IMC PISTON SYRINGES

{0}------------------------------------------------ DEC2 0 2010 # 8.0 510(K) SUMMARY K102969 | Trade Name: | IMC Piston Syringe | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Piston Syringe | | Classification Name: | Piston Syringe<br>(21 CFR subpart E §880.5860 and §880.5570) | | Submitter Information: | International Medsurg Connection<br>935 N Plum Grove Rd, STE F<br>Schaumburg, Illinois 60173 | | Summary Prepared By: | Peter Kim<br>Director of Quality Assurance<br>International Medsurg Connection<br>935 N Plum Grove Rd, STE F<br>Schaumburg, Illinois 60173<br>Telephone: 847-619-9926<br>Fax: 847-619-9927<br>e-mail: peterkim@intlmedsurg.com | | Date Prepared: | September 24, 2010 | | Predicate Devices: | ● IMC piston syringe (K022159) | #### Device Name(s): IMC Piston Syringe #### Classification Panel: General and Plastic Surgery # Legally Marketed Device Under Which Substantial Equivalence is Being Claimed: International Medsurg Connections, Inc is claiming substantial equivalence of the new piston syringe with the currently marketed: | Description | 510(k) Number | Clearance Date | |--------------------|---------------|----------------| | IMC piston syringe | K022159 | 11/7/2002 | #### Device Description The device consists of a calibrated hollow barrel and a movable plunger with piston. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into or withdraw fluids from, the body. {1}------------------------------------------------ ## Statement of Intended Use This device is intended for the injection of fluids into, or withdraws of fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger. This submission includes drapes that will be sold both sterile and non-sterile. This submission includes piston syringe that will be sold both sterile and non-sterile. Non-sterile syringes are to be sold to OEMs for EtO sterilization according to their validated process per ANSI/AMMI/ISO 11135. Sterile syringes are to be sold directly to users after EO sterilization validation per ANSI/AMMI/ISO 11135 | Category | Device Name | Sterility | |----------------|-------------------------|-------------------------| | Piston syringe | Syringe 1cc Luer Slip | Sterile and Non-sterile | | | Syringe 2cc Luer Lock | Sterile and Non-sterile | | | Syringe 2cc Luer Slip | Sterile and Non-sterile | | | Syringe 3cc Luer lock | Sterile and Non-sterile | | | Syringe 3cc Luer Slip | Sterile and Non-sterile | | | Syringe 5cc Luer lock | Sterile and Non-sterile | | | Syringe 5cc Luer Slip | Sterile and Non-sterile | | | Syringe 10cc Luer lock | Sterile and Non-sterile | | | Syringe 10cc Luer Slip | Sterile and Non-sterile | | Piston syringe | Syringe 20cc Luer lock | Sterile and Non-sterile | | | Syringe 20cc Luer Slip | Sterile and Non-sterile | | | Syringe 30cc Luer lock | Sterile and Non-sterile | | | Syringe 30cc Luer Slip | Sterile and Non-sterile | | | Syringe 60cc Luer lock | Sterile and Non-sterile | | | Syringe 60cc Luer Slip | Sterile and Non-sterile | | | Syringe 100cc Luer lock | Sterile and Non-sterile | | | Syringe 100cc Luer Slip | Sterile and Non-sterile | ## New Devices as Compared to Marketed Device(s) The new piston syringe and the predicate device (IMC piston syringe – K022159) are used to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The new piston syringe has the same intended use, the same technological characteristics and the same materials with exception of the piston material. Design differences are considered minor. The current piston material for IMC piston syringe is Santoprene but new piston syringe will use the alternative piston material (Isoprene) which is widely used in syringe manufacturing industry. {2}------------------------------------------------ | Feature/ Characteristic | New piston syringe (with Isoprene) | IMC piston syringe- K022159 (Predicate) | |-------------------------|---------------------------------------------------------|-----------------------------------------| | Material Composition | | | | Barrel | Polyethylene R370Y | Same | | Piston | Isoprene | Santoprene | | Plunger | Polyethylene R370Y | Same | | Lubricant | High capability