JMS SYRINGE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for JMS North America Corporation. The logo features the letters "JMS" in a bold, stylized font, with horizontal lines running through the letters. Below the letters, the words "North America Corporation" are written in a smaller, serif font. MAIN OFFICE 2320 Foothill Blvd. Suite 350 avward. CA 944 el. (510) 888-9090 Fax (510) 888-9099 SALES OFFICE 480 Sawgrass Corp. Pkwy. Sulte 120 Sunrise, FL 33325 Tel. (954) 689-9280 Fax (954) 689-9289 ## Section 05: 510(k) Summary [807.92(c)] ### Owner [807.92(a)1]: | Company Name: | JMS North America Corp. | |------------------|------------------------------------------------------| | Company Address: | 22320 Foothill Blvd., Suite 350<br>Hayward, CA 94541 | | Telephone: | 510-888-9090 | |------------|--------------| | Fax: | 510-888-9099 | | Contact Person: | Sho Hosoki | |---------------------------|------------| | Summary Preparation Date: | 09/01/2013 | ### Device of Submission [807.92(a)(2)] | Classification Name: | Piston Syringe | |------------------------------|-----------------| | Common/Usual Name: | Piston Syringe | | Proprietary Name: | JMS Syringe | | Classification: | Class II | | Product Code: | FMF | | Code of Federal Regulations: | 21 CFR 880.5860 | # Predicate Device [807.92(a)(3)] | <br>140 And 146<br>Number<br>AN AND CHARLES AND ALL AN AND EN | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | THE PER ALLER CHRIST OF CHICAL COLLECTION COLLEGION OF CLE CLASS OF CLEASE OF CLEASE OF CLEASE OF<br>VOO100 | . CALL | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>THE FERENCE FREE FREE FREE FOR LE LE LE FREE FOR A FILE CONSTITUTION AND A LE CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONST | 1<br>VIDD<br>on Advances Chicago Children Corporation Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Com<br>- CHILL A A A REGIO CHICA CLAND | | ## Device Description [807.92(a)(4)} JMS syringe is a single use standard piston syringe without hypodermic needle, which consists of a calibrated hollow barrel and a movable plunger with a male Luer lock or Luer slip connector on the tip of barrel. ### Intended Use [807.92(a)(5)] JMS Syringe is intended to be used to inject fluids into or withdraw fluids out of the body. Predicate of this device includes intended use of JMS needle and JMS syringe. This submission only covers JMS syringe so the intended use portion which describes JMS needle has been excluded. FEB 2 0 2014 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo features the letters "JMS" in a bold, stylized font, with horizontal lines running through the letters. Below the letters, the words "North America Corporation" are written in a smaller, simpler font. MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. (510) 888-9090 Fax (510) 888-9099 SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. (954) 689-9280 Fax (954) 689-9289 | | Modified Device | Predicate | |-----------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | JMS Syringe | Modification of JMS Needle and Syringe | | 510(k) # | --- | K991904 | | Classification | Class II | Class II | | Intended Use | JMS Syringe is intended to be used to inject fluids into or withdraw fluids out of the body. | JMS Needle is intended to be used for infusion of drug, collecting solution or blood. Insert the Needle to patient's body and use it as a fluid pathway which connects inside and outside of the body. JMS Syringe is intended to be used for infusion of solution or collecting blood connecting JMS Needle. It is also used for continuous drug infusion put in Syringe Pump. JMS Needle and JMS Syringe must be discarded after one time use. | | Material | See Section 15 for material comparison<br>Used materials are the same, but some have different grades | See Section 15 for material comparison<br>Used materials are the same, but some have different grades | | Syringe tip type | Luer Slip/Luer Lock | Luer Slip/Luer Lock | | Syringe Volume | 30, 50, 100mL | 1, 2, 2.5, 5, 10, 20, 30, 50, 100mL | | Nozzle Type | Center/ Side | Center/ Side | | Graduation Legibility | Legible | Legible | | Movability (KPa) | 30, 50 100mL : Less than 98 | 30, 50 100mL : Less than 98 | | Leakage (KPa) | 30, 50 100mL: More than 196 | 30, 50 100mL: More than 200 | | Dead Space | 30mL: Less than 0.17mL<br>50mL: Less than 0.20mL<br>100mL: Less than 0.20mL | 30mL: Less than 0.17mL<br>50mL: Less than 0.20mL<br>100mL: Less than 0.20mL | | Labeling | See Section 13 for Labeling | See Section 13 for Labeling | | Sterilization | E-beam sterilization | y-sterilization | #### Predicate Comparison [807:92(a)(6)] The submitted device is equivalent to the predicate device. It has same technological characteristics as a syringe. The only difference is the method of sterilization and material grade in which respective section of this submission show equivalency to predicate. