BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
Device Facts
| Record ID | K121270 |
|---|---|
| Device Name | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM |
| Applicant | Bioject Medical Technologies, Inc. |
| Product Code | KZE · General Hospital |
| Decision Date | Jul 19, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5430 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers who routinely administer injections. The Biojector® 2000 may also be used by patients authorized by their healthcare practitioner to self inject, or have other individuals administer injections of prescribed medication.
Device Story
Biojector 2000 is a needle-free jet injection system using high-pressure CO2 gas to deliver liquid medication through the skin. System components include the injector, sterile single-use disposable syringes (various orifice sizes), and an intradermal (ID) spacer. For ID injections, the ID spacer is attached to a No. 2 syringe to control penetration depth by maintaining optimal distance from the skin. Operated by healthcare providers or authorized patients/caregivers in clinical or home settings. Operator fills syringe via vial adapter, loads into injector, and triggers injection at 90-degree angle. Output is a high-pressure fluid stream penetrating the dermis. Benefits include needle-free administration, reducing needle-stick risks and patient anxiety. Performance verified against ISO 21649:2006.
Clinical Evidence
No human clinical trials. Bench testing verified compliance with ISO 21649:2006. Biocompatibility testing (ISO 10993) performed on ID spacer and disposables. Porcine model study compared ID injections using B2000 with ID spacer versus needle and syringe, demonstrating equivalence in wheal size, depth of penetration, and dye dermal contact area.
Technological Characteristics
CO2-powered jet injector. Disposables: high-density polyethylene ID spacer, sterile syringes (0.1-1.0 ml). Orifice diameters: 0.004" to 0.014". Sterilization: Ethylene Oxide (EtO). Compliance: ISO 21649:2006. Biocompatibility: ISO 10993-4, -5, -7, -10, -11. Dose accuracy: ±5%.
Indications for Use
Indicated for delivery of SC, IM, or ID injections of vaccines and pharmaceutical injectables in patients requiring such therapy, including those authorized for self-injection or caregiver administration.
Regulatory Classification
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.
Predicate Devices
- Biojector® 2000 Needle-Free Injection Management System (K960373)
- Becton Dickinson Single Use Hypodermic and Insulin Syringe (K980580)
- Terumo America, Inc Disposable Hypodermic Needle (K771203)
- PharmaJet 0.1 ml Needle-free Injector System (K110456)
Submission Summary (Full Text)
{0}------------------------------------------------
K.121270
# PREMARKET NOTIFICATION
JUL 19 2012
# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
as required by section 21 CFR 807.92(c)
Date Prepared:
April 23, 2012
Submitted By:
Bioject, Inc. Christine Breitbach QA/QC/RA Manager 7180 SW Sandburg St., Suite 100 Tigard, OR, 97223, USA 503-692-8001 Phone 503-692-6698 Fax
Device Name:
Proprietary Name: Biojector® 2000 Needle-Free Injection Management System (B2000)
Common Name: Needle-Free Jet Injector
Classification Name: Injector, Fluid, Non-Electrically Powered 21 CFR 880.5430, Product Code KZE
Predicate Device(s):
Biojector® 2000 Needle-Free Injection Management System (K960373) Becton Dickinson Single Use Hypodermic and Insulin Syringe (K980580) Terumo America, Inc Disposable Hypodermic Needle (K771203)
PharmaJet 0.1 ml Needle-free Injector System (K110456)
Purpose of Submission: To add a new Indication for Use with the Biojector® 2000 to administer intradermal injections using the ID Spacer.
## Device Description:
The Bioject® 2000 Needle-Free Injection Management System is designed to deliver vaccines and other pharmaceutical injectables by producing a high pressure injectate stream that penetrates the dermis. The system is composed of three major components: (1) the injector -Biojector® 2000; (2) sterile single use disposables - syringes in multiple orifice sizes, safety cap, filling adapter and intradermal spacer (packaged for use with a No. 2 syringe only); and (3) power source - carbon dioxide (CO2) cartridge or tank.
