HUMAPEN AND HUMAPEN ERGO

K982842 · Eli Lilly and Co. · FMF · Sep 25, 1998 · General Hospital

Device Facts

• Record ID: K982842
• Device Name: HUMAPEN AND HUMAPEN ERGO
• Applicant: Eli Lilly and Co.
• Product Code: FMF · General Hospital
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HumaPen and the HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The peninjector uses 3.0 mL cartridges of insulin (Humalog® or Humulin®) and a single use, detachable and disposable pen needle (supplied separately). The pen-injector allows the user to dial the desired dose one unit at a time up to 60 units.

Device Story

HumaPen and HumaPen Ergo are reusable pen-injectors for insulin self-administration by diabetic patients. The device accepts 3.0 mL insulin cartridges and a detachable, single-use pen needle. Users manually dial the desired dose in one-unit increments up to 60 units. The device features two-way dose correction, allowing users to dial forward or backward to adjust the dose before injection. Audible clicks provide feedback during dose selection. The device is intended for home use by patients. It improves upon previous designs by offering increased cartridge volume (3.0 mL vs 1.5 mL), higher maximum dose capacity (60 units vs 30 units), and simplified dose correction mechanisms compared to the predicate.

Clinical Evidence

bench testing only

Technological Characteristics

Reusable pen-injector; mechanical operation; 3.0 mL cartridge capacity; 60-unit maximum dose; two-way dose adjustment; audible click feedback; meets ISO/DIS 11608-1.2 requirements for delivery accuracy.

Indications for Use

Indicated for diabetics requiring self-injection of insulin using 3.0 mL 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

• B-D Pen

Submission Summary (Full Text)

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# 6.0 510(k) Summary of Safety and Effectiveness

| 1. | Submitter's Name: | Eli Lilly and Company<br>Lilly Corporate Center<br>Indianapolis, Indiana 46285<br>[phone]<br>[phone]<br>FAX no. [phone] | |
|----|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Contact Person: | LeeAnn Chambers, RAC<br>Associate Regulatory Consultant<br>Telephone: [phone]<br>FAX: [phone] | |
| | Date Prepared: | August 7, 1998 | |
| 2. | Device Name: | Proprietary Name: | HumaPen and HumaPen Ergo |
| | | Common Name: | Insulin Pen |

Classification Name: Piston Syringe

- 3. Predicate Device:
HumaPen and HumaPen Ergo are substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed B-D Pen.

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#### Device Description: 4.

HumaPen and HumaPen Ergo are two versions of 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 insulin (Humalog® (human insulin[rDNA origin]) or Humulin® (insulin lispro injection [rDNA origin]) and a single use, detachable and disposable pen needle (supplied separately). The peninjector allows the user to dial the desired dose one unit at a time up to 60 units.

- న. Intended Use: Insulin delivery device.

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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '982842'. The numbers are written in a slightly irregular style, but they are still easily readable. The image appears to be a close-up of the handwritten sequence.

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### 6. Technological Characteristics:

| Pen Feature | New Device | Predicate Device |
|----------------------------------------|-----------------------------------------|-----------------------------------------|
| Similarities: | | |
| Syringe type | Insulin Pen-injector | Insulin Pen-injector |
| Intended use(s) | Insulin delivery device | Insulin delivery device |
| Specific drug use | Insulin | Insulin |
| Delivery accuracy | meets ISO/DIS 11608-1.2<br>requirements | meets ISO/DIS 11608-1.2<br>requirements |
| Unit increments | one Unit increments | one Unit increments |
| Audible clicks with each<br>increment? | yes | yes |
| Can dial remaining<br>insulin? | no | no |

| Pen Feature | New Device | Predicate Device |
|-------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences: | | |
| Volume | 3.0 mL (300 Units) | 1.5 mL (150 Units) |
| Maximum dose size | 60 Units | 30 Units |
| Dosing adjustment | two-way dose correction (can dial<br>forward or backward to desired dose) | if incorrect dose is set, the patient<br>needs to turn the dose knob as far as it<br>will turn to the reset groove then push<br>in the injection button and redial to the<br>desired dose. |

・・・・・・・・・・・

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is printed in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 25 1998

LeeAnn Chambers, RAC Associate Regulatory Consultant Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285

Re : K982842 HumaPen and HumaPen Ergo Trade Name: Requlatory Class: II Product Code: FMF Dated: August 7, 1998 August 12, 1998 Received:

Dear Ms. Chambers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Chambers

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Russo

Timothy A. Ulatowski Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: Indications for Use:

The HumaPen and the HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The peninjector uses 3.0 mL cartridges of insulin (Humalog® or Humulin®) and a single use, detachable and disposable pen needle (supplied separately). The pen-injector allows the user to dial the desired dose one unit at a time up to 60 units.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cavazos

Division Sign-Off ivision of Dental, Int nd General Hospita

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use 2

(Optional Format 1-2-96)

HumaPen and HumaPen Ergo Premarket Notification Eli Lilly and Company