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).

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 30, 2015

Eli Lilly and Company, Inc. Christine A. Phillips, PhD, RAC Advisor - Global Regulatory Affairs - Devices Lilly Corporate Center Indianapolis. Indiana 46285

Re: K151686

Trade/Device Name: HumaPen Ergo II Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: November 19, 2015 Received: November 20, 2015

Dear Dr. Phillips:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K151686

Device Name HumaPen Ergo II

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K151686

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

807.92(a)(1)

Submitter Information

Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285

Contact Person:

Christine Phillips, PhD, RAC Advisor, Global Regulatory Affairs – Devices Mobile: (317) 625-6045 phillips_christine_ann@lilly.com

Date: 29 December 2015

807.92(a)(2)	Proposed Device
Trade Name:	HumaPen Ergo II
Common Name:	Pen-Injector
Classification Name:	Piston Syringe
Regulation:	21 CFR 880.5860
Product Code:	FMF
Class:	II
807.92(a)(3)	Predicate Device
Trade Name:	HumaPen Luxura (K142518
Common Name:	Pen-Injector
Classification Name:	Piston Syringe
Regulation:	21 CFR 880.5860
Product Code:	FMF
Class:	II

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807.92(a)(4) Device Description

807.92(a)(5) Intended Use(s)

HumaPen Ergo II is a reusable insulin pen intended for the self-injection of HUMALOG® (insulin lispro for injection, U-100) available in 3 mL cartridges using disposable pen needles (sold separately).

807.92(a)(6) Technological Characteristics

The HumaPen Ergo II pen-injector is a modification of the predicate device cleared under K142518. Both devices have the same internal materials of construction, but different exterior components (twotoned blue plastic exterior components for the new device and burgundy and champagne colored metallic exterior components for the predicate device).

Pen Feature	New Device:HumaPen Ergo II(under review in this submission)	Predicate Device:HumaPen Luxura(K142518)
Similarities
Intended Use	Delivery of Humalog (insulin lispro forinjection, U-100) in 3 mL cartridges	Delivery of Humalog (insulin lispro forinjection, U-100) in 3 mL cartridges
Cartridge Volume	3 mL (300 units of U-100 insulin)	3 mL (300 units of U-100 insulin)
Mechanism	Mechanical pen-injector/needle-based injection system	Mechanical pen-injector/needle-based injection system
Reusable device	Yes	Yes
Two-way dose dialing	Yes	Yes
Delivery Accuracy	Meets ISO 11608-1:2014requirements	Meets ISO 11608-1:2014ª requirements
Dial Increments	0.01 mL per increment providing oneunit (1U) dose increments	0.01 mL per increment providing oneunit (1U) dose increments
Maximum Delivered Dose	60 Units	60 Units
Sterility	Not a sterile device	Not a sterile device
Differences
Exterior Materials	Injection-molded plastics	Powder-coated and chrome-platedmetals
Use life	3 years	6 years

4 Performance testing of the HumaPen Luxura pen-injector was performed in accordance with ISO 11608-1:2012. A newer version of the standard has been published that provides editorial changes and corrections that have no impact on test methods or requirements. Testing performed in accordance with the 2012 version also meets the requirements of the 2014 version.

Non-Clinical Performance Data 807.92(b)(1)

The HumaPen Ergo II pen-injector meets the requirements specified in ISO 11608-1:2014 Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection

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systems. The device design has passed the dose accuracy requirements, after preconditioning, in the following conditions defined in the ISO 11608-1:2014 standard:

Standard Atmosphere ●
. Cool Atmosphere
. Warm Atmosphere
Last-dose Accuracy ●
Dry Heat ●
. Cold Storage
Free Fall ●
. Vibration
. Damp Heat
Temperature cycling (Cyclical)
Life-cycle test ●
- . To support a 3 year in-use life, devices were operated the number of actuations expected for 4.5 years of operation prior to performing dose accuracy testing

The HumaPen Ergo II is a surface-contacting device that contacts intact skin only according to the definitions in ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The exterior materials of the device were evaluated for in vitro cytotoxicity, skin irritation, and sensitization in accordance with this standard and meet the biocompatibility standard.

The results of Human Factors testing have demonstrated that the HumaPen Ergo II pen-injector is substantially equivalent to the predicate device.

Clinical Performance Data 807.92(b)(2)

No clinical tests were performed.

Conclusions 807.92(b)(3)

HumaPen Ergo II has met the standards for dose accuracy and functionality identified in the international standard for needle-based injection systems. The device materials meet the biocompatibility standard. Pen operation and pen function are unchanged from the currently cleared HumaPen Luxura. All the testing performed demonstrates that the new device is substantially equivalent to the predicate device.

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).