BI-3M NEEDLE-FREE INJECTOR SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Felton International. The logo features a stylized "fi" in a bold, black font. To the right of the "fi" is the word "Felton" in a slanted, serif font, with the word "INTERNATIONAL" underneath in a smaller, sans-serif font. 013256 Ke | of 3 3210 Marshall Drive, Lenexa, KS 66214 U.S.A. 913-599-1590 FAX 913-599-0909 1-800-448-8522 Email: fi@feltonint.com ## 3. 510(k) SUMMARY DEC 0 7 2001 #### A. Submitter Information: | Name: | Felton International, Inc. | |-------------------------|--------------------------------------------------------------------| | Address: | 8210 Marshall Drive<br>Lenexa, KS 66214 | | Phone: | (913) 599-1590 | | FAX: | (913) 599-0909 | | E-mail: | fi@feltonint.com | | Contact: | Alan Felton, President | | Date: | September 28, 2001 | | B. Device Information: | | | Trade/Proprietary Name: | Bi-3M Needle-Free Injector System | | Common Name: | Needle-free fluid injector system | | Classification Name: | Nonelectrically powered fluid injector (Title 21 CFR<br>§880.5430) | | Predicate Devices: | Ped-O-Jet (preamendment device) | # C. Description of the Device: The Bi-3M Needle-Free Injector System consists of a hand-held injector unit to which a multiple-dose vial of vaccine or medication can be attached. The unit is spring-powered and is connected to its hydraulic fluid power source, which is operated by a foot pump. MEDiVAX (K945548) The Bi-3M Needle-free Injector System is identical to the Bi-3 injector which was first introduced into the public health system in Russia in 1974. Five modifications are made to the Bi-3M, the subject device of this submission. Three modifications to the injector are as follows: 1) the injected volume is fixed at 0.5 mL, whereas the Bi-3 can adjust to variable volume delivery (0.1 to 1.0 mL); 2) the device has a single nozzle for subcutaneous delivery, whereas the Bi-3 has three nozzle attachments for subcutaneous, intramuscular, and intradermal delivery; 3) a vial mount assembly holds the vial in place with a vial cap mount, whereas the original Bi-3 has metal clamps to hold the vial in place. {1}------------------------------------------------ The fourth and fifth modifications were made for the most significant feature of the Bi-3M needle-free injector system: the presterilized, single-use protector cap, and a redesign of the distal end of the hand unit to accommodate the cap. The cap is attached to the injector head before each injection and automatically removed before the next injection to prevent cross-contamination. All five modifications do not alter the basic mechanics of the device, or any component or aspect of the fluid path. The effectiveness in preventing cross-contamination is documented in the safety study discussed under Section 7.B. ## D. Intended Use of the Device The Bi-3M is designed to administer vaccines or medicines to the subcutaneous tissue by penetrating the skin under high pressure. It is intended for high-workload multiplepatient use by a health care professional, such as in mass immunization programs. ### E. Technological Characteristics in Comparison to Predicate Devices Similar to the Ped-O-Jet and MEDIVAX devices, Bi-3M is a needle-free injector system that consists of a hand-held injector unit and a connecting power source that is activated by a foot pump. The Bi-3M uses hydraulic fluid, which is identical to the power source of the Ped-O-Jet; MEDiVAX is powered by compressed air. All three devices hold a manufacturer's multiple-dose vial in position on the hand unit. A vial mount assembly that locks the vial cap to the Bi-3M hand unit holds the medicine vial in position. A 'U'-shaped clamp holds the vial cap in position on the Ped-O-Jet unit. The vial is attached first to a removable vial holder that is attached to the hand unit of MEDiVAX. The delivery of medication from the vial to the primary container in the hand unit is through stainless steel in all three devices. A presterilized protector cap is placed on the nozzle end of the Bi-3M before each injection to prevent cross-contamination; this cap is automatically removed after each use. MEDiVAX has a removable protector shield for the same purpose. No protective feature is on the preamendment Ped-O-Jet device. All three devices have removable injector heads to facilitate cleaning and sterilization of the components in contact with the medication fluid path and human skin. These components require steam sterilization before each injection session. I 1 #### F. Nonclinical Performance Tests A battery of performance testing was done to assess the substantial equivalency of the Bi-3M to Ped-O-Jet. Based on results of testing for dosage accuracy, there was no significant difference between the two injectors. Penetration, focus, force, and stream quality tests showed the two devices to be similar in these parameters. Additionally, environmental testing that tested the Bi-3M at temperature extremes and after free fall indicated consistent functionality. Operation of the Bi-3M produces sound that is below the exposure limits set by OSHA. {2}------------------------------------------------ #### G. Safety Tests The effectiveness of the Bi-3M to prevent cross-contamination was tested with an in vitro model designed to produce a high probability of contamination. In this study, an injection was made first into a contaminated (fluorescein) fixture, then into a clean vessel to assess the downstream contamination. The results showed the Bi-3M had a 99.8% clean sample rate, whereas Ped-O-Jet had a 54% clean sample rate. The one Bi-3M sample for which fluorescein was reported in the downstream collection did not have any fluorescein evident in the protector caps, which indicates that the fluorometer reading was an error. The high clean sample rate by the Bi-3M in this study that was designed to have a high rate of contamination is indicative that cross-contamination is unlikely with this device. ## H. Conclusions: The Bi-3M injector system is designed similarly to the cited predicate devices. Based on the results of the performance tests for dose accuracy, penetration, focus, force, and stream quality, the Bi-3M has demonstrated substantial equivalence to the Ped-O-Jet predicate device. Furthermore, the results of the safety test demonstrated a high level of safety relative to cross-contamination. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # DEC 0 7 2001 Mr. Alan Felton President Felton International, Incorporated 8210 Marshall Drive Lenexa, Kansas 66214 Re: K013256 Trade/Device Name: Bi-3M Needle Injector System Regulation Number: 880.5430 Regulation Name: Needle-Free Fluid Injector System Regulatory Class: II Product Code: KZE Dated: September 28, 2001 Received: October 1, 2001 Dear Mr. Felton: 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. 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. {4}------------------------------------------------ ### Page 2 - Mr. Felton You must comply with all the Act's requirements, including, but not limited to: registration You must collibry with an the Fict 5 requirements, and 801); good manufacturing practice and listing (21 CFR Part 067), lacelity systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality ijon 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 This letter will anow you to ochi marketing your substantial equivalence of your device to 310(k) premiented 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 II you desire specific at not 2009.10 for in vitro diagnostic devices), please contact the and additionally 21 OF 1 301) 594-4618. Additionally, for questions on the promotion and Office of Colliphance are, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Also, product note are rogan 2019 - Other general information on your responsibilities under notheation (21 OF ICP of It is on the Division of Small Manufacturers, International and the Act may be obtained 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 yours, Timothy A. Ulatowski Timothy I Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ Applicant: Felton International, Inc. Device Name: Bi-3M Needle-free Injector System # 2. INDICATIONS FOR USE This needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. This device is to be used by a health care professional only. Patrizia Cucurachi IDivision Sign-Off) (Division Sign-On) Division of Dental, Infection Control, Division of Dental, Infection Devices Division of Boital Devices 510(k) Number_Kal