ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a group of people in profile. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 9, 2015 UltiMed Incorporated c/o Mary Beth Henderson, Ph.D. Regulatory & Clinical Research Institute, Incorporated. VP Regulatory Affairs and Quality Systems 5353 Wayzata Boulevard, Suite 505 Minneapolis, MN 55416 Re: K140949 Trade/Device Name: UltiCare™ 3mL Luer Lock Safety Syringes with Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF, FMI Dated: January 30, 2015 Received: February 2, 2015 Dear Dr. Henderson: 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. {1}------------------------------------------------ Page 2 - Mary Beth Henderson, Ph.D. 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, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K140949 #### Device Name UltiCare™ 3mL Luer Lock Safety Syringe with Needle #### Indications for Use (Describe) The UltiCare Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety mechanism aids in the prevention of needle stick injuries. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. {3}------------------------------------------------ :of .nebrud sint guisuber 10 suoitsegypus pribuloni .noitsellos noitsmonni sinfi 10 sees control and a stamise nebund sint published in one summer in one not worker one and the bebest and and and reserves gourses, general and prisesses in operations of emily and only and io noilsellos e ,ot buodser of beinupes tou si nossed в bnв ,losnogs 10 ,suburo ton year your of "We will be and the mate are the PHT OT MAC and and and See sid " เอปทนน ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ se se se memor bress different se vice mont se vices PRASStaff@fda.hhs.gov Paperwork Reduction Act (PRA) State (Chie) 1888 Add MAOF Page 2 of 2 {4}------------------------------------------------ #### TRADITIONAL 510(K) SUMMARY 5.0 | Submitted by: | UltiMed Inc.<br>350 Hwy 7, Suite 100<br>Excelsior, MN 55331 | | | | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-------------------|----------------------------------| | Contact Person: | Thomas Sauro<br>Telephone: 651-291-7909 x 206 | | | | | Date of Summary: | December 05, 2014 | | | | | Device Trade Name: | UltiMed UltiCare™ 3 mL Luer Lock Safety Syringes with Needle | | | | | Common or Usual Name: | Syringe with Sharps Injury Prevention Feature | | | | | Classification: | Piston Syringe<br>Anti-stick Syringe<br>Hypodermic Single Lumen Needle | § 880.5860<br>§ 880.5860<br>§ 880.5570 | FMF<br>MEG<br>FMI | Class II<br>Class II<br>Class II | | Predicate Device: | UltiCare Safety Syringe (K080600)<br>Sherwood (Tyco) Monoject® Safety Syringe (K922522) | | | | | Device Description: | The UltiCare™ 3 mL Luer Lock Safety Syringes with Needle is a<br>standard piston type syringe with a removable needle and protective<br>shield.<br>This sterile, single-use, disposable 3 ml piston syringes consist of a<br>syringe barrel, plunger rod with gasket, removable single lumen needle,<br>needle cap, and protective shield. The UltiCare Safety Syringes are<br>non-toxic and non-pyrogenic, and will be available in a range of needle<br>gauges and lengths between the smallest (27G x 5/16") and the largest<br>(21G x 1 1/2"). | | | | | Intended Use: | The UltiCare™ Safety Syringe is intended to inject fluid into, or<br>withdraw fluid from the body. The safety mechanism aids in the<br>prevention of needle stick injuries. | | | | | Technological<br>Characteristics: | The UltiCare™ 3 mL Luer Lock Safety Syringes with Needle is an<br>extension of the UltiCare Safety Syringe product line and is<br>substantially equivalent in device description, function, principle of<br>operation, and basic composition to the predicate device. The subject<br>and predicate devices consist of a syringe barrel, plunger rod with<br>gasket, removable single lumen needle, needle cap, and protective<br>shield.<br>The UltiCare Safety Syringe product line safety shield is made of clear<br>plastic and is furnished in a retracted position (with the needle cap over<br>the needle). After use of the syringe, the protective shield is engaged<br>by sliding it away from the finger grip to an extended position over the<br>needle and rotated to lock in place. | | | | | Testing: | The subject UltiCare 3 mL Luer Lock Safety Syringes with Needle have<br>been designed and tested to meet the requirements of voluntary<br>standards and FDA guidance documents applicable to the subject and<br>predicate devices. Results of the non-clinical testing support the<br>conclusion of substantial equivalence to the UltiCare Safety Syringes to<br>the predicate devices. | | | | {5}------------------------------------------------ ## Performance Testing: The subject UltiCare 3 mL Luer Lock Safety Syringes with Needle have been designed and successfully tested to meet the applicable requirements outlined in ISO 594, ISO 6009, ISO 7864, ISO 7886-1, ISO 8537, and ISO 9626. ## Biocompatibility Testing: The subject UltiCare Safety Syringe body is produced using the same manufacturing processes and uses the same materials, dyes/inks, manufacturing process, adhesives, and sterilization process/cycle as the previously cleared UltiCare Safety Syringes (K080600); therefore additional biocompatibility testing to ISO 10993 standards is not required. The removable needles are considered externally communicating devices with limited duration contact with circulating blood, and have been tested to meet the biocompatibility requirements of ISO 10993 to include cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity testing, and hemocompatibility. ## Sterilization and Shelf-life Testing: Sterilization of the UltiCare Safety Syringes is validated using the Half Cycle method as outlined in ISO 11135. The maximum levels of residues of ethylene oxide and ethylene chlorohydrin will not exceed the limits presented in ISO 10993-7. ## Pyrogenicity Testing: The UltiCare 3 mL Luer Lock Safety Syringes with Needle have successfully passed pyrogenicity testing (USP <151> Rabbit Method). ## Clinical Data: No prospective clinical trials were conducted in support of this Traditional 510(k). Substantial Equivalence: The major similarities of the UltiCare Safety Syringe with Removable Needle to the predicate devices support the substantial equivalence in intended use, principles of operation, function and basic composition. The non-clinical testing to voluntary standards and applicable FDA guidances provide additional evidence the subject UltiCare Safety Syringe is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance. > The minor differences between the subject UltiCare Safety Syringe and the predicate devices do not raise new issues of safety or effectiveness.