INNOJECT AUTO-INJECTOR

K042557 · Innoject, Inc. · KZH · Nov 8, 2004 · General Hospital

Device Facts

• Record ID: K042557
• Device Name: INNOJECT AUTO-INJECTOR
• Applicant: Innoject, Inc.
• Product Code: KZH · General Hospital
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Semi-automatic injection system; utilizes spring-loaded mechanism to insert hypodermic needle to predetermined depth; performs automatic needle insertion, drug injection, and needle withdrawal; features automatic needle retraction to prevent accidental sticks; masks needle from patient view. Used in clinical or home settings under physician direction. Device is button-actuated; single-use; ETO sterilized. Benefits include reduced risk of needle stick injuries and improved patient comfort via needle concealment.

Clinical Evidence

Bench testing only. Assessed dose accuracy, dead space, flow rate, injection/dwell time, reliability, penetration depth accuracy, needle bond strength, leakage, non-coring properties, penetration force, actuation force, safety button force, cap removal force, button torque, syringe marking accuracy, chemical resistance, free fall resistance, and environmental stability. All results met specifications.

Technological Characteristics

Spring-loaded auto-injector; includes syringe cartridge with prefixed needle, power pack housing, and window tube. Single-use; ETO sterilized. Mechanical actuation via button. Features automatic needle retraction mechanism.

Indications for Use

Indicated for patients requiring subcutaneous or intracavernosal injection of liquid drugs or biologics. Use under physician direction per approved drug labeling.

Regulatory Classification

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.

Predicate Devices

• Autoject Mini (K953735)
• B-D Auto Injector (K974678)
• Pen-ject 2.25 (K954729)
• Autoject 2 Model AJ 1330 Auto-injector (K945660)

Submission Summary (Full Text)

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# NOV - 8 2004

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Innoject, Inc. 6136 FM 1616 Athens, TX 75752 Phone: [phone] Facsimile: [phone]

Contact Person: Richard D. Gillespie III, P.E.

Date Prepared: September 15, 2004

#### Name of Device and Name/Address of Sponsor:

| Trade Name:<br>Name / Address of sponsor: | Innoject Auto-injector<br>Innoject, Inc.<br>6136 FM 1616<br>Athens, TX 75752<br>Phone:<br>1-903-677-5017<br>Facsimile:<br>1-903-677-6083 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Auto Injector |
| Classification Name: | Introducer, Syringe Needle<br>Regulation Number: 880.6920<br>Medical Specialty: General Hospital<br>Product Code: KZH<br>Device Class: Class II |
| Predicate Devices: | • Owen Mumford Inc.; Autoject Mini (K953735),<br>• Becton Dickinson; B-D Auto Injector (K974678),<br>Scandinavian Health Ltd.; Pen-ject 2.25 (K954729),<br>and<br>• Owen Mumford Inc.; Autoject 2 Model AJ 1330<br>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.

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### 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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#### 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)

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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