(404 days)
No
The device description details a mechanical, non-electrically powered system for needle-free injection, with no mention of computational or learning capabilities.
No.
Explanation: The device is designed to deliver injections of vaccines and other injectable drugs, acting as a delivery system for therapeutic substances rather than being a therapeutic device itself.
No
Explanation: The Biojector® 2000 is described as a needle-free injection management system designed to deliver drugs, not to diagnose medical conditions. Its purpose is to administer medication, not to provide diagnostic information.
No
The device description clearly outlines physical components (syringe, injector, CO2 cartridge) and a mechanical mechanism for drug delivery, indicating it is a hardware-based device. There is no mention of software as a primary or even secondary component.
Based on the provided text, the Biojector® 2000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs. This is a method of administering medication into the body, not for testing samples outside the body.
- Device Description: The description details a needle-free injection system that uses a high-velocity jet of fluid to penetrate the skin and deliver drug to the body. This is a drug delivery device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Biojector® 2000's function is solely to administer substances into the body.
N/A
Intended Use / Indications for Use
The Biojector® 2000 is indicated for delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. The Biojector® 2000 may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Biojector@ 2000 may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
Product codes
KZE
Device Description
The Biojector® 2000 is a needle free injection management system designed to deliver drugs both subcutaneously (SC) and intramuscularly (IM). It is a non-electrically powered device which is intended to administer an injection by means of a high velocity jet of fluid that penetrates the surface of the skin and delivers drug to the body. The system is comprised of three major components: The single use sterile medication syringe (medication container), the Biojector® (injector), and the Carbon Dioxide (CO2) cartridge (power source). The device is also capable of being powered with a CO2 tank with a specialized adapter.
The syringe holds a variable volume of drug up to a maximum of one cubic centimeter (cc) or milliliter (ml.). Volume increments are marked at 0.10, 0.20, 0.25, 0.30, 0.40, 0.50, 0.60, 0.75, 0.80, 0.90, and 1.0 cc or ml. The syringe is filled using either a fill needle, or a plastic fluid transfer device. Once the syringe is filled, it is loaded in the Biojector®. Syringes are available in five sizes which are numbered 2, 3, 4, 5 and 7. The syringe sizes have the following orifice diameters: 0.004, 0.008, 0.010 & 0.014 inches, respectively. The number 2 syringe is used for all subcutaneous injections. The remaining syringes, numbered 3, 4, 5, and 7, are used for intramuscular injections. Depth of penetration of the drug varies with the orifice diameter selected. The larger the orifice diameter, the deeper the penetration of the drug.
Activation of the Biojector® is initiated when the actuator is depressed. CO2 gas is released. through the action of a series of valves within the injector. This causes the plunger to push the drug out of the sterile syringe, through the syringe orifice at a high velocity, allowing it to penetrate the skin and be deposited in the tissue. Exhaust CO2 is expelled, through the exhaust and bleed valves, in the rear section of the Biojector®, as well as into the cartridge compartment. The CO2 does not come in contact with the drug.
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
physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections.
patients authorized by their physicians to self inject at home, or have other individuals administer injections of prescribed drug.
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)
Product qualification testing and biocompatibility data for the modified device (subject of submission) and the current, predicate device (K920631), demonstrate the new model to be functionally equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1997
Mr. Mary K. Norton Manager, Regulatory Affairs/Quality Assurance Bioject, Incorporated -----7620 S.W. Bridgeport Road 97224 Portland, Oregon
K960373 Re : Biojector 2000 Needle-Free Injection Trade Name: Management System Regulatory Class: II Product Code: KZE December 5, 1996 Dated: Received: December 6, 1996
Dear Ms. Norton:
We have reviewed your Section 510(k) notification of intent to we have reviewed your becases be have have determined the market the device referenced above the indications for device Is substancially equivaler (and in the enclosed in interstate use stated in the encreases, so the enactment date of the commerce prior to nay be , or to devices that have been Medical Device Amendically, of the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore), rood, brag, and Coomeric not the general controls provisions The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of Include requirementacturing practice, labeling, and devices, good manazaomisbranding and adulteration.
If your device is classified (see above) into either class II il your device is class III (Premarket Approval), it may (Special Controls) of the mal controls. Existing major be subject to such adable device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A Federal Regulations, freic arr instion assumes compliance with substantially equivalent actice for Medical Devices: General the Good Manufacturing Prascros o) and that, through periodic (GMP) regulacion (2) erk Fard Orug Administration (FDA) will GMF Inspections) Failure to comply with the GMP verly such assumpeloni. regulatory action. In addition, FDA may publish further announcements concerning your device in may publish farenes and es this response to your the reactar Region submission does not affect any premarked nocersight have under sections 531 through 542 of
1
Page 2 - Ms. Norton
the Act for devices under the Electronic Product Radiation the Act for devices ander one beeral laws or regulations.
