HUMAPEN LUXURA HD

K100988 · Eli Lilly and Company · FMF · Aug 17, 2010 · General Hospital

Device Facts

• Record ID: K100988
• Device Name: HUMAPEN LUXURA HD
• Applicant: Eli Lilly and Company
• Product Code: FMF · General Hospital
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HumaPen Luxura HD is 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 Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

Device Story

HumaPen Luxura HD is a reusable mechanical pen-injector for insulin self-administration. Device accepts 3.0 mL insulin cartridges and attaches to single-use, disposable pen needles. User manually dials desired dose (0.5 to 30 units) in 0.5-unit increments; audible clicks confirm dose selection. Two-way dose dialing enabled. Device intended for patient self-use in home or clinical settings. Mechanical operation; no electronic components or software. Benefits include precise insulin delivery for diabetes management.

Clinical Evidence

Bench testing only. Dose accuracy and functionality tested per ISO 11608-1. Biocompatibility evaluated per ISO 10993-1.

Technological Characteristics

Reusable mechanical piston syringe. Materials evaluated for biocompatibility per ISO 10993-1. Dose accuracy meets ISO 11608-1:2000. 3 mL cartridge capacity. 0.5 to 30 unit dose range with 0.5-unit increments. Audible click mechanism for dose dialing. Two-way dose dialing capability.

Indications for Use

Indicated for diabetics requiring self-injection of insulin using 3.0 mL cartridges and compatible disposable pen needles. Allows dosing from 0.5 to 30 units in 0.5-unit increments.

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 (K063151)

Submission Summary (Full Text)

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# 510(k) Summary

AUG 1 7 2010

09988

#### 1. Submitter's Name

Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 [phone]

### Contact Person

Steve Johnson, M.B.A, P.E. Associate Regulatory Consultant Phone: [phone] Fax:

Date Prepared: April 2, 2010

#### 2. Device Name

| Proprietary Name: | HumaPen Luxura HD |
|----------------------|-------------------|
| Common Name: | Pen-Injector |
| Classification Name: | Piston Syringe |
| Regulation: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Class: | II |

#### 3. Predicate Device

| Manufacturer: | Eli Lilly and Company |
|-------------------|-----------------------|
| Proprietary Name: | HumaPen Luxura HD® |
| Submission: | K063151 |

#### 4. Device Description

HumaPen Luxura HD 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 3.0 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately).

LY888889 HumaPen Luxura 0.5 Response to Questions US (Quality)

August 2010 CONFIDENTIAL - Eli Lilly and Company

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### 5. Intended Use

The HumaPen Luxura HD is 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 Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

### 6. Technological Characteristics

| Pen Feature | New Device | Predicate Device |
|---------------------------------------|--------------------------------------------------|--------------------------------------------------|
| Similarities | | |
| Syringe Type | Piston Syringe | Piston Syringe |
| Intended Use | Delivery of Lilly insulins in<br>3 mL cartridges | Delivery of Lilly insulins in<br>3 mL cartridges |
| Reusable Device | Yes | Yes |
| Delivery Accuracy | Meets ISO 11608-1.2000<br>requirements | Meets ISO 11608-1.2000<br>requirements |
| Cartridge Volume | 3 ml (300 units) | 3 ml (300 units) |
| Maximum Delivered Dose | 30 Units | 30 Units |
| Audible Clicks with<br>Each Increment | Yes | Yes |
| Two-Way Dose Dialing | Yes | Yes |
| Differences | | |
| Unit Increments | Half-Unit increments after<br>0.5 Unit | Half-Unit increments after<br>1 Unit |

### 7. Performance data

HumaPen Luxura HD was tested per ISO 11608-1 for dose accuracy and functionality. HumaPen Luxura. HumaPen Luxura HD components were evaluated for biocompatibility per ISO 10993-1.

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### 8. Conclusion

HumaPen Luxura HD has met the standards for dose accuracy and functionality. HumaPen Luxura HD has also met tighter dose accuracy tolerance based on the dialing resolution of 0.5 units. Biocompatibility investigation of materials has shown that the materials used in the HumaPen Luxura HD are safe for patient contact. Pen operation and pen function are unchanged from the currently cleared HumaPen Luxura HD. The HumaPen Luxura HD is substantially equivalent to the currently cleared HumaPen Luxura HD.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.

#### Public Health Service

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

Mr. Steven T. Johnson PE, MBA Associate Regulatory Consultant Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285

AUG | 7 2010

Re: K100988

Trade/Device Name: HumanPen Luxura HD Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 26, 2010 Received: July 27, 2010

Dear Mr. Johnson:

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 vour 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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Page 2- Mr. Johnson

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for . the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):

Device Name: HumaPen Luxura HD

Indications for Use:

The HumaPen Luxura HD is a reusable pen injector designed for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR

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

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Adel C. Chapman

(Division Sign-Off)
(Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anestheciolors of Devices
Infection Control, Dental Devices

510(k) Number: K100988