HumaPen Luxura

K142518 · Eli Lilly and Company · FMF · Jun 5, 2015 · General Hospital

Device Facts

• Record ID: K142518
• Device Name: HumaPen Luxura
• Applicant: Eli Lilly and Company
• Product Code: FMF · General Hospital
• Decision Date: Jun 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

HumaPen Luxura is a reusable mechanical pen-injector for self-injection of insulin. User inserts 3 mL insulin cartridge and attaches disposable pen needle. User manually dials desired dose (1 to 60 units, 1-unit increments) via two-way dial. Mechanical mechanism delivers insulin through needle into skin. Used by patients in home or clinical settings. Device provides accurate insulin delivery; helps manage diabetes through precise dosing. No software or electronic components.

Clinical Evidence

No clinical tests were performed. Evidence consists of bench testing for dose accuracy per ISO 11608-1:2012 (including environmental stress, life-cycle, and drop testing) and biocompatibility evaluation per ISO 10993-1:2009.

Technological Characteristics

Reusable mechanical pen-injector. Materials evaluated per ISO 10993-1:2009 for surface-contacting devices. Dose delivery mechanism: mechanical, two-way dial. Increments: 1 unit. Max dose: 60 units. Compatible with 3 mL cartridges. Non-sterile. No energy source. No software.

Indications for Use

Indicated for self-injection of insulin (HUMALOG) in patients requiring insulin therapy using 3 mL cartridges.

Regulatory Classification

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.

Predicate Devices

• HumaPen Luxura HD (K100988)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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 [e-mail]

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 |

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#### 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:<br>HumaPen Luxura | Predicate Device:<br>HumaPen Luxura HD<br>K100988 |
|------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Delivery of Humalog (insulin lispro<br>for injection) in 3 mL cartridges | Delivery of Humalog (insulin lispro<br>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-<br>based injection system | Mechanical pen injector / needle-<br>based injection system |
| Reusable Device | Yes | Yes |
| Two-Way Dose Dialing | Yes | Yes |
| Delivery Accuracy | Meets ISO 11608-1:2012<br>requirements | Meets ISO 11608-1:2000<br>requirements |
| Sterility | Not a sterile device | Not a sterile device |
| Differences | | |
| Dial Increments | 0.01 mL per increment providing<br>one unit (1U) dose increments | 0.005 mL per increment providing<br>one half unit (0.5 U) dose<br>increments |
| Maximum Delivered Dose | 60 Units | 30 Units |

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#### 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.