(107 days)
The HumaPen Memoir is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of insulin (Humalog® and Humulin®) and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose in one-unit increments up to 60 units.
HumaPen Memoir is a reusable mechanical pen-injector with electronic display designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company Humalog and Humulin 3.0 mL cartridges and single-use, detachable and disposable pen needles (supplied separately).
The provided text is related to a 510(k) submission for a medical device called "HumaPen Memoir," which is a pen-injector for insulin. The information primarily focuses on describing the device, its intended use, and comparing its technological characteristics to a predicate device.
The document does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. The only mention of performance criteria is:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Delivery accuracy meets ISO 11608-1.2000 requirements | Meets ISO 11608-1.2000 requirements |
The document states that the "Delivery accuracy meets ISO 11608-1.2000 requirements," but does not provide the specific metrics or values from a study that demonstrate this.
The remaining requested information is not available in the provided text:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not mentioned. This type of device (an insulin pen-injector) would typically not involve expert consensus for ground truth as an AI/software device would.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 relevant or mentioned for this type of device. The HumaPen Memoir is a mechanical pen-injector with an electronic display, not an AI-assisted diagnostic tool for human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant or mentioned. This is a medical device for drug delivery, not an algorithm or AI.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For delivery accuracy, the ground truth would be based on metrological measurements against the ISO standard, not expert consensus or pathology. No specific details are provided beyond "Meets ISO 11608-1.2000 requirements."
- 8. The sample size for the training set: Not applicable for this type of mechanical device.
- 9. How the ground truth for the training set was established: Not applicable for this type of 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).