SiO2 Coated syringe 3 ml

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 17, 2016 SiO2 Medical Products c/o Mr. Paul Dryden Consultant 350 Enterprise Drive Auburn, Alabama 36830 Re: K153553 Trade/Device Name: SiO2 Coated Syringe 3 mL Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 15, 2016 Received: April 18, 2016 Dear Mr. Dryden: 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}------------------------------------------------ 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 - 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 ### K153553 Device Name #### SiO2 Coated Syringe 3 mL Indications for Use (Describe) The SiO2 Coated Syringe 3 mL is intended to be used to inject fluids into, or withdraw fluids from, the body. Type of Use (Select one or both, as applicable) XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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FORM FDA 3881 (8/14) Page 1 of 1 EF PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ 510(k) Summary Page 1 of 4 16-May-16 | SiO2 Medical Products<br>350 Enterprise Drive<br>Auburn, Alabama 36830 | Tel – 334-321-5060<br>Email: randy.crenshaw@sio2med.com | |------------------------------------------------------------------------|---------------------------------------------------------| | Official Contact: | Randy Crenshaw<br>Director of Quality and Regulatory | | Proprietary or Trade Name: | SiO2 Coated Syringe 3 mL | | Common/Usual Name: | Syringe, Piston | | Classification Name/Code: | FMF - Syringe, Piston<br>21 CFR 880.5860<br>Class II | | Device: | SiO2 Coated Syringe 3 mL | | Predicate Device: | K110771 – Becton Dickinson – Single Use syringe | | Reference Device: | K111091 - Merit Medical Syringe | #### Device Description: SiO2 Coated Syringe 3 mL is a plastic disposable standard 3 mL piston syringe without needle is made of a cyclic olefin polymer (COP) and coated internally with silica glass layers. The layer is deposited by plasma enhanced chemical vapor deposition (PECVD) process. This is a standard 3 mL single use, disposable syringe without needle. #### Indications for Use: The SiO2 Coated Syringe 3 mL is intended to be used to inject fluids into, or withdraw fluids from, the body. #### Contraindications - Do not use this syringe with sesame oil-based drugs. - . Do not use this syringe with non-polar solvents. ### Discussion of Substantial Equivalence | Element of<br>Comparison | Subject Device | Becton Dickinson Single Use Syringe<br>K110771 | |--------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Syringe Type | Piston Syringe - FMF | Piston Syringe - FMF | | Intended Use(s) | The SiO2 Coated Syringe 3 mL is intended to<br>be used to inject fluids into, or withdraw<br>fluids from, the body. | For use by health care professionals for<br>general purpose fluid aspiration/injection. | | Length | 82.77mm | 79.3 – 80.7mm | | Barrel diameter | ID: 8.62mm<br>OD: 11.34mm | ID: 8.5 – 8.7mm<br>OD: 10.0 – 10.2mm | #### Table 1 - Substantial Equivalence Comparative Table {4}------------------------------------------------ ### 510(k) Summary Page 2 of 4 16-May-16 | Element of<br>Comparison | Subject Device | Becton Dickinson Single Use Syringe<br>K110771 | |----------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Finger Grip Size and<br>Shape | Length: 24.64 – 25.14mm<br>Width: 14.43 - 14.93mm<br>Thickness: 1.85-2.11mm | Length: 24.33 - 24.59mm<br>Width: 12.57 – 12.83mm<br>Thickness: 1.85-2.11mm | | Tip type | Centric - male luer lock<br>Complying with ISO 594-1, -2 | Centric - male luer lock<br>Complying with ISO 594-1,-2 | | Volume | 3 mL | 3 mL<br>Plus various sizes | | Barrel marking specs | Complies with ISO 7886-1 | Complies with ISO 7886-1 | | Graduations legibility | Legible | Legible | | Lubricant type | Silicone | Silicone | | Plunger Operation<br>(Fi and Fm Forces) | Plunger Withdraw:<br>Fi=2.11 N, Fm=2.39 N<br>Plunger Deploy:<br>Fi=2.35 N, Fm=0.58 N | Plunger Withdraw:<br>Fi=1.18 N, Fm=1.48 N<br>Plunger Deploy:<br>Fi=2.21 N, Fm=1.68 N | | Barrel transparency | Transparent and Clear | Transparent and Clear | | Delivery accuracy | Complies with ISO 7886-1<br>ISO 7886-1 | Complies with ISO 7886-1<br>ISO 7886-1 | | Labeling | ISO 7886-1<br>ISO 15223-1<br>21 CFR Part 801 | 21 CFR Part 801 | | Sterilization | E-beam Irradiation sterilization 25KGy;<br>achieving 10-6 SAL | Ethylene Oxide or Irradiation sterilization<br>10-6 SAL | | Shelf-life and<br>Age testing | 12 months empty | | | Mechanical and<br>environmental<br>stressors | Mechanical force<br>Freeze / thaw testing | | | Verification of coating<br>chemistry | Using FTIR Microscopy Test Method | | The subject device is viewed as substantially equivalent to the predicate device because: Indications for Use – The proposed