or cannot be extracted from this type of document.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (HumaPen Luxura) |
|---|---|
| Dose Accuracy | Meets ISO 11608-1:2012 requirements |
| - Standard Atmosphere | Passed |
| - Cool Atmosphere | Passed |
| - Warm Atmosphere | Passed |
| - Last-dose Accuracy | Passed |
| - Dry Heat | Passed |
| - Cold Storage | Passed |
| - Free Fall | Passed |
| - Vibration | Passed |
| - Damp Heat | Passed |
| - Temperature cycling | Passed |
| - Life-cycle test (9 years operation) | Passed dose accuracy testing after preconditioning |
| Biocompatibility | Meets ISO 10993-1:2009 (exterior materials) |
| Human Factors | Substantially equivalent to predicate device |
| Sterility | Not a sterile device (acceptance: not required to be sterile) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of devices or test cycles used for each non-clinical performance test. It mentions "sample devices" for the life-cycle test without giving a number.
- Data Provenance: The data is generated from non-clinical performance testing conducted by the device manufacturer, Eli Lilly and Company. This is prospective testing related to device design and manufacturing, not clinical data from patients. The country of origin of the data is implied to be within the company's testing facilities, likely in the US (Indianapolis, IN, is the submitter's location).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The referenced standards (ISO 11608-1:2012, ISO 10993-1:2009) define objective, quantifiable performance metrics, not expert-derived ground truth. Human Factors testing would involve users, but the document does not specify experts for "ground truth" establishment in the sense of AI evaluation.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements against predefined criteria in international standards. There is no mention of an adjudication process for subjective assessments.
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:
Not applicable. This device is a mechanical insulin pen and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical performance tests is the defined limits and methodologies within the referenced international standards (ISO 11608-1:2012 for dose accuracy and functionality, ISO 10993-1:2009 for biocompatibility). These are objective, empirically verifiable standards.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this mechanical device.
§ 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).