This letter will allow you to begin marketing your device as Info recei will arrow ) premarket notification. The FDA described in your sitem privalence of your device to a legally finding of subbeancear equresults in a classification for your marketed predicate acvice pour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regulation (ar c devices), please contact the Office of Vicio draghobere at (301) 594-4618. Additionally, for questions on Compriance at (501) Sectising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to enc regaracton" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on Journaion of Smail Manufacturers Assistance obtained from the British on 63-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Timot Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
ਿ
Enclosure
2
510(k) Number (if known) K960373
Device Name: Biojector® Needle-Free Injection Management System, Biojector® 2000
Indications For Use:
The Biojector® 2000 is indicated for delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. The Biojector® 2000 may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Biojector@ 2000 may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) fallice Division of Dental, Infection Control and General Hospital Device
General Hospital Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over The-Counter Use
Optional Format 1-2-96)
011-1
3
January 24, 1996
MAR - 5 1997
BIOJECT INC.
7620 S.W. BRIDGEPORT ROAD
PORTLAND, OREGON 97224
TELEPHONE: (503) 639-7221
FAX: (503) 624-9002
510(k) SUMMARY (21CFR Subpart 807.92)
(a)(1) Submitter Identification:
Bioject, Inc. 7620 SW Bridgeport Road Portland, OR 97224 800-683-7221 503-624-9002 (fax)
Contact Person: Mary K. Norton Manager, Regulatory Affairs/Quality Assurance
| (a)(2) Device Name: | Biojector® 2000 Needle-Free Injection Management System™ |
|---|---|
| Common Name: | Needleless Injector, Jet Injector |
| Classification Name: | Non-electrically Powered Fluid Injector, 21 CFR 880.5430 |
Biojector® 2000 Jet Injection System (K920631) (a)(3) Predicate Device:
The Biojector® 2000 is a needle free injection management (a)(4) Device Description: system designed to deliver drugs both subcutaneously (SC) and intramuscularly (IM). It is a non-electrically powered device which is intended to administer an injection by means of a high velocity jet of fluid that penetrates the surface of the skin and delivers drug to the The system is comprised of three major components: The single use sterile bodv. medication syringe (medication container), the Biojector® (injector), and the Carbon Dioxide (CO2) cartridge (power source). The device is also capable of being powered with a CO2 tank with a specialized adapter.
The syringe holds a variable volume of drug up to a maximum of one cubic centimeter (cc) or milliliter (ml.). Volume increments are marked at 0.10, 0.20, 0.25, 0.30, 0.40, 0.50, 0.60, 0.75, 0.80, 0.90, and 1.0 cc or ml. The syringe is filled using either a fill needle, or a plastic fluid transfer device. Once the syringe is filled, it is loaded in the Biojector®. Syringes are available in five sizes which are numbered 2, 3, 4, 5 and 7. The syringe sizes have the following orifice diameters: 0.004, 0.008, 0.010 & 0.014 inches, respectively. The number 2 syringe is used for all subcutaneous injections. The remaining syringes, numbered 3, 4, 5, and 7, are used for intramuscular injections. Depth of penetration of the drug varies with the orifice diameter selected. The larger the orifice diameter, the deeper the penetration of the drug.
022
4
Activation of the Biojector® is initiated when the actuator is depressed. CO2 gas is released. through the action of a series of valves within the injector. This causes the plunger to push the drug out of the sterile syringe, through the syringe orifice at a high velocity, allowing it to penetrate the skin and be deposited in the tissue. Exhaust CO2 is expelled, through the exhaust and bleed valves, in the rear section of the Biojector®, as well as into the cartridge compartment. The CO2 does not come in contact with the drug.
(a)(5) Intended Use: The Biojector® 2000 Needle-Free Injection Management System™ which is the subject of this submission and the currently marketed (predicate) Biojector® 2000 Jet Injection System (with tank adapter), K920631, are intended to deliver subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable medications. Both the Biojector® 2000 (subject of submission) and the predicate device may be used by physicians, nurses, veterinarians, and podiatrists and other practitioners who routinely administer injections. The Biojector® 2000 (subject of submission) may also be used by patients authorized by their physicians to self inject at home, or have other individuals administer injections of prescribed drug. It should be noted that a prior submission made by Bioject (K861687), predicate to K920631, was cleared via the 510(k) process for professional and home use.
(a)(6) This Premarket Notification describes modifications to the Biojector® 2000 device previously described via the 510(k) process (K920631). A summary of these modifications includes:
- . Changing from a two piece to a one piece main body design with related minor design changes to ease manufacturing:
- . Incorporation of design modifications to the exhaust and bleed valves to improve CO2 efficiency and performance:
- Changes in material involved replacing metal parts with plastic parts for cost reduction . purposes and to add alternate vendors for existing materials;
- . Labeling revisions including the addition of a Home Use Instruction Manual.
There are no changes in intended use or operational principle. Substantial equivalence is based upon equivalence in intended use, labeling, design, materials and operational principle to the Biojector® Jet Injection System (with tank adapter). K920631 and there are no new safety and efficacy issues as a result of the design modifications.
Product qualification testing and biocompatibility data for the modified device (subject of submission) and the current, predicate device (K920631), demonstrate the new model to be functionally equivalent to the predicate device. The device is as safe and effective as the legally marketed, predicate device, and does not raise questions of safety and efficacy different than that of the predicate.