HUMAPEN LUXURA HD

K063151 · Eli Lilly and Co. · NSC · Jan 9, 2007 · General Hospital

Device Facts

• Record ID: K063151
• Device Name: HUMAPEN LUXURA HD
• Applicant: Eli Lilly and Co.
• Product Code: NSC · General Hospital
• Decision Date: Jan 9, 2007
• 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 1 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; utilizes 3 mL insulin cartridges and detachable, disposable pen needles. User dials dose (1 to 30 units) in 0.5-unit increments; mechanical mechanism delivers insulin. Intended for diabetic patients; used in home or clinical settings. Device provides precise dosing control for insulin therapy; benefits patient through simplified, accurate self-injection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable mechanical pen-injector; 3 mL cartridge capacity; 30-unit maximum dose; 0.5-unit dose increments. Compatible with Eli Lilly 3 mL insulin cartridges and standard disposable pen needles. Non-electronic, purely mechanical operation.

Indications for Use

Indicated for diabetics requiring self-injection of insulin using 3.0 mL Lilly insulin cartridges and compatible disposable pen needles.

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

• NovoPen® Junior (NDA 20-986/S-004)
• Autopen® (K983874)

Submission Summary (Full Text)

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# 510(k) Summary

#### 1. Submitter's Name

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

### Contact Person

LeeAnn Chambers, M.S., RAC Associate Regulatory Consultant Phone: [phone] FAX: [phone]

Date Prepared: October 11, 2006

#### 2. Device Name

| Proprietary Name: | HumaPen Luxura HD |
|----------------------|-------------------|
| Common Name: | Pen-Injector |
| Classification Name: | Piston Syringe |

#### 3 Predicate Devices

| Manufacturer: | Novo Nordisk Pharmaceuticals, Inc |
|-------------------|-----------------------------------|
| Proprietary Name: | NovoPen® Junior |
| Submission: | NDA 20-986/S-004 |

| Manufacturer: | Owen Mumford Inc. |
|-------------------|-------------------|
| Proprietary Name: | Autopen® |
| Submission: | K983874 |

### 4. Device Description

HumaPen Luxura HD is a reusable mechanical pen-injector designed 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).

#### 5. Intended Use

HumaPen Luxura HD has been developed for the injection of insulin from Eli Lilly and Company 3 mL cartridges.

JAN - 9 2007

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## 6. Technological Characteristics

| Pen Feature | New Device<br>HumaPen Luxura HD | Predicate Device<br>NovoPen Junior | Predicate Device<br>Autopen |
|------------------------------|---------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------|
| Intended Use | Delivery of Lilly insulins<br>in 3 mL cartridges. | Delivery of Novo Nordisk<br>insulins from PenFill 3 mL<br>cartridges. | Delivery of insulin from<br>replaceable 3 mL<br>cartridges. |
| Compatible<br>drug products | HumaLog and Humulin | Novolog, Novolin R,<br>Novolin N, Novolin 70/30 | Eli Lilly 3 mL insulin<br>cartridges |
| Reusable<br>device | Yes | Yes | Yes |
| Cartridge<br>Volume | 3 mL (300 units) | 3 mL (300 units) | 3 mL (300 units) |
| Maximum<br>Delivered<br>Dose | 30 Units | 35 Units | 42 Units |
| Unit<br>increments | Half-Unit increments<br>after 1 Unit | Half-Unit increments after<br>1 Unit | 2 Unit increments |

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eli Lilly and Company Ms. LeeAnn Chambers Regulatory Scientist Pharmaceutical Delivery Systems Lilly Corporate Center Indianapolis, Indiana 46285

JAN - 9 2007

Re: K063151

Trade/Device Name: HumaPen Luxura HD Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: NSC Dated: October 11, 2006 Received: October 18, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Chambers

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

Chules

Tin-Lien, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOG3151

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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 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 1 to 30 units in one-half (1/2) unit increments.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

f.e. HBV

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

Number: K06315)

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