(270 days)
No
The device description and performance studies indicate a purely mechanical insulin pen with no mention of AI or ML capabilities.
Yes
The device is intended for the self-injection of insulin, which is a therapeutic intervention for conditions like diabetes.
No
The device is an insulin pen intended for self-injection of insulin. It functions as a delivery mechanism for medication, not for diagnosing medical conditions.
No
The device description clearly states it is a "reusable mechanical pen-injector" and mentions testing against ISO 11608-1, which is a standard for needle-based injection systems (hardware). There is no mention of software as the primary or sole component.
Based on the provided information, the HumaPen Luxura 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 a mechanical pen-injector for delivering medication. It does not perform any analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to analyzing blood, urine, tissue, or other biological samples, which are the hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HumaPen Luxura's function is solely to administer a drug.
N/A
Intended Use / Indications for Use
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
Product codes
FMF
Device Description
The HumaPen Luxura is a reusable mechanical pen-injector designed for use for the selfinjection 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
Non-Clinical Performance Data: The HumaPen Luxura device meets the requirements specified in ISO 11608-1:2012 Needlebased 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 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 6 year in-use life, the sample devices were operated the number of actuations expected for 9 years of operation prior to performing dose accuracy testing.
The HumaPen Luxura 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 in accordance with this standard and meet the biocompatibility standard.
The results of Human Factors testing have demonstrated that the HumaPen Luxura is substantially equivalent to the predicate device.
Clinical Performance Data: No clinical tests were performed.
Key Metrics
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 seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
Eli Lilly and Company c/o Ms. LeeAnn Chambers, M.S., RAC Global Regulatory Affairs, Devices Lilly Corporate Center Indianapolis, Indiana 46285
Re: K142518
Trade/Device Name: HumaPen Luxura Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product code: FMF Dated: April 10, 2015 Received: April 13, 2015
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 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/ResourcesforYou/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 yours,
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
2
Indications for Use
510(k) Number (if known) K142518
Device Name HumaPen Luxura
Indications for Use (Describe)
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (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
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.
807.92(a)(1)
Submitter Information
Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285
Contact Person: LeeAnn Chambers, M.S., RAC 317-277-1813 chambers_leeann@lilly.com
Date: September 5, 2014
807.92(a)(2)
Device
| Trade Name: | HumaPen Luxura |
|---|---|
| Common Name: | Pen-Injector |
| Classification Name: | Piston Syringe |
| Regulation: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Class: | II |
807.92(a)(3)
Predicate Device
| 510(k) Number | Device Name | Submitter Name |
|---|---|---|
| K100988 | HumaPen Luxura HD | Eli Lilly and Company |
4
Device Description 807.92(a)(4)
The HumaPen Luxura is a reusable mechanical pen-injector designed for use for the selfinjection 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.
Intended Use(s) 807.92(a)(5)
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
Technological Characteristics 807.92(a)(6)
The HumaPen Luxura is a modification of the predicate device cleared under K100988. Both devices have the same materials of construction but different colors (burgundy and champagne for the new device versus green for the predicate) and different dose increments on the dial (1 unit on the new device dial vs 0.5 unit on the predicate device dial).
| Pen Feature | New Device:
HumaPen Luxura | Predicate Device:
HumaPen Luxura HD
K100988 |
|------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Delivery of Humalog (insulin lispro
for injection) in 3 mL cartridges | Delivery of Humalog (insulin lispro
for injection) 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 11608-1:2012
requirements | Meets ISO 11608-1:2000
requirements |
| Sterility | Not a sterile device | Not a sterile device |
| Differences | | |
| Dial Increments | 0.01 mL per increment providing
one unit (1U) dose increments | 0.005 mL per increment providing
one half unit (0.5 U) dose
increments |
| Maximum Delivered Dose | 60 Units | 30 Units |
5
Non-Clinical Performance Data 807.92(b)(1)
The HumaPen Luxura device meets the requirements specified in ISO 11608-1:2012 Needlebased 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 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 6 year in-use life, the sample devices were operated the ● number of actuations expected for 9 years of operation prior to performing dose accuracy testing.
The HumaPen Luxura 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 in accordance with this standard and meet the biocompatibility standard.
The results of Human Factors testing have demonstrated that the HumaPen Luxura is substantially equivalent to the predicate device.
Clinical Performance Data 807.92(b)(2)
No clinical tests were performed.
807.92(b)(3)
Conclusions
HumaPen Luxura 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 HD. All the testing performed demonstrates that the new device is as safe and effective as the predicate device.