meso-relle (AAL34, AAL36, AM30G)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 19, 2017 Biotekne S.r.1. % Enrico Bisson President Studio di Ingegneria Enrico Bisson Via Marzia 9 Abano Terme, Padova 35031 ITALY Re: K161255 Trade/Device Name: meso-relle (AAL34, AAL36, AM30G) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 21, 2016 Received: December 22, 2016 Dear Enrico Bisson: 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. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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. Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang-S". The signature is a stylized, looping design to the left of the name. The name is written in a simple, sans-serif font, with "Tina" stacked above "Kiang-S". 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K161255 Device Name meso-relle AAL34, AAL36, AM30G Indications for Use (Describe) The meso-relle needles are intended to inject fluids intradermally. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-family: sans-serif;"> ☑ </span> Representation Use (Part 21 CFR 601 Subpart D) | <span style="font-family: sans-serif;"> ☐ </span> Compassionate Use (21 CFR 601 Subpart E) | |-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| > 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}------------------------------------------------ ## Section 05 510(k) Summary # 510 (k) Summary ## K161255 #### APPLICANT | Company Name: | Biotekne S.r.l. | |------------------|----------------------------------------| | Company Address: | Via della Bastia, 9 | | | 40033 Casalecchio di Reno (BO) - ITALY | | Company Phone: | +39 051565211 | | Company Fax: | +39 0516182524 | | Company e-mail | info@biotekne.it | | CONTACT PERSON: | Enrico Bisson - Studio ingegneria Enrico Bisson | |-----------------|-------------------------------------------------| | | Via Marzia n. 9 | | | Abano Terme (PD) - ITALY | | Contact Phone: | +39 0498630080 | | Contact Fax | +39 0498630080 | | Contact E-mail | enrico.bisson@gmail.com | Date Summary Prepared: January 17, 2017 ### DEVICE IDENTIFICATION - A. Trade name: meso-relle AAL34, AAL36, AM30G - B. Generic/ Common Name: Hypodermic Needle - ். Classification name: Hypodermic single lumen needle, 21 CFR 880.5570, Class II - D. Product Code: FMI ## LEGALLY MARKETED DEVICES (PREDICATE DEVICES) K110606, MV Intradermic Needles, MV S.R.L. Reference Predicate Device: K051783, Artsana Hypodermic Needles, ARTSANA SPA. {4}------------------------------------------------ #### INDICATIONS FOR USE The meso-relle needles are intended to inject fluids intradermally. #### DEVICE DESCRIPTION The meso-relle® needles are single lumen needle intended to inject fluids intradermally. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe. Needles have different length, which make them suitable to inject fluids intradermally. The meso-relle are not intended for injection in the bloodstream. The devices do not contact the central nervous system. The meso-relle® needles are suitable for administration of fluids intradermally. Each needle is provided with a protective cap (cover is rigid and not colored. The dimensions are suitable to accommodate the corresponding needle and vary according to the dimensions of the needle. The meso-relle® needles are disposable single use devices, sold sterilized by ethylene oxide. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The meso-relle Needles are same or similar in materials, design and intended use to the predicate devices. Both the subject and the predicate devices are intended to inject fluids intradermally; they have the same indications for use. Each of the technical attributes of the meso-relle Needles are present in the predicate devices. The materials, tip configuration and other fundamental design characteristics are all the same. Comparison elements are as follows: {5}------------------------------------------------ | ATTRIBUTE / | meso-relle NEEDLES | MV Intradermic Needles | Artsana Hypodermic | Comparison | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CHARACTERISTICS | (Submitted Product) | (Legally Marketed | Needles (Reference | | | | | Predicate Device) | Predicate Device) | | | 'K" numbers | K161255 | K110606 | K051783 | | | CFR Section | 880.5570 | 880.5570 | 880.5570 | same | | Pro-code | FMI | FMI | FMI | same | | Classification name | Hypodermic single lumen needle | Hypodermic single lumen needle | Hypodermic single lumen needle | same | | Intended / Indications<br>For Use | The meso-relle needles are<br>intended to inject fluids<br>intradermally. | The MV intradermic needles<br>are intended to inject fluids<br>intradermally. | Artsana disposable sterile<br>hypodermic needles are<br>intended for use to inject fluids<br>into, or withdraw fluids from,<br>parts of the body below the<br>surface of the skin. | same as the primary<br>predicate | | Cannula material | AISI 304 Stainless Steel | AISI 304 Stainless Steel | AISI 304 Stainless Steel | same | | Hub material | Polypropylene (Polypropylene<br>MG03MA) | Polypropylene (Polypropylene<br>MG03MA) | Polypropylene | same | | Hub color | Yellow<br>CAS No.<br>22094-93-5,<br>Dispersant (CAS No.557-04-0)<br>internal material code:<br>SCP-19906<br>color coded ISO 6009 | Yellow<br>CAS No.<br>22094-93-5,<br>Dispersant (CAS No.557-04-0)<br>internal material code:<br>SCP-19906<br>color coded ISO 6009 | Not available | same as the primary<br>predicate | | Cover | rigid cover, polypropylene or<br>propylene\ethylene<br>copolymer | rigid cover, polyethylene | rigid cover, non toxic<br>propylene | same or similar | | Adhesive | epoxy type adhesive | epoxy type adhesive | epoxy type adhesive | same | | Lubricant | medical grade silicone oil | medical grade silicone oil | medical grade silicone oil | same | | ATTRIBUTE /<br>CHARACTERISTICS | meso-relle NEEDLES<br>(Submitted Product) | MV Intradermic Needles<br>(Legally Marketed<br>Predicate Device) | Artsana Hypodermic<br>Needles (Reference<br>Predicate Device) | Comparison | | 'K" numbers | K161255 | K110606 | K051783 | | | Needle diameter (gauge) | 30G | 22G, 25G, 26G, 27G, 30G /<br>pilot needle: 21G, 23G, 26G,<br>27G | 27G, 30G | The needle diameter of the<br>subject device is included<br>within the configuration of<br>the predicate devices | | Needle length (mm) | 4, 6, 12 | 25, 27,35, 37, 40, 50, 57, 70 /<br>pilot needle: 13, 25 | 4, 6, 13 | The differences in the needle<br>length between the subject<br>and the primary predicate<br>device do not raise new<br>questions of safety or<br>effectiveness for the subject<br>device. Shorter length<br>needles are more appropriate<br>for intradermal use. | | Tip configuration | triple sharpened, non-coring | Injection needle: closed blunt<br>tip, lateral opening<br>Pilot needle: triple sharpened,<br>non-coring | triple sharpened, non-coring | same as the MV pilot needle<br>and as the reference<br>predicate device | | Connection to syringe or<br>injection device | Luer taper | Luer taper | Luer taper | same | | Sterilization | Ethylene Oxide (EO)<br>Per ISO 11135-1:2007 | Ethylene Oxide (EO)<br>Per ISO 11135-1:2007 | Not available | same as the primary<br>predicate | | SAL Level | SAL 10-6 | SAL 10-6 | Not available | same as the primary<br>predicate | | Biocompatibility | ISO 10993-1 | ISO 10993-1 | Not available | same as the primary<br>predicate | | ATTRIBUTE /<br>CHARACTERISTICS | meso-relle NEEDLES<br>(Submitted Product) | MV Intradermic Needles<br>(Legally Marketed<br>Predicate Device) | Artsana Hypodermic<br>Needles (Reference<br>Predicate Device) | Comparison | | "K" numbers | K161255 | K110606 | K051783 | | | Functional testing | ISO 7864:2016<br>ISO 9626:2016<br>ISO 594-1:1986 | ISO 7864:1993<br>ISO 9626:1991<br>ISO 594-1:1986 | Not available | same as the primary<br>predicate | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ The shorter length of the subject device do not raise new issues of safety or effectiveness; shorter lengths are even more suitable for intradermal use as they are less invasive. This difference does not affect the substantial equivalence of the subject device. The test results and comparison results show that the subject device is substantial equivalent to the predicate in performance. #### NON-CLINICAL PERFORMANCE DATA All materials used for the meso-relle needles have a long history of safe use for the same or equivalent intended use. Biocompatibility has been tested according to the requirements of ISO 10993-1. In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, following biocompatibility tests were performed on the final finished device to evaluate: Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity and Haemolysis. The sterility of the meso-relle Needles is assured by using a validated sterilization method which complies with the requirements of the Recognized Consensus Standard: AAMI / ANSI / ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. Ethylene oxide (EtO) and Ethylene Chlorohydrin (ECH) residuals were tested according to UNI EN ISO 10993-7: 2008 - Method K.4.3.+ HRGC/MS Detection for EtO and Method K.4.8+ HRGC/MS Detection for ECH and met the acceptance criteria. Meso-relle Needles were tested according to ISO 7864:2016 "Requirements and test methods Sterile hypodermic needles for single use", ISO 9626:2016 "Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods" and ISO 594-1.1986 "Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements" in order to demonstrate that the proposed device is substantial equivalent to the predicate in safety and performance. #### CONCLUSION: The subject and the predicate devices have the same indications for use and they have same technological characteristics. The test results and comparison results show that the proposed device is substantial equivalent to the predicate in performance. Based on the intended use, technological characteristics and performance testing, the proposed product meso-relle Needles is considered to be substantially equivalent to the predicate device.