MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM

{0}------------------------------------------------ 4/23/99 510(k) SUMMARY (As required by 21 CFR 807.92(a)) ### Submitter Information: A. Medi-Ject Corporation 161 Cheshire Lane, Suite 100 Minneapolis, MN 55441 USA | Phone: | (612) 475-7700 | |--------|----------------| | Fax: | (612) 476-1009 | | Contact Person: | Peggy L. Holland | |-----------------|------------------| | Date: | April 9, 1999 | #### B. Device Information: | Trade/Proprietary Name: | Medi-Ject Corporation Medi-Jector Choice<br>Needle-Free Insulin Delivery System | |-------------------------|-----------------------------------------------------------------------------------------| | Common Name: | Fluid Injector | | Classification Name: | Non-electrically powered fluid injector<br>(880.5430) | | Predicate Device: | Medi-Jector Choice, K962956 | | Device Description: | Needle-Free Insulin Delivery System | | Intended Use: | The device is sold over the counter for the<br>subcutaneous injection of U-100 insulin. | #### C. Comparison of Required Technological Characteristics: This submission changes the labeling of the Medi-Jector Choice (K962956) to allow the device to be sold over the counter. No other significant changes have been made to the device design, function or intended use. #### D. Summary of Nonclinical Tests: None were performed in support of this submission. This request is for a labeling change only. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 3 1999 Peggy L. Holland Mr. Medi-Ject Corporation 161 Cheshire Lane, Suite 100 Minneapolis, Minnesota 55441 Re : K991294 Medi-Ject Corporation Medi-Jector Choice Trade Name: Needle-Free Insulin Delivery System Regulatory Class: II Product Code: KZE April 12, 1999 Dated: Received: April 15, 1999 Dear Ms. Holland 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 The general controls provisions of the Act 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 requlations 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) requlation (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 {2}------------------------------------------------ Page 2 - Ms. Holland 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 asbiring of substantial equivalence of your device to a legally marketed predicate device results in a classification for your mazice and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.jgov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## the first the contentor Devices and Radiological Health Sales Childer Page 1 of 1 510(k) Number (if known): .. Device Name: Medi-Jector Choice Needle-Free Insulin Delivery System Indications for Use: The over the counter Medi-Jector Choice Needle-Free Insulin Delivery System is intended for the subcutaneous injection of U-100 insulin. The injector is labeled as suitable for administration of 2 to 50 insulin units in a 0.5 unit increment. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Valtine Cascenite (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K99 129 V NOT A PRESCRIPTION DEVICE