(190 days)
Not Found
No
The device description and performance studies indicate a purely mechanical pen-injector with no mention of AI or ML capabilities.
No.
The device is an insulin pen intended for the self-injection of insulin, which is a drug delivery device, not a therapeutic device itself.
No
This device is a pen-injector for self-administration of insulin, focusing on drug delivery rather than diagnosis.
No
The device description clearly states it is a "reusable mechanical pen-injector" and mentions testing related to mechanical performance (dose accuracy, life-cycle test, free fall, vibration) and material biocompatibility, indicating it is a hardware device.
Based on the provided information, the HumaPen Ergo II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the self-injection of insulin. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "reusable mechanical pen-injector" designed for delivering medication (insulin).
- Lack of IVD Characteristics: The description does not mention any features related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HumaPen Ergo II's function is solely to administer medication.
N/A
Intended Use / Indications for Use
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).
Product codes
FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-injection
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in a dark color, creating a sense of depth and unity.
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.
1
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
2
Indications for Use
510(k) Number (if known) K151686
Device Name HumaPen Ergo II
Indications for Use (Describe)
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).
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 |
4
807.92(a)(4) 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.
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 for
injection, U-100) in 3 mL cartridges | Delivery of Humalog (insulin lispro for
injection, 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 11608-1:2014
requirements | Meets ISO 11608-1:2014ª requirements |
| Dial Increments | 0.01 mL per increment providing one
unit (1U) dose increments | 0.01 mL per increment providing one
unit (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-plated
metals |
| 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
5
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.