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.

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.

AI/ML Overview

The provided document describes the Innoject Auto-injector, a semi-automatic injection system. However, the document is a 510(k) premarket notification for substantial equivalence, not a detailed study report with specific acceptance criteria and performance metrics in the format requested.

The document states that "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." but does not provide the quantitative acceptance criteria or detailed results of these tests.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Not explicitly stated in quantitative terms)	Reported Device Performance
Dose accuracy	Met requirements/specifications, functioned as intended.
Dead space	Met requirements/specifications, functioned as intended.
Flow rate	Met requirements/specifications, functioned as intended.
Injection time / dwell time	Met requirements/specifications, functioned as intended.
Reliability (number of activations without failure)	Met requirements/specifications, functioned as intended.
Accuracy of penetration depth	Met requirements/specifications, functioned as intended.
Needle bond strength	Met requirements/specifications, functioned as intended.
Absence of leakage	Met requirements/specifications, functioned as intended.
Verification of non-coring needle properties	Met requirements/specifications, functioned as intended.
Needle penetration force	Met requirements/specifications, functioned as intended.
Device actuation force	Met requirements/specifications, functioned as intended.
Force necessary to defeat the button safety	Met requirements/specifications, functioned as intended.
Force necessary to remove the cap	Met requirements/specifications, functioned as intended.
Torque necessary to rotate the actuation button	Met requirements/specifications, functioned as intended.
Verification of syringe markings accuracy	Met requirements/specifications, functioned as intended.
Chemical resistance	Met requirements/specifications, functioned as intended.
Free fall resistance	Met requirements/specifications, functioned as intended.
Environmental stability	Met requirements/specifications, functioned as intended.

Note: The document only generically states "The device met all the requirements and specifications" without providing the specific quantitative requirements (e.g., "Dose accuracy: +/- 5%").

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided document.
Data Provenance: Not specified in the provided document. This is likely internal testing data generated by Innoject, Inc., as per the "extensive testing performed by the company" statement, but details like country of origin or retrospective/prospective nature are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a medical instrument (hardware), and the performance data described relates to its physical and functional characteristics (e.g., mechanical forces, accuracy of fluid delivery, material properties), not diagnostic interpretation requiring expert ground truth establishment in the way an AI diagnostic tool would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3 above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical auto-injector, not an algorithm. The document describes its standalone mechanical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests conducted, the "ground truth" would be established by standard engineering and metrology principles and validated measurement techniques for each parameter (e.g., using calibrated scales for dose accuracy, force gauges for penetration force, timing devices for injection time). It's based on objective physical measurements against predefined engineering specifications, not expert consensus or medical outcomes data in the typical sense for a diagnostic device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8 above.

Summary

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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: (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-injectorInnoject, Inc.6136 FM 1616Athens, TX 75752Phone:1-903-677-5017Facsimile:1-903-677-6083
Common or Usual Name:	Auto Injector
Classification Name:	Introducer, Syringe NeedleRegulation Number: 880.6920Medical Specialty: General HospitalProduct Code: KZHDevice 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 1330Auto-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

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Technological Characteristics and Substantial Equivalence

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 (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

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Indications for Use Statement

510(k) Number (if known):	K042557
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Device Name: Innoject Auto-injector

Indications for Use:

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

Regulation Number and Section

§ 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).