(91 days)
NDA -19-430
No
The description focuses on the mechanical aspects of a spring-loaded auto-injector and does not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is an auto-injector designed to assist with drug delivery, but it does not directly treat a disease or condition itself. Its function is to facilitate the self-administration of AVONEX®, which is the therapeutic agent.
No
Explanation: The device is described as an auto-injector for self-administration of medication, specifically designed to assist with injecting a fixed dose of AVONEX®. It is a reusable, spring-loaded injection device that delivers medication. There is no mention of it being used to identify or analyze a disease or condition.
No
The device description clearly states it is a reusable, spring-loaded injection device with four separate physical components (Syringe Adapter, Syringe Holder, Base Unit, and Power Pack). This indicates it is a hardware device, not software-only.
Based on the provided information, the Invisiject™ Reusable Auto-Injector is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to assist with the self-administered injection of a drug (AVONEX®) into the patient. This is a therapeutic delivery device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a mechanical device for delivering medication, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, calibrators, or controls typically associated with IVD devices.
The device is a drug delivery system designed to make injections easier for the patient.
N/A
Intended Use / Indications for Use
The Invisiject™ Reusable Auto-Injector is a reusable device intended to be used by the patient to assist with the self-administered injection of a fixed dose of AVONEX® from a pre-filled syringe through a single lumen hypodermic needle. The auto-injectors are intended to be used in any setting including the home.
Product codes
KZH
Device Description
The Invisiject" Reusable Auto-Injector is a reusable, spring-loaded injection device that is designed to deliver 0.5 mL of AVONEX® from a pre-filled syringe. Using the Auto-Injector instead of direct injection with the pre-filled syringe provides an alternative method of injection to address needle phobia and injection anxiety by covering the svringe and needle during the injection process. The product consists of four separate components that are used to prepare and inject the drug from the pre-filled syringe through the single lumen hypodermic needle. The components, a Syringe Adapter, Syringe Holder, Base Unit, and Power Pack are packaged together in a plastic case, which doubles as the Handling Console used for assembly and charging the Power Pack. The AVONEX® pre-filled syringes and commercially available single lumen hypodermic needles are provided separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used by the patient to assist with the self-administered injection, in any setting including the home.
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)
Performance of the Invisiject™ Reusable Auto-Injector was assessed using applicable sections and methods specified in the ISO standard, ISO 11608-1, "Pen-injectors for Medical Use - Part 1: Requirements and Test Methods". Penetration depth, activation force for injection, loading force and Injection time were also assessed. The device met all requirements and specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
NDA -19-430
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 - 5 2003
510(K) SUMMARY June 30, 2003
Summary of Safety and Effectiveness 8.0
| 8.1 | Submitter's Name and Address: | Biogen
14 Cambridge Center
Cambridge, MA 02142 |
|-----|-------------------------------|---------------------------------------------------------------|
| | Contact Person: | Michael Poirier
Tel: 1-617-679-6459
Fax: 1-617-679-3170 |
| 8.2 | Trade/Proprietary Name: | Invisiject™ Reusable Auto-Injector |
| 8.3 | Common/Usual Name: | Auto-injector |
| 8.4 | Classification Name: | Introducer, Syringe Needle |
8:5 Substantial Equivalence:
The Invisiject " Reusable Auto-Injector is substantially equivalent to the B-D Auto-Iniector (K974678), the Owen Mumford Autoject 2 (K013362), the standard Piston Syringe (Numerous Devices) and Meridian's EpiPen® (NDA -19-430). The attached documentation supports the equivalence.
8.6 Description:
The Invisiject" Reusable Auto-Injector is a reusable, spring-loaded injection device that is designed to deliver 0.5 mL of AVONEX® from a pre-filled syringe. Using the Auto-Injector instead of direct injection with the pre-filled syringe provides an alternative method of injection to address needle phobia and injection anxiety by covering the svringe and needle during the injection process. The product consists of four separate components that are used to prepare and inject the drug from the pre-filled syringe through the single lumen hypodermic needle. The components, a Syringe Adapter, Syringe Holder, Base Unit, and Power Pack are packaged together in a plastic case, which doubles as the Handling Console used for assembly and charging the Power Pack. The AVONEX® pre-filled syringes and commercially available single lumen hypodermic needles are provided separately.
8.7 Intended Use:
The Invisiject" Reusable Auto-Injector is a reusable device intended to be used by the patient to assist with the self-administered injection of a fixed dose of AVONEX® from a pre-filled syringe through a single lumen hypodermic needle. The auto-injectors are intended to be used in any setting including the home.
1
8.8 Technological Characteristics:
The technological characteristics of the AVONEX® Reusable Auto-Injector are the same as products currently legally marketed in the USA
8.9 Performance Data:
Performance of the Invisiject™ Reusable Auto-Injector was assessed using applicable sections and methods specified in the ISO standard, ISO 11608-1, "Pen-injectors for Medical Use - Part 1: Requirements and Test Methods". Penetration depth, activation force for injection, loading force and Injection time were also assessed. The device met all requirements and specifications.
8.10 Conclusion:
Biogen concludes based on the information presented that the Invisiject™ Reusable Auto-Injector is substantially equivalent to products currently legally marketed in the USA.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
NOV - 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biogen Mr. Michael Poirier Associate Director Regulatory Affairs 14 Cambridge Center Cambridge, Massachusetts 02142
Re: K032425
Trade/Device Name: Invisiject ™ Reusable Auto-Injector Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: August 5, 2003 Received: August 7, 2003
Dear Mr. Poirier:
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. Poirier
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Susan Runno
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) File Number: K032425
Device Name:
Invisiject™Reusable Auto-Injector
Indications For Use:The Invisiject™ Reusable Auto-Injector is a reusable device indicated for use by the patient to assist with the self-administered injection of a fixed dose of AVONEX® from a pre-filled syringe through a single lumen hypodermic needle. The auto-injectors are intended to be used in any setting including the home.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cuccente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032425