EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

{0}------------------------------------------------ ## K182268 510(k) Summary - Submitter 1. Official Contact Name: Shao Wei, Tseng Title: Chief of Regulatory Officer Email: shaowei@flatmedical.com Telephone number: +886-2-25672959 #13 Flat Medical Co., Ltd. Address: Rm. 1, 9F., No. 27, Sec. 1, Chang'an E. Rd., Zhongshan Dist., Taipei City 10441, Taiwan April 4, 2019 Date of Preparation 2. Subject Device EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFit) Name of Device: Syringe, Piston Common/Usual Name: - Class II Device Classification: Piston Syringe Classification Name: 21 CFR 880.5860 Regulation Number Product Code: FMF Image /page/0/Picture/3 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white. 1 Image /page/0/Picture/4 description: The image contains the logo for Flat Medical. The logo consists of a blue and gray icon to the left of the text "Flat Medical". Below the word "Medical" is the text "Safe care for All" in a smaller font. The icon is a stylized cross shape. {1}------------------------------------------------ #### 3. Predicate Devices | Name of Device: | AutoDetect Syringe | |------------------------|--------------------| | Common/Usual Name: | Syringe, Piston | | Device Classification: | Class II | | Classification Name: | Piston Syringe | | Regulation Number | 21 CFR 880.5860 | | Product Code: | FMF | | Premarket Notification | K041590 | #### 4. Device Description and technology Characteristics The EpiFaith is a loss of resistance syringe with a spring-loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of the LOR technique, the piston will simultaneously move forward when the pressure drop occurs due to the spring force. The moving of the piston can provide a visual signal to indicate the LOR as well as assist in verifying the needle tip placement in the epidural space. The EpiFaith syringe is compatible to a 16-18 gauge epidural needle with Luer or NRFit connector. The user can push the plunger to increase the pressure after the syringe is connected to an inserted needle. Then, the user can advance the needle until the visual signal occurs. Because the piston is spring loaded, the automatic ejection of the content of the syringe will happen when the LOR occurs, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed in Table 4.1. The only differences between two models are the type of the connector and color. | Flat Medical EpiFaith Syringe | | |-------------------------------|----------------| | Model # | Connector type | | FM-01SLR | Luer slip | | FM-02SNR | NRFit | ### Table 4.1: Proposed models of Flat Medical EpiFaith Syringe Image /page/1/Picture/6 description: The image is a logo for Flat Medical. The logo consists of a blue and gray symbol on the left, followed by the words "Flat Medical" in blue and gray. Below the word "Medical" is the phrase "Safe care for All" in a smaller font. {2}------------------------------------------------ #### 5. Indications for Use EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space. | ELEMENT OF<br>COMPARISON | SUBJECT DEVICE | PREDICATE DEVICE | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name | EpiFaith Syringe | AutoDetect Syringe | | 510(k) number | K182268 | K041590 | | Regulation Number | 21 CFR 880.5860 | 21 CFR 880.5860 | | Regulation Name | Piston Syringe | Piston Syringe | | Regulatory Class | II | II | | Product Code | FMF | FMF | | Syringe type | Piston Syringe | Piston Syringe | | Intended use | EpiFaith Syringe is intended for use with an<br>epidural needle for detecting a loss of<br>resistance, which aids a clinician in verifying<br>needle tip placement in the epidural space. | The AutoDetect Syringe is intended for use<br>with an epidural needle for the verification<br>of needle tip placement in the epidural<br>space. | | Principle of operation | EpiFaith Syringe is based on the principle of<br>LOR, loss of resistance | The AutoDetect Syringe is based on the<br>principle of LOR, loss of resistance | | Nozzle type | There are two models.<br>Luer slip (follow ISO80369-7)<br>NRFit (follow ISO80369-6) | - | | Lubricant | Silicone oil | - | | Reuse durability | Single use only | - | | Material | Polypropylene | Polypropylene | | | natural & synthetic rubber | Silicone | | | The spring is made of stainless steel. | Polycarbonate | | Biocompatibility | Meets guidelines presented in Use of<br>International Standard ISO 10993-1,<br>"Biological evaluation of medical devices –<br>Part 1: Evaluation and testing within a risk<br>management process. | Meets guidelines presented in ISO 10993-<br>1:2009. | | Sterilization method | E.O gas sterilization<br>Sterile assurance level : 10-6 | - | | Dimensions | Length:103.0mm to 134.0mm | - | | | Outer diameter of barrel:14.6mm | | | | Weight: 7.0g | | | | Maximum usable capacity:4ml | | | Applicable standard | ISO 7886-1<br>ISO 80369-6<br>ISO 80369-7 | ISO 7886-1 | | Packaging | Single device is