EpiFaith Syringe

{0}------------------------------------------------ Image /page/0/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 and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. September 27, 2019 Flat Medical Co., Ltd Shao Wei Tseng Cheif of Regulatory Officer 9F-1., No27, Sec.1, Chang' An E. Rd., Zhongshan Dist., Taipei City 10441, Taiwan Re: K192421 Trade/Device Name: EpiFaith Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 28, 2019 Received: September 4, 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192421 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) | | |-------------------------------------------------|-------------| | <input type="checkbox"/> | Residential | | <input type="checkbox"/> | Commercial | X | 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary K192421 #### 1. Submitter Title: Chief of Regulatory Officer Email: shaowei@flatmedical.com Telephone number: +886-2-25672959 #13 Flat Medical Co., Ltd. Address: 9F.-1, No. 27, Sec. 1, Chang'an E. Rd., Zhongshan Dist., Taipei City 10441, Taiwan Date of Preparation August 28, 2019 - Subject Device 2. | Name of Device: | EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFit) | |------------------------|--------------------------------------------------------| | Common/Usual Name: | Syringe, Piston | | Device Classification: | Class II | | Classification Name: | Piston Syringe | | Regulation Number | 21 CFR 880.5860 | | Product Code: | FMF | Image /page/3/Picture/9 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 text is the phrase "Safe care for All" in a smaller font. {4}------------------------------------------------ #### Predicate Devices 3. | Name of Device: | EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFit) | |------------------------|--------------------------------------------------------| | Common/Usual Name: | Syringe, Piston | | Device Classification: | Class II | | Classification Name: | Piston Syringe | | Regulation Number | 21 CFR 880.5860 | | Product Code: | FMF | | Premarket Notification | K182268 | #### Device Description and technology Characteristics 4. The EpiFaith is a loss of resistance syringe with spring loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of 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 verify 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 occurring. Because the piston is spring loaded, the automatic ejection of the syringe will happen when the LOR occurring, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed below. The only difference between two models is the type of the connector. | Flat Medical EpiFaith Syringe | | |-------------------------------|----------------| | Model # | Connector type | | FM-01SLR | Luer slip | | FM-02SNR | NRFit | #### 5. Intended 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. Image /page/4/Picture/8 description: The image shows the logo for Flat Medical. The logo consists of a gray and blue 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. {5}------------------------------------------------ | ELEMENT OF<br>COMPARISON | SUBJECT DEVICE | CLAIM SUBSTANTIALLY EQUIVALENT<br>DEVICE | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | Trade name | EpiFaith Syringe | EpiFaith Syringe | | 510(k) number | To be determined | K182268 | | Regulation Number | 21 CFR 880.5860 | | | Regulation Name | Piston Syringe | | | Regulatory Class | II | | | Product Code | FMF | | | Syringe type | Piston Syringe | | | Intended use | EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of<br>resistance, which aids a clinician in verifying needle tip placement in the epidural space. | | | Principle of operation | EpiFaith Syringe is based on the principle of LOR, loss of resistance | | | Nozzle type | There are two models.<br>Luer slip (follow ISO 80369-7)<br>NRFit (follow ISO 80369-6) | | | Lubricant | Silicone oil | | | Reuse durability | Single use only | | | Material | polypropylene<br>synthetic & silicone rubber<br>stainless steel. | polypropylene<br>synthetic & natural rubber<br>stainless steel. | | Biocompatibility | Meets guidelines presented in Use of International Standard ISO 10993-1, "Biological<br>evaluation of medical devices - Part 1: Evaluation and testing within a risk management<br>process. | | | Sterilization method | E.O gas sterilization<br>Sterile assurance level : 10-6 | | | Applicable standard | ISO 7886-1<br>ISO 80369-6<br>ISO 80369-7 | | | Packaging | Tyvek and PET | | #### Comparison of Technological Characteristics with the Predicate Device 6. This submission addressed a material change to the syringe piston. The indication for use, the principle of operation, and technological characteristics of the subject device are identical to the predicate device. The subject device is substantially equivalent to the predicate device. Image /page/5/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 company name. The icon is made up of four curved shapes, two blue and two gray, arranged in a square. The text "Flat Medical" is written in blue, with the word "Flat" being larger than the word "Medical". Below the company name, in smaller gray text, is the phrase "Safe care for All". Confidential {6}------------------------------------------------ #### Performance Data: 7. ## Non-Clinical Tests We have conducted non-clinical testing based on its risk assessment utilizing Failure Mode Effect Analysis (FMEA). The following evaluations were conducted to validate the modifications made to the subject device: - Risk assessment (ISO 14971: 2007) - -Friction forces test and liquid leakage test (ISO 7886-1: 2017) - -Biocompatibility Assessment per ISO 10993: In vitro cytotoxicity, Skin sensitization, Intracutaneous irritation, Acute systemic toxicity, Pyrogen test, Limulus amebocyte lysate endotoxin. #### 8. Conclusion Based on the intended use, materials, design, biocompatibility testing and performance testing, the material change of syringe piston meets the requirements that are considered essential for its intended use and the subject device is considered substantially equivalent to the predicate device, the EpiFaith Syringe, cleared under K182268. ## 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 necessary tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the material of syringe piston do not change the intended use of the device or raise different questions of safety and effectiveness. 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 predicate devices. Image /page/6/Picture/11 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.