5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION". September 3, 2019 TOP Corporation % Jonathan Gilbert Regulatory Affairs Consultant to TOP/MHC Jon Gilbert 1641 Jeurissen Lane Chanhassen, Minnesota 55317 Re: K182765 Trade/Device Name: TOP Corporation NRFit™ Tip Glass Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: OEH Dated: July 30, 2019 Received: July 31, 2019 Dear Jonathan Gilbert: 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 {1}------------------------------------------------ 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 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 (QS) 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 medical devices and radiation-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, For Alan Stevens Assistant Director Team Health Technology 3 - Injection Devices Division of Health Technology 3 Office of Health Technology 3 Office of Product Evaluation and Quality Center For Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182765 Device Name TOP Corporation NRFit™ Tip Glass Syringes #### Indications for Use (Describe) The Top NRFit Lock Tip and Slip Tip LOR Syringes and the Additive Slip Tip Syringe are intended to be used with the ISO 80369-6 NRFit neuraxial compliant epidural needles for locating the epidural space, for local administration, and regional administration excluding subarachnoid/spinal block. Type of Use (Select one or both, as applicable) > 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 - K182765 | Submitter | TOP Corporation | |----------------------|--------------------------------------------| | Sponsor: | 19-10 Senju | | | Nakai-cho | | | Adachi-ku | | | Tokyo, Japan | | Contact: | Jon Gilbert, Consultant | | | +01 (906) 361-3237 | | | jgilb.raca@gmail.com | | Date of Preparation: | September 24, 2018 | | Subject Device: | | | Common Name: | Neuraxial Tip Syringes | | Trade Name: | TOP Corporation NRFitTM Tip Glass Syringes | | Regulation Number: | 21 CFR880.5860 | | Regulation Name: | Piston syringe | | Review Panel: | General Hospital | | Regulatory Class: | Class II | | Product Code: | QEH | | Primary Predicate: | Vesco Medical NRFit Tip | | Syringe 510(k): | K170218 cleared Feb 24, 2017 | ## Device Description: The TOP NRFit™ Tip Syringes are provided sterile. They are single use devices consisting of rigid USP 2 glass plungers and glass barrels with metal slip tips designed as the ISO 80369 - 6 compliant neuraxial connector which allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrels are printed with graduated markings in cc (milliliters) indicating the volume of liquid inside the syringe barrel. The proposed models for the neuraxial devices are listed below in Table 1 and 1a, where Table 1a part numbers identify products which include a distributor logo on the syringe barrel. | Table 1. TOP Corporation Models and Description | | |-------------------------------------------------|-----------------------------------------------| | TDR-621-01 | 5cc Neuraxial Slip Tip Glass Syringe | | TDR-621-02 | 5cc Neuraxial Lock Tip Glass Syringe | | TDR-620-11 | 5cc Neuraxial Additive Slip Tip Glass Syringe | | TDR-621-21 | 10cc Neuraxial Slip Tip Glass Syringe | | TDR-621-22 | 10cc Neuraxial Lock Tip Glass Syringe | {4}------------------------------------------------ | Table 1a. Part Numbers and Descriptions for syringes with logo | | |----------------------------------------------------------------|---------------------------------------------------------| | TDR-134-01 | 5cc Neuraxial Slip Tip Glass Syringe (w/ logo) | | TDR-134-02 | 5cc Neuraxial Lock Tip Glass Syringe (w/ logo) | | TDR-133-01 | 5cc Neuraxial Additive Slip Tip Glass Syringe (w/ logo) | | TDR-621-31 | 10cc Neuraxial Slip Tip Glass Syringe (w/ logo) | | TDR-621-32 | 10cc Neuraxial Lock Tip Glass Syringe (w/ logo) | # Indications for Use: The Top NRFit Lock Tip and Slip Tip LOR Syringes and the Additive Slip Tip Syringe are intended to be used with the ISO 80369-6 NRFit neuraxial compliant epidural needles for locating the epidural space, for local administration, and regional administration excluding subarachnoid/spinal block. ## Discussion of differences in Indications for Use The subject device indications are a subset of indications within the broader indications recently cleared in predicate K170218, and as such are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and, do not affect the safety and effectiveness when used as labeled. # Technological Characteristics: ## Table 2. Technological Characteristics & Substantial