contained in an E.O. gas<br>permeable bag as the sterile barrier. The<br>bag is made by Tyvek and PET with<br>200mm*75mm of dimension. Fifty bags are<br>contained in a folding carton<br>(205*175*160mm). | - | #### Comparison of Technological Characteristics with the Predicate Device 6. Image /page/2/Picture/4 description: The image shows the logo for Flat Medical. The logo consists of a blue and gray symbol on the left, followed by the words "Flat Medical" in blue and gray. Below the word "Medical" is the phrase "Safe care for All" in a smaller font. {3}------------------------------------------------ ## Substantial Equivalence The subject device has the same intended use, technology, operation principle and the technical characteristics with the predicate device. Design Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product. We conclude that subject device is substantially equivalent to the predicate device. Image /page/3/Picture/3 description: The image shows the logo for Flat Medical. The logo consists of a blue and gray symbol on the left, followed by the text "Flat Medical" in blue and gray. Below the text is the phrase "Safe care for All" in a smaller font. {4}------------------------------------------------ #### 7. Performance Data: ## Non-Clinical Tests | | FDA guidance and recognized consensus standards have been<br>established for Piston Syringes under FDA Product Code FMF<br>and 21 CFR 880.5860. A battery of tests was performed based<br>on the requirements of the below recognized consensus<br>standards and guidance, as well as biocompatibility,<br>sterilization, and packaging standards and guidance.<br>Conformity to these standards demonstrates that the proposed<br>EpiFaith Syringe met the standards' established acceptance<br>criteria for the device. | | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance<br>Data | ISO 7886-1:2017, Sterile hypodermic syringes for single<br>use – Part 1: Syringes for manual use ISO 80369-6:2016, Small-bore connectors for liquids and<br>gases in healthcare applications – Part 6: Connectors for<br>neuraxial applications ISO 80369-7: 2016, Small-bore connectors for liquids and<br>gases in healthcare applications - Part 7: Connectors for<br>intravascular or hypodermic applications | | | | ISO 80369-20: 2015, Small-bore connectors for liquids and<br>gases in healthcare applications – Part 20: Common test<br>methods ISO 10993-1, Biological Evaluation Of Medical Devices -<br>Part 1: Evaluation And Testing Within A Risk Management<br>Process ISO 10993-4, Biological evaluation of medical devices—<br>Part 4: Selection of tests for interactions with blood ISO 10993-5, Biological evaluation of medical devices—<br>Part 5: Tests for in vitro cytotoxicity | | | Performance<br>Data cont'd | • | ISO 10993-7, Biological evaluation of medical devices—<br>Part 7: Ethylene oxide sterilization residuals | | | • | ISO 10993-10, Biological evaluation of medical devices—<br>Part 10: Tests for irritation and skin sensitization | | | • | ISO 10993-11, Biological evaluation of medical devices—<br>Part 11: Tests for systemic toxicity | | | • | ASTM F1980-16, Standard Guide for Accelerated Aging of<br>Sterile Barrier Systems for Medical Devices | | | • | ISO 11135, Sterilization of health-care products – Ethylene<br>oxide - Requirements for the development, validation and<br>routine control of a sterilization process for medical devices | | | • | ASTM F1140, Standard Test Methods for Internal<br>Pressurization Failure Resistance of Unrestrained<br>Packages | | | • | ASTM F1608-00, Standard Test Method for Microbial<br>Ranking of Porous Packaging Materials (Exposure<br>Chamber Method) | | | • | ISO 15223-1, Medical devices—Symbols to be used with<br>medical device labels, labelling and information to be<br>supplied—Part 1: General requirements | | | • | ASTM F756-17, Standard Practice for Assessment of<br>Hemolytic Properties of Materials | | | • | USP <85>, Bacterial Endotoxins Test | | | • | USP <151>, Pyrogenicity Test | | Performance | • | USP <161>, Medical Devices-Bacterial Endotoxin and<br>Pyrogen Tests | | Data cont'd | ISO 28590, Sampling procedure for inspection by attributes Introduction to the ISO2859 series of standards for sampling for inspection by attributes ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F1886, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection ASTM F1929, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ISO 11737-2, Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process ISO 14971, Medical devices. Application of risk management to medical devices USP <788>, Particulate Matter in Injections | | | | <b>Performance Bench Testing</b> Visual indicator response time Needle protruding length and visual indicator activation on an epidural simulator Resistance of the O-ring Human Factors and Usability Testing on an epidural simulator The EpiFaith Syringe complies with the FDA recognized consensus standards: ISO 