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo consists of the letters "JMS" in a bold, stylized font, with horizontal lines running through the letters. Below the letters, the words "North America Corporation" are written in a smaller, serif font. The logo is black and white. MAIN OFFICE 22320 Foothill Blvd. Sulte 350 Hayward, CA 94541 Tel. (510) 888-9090 Fax (510) 888-9099 SALES OFFICE 480 Sawgrass Corp. Pkwy. Sulte 120 Sunrise, FL 33325 Tel. (954) 689-9280 Fax (954) 689-9289 #### Non-Clinical Performance Data [807.92(b)(1)] | Test | | Pass or Fail | |-----------------------------------|---------------------------------------------------------------------------|--------------| | Physical requirements | cleanliness | Pass | | Chemical requirements | Limits for acidity or alkalinity | Pass | | | Limits for extractable metals | Pass | | Lubrication | Amount of lubrication | Pass | | Tolerance of the nominal capacity | Tolerance on graduated capacity | Pass | | Piston/plunger assembly | Design | Pass | | Nozzle | Nozzle Lumen | Pass | | Performance | Dead space | Pass | | | Freedom from air and liquid<br>leakage past piston (positive<br>pressure) | Pass | | | Freedom from air and liquid<br>leakage past piston (negative<br>pressure) | Pass | Summary of Non-clinical performance data More detailed description of non-clinical performance data is described in section 18 of this submission and all show acceptable results. #### J807.92(b)(2)I Not applicable as no clinical tests were referenced in this submission #### Conclusion {807.92(b)(3)} The device of submission is the modification of predicate device (K991904). This submission does not include needles so the needle portion has been omitted from the submission. In addition, only the larger sizes (30, 50, and 100mL) will be covered in this modification. The only difference between the submitted device and predicate are some material components and method of sterilization. The intended use of the predicate syringe is identical to the intended use of the submitted device for the syringe portion (JMS needle excluded). {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 20, 2014 JMS North America Corporation Mr. Sho Hosoki Regulatory 22320 Foothill Boulevard, Suite 350 Hayward, CA 94541 Re: K132321 Trade/Device Name: JMS Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 15, 2013 Received: August 1, 2013 Dear Mr. Hosoki: 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. Hosoki 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/4/Picture/7 description: The image shows the name "Kwame Ulmer's" in a stylized font. The letters are bold and black, and they appear to be slightly distorted. The name is arranged in two lines, with "Kwame" on the top line and "Ulmer's" on the bottom line. The letters are overlapping each other, creating a sense of depth and dimension. Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health for Enclosure {5}------------------------------------------------ Section 4: Indications for Use 510(k) Number (if known): K132321 Device Name: JMS Syringe Indications for Use: JMS Syringe is intended to be used to inject fluids into or withdraw fluids out of the body. 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 OF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/5/Picture/10 description: The image is blurry and contains a lot of noise, making it difficult to discern any specific details. There are some dark spots and lighter areas scattered throughout the image. Due to the poor quality, it is impossible to identify any objects, text, or patterns with certainty. Digitally signed by Richard C. Chapman Date: 2014.02.19 15:17:07 -05'00' Page __ of_