silicon oil | Same | | Design Feature | | | | Design | See section 13 | Similar | | Dimension | See section 13 | Similar | | Volume | 1cc, 2cc, 3cc, 5cc, 10cc, 20cc, 30cc, 60cc<br>and 100cc | Similar | # Performance Data: | Performance Characteristics | Test Method | New piston syringe<br>(with Isoprene) | IMC piston syringe-<br>K022159<br>(Predicate) | |----------------------------------------------------------------------------------------------------------------------|--------------------|---------------------------------------|-----------------------------------------------| | Test method for air leakage past<br>syringe piston during aspiration,<br>and for separation of piston and<br>plunger | ISO 7886-1:Annex B | Meet the requirement | Same | | Test method for liquid leakage at<br>syringe piston under compression | ISO 7886-1:Annex D | Meet the requirement | Same | ## Conclusions: The indications for use, technology, specification, safety of the piston syringe with Isoprene and the current IMC piston syringe (K022159) are essentially the same. The differences between the syringes are minor and do not raise new issues of safety or effectiveness. Hence, the piston syringe with Isoprene is substantially equivalent to the current IMC piston syringe. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, stylized with three parallel lines forming the wings and body. The eagle appears to be in flight or poised for action. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Peter Kim Director of Quality Assurance International Medsurg Connection 935 North Plum Grove Road, Suite F Schaumburg, Illinois 60173 DEC 2 0 2010 Re: K102969 > Trade/Device Name: IMC Piston Syringes Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF, FMF, FMI Dated: November 2, 2010 Received: November 2, 2010 Dear Mr. Kim: 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. {4}------------------------------------------------ #### Page 2- Mr. Kim . Enclosure 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 (OS) 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/ucm1115809.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, 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 {5}------------------------------------------------ # 4.0 INTENDED USES / INDICATION: International Medsurg Connection's piston syringe is intended for the injection of fluids into, or withdraw of fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger. The intended use is the same as the intended use on IMC piston syringe sold by International Medsurg Connection, Reference K022159. This submission includes piston syringe that will be sold both sterile and non-sterile syringes are to be sold to OEMs for EtO sterilization according to their validated process per ANSVAMMISO 11135. Sterile syringes are to be sold directly to users after EO sterilization validation per ANSVAMMI/ISO 11135 | Category | Device Name | Sterility | |----------------|-------------------------|-------------------------| | Piston syringe | Syringe 1cc Luer Slip | Sterile and Non-sterile | | | Syringe 2cc Luer Lock | Sterile and Non-sterile | | | Syringe 2cc Luer Slip | Sterile and Non-sterile | | | Syringe 3cc Luer lock | Sterile and Non-sterile | | | Syringe 3cc Luer Slip | Sterile and Non-sterile | | | Syringe 5cc Luer lock | Sterile and Non-sterile | | | Syringe 5cc Luer Slip | Sterile and Non-sterile | | | Syringe 10cc Luer lock. | Sterile and Non-sterile | | | Syringe 10cc Luer Slip | Sterile and Non-sterile | | | Syringe 20cc Luer lock | Sterile and Non-sterile | | | Syringe 20cc Luer Slip | Sterile and Non-sterile | | | Syringe 30cc Luer lock | Sterile and Non-sterile | | | Syringe 30cc Luer Slip | Sterile and Non-sterile | | | Syringe 60cc Luer lock | Sterile and Non-sterile | | | Syringe 60cc Luer Slip | Sterile and Non-sterile | | | Syringe 100cc Luer lock | Sterile and Non-sterile | | | Syringe 100cc Luer Slip | Sterile and Non-sterile | Related items are indicated at the table below. AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (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) 12/21/16 (Division Sign-Off) 510(k) Number: K/02969