(38 days)
No
The description focuses on the mechanical operation of a needle-free injection system and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is described as an "Injex 30 Needle-Free Insulin Injector System" intended for the "subcutaneous injection of U-100 insulin." It is used to administer insulin, which is a treatment for diabetes, thereby performing a therapeutic function.
No
The device is described as an "Insulin Injector System," which is used for the "subcutaneous injection of U-100 insulin." Its function is to administer insulin, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components: the Injector, Reset Box, Insulin Ampule, and Vial Adapter. There is no mention of software as a component or the primary function of the device.
Based on the provided text, 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 administering medication directly into the body, not a test performed on a sample taken from the body.
- Device Description: The description details a system for delivering liquid medication through the skin using a jet, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly designed for drug delivery, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The over the counter Injex 30 Needle-Free Insulin Injector System is intended for the subcutaneous iniection of U-100 insulin. The Injex 30 Insulin Ampule is labeled as suitable for administration of 5 to 30 insulin units with a scale in 1 unit increments.
Product codes (comma separated list FDA assigned to the subject device)
KZE
Device Description
Equidyne Systems Injex 30 Needle Free Insulin Injector System is a means of administering insulin in the subcutaneous tissue without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the insulin in the subcutaneous tissue. The process takes place in a fraction of a second.
The Injex 30 Needle-Free Insulin Injector System consists of four main components:
- Iniex 30 Needle-Free Insulin Injector A small re-usable hand held Iniector.
- Reset Box - A compact re-usable Reset Box used to reset the Injex 30 Needle Free Insulin Injector,
- Injex 30 Insulin Ampule - A disposable, sterile 30 unit Injex 30 Insulin Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Injex 30 Insulin Ampule is loaded into the Injex 30 Needle Free Insulin Injector, the dose is injected into the individual by releasing the Safety and pressing the trigger.
- Vial Adapter - A disposable, sterile Vial Adapter facilitates the transfer of the insulin from the medicine bottle or vial to the Injex 30 Insulin Ampule.
The Injex 30 Needle Free Insulin Injector can deliver variable doses of insulin from 5 to 30 units. The Injex 30 Insulin Ampule scale is in 1 unit increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
The clinical study had a good distribution of age among the subjects with the average age being 48.5 years with a range of 25 to 77 years old.
Intended User / Care Setting
Over the counter, individual self-administration.
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
A clinical study was conducted to determine if the labeling and Instructions for Use for the Injex System are adequate instruction for an individual to administer an injection using the Injex family of injectors and to determine if the ease of use and pain using the Injex family of injectors are substantially equivalent to that of a needle and syringe. Subjects were given a Labeling and Substantial Equivalence Questionnaires after injecting themselves. Sample size: Not Found. Data source: Not Found. Annotation protocol: Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study. Sample size: Not Found. Key results:
- 100% of the subjects said that it was either easy or somewhat easy to give themselves an injection after viewing the training video and reading the Instructions for Use.
- 84% of the subjects said that they either prefer the Injex 30 Needle-Free Insulin Injector or would use either the Injex 30 Needle-Free Insulin Injector or a needle and syringe in the future.
- 91% of the subjects said the pain from the Injex 30 Needle-Free Insulin Injector was either the same as, a little less or a lot less than the insulin needle and syringe.
- 91% of the subjects felt that the Injex 30 Needle-Free Insulin Injector was just as easy to use as an insulin needle and syringe.
- 100% of the subjects felt it was just as easy to give themselves an injection using the Injex 30 Needle-Free Insulin Injector as it was with a insulin needle and syringe.
The results of this clinical study show that the Injex labeling and instructions for use are adequate for an individual to give themselves an insulin injection using the family of Injex Injectors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K022502
Page 1 of 3
SEP 5 2002
510(k) Summary (As required by 21 CFR 807.92(a))
- Submitter Information A.
Equidyne Systems Inc. 11770 Bernardo Plaza Court, Suite 351 San Diego, CA 92128
858-451-7001 Phone Number: Fax Number: 858-451-7002 Contact: Jim Barley Regulatory Affairs July 26, 2002 Date:
Device Information B.
Trade/Proprietary Name:
Common name of device:
Classification Name:
- C: Predicate Device:
Predicate 510(k) #:
D. Device Description:
Equidyne Systems Injex 30 Needle Free Insulin Injector System is a means of administering insulin in the subcutaneous tissue without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the insulin in the subcutaneous tissue. The process takes place in a fraction of a second.
