(8 days)
Not Found
No
The summary describes a mechanical needle-free insulin delivery system and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is used for the delivery of insulin, which is a therapeutic agent, but the device itself does not provide a therapeutic effect. It is a delivery system.
No
The device is an insulin delivery system, which administers insulin rather than diagnosing a condition.
No
The device description clearly states "Needle-Free Insulin Delivery System," which implies a physical hardware component for delivering insulin. The submission is for a labeling change only, further suggesting an existing hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of U-100 insulin." This describes a method of delivering a substance into the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as a "Needle-Free Insulin Delivery System." This further reinforces its function as a delivery mechanism.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to administer medication, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
KZE
Device Description
Needle-Free Insulin Delivery System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
None were performed in support of this submission. This request is for a labeling change only.
Key Metrics
Not Found
Predicate Device(s)
Medi-Jector Choice, K962956
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).
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
Needle-Free Insulin Delivery System |
|-------------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Fluid Injector |
| Classification Name: | Non-electrically powered fluid injector
(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
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