0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 19, 2016 Sol-Millennium Medical, Inc. Jim Barley Director Of RA/OA 1735 North Brown Road, Suite 120 Lawrenceville, Georgia 30043 Re: K162030 Trade/Device Name: 0.5ml Sol-Care™ Retractable Safety Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: July 14, 2016 Received: July 22, 2016 Dear Jim Barley: 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. 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 devicerelated 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting 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) #### K162030 Device Name 0.5ml Sol-CareTM Retractable Safety Syringes Indications for Use (Describe) The 0.5ml Sol-Care™ Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the 0.5ml Sol-Care™ Retractable Safety Syringes is designed to aid in the prevention of needle stick injuries. | Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 10px;">Prescription Use (Part 21 CFR 801 Subpart D)</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # Sol-Millennium Medical | | Special 510(k) Summary | | |----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (As required by 21 CFR 807.92(a)) | | | | Date Prepared: August 16, 2016 | | | A. | Submitter Information | | | | Sol-Millennium Medical, Inc.<br>1735 North Brown Road<br>Suite 120<br>Lawrenceville, GA 30043<br>Phone Number: | 404-973-2200 | | | Trade Name: | 0.5ml Sol-Care™ Retractable Safety Syringes | | B. | Device Information<br>Trade/Proprietary Name:<br>Common name of device:<br>Regulation Name:<br>Product Code:<br>Regulatory Class:<br>Regulation Number:<br>Reason for 510(k): | 0.5ml Sol-Care™ Retractable Safety Syringes<br>Piston Syringe with Safety Feature<br>Piston Syringe<br>MEG<br>II<br>880.5860<br>Special 510(k) Device Modification to add 0.5ml<br>Sol-Care™ Retractable Safety Syringe | | C. | Predicate Device: | 1, 3, 5, 10 and 20ml Sol-Care™ Retractable Safet<br>Syringe<br>Syringes received marketing clearance on<br>September 4, 2009 under 510(k) # K092430. | | | Predicate product code: | MEG | | | | | - D. Device Description The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is a sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is also designed to aid in the prevention of needle stick injuries. {4}------------------------------------------------ The retractable piston syringe is a plastic disposable syringe made of the following components: - 1. Barrel - The barrel has a scale showing the capacity of the syringe as well as the company brand name with the "Do Not Reuse" symbol. - 2. Plunger - Once the plunger is fully depressed, it engages the needle assembly. As the plunger is retracted, the needle assembly is retracted into the barrel. Once the plunger is fully retracted and locked into place, the plunger is snapped off leaving the needle inside the barrel of the syringe. - 3. Stopper - The Stopper maintains the fluid in the barrel between the base of the barrel and Plunger. - Cannula The cannula/needle penetrates the patient's skin to 4. inject/withdraw fluid from the body. - 5. Locking Ring - A plastic insert at the top of the barrel. After the injection, the health care professional retracts the plunger with the needle into the barrel. Once the plunger is fully retracted, the plunger is locked onto position at the bottom of the barrel. This safety mechanism ensures the needle cannot be pushed back - 6. Needle Cap - The Cap is used to cover and protect the tip of the cannula/needle from being damaged. - 7. O-Ring – The O-Ring minimizes the risk of leakage around the adapter - 8. Protective Cap - The Protective Cap prevents pre-engagement of the safety mechanism. Only provided with products packaged in a ten pack. After use, the health care professional firmly pushes the plunger past the zero line to engage the safety mechanism. Once the safety mechanism is engaged, pulling back the plunger causes the needle to be retracted into the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and the plunger are discarded into a sharps container. