The ConfiDose™ IM auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and intramuscular injection of liquid drugs and biologics under the direction of a physician. The ConfiDose™ IM auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The ConfiDose™ IM auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.

Device Description

The ConfiDose™ IM 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 springloaded retraction mechanism. It is pressure actuated. Once activated, the device automatically performs all three steps of the injection process, needle insertion, drug injection and needle withdrawal. The ConfiDose™ IM auto-injector is individually packaged and ETO sterilized for single use.

AI/ML Overview

The provided text describes a 510(k) submission for the ConfiDose™ IM Auto-injector. The nature of this submission focuses on demonstrating substantial equivalence to existing devices through performance testing against established standards, rather than a clinical study involving human subjects or AI-driven diagnostics. Therefore, many of the requested categories (like MRMC studies, expert ground truth, sample sizes for training/test sets in AI/ML context) are not applicable to this type of device clearance.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were "requirements and specifications" defined by ISO 11608-1: Pen-Injectors for Medical Use-Part 1: Requirements and Test Method. The reported performance was that "The device met all the requirements and specifications."

Performance Metric (from ISO 11608-1)	Acceptance Criteria (Implicitly from ISO 11608-1)	Reported Device Performance
Dose accuracy	Met requirements & specifications	Met all requirements
Dead space	Met requirements & specifications	Met all requirements
Flow rate	Met requirements & specifications	Met all requirements
Injection time / dwell time	Met requirements & specifications	Met all requirements
Reliability (number of activations without failure)	Met requirements & specifications	Met all requirements
Accuracy of penetration depth	Met requirements & specifications	Met all requirements
Needle bond strength	Met requirements & specifications	Met all requirements
Absence of leakage	Met requirements & specifications	Met all requirements
Verification of non-coring needle properties	Met requirements & specifications	Met all requirements
Needle penetration force	Met requirements & specifications	Met all requirements
Device actuation force	Met requirements & specifications	Met all requirements
Torque necessary to defeat the safety of the device	Met requirements & specifications	Met all requirements
Verification of syringe markings accuracy	Met requirements & specifications	Met all requirements
Chemical resistance	Met requirements & specifications	Met all requirements
Free fall resistance	Met requirements & specifications	Met all requirements
Environmental stability	Met requirements & specifications	Met all requirements

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each specific test or the overall test set. It mentions "extensive testing performed by the company." The testing was conducted according to ISO 11608-1, which would dictate the appropriate sample sizes for each test. The data provenance is internal to the company (Pharma-Pen, Inc.) and is prospective testing of the device prototypes/production samples. There is no indication of country of origin of data beyond the company being based in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a mechanical auto-injector, and its performance is evaluated against engineering and functional specifications, not against expert interpretation of medical images or symptoms. The "ground truth" is typically defined by the objective measurement of physical properties and functions as per the ISO standard.

4. Adjudication Method for the Test Set

Not applicable. As described above, the testing involves objective measurements against engineering standards, not subjective expert judgment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., radiologists reading images) and AI assistance. The ConfiDose™ IM Auto-injector is a mechanical device, and its evaluation focuses on its physical and functional performance, not on aiding human interpretation for diagnosis.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study in the context of an AI/ML algorithm was not done. This device does not feature an AI/ML algorithm. The performance evaluation was of the physical device functioning independently.

7. The Type of Ground Truth Used

The ground truth used was based on the objective performance specifications and requirements outlined in ISO 11608-1. This involves precise measurements of physical parameters such as dose accuracy, penetration depth, flow rate, and reliability against the defined tolerances of the standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI/ML training set for this device.

Summary

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K0600389
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510(k) SUMMARY ConfiDose™ IM Auto-injector

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

Pharma-Pen, Inc. 6136 FM 1616 Athens, TX 75752 Phone: (903) 677-5017 Facsimile: (903) 677-6083

JUN - 6 2006

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

Date Prepared: February 6, 2006

Name of Device and Name/Address of Sponsor:

Trade Name:Name / Address of sponsor:	Confi Dose ™ IM Auto-injectorPharma-Pen, 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:	• Union Medico Aps.; Personal Injector (K033696),• Biogen; Invisiject™ Reusable Auto Injector (K032425),• Pharma-Pen Inc.; Confi Dose Auto-Injector (K042557).

Intended Use:

The ConfiDose™ IM auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and intramuscular injection of liquid drugs and biologics under the direction of a physician. The ComfiDose™ IM auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The ConfiDose™ IM 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 ConfiDose™ IM 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 includes an automatic spring-loaded retraction mechanism. The same technological characteristics are found in various commercially marketed autoinjectors, which operate on the generally same principle.

In contrast to ConfiDose™ IM auto-injector, the predicate devices (except the ConfiDose auto-injector K042557) do not automatically retract the hypodermic needle after the injection process is completed.

The ConfiDose™ IM auto-injector is substantially equivalent to the other currently marketed auto-injectors, which are referenced above. The ConfiDose™ IM 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 ConfiDose™ IM auto-injector raises no new issues of safety or effectiveness.

Performance Data:

FDA has established no performance standards for this device classification. Performance of the ConfiDose™ IM auto-injector was assessed using applicable sections and methods specified in ISO 11608-1: Pen-Injectors for Medical Use-Part 1: Requirements and Test Method. 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, torque necessary to defeat the safety of the device, 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 ConfiDose™ IM auto-injector functioned as intended and the observed results were as expected.

Conclusion

Pharma-Pen, Inc. concludes, based on the information presented herein, that the ConfiDose™ IM auto-injector is substantially equivalent to similar products that have received FDA clearance and are currently legally marketed in the USA.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines, representing health and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.

JUN -6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pharma-Pen, Incorporated C/O Mr. Jonathan S. Kahn, Esquire Hogan & Hartson, L.L.P. 555 Thirteenth Street Washington, D.C. 20004-1109

Re: K060389

Trade/Device Name: ConfiDose™ IM Auto-Injector Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: May 16, 2006 Received: May 16, 2006

Dear Mr. Kahn:

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.

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Page 2 - Mr. . Kahn

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. 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), please contact the Office of 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 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.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clues

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):_____________________________________________________________________________________________________________________________________________________

Device Name: ConfiDose™ IM 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)

K06038

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(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A. Murphy, MD. Anthony Watson 6/1/04

Anas " Balogy General Hospital n Control, Lental Devic

Number: K060389

ATTACHMENT L Page 1

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).