Equivalence | Device | Vesco Medical<br>K170218<br>Primary Predicate | TOP<br>K843414<br>Secondary<br>Predicate | TOP<br>CORPORATION<br>Neuraxial*<br>K182765<br>Subject Device | Comparison | |------------------------------------|-------------------------------------------------|------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------| | Syringe<br>Barrel: | Polypropylene | USP 2<br>borosilicate<br>glass | USP 1<br>borosilicate glass | Same as<br>K843414,<br>Different<br>materials<br>K170218 | | Plunger Tip: | Synthetic Rubber | Synthetic<br>Rubber | Synthetic Rubber | Same as<br>K843414 &<br>K170218 | | Plunger: | Polypropylene | USP 2<br>borosilicate<br>glass | USP 1<br>borosilicate glass,<br>or<br>Polypropylene | Same as<br>K843414,<br>Different<br>materials<br>K170218 | | Syringe<br>Piston Lube<br>Coating: | Polydimethylsiloxa<br>ne, Silanol<br>Terminated | Medical<br>Grade Oil | Medical Grade Oil | Same as<br>K843414,<br>Different<br>materials | {5}------------------------------------------------ | | | | | K170218 | |-----------------------------------|---------|-------------------------|--------------|--------------------------------------------------------| | Syringe sizes: | 3-20mL | 1-100mL | 5mL and 10mL | Different<br>sizes<br>K170218 | | Connection: | NRFitTM | Luer lock,<br>Luer Slip | NRFitTM | Same<br>K170218,<br>Different<br>connection<br>K843414 | | Calibrated Barrel Volume: | Yes | Yes | Yes | Same as<br>K843414 &<br>K170218 | | Recommended Sterilization method: | EtO | EtO | EtO | Same as<br>K843414 &<br>K170218 | # Discussion of differences in technological characteristics Differences in materials between the subject device K182765 and primary predicate K170218 were addressed through biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices. Differences in syringe sizes and neuraxial tip between the subject device K182765 and K843414 were addressed through ISO 80369-6, ISO 80369-20 and ISO 7886-1 performance testing. These differences do not raise different questions of safety and effectiveness. The clinical technique, technical specifications, materials used, and sterility status (validation and sterility assurance level) are substantially equivalent to either K843414 or K170218. As stated above, the NRFit™ tip syringes provide connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. # Performance Testing: The performance of the subject TOP NRFit™ Tip Syringes is demonstrated as tested per ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -Part 6: Connectors for neuraxial applications. Non-Clinical Tests: - 1. Ink Adhesion - 2. Visual Inspection, including (burrs, hooks, cracks, foreign contamination, missing components) - 3. NRFit Associated Device Testing - 4. NRFit Device Interconnectibility - 5. Pressure/Injection Testing - 6. Tolerance on Graduated Capacity per ISO 7886-1:2017 - 7. Determination of Dead Space per ISO 7886-1:2017 {6}------------------------------------------------ - 8. Liquid Leakage at Syringe Piston under Compression per ISO 7886-1:2017 - 9. Force to Operate Piston per ISO 7886-1:2017 - 10. Fit of Piston within Barrel per ISO 7886-1:2017 - 11. Leakage Under Pressure/During Aspiration per ISO 7886-1:2017 - 12. Stress Cracking per ISO 80369-20:2015 with conformance to ISO 80369-6:2016 - 13.Fluid Leakage by Pressure Decay per ISO 80369-20:2015 with conformance to ISO 80639-6:2016 - 14.Subatmospheric Leakage per ISO 80369-20:2015 with conformance to ISO 80369-6:2016 - 15.Resistance to Separation from Unscrewing per ISO 80369-20:2015 with conformance to ISO 80369-6:2016 - 16.Resistance to Separation from Axial Load per ISO 80369-20:2015 with conformance to ISO 80369-6:2016 - 17. Resistance to Overriding per ISO 80369-20:2015 with conformance to ISO 80369-6:2016 - 18. Particulate Matter per USP <788> Biocompatibility testing has demonstrated the subject devices [externally communicating device, indirect blood path with limited (<24 hours) duration] meet the guidelines as described in the FDA guidance document entitled, "Use of International Standard ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." ## Clinical and Animal Tests: Clinical tests were not required to demonstrate performance of between the subject and predicate devices. Product functionality has been adequately assessed by nonclinical tests # Conclusion: The materials, intended use, technological and operational characteristics of the subject devices are substantially equivalent to the predicate TOP syringes of K843414 and the neuraxial syringes cleared in K170218.