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle are sterilized by Ethylene Oxide and supplied sterile in a blister pack or tray pack. One hundred syringes are packaged in a chipboard box. Each blister pack/tray pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements. {5}------------------------------------------------ ## Sol-Millennium Medical E. Statement of Indications for Use The 0.5ml Sol-Care™ Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the 0.5ml Sol-Care™ Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries. - F. Comparison of Required Technological Characteristics Information was submitted to demonstrate that there are no significant differences in technological characteristics between the 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle and the cited predicate device. The following comparison chart shows the subject device and the predicate device are substantially equivalent: ## 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle versus 1, 3, 5, 10 and 20ml Sol-Care™ Retractable Safety Syringe | ELEMENT OF<br>COMPARISON | 0.5ml Sol-Care™<br>Retractable Safety Syringe | 1, 3, 5, 10, 20ml Sol-Care™<br>Retractable Safety Syringe<br>(Predicate Device – 510(k)#<br>K092430) | Comparison<br>Summary | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Intended Use(s) | The 0.5ml Sol-Care™<br>Retractable Safety Syringe<br>with Fixed Needle is used to<br>inject fluids into, or<br>withdraw fluids from, the<br>body. In addition, the 0.5ml<br>Sol-Care™ Retractable<br>Safety Syringe with Fixed<br>Needle is designed to aid in<br>the prevention of needle<br>stick injuries. | The Sol-Care™ Retractable<br>Safety Syringe is used to<br>inject fluids into, or<br>withdraw fluids from, the<br>body. In addition, the Sol-<br>Care™ Retractable Safety<br>Syringe is designed to aid in<br>the prevention of needle<br>stick injuries. | Identical | | Principle of<br>Operation | After use, the plunger is<br>fully retracted into the barrel<br>providing protection against<br>needle sticks, rendering the<br>device unusable. | After use, the plunger is<br>fully retracted into the barrel<br>providing protection against<br>needle sticks, rendering the<br>device unusable. | Identical | | Syringe Type | Piston | Piston | Identical | Side by Side Comparison Table {6}------------------------------------------------ | Tip Type | Fixed Needle | Fixed needle and Luer Lock | Similar | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Volume | 0.5ml | 1, 3, 5, 10, and 20 ml | Similar | | Barrel<br>Transparency | Clear | Clear | Identical | | Biocompatibility | Cytotoxicity Sensitization Study Irritation<br>Test/Intracutaneous<br>Reactivity USP and ISO<br>Systemic Toxicity<br>Studies Haemolysis test | Cytotoxicity Sensitization Study Irritation<br>Test/Intracutaneous<br>Reactivity USP and ISO<br>Systemic Toxicity<br>Studies Haemolysis test | Identical | | Sterilization | ETO | ETO | Identical | | Materials | Plunger, Barrel, Cap -<br>Polypropylene<br>Stopper - Santoprene<br>Thermoplastic Elastomer<br>Needle - Stainless steel | Plunger, Barrel, Cap -<br>Polypropylene<br>Stopper - Santoprene<br>Thermoplastic Elastomer<br>Needle- Stainless steel | Identical | | Labeling | Per 21 CFR 801 | Per 21 CFR 801 | Identical | G. Summary and Conclusion of Nonclinical and Clinical Tests: The 0.5ml Sol-Care™ Retractable Safety Syringe met the appropriate requirements contained in the following standards: - 1. ISO 7886:1993, Sterile Hypodermic Syringes for Single Use - 2. ISO 7886-4:2006, Sterile Hypodermic Syringes for Single Use Syringes with re-use prevention feature - 4. ISO 11607-1,-1:2006, Packaging for terminally sterilized medical devices - 5. ISO 11135:2007, Medical Apparatus Epoxy Ethane Sterilization - Confirmation and Routine Control 6. ISO 10993-1:2006, Biological evaluation of medical devices Part 1: Evaluation and testing 7. ISO 9626:1991, Stainless Steel needle tubing for the manufacture of medical devices {7}------------------------------------------------ - H. Discussion of Clinical Tests: None submitted. I. Conclusions Demonstrating Safety, Effectiveness and Performance: The device has been tested and found to meet all product specifications and requirements. Product labeling clearly shows that the device is for single use only. After review of the Risk Analysis, all verification and validation test data and reports, the conclusion of the Design Review Committee was that the 0.5ml Sol-Care™ Retractable Safety Syringe is substantially equivalent to the predicate device.