(49 days)
Not Found
No
The description focuses on mechanical and spring-loaded mechanisms for automated injection, with no mention of AI or ML terms, data processing, or training/test sets.
No
The device is an auto-injector system used for the mechanical transfer and injection of liquid drugs, not for therapeutic purposes itself. Its function is to administer medication, which then has a therapeutic effect.
No
The device description and intended use clearly state that the Innoject auto-injector is for the "manual transfer, containment and subcutaneous or intracavernosal injection of liquid drugs and biologics." It is an injection system, not a diagnostic one.
No
The device description clearly outlines physical components like a syringe cartridge, power pack housing, spring-loaded mechanisms, and a window tube, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "manual transfer, containment and subcutaneous or intracavernosal injection of liquid drugs and biologics." This describes a device used for administering substances into the body, not for testing samples from the body.
- Device Description: The description details a system for injecting drugs, including a syringe, needle, and injection mechanism. This aligns with drug delivery, not diagnostic testing.
- Lack of Diagnostic Elements: 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 diagnostic, monitoring, or compatibility purposes. This device's function is solely for drug administration.
N/A
Intended Use / Indications for Use
The Innoject auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and subcutaneous or intracavernosal injection of liquid drugs and biologics under the direction of a physician and according to approved drug or biologic labeling. The Innoject auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The Innoject auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
Product codes
KZH
Device Description
The Innoject auto-injector consists of a syringe cartridge with prefixed needle, power pack housing with spring loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and a window tube with spring-loaded retraction mechanism. It is button actuated, and once activated, the device automatically performs all three steps of the injection process, needle insertion, drug injection and needle withdrawal. The Innoject auto-injector is individually packaged and ETO sterilized for single use.
The Innoject auto-injector utilizes a spring-loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and dispense the medication, and an automatic spring-loaded retraction mechanism. The same technological characteristics are found in various commercially marketed auto-injectors, which operate on the generally same principle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous or intracavernosal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under the direction of a physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been established by FDA for this device. Dose accuracy, dead space, flow rate, injection time / dwell time, reliability (number of activations without failure), accuracy of penetration depth, needle bond strength, absence of leakage, verification of non-coring needle properties, needle penetration force, device actuation force, force necessary to defeat the button safety, force necessary to remove the cap, torque necessary to rotate the actuation button, verification of syringe markings accuracy, chemical resistance, free fall resistance, environmental stability were assessed. The device met all the requirements and specifications. In all instances, the Innoject auto-injector functioned as intended and the observed results were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K953735, K974678, K954729, K945660
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).
0
NOV - 8 2004
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Innoject, Inc. 6136 FM 1616 Athens, TX 75752 Phone: (903) 677-5017 Facsimile: (903) 677-6083
Contact Person: Richard D. Gillespie III, P.E.
Date Prepared: September 15, 2004
Name of Device and Name/Address of Sponsor:
| Trade Name:
Name / Address of sponsor: | Innoject Auto-injector
Innoject, Inc.
6136 FM 1616
Athens, TX 75752
Phone:
1-903-677-5017
Facsimile:
1-903-677-6083 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Auto Injector |
| Classification Name: | Introducer, Syringe Needle
Regulation Number: 880.6920
Medical Specialty: General Hospital
Product Code: KZH
Device Class: Class II |
| Predicate Devices: | • Owen Mumford Inc.; Autoject Mini (K953735),
• Becton Dickinson; B-D Auto Injector (K974678),
Scandinavian Health Ltd.; Pen-ject 2.25 (K954729),
and
• Owen Mumford Inc.; Autoject 2 Model AJ 1330
Auto-injector (K945660) |
Intended Use
The Innoject auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and subcutaneous or intracavernosal iniection of liguid drugs and biologics under the direction of a physician and according to approved drug or biologic labeling. The Innoject auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The Innoject auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
Attachment J Page 1 of 2
1
Technological Characteristics and Substantial Equivalence
The Innoject auto-injector consists of a syringe cartridge with prefixed needle, power pack housing with spring loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and a window tube with spring-loaded retraction mechanism. It is button actuated, and once activated, the device automatically performs all three steps of the injection process, needle insertion, drug injection and needle withdrawal. The Innoject auto-injector is individually packaged and ETO sterilized for single use.
The Innoject auto-injector utilizes a spring-loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and dispense the medication, and an automatic spring-loaded retraction mechanism. The same technological characteristics are found in various commercially marketed auto-injectors, which operate on the generally same principle.
In contrast to Innoject auto-injector, the predicate devices do not automatically retract the hypodermic needle after the injection process is completed.
The Innoject auto-injector is substantially equivalent to ther currently marketed auto injectors, which are referenced above. The Innoject auto-injector and its predicate devices are all Introducer, Syringe Needle products. As described in the substantial equivalency table and supported by the extensive testing performed by the company, the Innoject autoinjector raises no new issues of safety or effectiveness.
Performance Data
No performance standards have been established by FDA for this device. Dose accuracy, dead space, flow rate, injection time / dwell time, reliability (number of activations without failure), accuracy of penetration depth, needle bond strength, absence of leakage, verification of non-coring needle properties, needle penetration force, device actuation force, force necessary to defeat the button safety, force necessary to remove the cap, torque necessary to rotate the actuation button, verification of syringe markings accuracy, chemical resistance, free fall resistance, environmental stability were assessed. The device met all the requirements and specifications. In all instances, the Innoject auto-injector functioned as intended and the observed results were as expected.
Conclusion
Innoject, Inc. concludes based on the information presented herein that the Innoject autoinjector is substantially equivalent to similar products that have received FDA clearance and are currently legally marketed in the USA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Innoject, Incorporated C/O Mr. Jonathan S. Kahan Partner Hogan & Hartson, LLP 555 Thirteenth Street, NW Washington, DC 20004-5600
Re: K042557
Trade/Device Name: Innoject Auto-Injector Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: September 17, 2004 Received: September 20, 2004
Dear Mr. Kahan:
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 (1 vir 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.
3
Page 2 - Mr. Kahan
Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticase oc advisod that I D11 o termination that your device complies with other requirements moan that I Dr mas mass statutes and regulations administered by other Federal agencies. or the Act of ally I east a the Act's requirements, including, but not limited to: registration r ou intist confire with a 807); labeling (21 CFR Part 801); good manufacturing practice and ilsting (21 CF R Part 807), and lity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in adiation 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) This letter will anow you to objantial equivalence of your device 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), rr you desire spiering af Compliance at (240) 276-0115. 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 may overnit 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Liang, 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
4
Indications for Use Statement
| 510(k) Number (if known): | K042557 |
|---|---|
| --------------------------- | --------- |
Device Name: Innoject Auto-injector
Indications for Use:
The Innoject auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and subcutaneous or intracavernosal injection of liquid drugs and biologics under the direction of a physician and according to approved drug or biologic labeling. The Innoject auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The Innoject auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
Prescription Use __ V (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arthir Dinter
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: 大04255