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.

Device Description

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).

AI/ML Overview

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.

Summary

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K053563

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7 2006 APR 510(k) Summary

1. Submitter's Name

Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 (317) 276-2000

Contact Person

LeeAnn Chambers, M.S., RAC Associate Regulatory Consultant Phone: (317) 277-1813 FAX: (317) 276-1887

Date Prepared:

2. Device Name

Proprietary Name:	HumaPen Memoir
Common Name:	Pen-Injector
Classification Name:	Piston Syringe

3. Predicate Device

Manufacturer:	Novo Nordisk Pharmaceuticals
Proprietary Name:	Innovo®
Submission:	K010359

4. Device Description

5. Intended Use

HumaPen Memoir has been developed for the injection of Humalog and Humulin from Eli Lilly and Company 3.0 mL cartridges.

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K053563

6. Technological Characteristics

Pen Feature	New Device	Predicate Device
Similarities:
Syringe Type	Piston Syringe	Piston Syringe
Intended Use	Delivery of Humalog andHumulin in Lilly 3 mL cartridges.	Delivery of Novolin in NovoNordisk PenFill 3 mLcartridges.
Specific drug use	Insulin	Insulin
Reusable device	Yes	Yes
Delivery accuracy	Meets ISO 11608-1.2000requirements	Meets ISO 11608-1 (Part 1)requirements
Cartridge Volume	3ml (300 units)	3ml (300 units)
Unit increments	One Unit increments	One Unit increments
Audible clicks with each increment	Yes	Yes
Dose Display	Electronic LCD	Electronic LCD
Display check when powered on	Yes	Yes
Last Dose Indication	Yes	Yes
Two-way dose dialing	Yes	Yes
Non-replaceable battery	Yes	Yes
Differences:
Body Material	Metal	Plastic
Maximum dose units	60	70
Dose Memory	Last 16 doses	Last dose
Time and date of last dose	Yes	No
Pen life (battery)	3 yrs	5 yrs
Low battery displayindication	Yes	Yes

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 7 2006

Ms. LeeAnn Chambers Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285

Re: K053563

Trade/Device Name: HumaPen Memoir Regulation Number: 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: March 23, 2006 Received: March 27, 2006

Dear Ms. Chambers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sndtte Y. Micker
MD

Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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Indications For Use

510(k) Number (if known): K053563

Device Name: HumaPen Memoir

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinta V. nwm

Sendbagy, General Hospieri Genel Dantal Davices

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Regulation Number and Section

§ 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).