(91 days)
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.
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.
The Invisiject™ Reusable Auto-Injector is not an AI/ML device. The provided text is a 510(k) summary for a medical device that assists in the self-administration of injections. Therefore, many of the typical questions regarding acceptance criteria for AI/ML devices (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies) are not applicable to this document.
However, I can extract the acceptance criteria and performance information that is relevant to this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Applicability to ISO 11608-1 | Met applicable sections and methods of ISO 11608-1, "Pen-injectors for Medical Use - Part 1: Requirements and Test Methods" |
| Penetration depth | Assessed and met requirements/specifications |
| Activation force for injection | Assessed and met requirements/specifications |
| Loading force | Assessed and met requirements/specifications |
| Injection time | Assessed and met requirements/specifications |
2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device, and the performance assessment was based on physical device testing according to an ISO standard, not a data-driven test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert consensus on medical images) is not relevant here. Device performance was assessed against engineering specifications derived from an ISO standard.
4. Adjudication method for the test set
Not applicable.
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/ML device and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance assessment was established by the requirements and test methods specified in the ISO standard, ISO 11608-1, "Pen-injectors for Medical Use - Part 1: Requirements and Test Methods," along with specific engineering specifications for penetration depth, activation force, loading force, and injection time.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not have a training set.
9. How the ground truth for the training set was established
Not applicable.
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NOV - 5 2003
510(K) SUMMARY June 30, 2003
Summary of Safety and Effectiveness 8.0
| 8.1 | Submitter's Name and Address: | Biogen14 Cambridge CenterCambridge, MA 02142 |
|---|---|---|
| Contact Person: | Michael PoirierTel: 1-617-679-6459Fax: 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.
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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.
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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.
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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
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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
§ 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).