indications for use are similar, in that they are to be used to inject fluids into, or withdraw fluids from, the body, also referred to as general purpose fluid aspiration/injection. Discussion - The indications for use are similar for the subject device and the predicate -K110771 – BD single use syringe. Technology – The basic design of the subject device is similar as the subject device complies with ISO 7886-1. Discussion - The basic technology of a plunger style syringe is identical to the predicate. The technology of applying a glass coating to the inside of the barrel is different than the predicate but we have demonstrated that its performance is equivalent and complies with ISO 7886-1 as does the predicate - K110771 - BD Single Use Syringe. The difference in technology has been evaluated and do not raise any new questions related to risk, safety, or effectiveness. {5}------------------------------------------------ ### 510(k) Summary Page 3 of 4 16-May-16 Materials – The materials in fluid contact have been evaluated in accordance to the suggestions of ISO 7886-1 and ISO 10993-1 and G95-1 which consider the patient contact as Externally communicating, Circulating blood with Limited duration (<24 hours). We evaluated the subject device utilizing the following tests: - Cytotoxicity: Elution Test, Serum Supplemented MEM Extract ● - Skin Sensitization Test Protocol, Guinea Pig Maximization Test ● - Intracutaneous (Intradermal) Reactivity Test - Systemic Toxicity: Saline and Vegetable Oil Extracts - . Hemolysis Test (NIH Method) Saline Extract - Extractable and Leachables as described in ISO 7886-1 coated / uncoated . - . USP Rabbit Pyrogen Test (Material Mediated) - . Bacterial Endotoxin-Mediated Pyrogen test (Limulus Amebocyte Lysate Test) Discussion - We performed the applicable testing for biocompatibility and the materials were found to be non-reactive. We have made reference to the Merit Medical Syringe K111091 which has similar indications for use and the barrel is made of Cyclo-olefin polymer. We included this reference device to support that the Cyclo-olefin polymer is not a new material for use in syringes. # Non-clinical Testing We performed bench testing to demonstrate that the subject device meets the ISO 7886-1 and other applicable standards. Testing included: | Standard and Tests Performed | |-------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 7886-1- Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use | | Section 5, Cleanliness | | Section 6 & Annex A, Limits for Acidity or Alkalinity | | Section 7 & Annex A, Limits for Extractable Metals | | Section 8, Lubricant | | Section 9, Tolerance on Graduated Capacity | | Section 10.1, Scale | | Section 10.2, Numbering of Scale | | Section 10.3, Overall Length of Scale to Nominal Capacity Line | | Section 10.4, Position of Scale | | Section 11.1, Dimensions | | Section 11.2, Finger Grips | | Section 12.1, Design | | Section 12.2, Fit of Piston in Barrel | | Annex G, Force to Operate | | Section 12.3, Fiducial Line | | Section 13.2, Position of Nozzle on End of Barrel | | Section 13.3, Nozzle Lumen | | Section 14.1 - Annex C, Dead Space | | Section 14.2 - Annex D, Liquid Leakage Compression | | Section 14.2 - Annex B, Air Leakage past Syringe Piston during Aspiration | | ISO 594 - 1 and -2 - Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other<br>medical equipment -- Part 1 and Part 2 | | Section 5.1, Gauging | | Section 5.2, Liquid Leakage | {6}------------------------------------------------ #### 510(k) Summary Page 4 of 4 16-May-16 | Section 5.3, Air Leakage | |---------------------------------------------------------------------------------------------| | Section 5.4, Separation Force | | Section 5.5, Unscrewing Torque | | Section 5.6, Ease of Assembly | | Section 5.7, Resistance to Overriding | | Section 5.8, Stress Cracking | | ASTM D4169-14; Standard Practice for Performance Testing of Shipping Containers and Systems | | Manual handling – drop test and second Drop Sequence | | Vehicle stacking | | Loose Load Vibration | | Vehicle Vibration | | Concentrated Impact | - ASTM F1980-07 (2011); Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices - Real-time aging 24 months ● - Oxygen Transmission Rate ("OTR") ● - Container compatibility with certain drug products ● - Mechanical stressor - Environmental stressor - freeze-thaw study Summary - . Ink adhesion and Wipe & Tape Test Report - . Plunger Force Test - . Physical Characteristics Test - . Syringe Dimensions - Plunger Force Test . - . FTIR Test method for coating chemistry ## Substantial Equivalence Conclusion - The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the SiO2 Coated Syringe 3 mL and is substantially equivalent to the predicate device.