The depth of injectate penetration is dependant upon the svringe orifice diameter. In general. the larger the diameter of the syringe orifice, the deeper into the tissue the fluid will be
Biojector® 2000 ID Indication Traditional 510(k) Submission
{1}------------------------------------------------
K12/270
deposited. Disposable syringes with a variable volume from 0.1 ml to 1 ml are numbered 2, 3, 4, 5 and 7, and have increasing syringe orifice diameters, 0.04", 0.08", 0.10" and 0.14" respectively. Intradermal injections (ID) are only performed using a No. 2 syringe (the smallest diameter) and an ID Spacer. As the distance from the syringe orifice to the skin is increased, the energy density of the fluid stream is decreased. The ID Spacer utilizes this principle to provide the optimum distance from the syringe to the skin to provide enough energy for the injectate to penetrate the epidermis, but not enough energy to transverse the underlying dermal tissue Subcutaneous (SC) injections are performed using a No. 2 syringe that is in direct contact with the skin, no spacer is utilized. Intramuscular (IM) injections are performed using syringes in contact with the skin and with larger orifice diameters.
The disposable syringe assemblies are provided sterile in a Tyvek blister peel pouch. The ID Spacer is manufactured from a high density polyethylene that meets the same environmental, biocompatibility and sterility requirements as the disposable syringes. The ID Spacer is packaged as a component with Biojector® No. 2 syringe assemblies.
#### Intended Use:
The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers who routinely administer injections. The Biojector® 2000 may also be used by patients authorized by their healthcare practitioner to self inject, or have other individuals administer injections of prescribed medication.
The addition of the intradermal indication is facilitated by using the new Intradermal Spacer with a No. 2 Syringe. Intradermal injections of vaccines and other pharmaceuticals are performed on the same patient populations that are now being treated with the Biojector® 2000 for the previously cleared indications.
#### Device Use:
A device operator (healthcare worker, or a patient/family member authorized by their practitioner), aseptically opens the sterile packaging and fills the syringe with a desired amount of liquid medication using the provided disposable vial adapter. The filled syringe is then loaded into the Biojector® 2000 with a clockwise twisting motion until completely seated and a green color is visible in the syringe interlock window. The actuation (trigger) interlock is disengaged and the device is ready for use. The operator presses the syringe (or ID Spacer for intradermal injections) onto the skin at a 90° angle in a location appropriate for the route of administration and the actuator is pulled back initiating the injection. Following the injection, the syringe (and ID Spacer if used) is discarded in a normal medical waste container. The device is ready for reloading and can perform approximately 10 injections per each new CO2 cartridge. The Biojector® 2000 can also be attached to a large capacity CO2 tank with an adapter to perform increased numbers of injections between gas source changes.
## Non-Clinical Testing Summary
#### Performance:
The Biojector® 2000 Needle-Free Injection Management System including the Intradermal (ID) Spacer has been verified to meet the performance requirements of ISO 21649:2006, Needlefree injectors for medical use - Requirements and test methods.
{2}------------------------------------------------
K121270\$\varnothing\$
# Biological Safety:
The Bioject ID Spacer is a patient contact component and has been tested to, and met the established criteria for, the following biocompatibility requirements:
| Cytotoxicity | ISO 10993-5:2009 |
|--------------------------------------|-------------------|
| Sensitization | ISO 10993-10:2010 |
| Irritation/Intracutaneous Reactivity | ISO 10993-10:2010 |
The Biojector® 2000 disposables have patient and drug contact surfaces that are tested to, and met the established criteria for, the following biocompatibility requirements:
| Cytotoxicity | ISO 10993-5:2009 |
|--------------------------------------|-----------------------------|
| Irritation/Intracutaneous Reactivity | ISO 10993-10:2010 |
| Acute Systemic Toxicity | ISO 10993-11:2006 |
| Haemocompatibility | ISO 10993-4:2002/Amd 1:2006 |
# Sterilization:
The final packaged No. 2 Syringe with ID Spacer assembly has been tested to, and met the established criteria for, the following sterilization requirements: 、
| Ethylene Oxide Sterilization | ISO 11135:2007 |
|------------------------------|------------------|
| Ethylene Oxide Residuals | ISO 10993-7:2008 |
# Animal Studies:
Testing in an accepted porcine model was conducted and demonstrated that intradermal injections performed using the Biojector® 2000 with an Intradermal Spacer or with a needle and syringe are substantially equivalent for the criteria tested: 1) wheal size, 2}, depth of penetration, and 3) dye dermal contact area.
