(112 days)
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/testing data.
No.
The device is an auto-injector system intended for drug delivery, not for therapeutic action itself. Its function is to facilitate the administration of liquid drugs and biologics, which are the therapeutic agents.
No
The device is described as an auto-injector for the transfer and intramuscular injection of liquid drugs and biologics. It is designed for drug delivery, not for diagnosing a condition or disease.
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 text, the ConfiDose™ IM auto-injector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the "manual transfer, containment and intramuscular injection of liquid drugs and biologics". This describes a device used for administering substances into the body, not for testing samples outside the body (which is the definition of in vitro diagnostics).
- Device Description: The description details a mechanical system for injecting substances, including a needle, spring-loaded mechanisms, and automatic needle retraction. This aligns with an injection device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the ConfiDose™ IM auto-injector is a medical device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
KZH
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intramuscular
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K0600389
1 of 2
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-injector
Pharma-Pen, 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: | • 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
1
Technological Characteristics and Substantial Equivalence:
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.
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.
2
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.
3
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
4
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: ConfiDose™ IM Auto-injector
Indications for 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 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.
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
l of
(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