The HumaPen and the HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The peninjector uses 3.0 mL cartridges of insulin (Humalog® or Humulin®) and a single use, detachable and disposable pen needle (supplied separately). The pen-injector allows the user to dial the desired dose one unit at a time up to 60 units.

Device Description

HumaPen and HumaPen Ergo are two versions of 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® (human insulin[rDNA origin]) or Humulin® (insulin lispro injection [rDNA origin]) and a single use, detachable and disposable pen needle (supplied separately). The peninjector allows the user to dial the desired dose one unit at a time up to 60 units.

AI/ML Overview

The provided document is a 510(k) summary for the HumaPen and HumaPen Ergo insulin pen-injectors. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner requested. The document does mention "Delivery accuracy meets ISO/DIS 11608-1.2 requirements" as a similarity between the new and predicate devices, which implies an acceptance criterion, but it doesn't provide the study details.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Delivery accuracy meets ISO/DIS 11608-1.2 requirements	Delivery accuracy meets ISO/DIS 11608-1.2 requirements

The document does not provide a specific study that proves the device meets these criteria. It only states that it does meet them.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the document.

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 provided in the document, as this type of expert review is not generally applicable to the evaluation of an insulin pen's mechanical accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in the document.

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 is a medical device (insulin pen) and 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

This concept is not applicable to a mechanical insulin pen.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For delivery accuracy, the ground truth would typically be established based on precise measurements against a standard, often using specialized equipment to measure dispensed volume or mass. However, the document does not elaborate on this.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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6.0 510(k) Summary of Safety and Effectiveness

1.	Submitter's Name:	Eli Lilly and CompanyLilly Corporate CenterIndianapolis, Indiana 46285(317) 276-4122(317) 276-2098FAX no. (317) 276-1887
	Contact Person:	LeeAnn Chambers, RACAssociate Regulatory ConsultantTelephone: (317) 277-1813FAX: (317) 276-1887
	Date Prepared:	August 7, 1998
2.	Device Name:	Proprietary Name:	HumaPen and HumaPen Ergo
		Common Name:	Insulin Pen

Classification Name: Piston Syringe

1. Predicate Device:
  HumaPen and HumaPen Ergo are substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed B-D Pen.

190

Device Description: 4.

న. Intended Use: Insulin delivery device.

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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '982842'. The numbers are written in a slightly irregular style, but they are still easily readable. The image appears to be a close-up of the handwritten sequence.

: :

、

6. Technological Characteristics:

Pen Feature	New Device	Predicate Device
Similarities:
Syringe type	Insulin Pen-injector	Insulin Pen-injector
Intended use(s)	Insulin delivery device	Insulin delivery device
Specific drug use	Insulin	Insulin
Delivery accuracy	meets ISO/DIS 11608-1.2requirements	meets ISO/DIS 11608-1.2requirements
Unit increments	one Unit increments	one Unit increments
Audible clicks with eachincrement?	yes	yes
Can dial remaininginsulin?	no	no

Pen Feature	New Device	Predicate Device
Differences:
Volume	3.0 mL (300 Units)	1.5 mL (150 Units)
Maximum dose size	60 Units	30 Units
Dosing adjustment	two-way dose correction (can dialforward or backward to desired dose)	if incorrect dose is set, the patientneeds to turn the dose knob as far as itwill turn to the reset groove then pushin the injection button and redial to thedesired dose.

・・・・・・・・・・・

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is printed in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 25 1998

LeeAnn Chambers, RAC Associate Regulatory Consultant Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285

Re : K982842 HumaPen and HumaPen Ergo Trade Name: Requlatory Class: II Product Code: FMF Dated: August 7, 1998 August 12, 1998 Received:

Dear Ms. Chambers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Chambers

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Russo

Timothy A. Ulatowski Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cavazos

Division Sign-Off ivision of Dental, Int nd General Hospita

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use 2

(Optional Format 1-2-96)

HumaPen and HumaPen Ergo Premarket Notification Eli Lilly and Company

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).