# Technological Comparison:
| Characteristic | Biojector® 2000<br>with ID Spacer | Biojector® 2000<br>(IM & SC) | BD Syringe and<br>Terumo Needle | PharmaJet 0.1<br>ml NFI System |
|------------------------------|-----------------------------------|------------------------------|-------------------------------------|--------------------------------|
| Actuation | Trigger | Trigger | Standard Piston<br>Syringe & Needle | Trigger |
| Trigger Safety | Yes | Yes | NA | Yes |
| Power Source | CO2 gas | CO2 gas | Human | Mechanical<br>Spring |
| Injector Life Cycle | 33,000 injections | 33,000 injections | NA | 20,000 injections |
| Medication<br>Transfer | Vial Adapter | Vial Adapter | Hypodermic<br>needle | Vial Adapter |
| ISO 21649:2006<br>Compliance | Yes | Yes | NA | Yes |
| Volume of<br>Injectate | 0.1 ml only | 0.1 ml to 1.0 ml | 0.05 ml to 1.0 ml | 0.1 ml fixed |
| Dose Accuracy | $\pm 5%$ | $\pm 5%$ | Unknown | $\pm 5%$ |
Biojector® 2000 ID Indication Traditional 510(k) Submission
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows a sequence of handwritten characters. The characters are 'KJ21270'. The characters are written in a cursive style. The image is in black and white.
| Characteristic | Biojector® 2000<br>with ID Spacer | Biojector® 2000<br>(IM & SC) | BD Syringe and<br>Terumo Needle | PharmaJet 0.1<br>ml NFI System |
|---------------------------------------|-----------------------------------|----------------------------------------------|---------------------------------|--------------------------------|
| Orifice Diameter | 0.004" | 0.004", 0.006",<br>0.008", 0.010",<br>0.014" | NA | 0.007" |
| Single Use<br>Disposables | Yes | Yes | Yes | Yes |
| Sterile<br>Disposables | Yes | Yes | Yes | Yes |
| Disposable<br>Sterilization<br>Method | EtO | EtO | Unknown | Electron Beam |
# Conclusion:
The Biojector® 2000 with the Intradermal Spacer has the same indications for use as the predicate devices and is substantially equivalent to the performance of the PharmaJet 0.1 ml Needle-free Injector System and the use of a needle and syringe for intradermal injections. The Biojector ® 2000 when used with the Intradermal Spacer does not raise any new issues of safety and effectiveness.
{4}------------------------------------------------
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Ms. Christine Breitbach OA/OC/RA Manager Bioject Medical Technologies, Incorporated 7180 SW Sandburg Street. Suite 100 Tigard, Oregon 97223
JUI 19 2012
Re: K121270
Trade/Device Name: Biojector® Needle-Free Injection Management System, Biojector® B2000 Regulation Number: 21 CFR 880.5430 Regulation Name: Non-electrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: April 24, 2012 Received: April 26, 2012
Dear Ms. Breitbach:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{5}------------------------------------------------
## Page 2 - Ms. Breitbach
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Fx R. Shete
Pandit md
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{6}------------------------------------------------
# INDICATIONS FOR USE
510(K) # (if known):
Device Name:
Biojector® Needle-Free Injection Management System, Biojector® B2000
Indications for Use:
The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lyl Wini for REC July 18, 2012
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
K1212-10(k) Number:
