Artiglass NRFitTM Tip L.O.R. Glass Syringes

{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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 19, 2022 Artiglass Srl Sabrina Baccarin Quality Director Via Piemonte 13 Due Carrare, Padova 35020 Italy Re: K213800 Trade/Device Name: Artiglass NRFitTM Tip L.O.R. Glass Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QEH Dated: April 15, 2022 Received: April 21, 2022 Dear Sabrina Baccarin: 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 and Part 809); 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, Sub part 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/cdrl-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 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) K213800 Device Name Artiglass NRFit Tip L.O.R. Glass Syringes Indications for Use (Describe) The Artiglass NRFit tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration. Type of Use (Select one or both, as applicable): | <span style="font-family: sans-serif;"> <svg height="16" width="16"> <path d="M2 2 L14 2 L14 14 L2 14 Z M3 3 L13 3 L13 13 L3 13 Z" fill="none" stroke="black" stroke-width="1"></path> <path d="M4 7 L6 9 L12 3" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <svg height="16" width="16"> <rect fill="none" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over The Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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. 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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}------------------------------------------------ #### Applicant: Artiglass Srl via Piemonte 13, Due Carrare Padova. Italy | Contact Person: | Sabrina Baccarin | |-----------------------|-------------------------| | Contact Title: | Quality Director | | Contact Phone Number: | +39 049 5290442 | | Contact Fax Number: | +39 049 5290446 | | E-mail: | regulatory@artiglass.it | Official Correspondent: same as Contact Person ### Date Summary Prepared: April 15, 2022 Classification: 21 CFR § 880.5860, Class II Classification name: Piston Syringe Product Code: QEH Trade Names : Artiglass NRFit™ Tip L.O.R. Glass Syringes Generic/Common Name: NRFitTM Tip L.O.R. Glass Syringes #### Predicate device Predicate Device: Artiglass L.O.R. Glass Syringes 510(k) Number: K122416 510(k) Clearance Date: May 3, 2013 Regulation Number: 21 CFR § 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF ### Indications for use The Artiglass NRFit TM tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration. #### Intended population The syringe is intended for adult patient. ### Product Description The Artiglass NRFit TM tip Glass Syringes provided not sterile with ISO 80369-6 (NRFit™) compliant fittings. They are available in 5mL and 10mL, lock and slip configurations and 5mL and 10mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a borosilicate neutral with a graduated scale in milliliters (mL), a borosilicate neutral glass plunger and a nickel-plated brass tip. The plunger rod is amber colored to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. ### Comparison of Technological Characteristics The comparison table of technological characteristics is documented in the following table Predicate Device Comparison. {4}------------------------------------------------ | Model | Special 510(k) Artiglass<br>NRFitTM Tip L.O.R. Glass<br>Syringes<br>Subject Device | 510(k) Artiglass<br>L.O.R. Glass<br>Syringes | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | | Subject Device | K122416 | | Product Code | QEH | FMF (1) | | Common Name | Syringe, Piston | Same | | Regulation Number | 880.5860 | Same | | Regulation Description | Piston Syringe | Same | | Submission Type | 510(k) Special | 510(k) Traditional | | 510(k) Number | NA | K122416 | | Intended Use | The Artiglass NRFit ™ tip Glass<br>Syringe is intended for use, in<br>conjunction with an epidural<br>needle, to verify the needle tip<br>placement in the epidural space<br>by the Loss of Resistance<br>technique as explained in<br>standard textbooks. These<br>syringes are not intended for<br>injection or aspiration. The<br>syringe is intended for adult<br>patient. | Same | | Reusable/Sigle use | Single use (7) | Reusable | | Sterility | Provided not sterile<br>The non-sterile NRFit ™ syringe<br>is intended to be sterilized prior<br>to use to repackagers/medical<br>device manufacturers. | Same | | Tip | NRFit ™ Connector, Luer Metal<br>and Luer Lock | Luer Glass, Luer<br>Metal and Luer Lock<br>(2) | | Tip material | Nickel plated brass | Same | | Syringe Barrel | Borosilicate neutral glass | Same | | Plunger | Borosilicate neutral glass | Same | | Available Volumes | 5 mL, 10 mL | Same | | Model | Special 510(k) Artiglass<br>NRFitTM Tip L.O.R. Glass<br>Syringes<br>Subject Device | 510(k) Artiglass<br>L.O.R. Glass<br>Syringes<br>K122416 | | Calibrated Barrel<br>Volume | yes | Same | | Recommended<br>sterilization method | Steam | Same | | NRFit Connector | Yes; compliant with ISO<br>80369-6 | No; (2) | | Package | Individually, in bulk | Same | | Biocompatibility<br>Compliance | ISO 10993-1 Fifth edition 2018-<br>08 | ISO 10993-1 Fourth<br>edition 2009-10-15<br>(3) | | | 10993-4 Third edition 2017-04 | ISO 10993-<br>4:2002/amd 1:2006<br>Hemocompatibility<br>(Interaction with<br>blood) (4) | | | same | ISO 10993-5:2009 | | | same | ISO 10993-10:2010<br>Irritation and skin<br>sensitization | | | 10993-11 Third edition 2017-09 | ISO 10993-11:2006<br>Systemic toxicity<br>(5) | | Standard Compliance | ISO 595-1:1988, ISO 595-2:1987,<br>ISO 80369-6:2016, ISO 80369-<br>20:2015 | ISO 594-1:1986, ISO<br>594-2:1998,<br>ISO 595-1:1988, ISO<br>595-2:1987<br>(6) | ## TABLE: Predicate Device Comparison {5}------------------------------------------------ K213800 # SECTION 5 510 (K) Summary {6}------------------------------------------------ ### Discussions of differences in technological characteristics - (1) The Product code is different. The differences were addressed through ISO 80369-20 and performance testing. - (2) The tip of the subject device is specific. The differences were addressed through ISO 80369-20 performance testing. - (3) The differences were addressed through the "Artiglass NRFitTM Tip L.O.R. Glass Syringes Biological evaluation plan" - (4) The tests have been repeated according to 10993-4 Third edition 2017-04 and ASTM F756-17 (Hemolysis) - (5) The tests have been repeated according to 10993-11 Third edition 2017-09 - (6) The differences were addressed through ISO 80369-6, ISO 80369-20 and ISO 7886-1 performance testing. - (7) The syringe is intended for a single use. This not affect the effectiveness and safety of the device itself. ### Performance Testing in Support of Substantial Equivalence Determination The performance of the subject Artiglass NRFitTM Tip L.O.R. Glass Syringes is demonstrated as tested per the applicable requirements of ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -Part 6: Connectors for neuraxial applications. Non-Clinical Tests: - 1. Leakage by pressure decay per ISO 80369-6 - 2. Sub-atmospheric-pressure air leakage per ISO 80369-6 - 3. Resistance to separation from axial load per ISO 80369-6 - 4. Resistance to separation from unscrewing per ISO 80369-6 - 5. Resistance to overriding per ISO 80369-6 - 6. Leakage between piston and barrel per ISO 595-2 - 7. Ink adhesion (permanence of marking) per ISO 595-2 - 8. Identification of burrs, hooks, cracks, foreign contamination, missing components per visual inspection - 9. Fluid leakage requirement per ISO 80369-6 - 10. Stress Cracking per ISO 80369-6 Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-6:2016, using the test methods provided in ISO 80369-20. The testing demonstrates the proposed devices conform to the applicable requirements of ISO 80369-6:2016 | Individual test Defined in ISO 80369-6 | Requirement Defined in<br>ISO 80369-6 | Test Method Defined<br>in ISO 80369-20 | |---------------------------------------------|---------------------------------------|----------------------------------------| | Fluid leakage requirement | Clause 6.1.1 | Annex B | | Leakage by pressure decay | Clause 6.1.2 | Annex B | | Sub-atmospheric-pressure air leakage | Clause 6.2 | Annex D | | Stress Cracking | Clause 6.3 | Annex E | | Resistance to separation from axial load | Clause 6.4 | Annex F | | Resistance to separation from<br>unscrewing | Clause 6.5 | Annex G | | Resistance to overriding | Clause 6.6 | Annex H | {7}------------------------------------------------ Even though the geometry of the tip is slightly different in the subject device manufactured by Artiglass, the results of the biocompatibility testing performed by Artiglass on the previously cleared syringe can be considered adequate also to assess the biocompatibility of the subject device. The materials of the components of the test article are identical to the correspondent components of the subject medical device in its final finished form in formulation, processing, and no other chemicals have been added. No changes in material have occurred since the biocompatibility testing performed by the manufacturer on the predicate device Artiglass L.O.R. Glass Syringe. The tip shape does not pose new issues of biocompatibility as the test article represents a worst case in respect to the subject device. #### 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 submitted and the predicate device have the same indications for use and technological characteristics. The test results and comparison results show that the proposed device is substantially equivalent to the predicate devices in performance, materials, intended use, technological and operational characteristics. Based on the intended use, technological characteristics, and performance testing, the proposed Artiglass NRFitTM Tip L.O.R. Glass Syringes has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.