System
System
Jet Injector
Injex 30 Needle Free Insulin Injector
Injector, Fluid, Non-Electrically Powered
Medi Ject Choice Insulin Delivery
1
-
D. Device Description: (cont.)
The Injex 30 Needle-Free Insulin Injector System consists of four main components: -
Iniex 30 Needle-Free Insulin Injector A small re-usable hand held 1. Iniector.
-
- Reset Box - A compact re-usable Reset Box used to reset the Injex 30 Needle Free Insulin Injector,
-
- Injex 30 Insulin Ampule - A disposable, sterile 30 unit Injex 30 Insulin Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Injex 30 Insulin Ampule is loaded into the Injex 30 Needle Free Insulin Injector, the dose is injected into the individual by releasing the Safety and pressing the trigger.
-
- Vial Adapter - A disposable, sterile Vial Adapter facilitates the transfer of the insulin from the medicine bottle or vial to the Injex 30 Insulin Ampule.
The Injex 30 Needle Free Insulin Injector can deliver variable doses of insulin from 5 to 30 units. The Injex 30 Insulin Ampule scale is in 1 unit increments.
-
E. Intended Use:
The over the counter Injex 30 Needle-Free Insulin Injector System is intended for the subcutaneous iniection of U-100 insulin. The Injex 30 Insulin Ampule is labeled as suitable for administration of 5 to 30 insulin units with a scale in 1 unit increments. -
F. Comparison of Required Technological Characteristics:
This submission changes the labeling and design of the Injex 30 Needle Free Injector System, 510(k) number K022148 to allow the device to be sold over the counter for insulin use. The Injex 30 Needle Free Insulin Injector System has the same technological characteristics as the Medi-Ject Choice Insulin Delivery System. -
G. Summary and Conclusion of Nonclinical and Clinical Tests:
A clinical study was conducted to determine if the labeling and Instructions for Use for the Injex System are adequate instruction for an individual to administer an injection using the Injex family of iniectors and to determine if the ease of use and pain using the Injex family of injectors are substantially equivalent to that of a needle and syringe.
2
Study Results
There was a good distribution of age among the subjects with the average age being 48.5 years with a range of 25 to 77 years old.
Subject education was representative of the public with 18% of the subjects having an eighth grade education or less and 82% of the subjects had a high school education or less. Eighteen percent of the subjects had more than a high school education.
After injecting themselves using the Injex 30 Needle-Free Insulin Injector System and an insulin needle and syringe, subjects were given a Labeling and Substantial Equivalence Questionnaires.
Results from the questionnaire include:
100% of the subjects said that it was either easy or somewhat easy to give themselves an injection after viewing the training video and reading the Instructions for Use. None of the subjects said that it was difficult or they were not able to give themselves an injection after viewing the training video and reading the Instructions for Use.
84% of the subjects said that they either prefer the Injex 30 Needle-Free Insulin Injector or would use either the Injex 30 Needle-Free Insulin Injector or a needle and syringe in the future.
91% of the subjects said the pain from the Injex 30 Needle-Free Insulin Injector was either the same as, a little less or a lot less than the insulin needle and syringe.
91% of the subjects felt that the Injex 30 Needle-Free Insulin Injector was just as easy to use as an insulin needle and syringe.
100% of the subjects felt it was just as easy to give themselves an injection using the Injex 30 Needle-Free Insulin Injector as it was with a insulin needle and svringe.
Clinical Study Conclusion
The results of this clinical study show that the Injex labeling and instructions for use are adequate for an individual to give themselves an insulin injection using the family of Injex Injectors.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Public Health Service
5 2002 SEP
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jim Barely Equidyne Systems, Incorporated 11770 Bernardo Plaza Court, Suite 351 San Diego, California 92128
Re: K022502
Trade/Device Name: Injex 30 Needle Free Injection System Regulation Number: 880.5430 Regulation Name: Regulatory Class: II Product Code: KZE Dated: July 26, 2002 Received: July 29, 2002
Dear Mr. Barely:
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.
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.
4
Page 2 – Mr. Barely
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The over the counter Injex 30 Needle-Free Insulin Injection System is intended for the subcutaneous injection of U-100 insulin. The Ampule is labeled as suitable for administration of 5 to 30 insulin units in 1 unit increments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) --------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental
510(k) Number:_