7886-1:2017 | | Image /page/4/Picture/3 description: The image shows the logo for Flat Medical. The logo consists of a blue and gray icon to the left of the text "Flat Medical". Below the word "Medical" is the phrase "safe care for All" in a smaller font. {5}------------------------------------------------ 6 Image /page/5/Picture/2 description: The image shows the logo for Flat Medical. The logo consists of a blue and gray symbol resembling a plus sign made of rounded squares, followed by the words "Flat Medical" in blue and gray. Below the words "Flat Medical" is the phrase "Safe care for All" in a smaller font. {6}------------------------------------------------ Image /page/6/Picture/2 description: The image contains the logo for Flat Medical. The logo consists of a blue and gray icon to the left of the text "Flat Medical". Below the word "Medical" is the text "Safe care for All" in a smaller font. {7}------------------------------------------------ O ISO 80369-6:2016 O ISO 80369-7:2016, as outlined within this submission. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use. Biocompatibility testing The biocompatibility evaluation for the EpiFaith Syringe was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process, June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Management Process," as recognized by FDA. Testing included the following: ● Hemolysis ● In vitro cytotoxicity ● Skin sensitization ● Intracutaneous irritation O Acute systemic toxicity ● Material-Mediated Pyrogens 0 Limulus amoebocyte lysate endotoxin The EpiFaith Syringe is considered tissue/bone/dentin contacting for a duration of less than 24 hours. Image /page/7/Picture/2 description: The image contains the logo for Flat Medical. The logo consists of a blue and gray icon to the left of the company name. The company name is written in two different colors, with "Flat" in blue and "Medical" in gray. Below the company name is the text "Safe care for All" in a smaller font. {8}------------------------------------------------ #### 8. Conclusion Based on the intended use, materials, design, and performance testing, the EpiFaith Syringe meets the requirements that are considered essential for its intended use and is considered substantially equivalent to the predicate device, the AutoDetect Syringe, K041590. Image /page/8/Picture/2 description: The image contains the logo for Flat Medical. The logo consists of a blue and gray medical cross symbol on the left, followed by the text "Flat Medical" in blue and gray. Below the text, there is a tagline that reads "Safe care for All" in a smaller font. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Flat Medical Co., Ltd. Shao-Wei Tseng Chief Regulatory Officer Rm. 1, 9F., No.27, Sec.1, Chang' an E. Rd., Zhongshan Dist. Tainei. 10441 Tw Re: K182268 Trade/Device Name: EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFt) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: February 27, 2019 Received: March 5, 2019 Dear Shao-Wei Tseng: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for {10}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. 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 {11}------------------------------------------------ # 004 Indications For Use 1 Image /page/11/Picture/2 description: The image shows the logo for Flat Medical. The logo consists of a blue and gray symbol on the left, followed by the words "Flat Medical" in blue and gray. Below the word "Medical" is the phrase "Safe care for All" in a smaller font. {12}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K182268 Device Name EpiFaith Syringe (Luer Slip) EpiFaith Syringe (NRFit) Indications for Use (Describe) EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space. | Type of Use (Select one or both, as applicable) | <table border="0"><tr><td><table border="0"><tr><td></td><td>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr></table></td><td><table border="0"><tr><td></td><td>Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table></td></tr></table> | <table border="0"><tr><td></td><td>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr></table> | | Prescription Use (Part 21 CFR 801 Subpart D) | <table border="0"><tr><td></td><td>Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | | Over-The-Counter Use (21 CFR 801 Subpart C) | |---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------|--|---------------------------------------------| | <table border="0"><tr><td></td><td>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr></table> | | Prescription Use (Part 21 CFR 801 Subpart D) | <table border="0"><tr><td></td><td>Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | | Over-The-Counter Use (21 CFR 801 Subpart C) | | | | | Prescription Use (Part 21 CFR 801 Subpart D) | | | | | | | | | Over-The-Counter Use (21 CFR 801 Subpart C) | | | | | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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