HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500

{0}------------------------------------------------ JUN 2 4 2004 K\$\phi\$4128@ ## VIII. Special 510-(k) Summary The summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92. #### Submitter Information: Regulatory/Clinical Consultants, Inc. 200 NE Mulberry, Suite 200 Lees Summit, MO 64086 Contact Person: Jim Stanley Phone: 816-347-9224 Date Prepared: May 11, 2004 #### Device Information: Proprietary Name: Human Subcutaneous Injector system Common Name: Needle-free fluid injection system Classification Name: Nonelectrically powered fluid injector #### Predicate Devices: | K013256 | Felton International's Bi-3M | |--------------|------------------------------| | Preamendment | Ped-O-Jet | Device Description: The Human Subcutaneous 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. Intended Use: The 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. The device is to be used by a health care professional only. Summary: The performance characteristics are substantially equivalent to the Bi-3M according to test protocols conducted for dosage accuracy, penetration, force, focus, sound, and stream quality. Safety tests performed for contamination were successful. {1}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN 2 4 2004 Felton International, Incorporated C/O Mr. James E. Stanley Associate Director of Quality Assurance Regulatory/Clinical Consultants, Incorporated 200 NE Mulberry, Suite 200 Lee's Summit, Missouri 64086 Re: K041280 Trade/Device Name: Human Subcutaneous Injector System HSI 500 Regulation Number: 880.5430 Regulation Name: Nonelectrically Powdered Fluid Injector Regulatory Class: II Product Code: KZE Dated: June 10, 2004 Received: June 15, 2004 Dear Mr. Stanley: 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 approvisions 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 (1 wr ), it inch obe of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 -Mr. Stanley Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that ITDA \$ Issualles of a bacause complies with other requirements mean that FDA has made a determination that your device there Federal egencies mean that FDA has made a decemination hate Jour ministered by other Federal agencies. of the Act or any Federal statutes and regulations administered by pot limited to regist of the Act or any rederal statutes and regulations, but not limited to: registration You must comply with all the Act's requirements, including massise You must comply with an the Act 3 requirements intelles intelling practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laocing (21 CFR (05) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); a requirements as set form in the quality systems (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 5 10(k) This letter will anow you to begin maneting your and equivalence of your device to a premarket nothleation. THC I DA miding of cassification 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), If you desire specific advice to: your de at (301) 594-4618. Also, please note the regulation prease contact inc Office or Comphanes an (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other general mironma.let en en the mational and Consumer Assistance at its toll-free Division of Simall - 2011 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu-Lin, Ph.D. 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K041280 Device Name: Human Subcutaneous Injector System HSI 500 Indications For Use: This needle-free fluid injector system is indicated for the delivery f the skin the start start of the descriptions we tinsue by poperrating the skin un Indications For Use: This neede-ree-num nicolor eyeten to me of vaccines of medications to the Suboutanovas assure of the subscription only. Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sam Moreau for ADEC 6/24/04 nesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K041280 Page 1 of ____________________________________________________________________________________________________________________________________________________________________